Proactive Prophylaxis With Azithromycin and HydroxyChloroquine in Hospitalised Patients With COVID-19 (ProPAC-COVID): A structured summary of a study protocol for a randomised controlled trial.
Identifieur interne : 000E11 ( Main/Exploration ); précédent : 000E10; suivant : 000E12Proactive Prophylaxis With Azithromycin and HydroxyChloroquine in Hospitalised Patients With COVID-19 (ProPAC-COVID): A structured summary of a study protocol for a randomised controlled trial.
Auteurs : Pradeesh Sivapalan [Danemark] ; Charlotte Suppli Ulrik [Danemark] ; Rasmus Dahlin Bojesen [Danemark] ; Therese Sophie Lapperre [Danemark] ; Josefin Viktoria Eklöf [Danemark] ; Kjell Erik Julius H Kansson [Danemark] ; Andrea Browatzki [Danemark] ; Casper Tidemansen [Danemark] ; Jon Torgny Wilcke [Danemark] ; Julie Janner [Danemark] ; Vibeke Gottlieb [Danemark] ; Howraman Meteran [Danemark] ; Celeste Porsbjerg [Danemark] ; Birgitte Lindegaard Madsen [Danemark] ; Mia Moberg [Danemark] ; Lars Pedersen [Danemark] ; Thomas Lars Benfield [Danemark] ; Jens Dilling Lundgren [Danemark] ; Filip Krag Knop [Danemark] ; Tor Biering-S Rensen [Danemark] ; Muzhda Ghanizada [Danemark] ; Tine Peick Sonne [Danemark] ; Uffe Christian Steinholtz B Dtger [Danemark] ; Sidse Graff Jensen [Danemark] ; Daniel Bech Rasmussen [Danemark] ; Eva Br Ndum [Danemark] ; Oliver Djurhuus Tupper [Danemark] ; Susanne Wiemann S Rensen [Danemark] ; Gitte Alstrup [Danemark] ; Christian Borbjerg Laursen [Danemark] ; Ulla Weinrich M Ller [Danemark] ; Asger Sverrild [Danemark] ; Jens-Ulrik St Hr Jensen [Danemark]Source :
- Trials [ 1745-6215 ] ; 2020.
Descripteurs français
- KwdFr :
- Admission du patient (MeSH), Antiviraux (administration et posologie), Antiviraux (effets indésirables), Azithromycine (administration et posologie), Azithromycine (effets indésirables), Betacoronavirus (effets des médicaments et des substances chimiques), Betacoronavirus (pathogénicité), Calendrier d'administration des médicaments (MeSH), Danemark (MeSH), Durée du séjour (MeSH), Essais contrôlés randomisés comme sujet (MeSH), Facteurs temps (MeSH), Humains (MeSH), Hydroxychloroquine (administration et posologie), Hydroxychloroquine (effets indésirables), Indice de gravité de la maladie (MeSH), Infections à coronavirus (diagnostic), Infections à coronavirus (mortalité), Infections à coronavirus (traitement médicamenteux), Infections à coronavirus (virologie), Interactions hôte-pathogène (MeSH), Mortalité hospitalière (MeSH), Méthode en double aveugle (MeSH), Pandémies (MeSH), Patients hospitalisés (MeSH), Pneumopathie virale (diagnostic), Pneumopathie virale (mortalité), Pneumopathie virale (traitement médicamenteux), Pneumopathie virale (virologie), Résultat thérapeutique (MeSH), Soins de réanimation (MeSH), Ventilation non effractive (MeSH), Études multicentriques comme sujet (MeSH).
- MESH :
- administration et posologie : Antiviraux, Azithromycine, Hydroxychloroquine.
- diagnostic : Infections à coronavirus, Pneumopathie virale.
- effets des médicaments et des substances chimiques : Betacoronavirus.
- effets indésirables : Antiviraux, Azithromycine, Hydroxychloroquine.
- mortalité : Infections à coronavirus, Pneumopathie virale.
- pathogénicité : Betacoronavirus.
- traitement médicamenteux : Infections à coronavirus, Pneumopathie virale.
- virologie : Infections à coronavirus, Pneumopathie virale.
- Admission du patient, Calendrier d'administration des médicaments, Danemark, Durée du séjour, Essais contrôlés randomisés comme sujet, Facteurs temps, Humains, Indice de gravité de la maladie, Interactions hôte-pathogène, Mortalité hospitalière, Méthode en double aveugle, Pandémies, Patients hospitalisés, Résultat thérapeutique, Soins de réanimation, Ventilation non effractive, Études multicentriques comme sujet.
- Wicri :
- geographic : Danemark.
English descriptors
- KwdEn :
- Antiviral Agents (administration & dosage), Antiviral Agents (adverse effects), Azithromycin (administration & dosage), Azithromycin (adverse effects), Betacoronavirus (drug effects), Betacoronavirus (pathogenicity), COVID-19 (MeSH), Coronavirus Infections (diagnosis), Coronavirus Infections (drug therapy), Coronavirus Infections (mortality), Coronavirus Infections (virology), Critical Care (MeSH), Denmark (MeSH), Double-Blind Method (MeSH), Drug Administration Schedule (MeSH), Hospital Mortality (MeSH), Host-Pathogen Interactions (MeSH), Humans (MeSH), Hydroxychloroquine (administration & dosage), Hydroxychloroquine (adverse effects), Inpatients (MeSH), Length of Stay (MeSH), Multicenter Studies as Topic (MeSH), Noninvasive Ventilation (MeSH), Pandemics (MeSH), Patient Admission (MeSH), Pneumonia, Viral (diagnosis), Pneumonia, Viral (drug therapy), Pneumonia, Viral (mortality), Pneumonia, Viral (virology), Randomized Controlled Trials as Topic (MeSH), SARS-CoV-2 (MeSH), Severity of Illness Index (MeSH), Time Factors (MeSH), Treatment Outcome (MeSH).
- MESH :
- chemical , administration & dosage : Antiviral Agents, Azithromycin, Hydroxychloroquine.
- chemical , adverse effects : Antiviral Agents, Azithromycin, Hydroxychloroquine.
- geographic : Denmark.
- diagnosis : Coronavirus Infections, Pneumonia, Viral.
- drug effects : Betacoronavirus.
- drug therapy : Coronavirus Infections, Pneumonia, Viral.
- mortality : Coronavirus Infections, Pneumonia, Viral.
- pathogenicity : Betacoronavirus.
- virology : Coronavirus Infections, Pneumonia, Viral.
- COVID-19, Critical Care, Double-Blind Method, Drug Administration Schedule, Hospital Mortality, Host-Pathogen Interactions, Humans, Inpatients, Length of Stay, Multicenter Studies as Topic, Noninvasive Ventilation, Pandemics, Patient Admission, Randomized Controlled Trials as Topic, SARS-CoV-2, Severity of Illness Index, Time Factors, Treatment Outcome.
Abstract
OBJECTIVES
The aim of this randomised GCP-controlled trial is to clarify whether combination therapy with the antibiotic azithromycin and hydroxychloroquine via anti-inflammation/immune modulation, antiviral efficacy and pre-emptive treatment of supra-infections can shorten hospitalisation duration for patients with COVID-19 (measured as "days alive and out of hospital" as the primary outcome), reduce the risk of non- invasive ventilation, treatment in the intensive care unit and death.
TRIAL DESIGN
This is a multi-centre, randomised, Placebo-controlled, 2-arm ratio 1:1, parallel group double-blind study.
PARTICIPANTS
226 participants are recruited at the trial sites/hospitals, where the study will take place in Denmark: Aalborg, Bispebjerg, Gentofte, Herlev, Hillerød, Hvidovre, Odense and Slagelse hospitals.
INCLUSION CRITERIA
• Patient admitted to Danish emergency departments, respiratory medicine departments or internal medicine departments • Age≥ 18 years • Hospitalized ≤48 hours • Positive COVID-19 test / diagnosis during the hospitalization (confirmed). • Men or non-fertile women. Fertile women* must not be pregnant, i.e. negative pregnancy test must be available at inclusion • Informed consent signed by the patient *Defined as after menarche and until postmenopausal (no menstruation for 12 months) Exclusion criteria: • At the time of recruitment, the patient uses >5 LO2/min (equivalent to 40% FiO2 if measured) • Known intolerance/allergy to azithromycin or hydroxychloroquine or hypersensitivity to quinine or 4-aminoquinoline derivatives • Neurogenic hearing loss • Psoriasis • Retinopathy • Maculopathy • Visual field changes • Breastfeeding • Severe liver diseases other than amoebiasis (INR> 1.5 spontaneously) • Severe gastrointestinal, neurological and hematological disorders (investigator-assessed) • eGFR <45 ml/min/1.73 m2 • Clinically significant cardiac conduction disorders/arrhythmias or prolonged QTc interval (QTc (f) of> 480/470 ms). • Myasthenia gravis • Treatment with digoxin* • Glucose-6-phosphate dehydrogenase deficiency • Porphyria • Hypoglycaemia (Blood glucose at any time since hospitalization of <3.0 mmol/L) • Severe mental illness which significantly impedes cooperation • Severe linguistic problems that significantly hinder cooperation • Treatment with ergot alkaloids *The patient must not be treated with digoxin for the duration of the intervention. For atrial fibrillation/flutter, select according to the Cardiovascular National Treatment Guide (NBV): Calcium antagonist, Beta blocker, direct current (DC) conversion or amiodarone. In case of urgent need for digoxin treatment (contraindication for the aforementioned equal alternatives), the test drug should be paused, and ECG should be taken daily.
INTERVENTION AND COMPARATOR
Control group: The control group will receive the standard treatment + placebo for both types of intervention medication at all times. If part or all the intervention therapy being investigated becomes standard treatment during the study, this may also be offered to the control group. Intervention group: The patients in the intervention group will also receive standard care. Immediately after randomisation to the intervention group, the patient will begin treatment with: Azithromycin: Day 1-3: 500 mg x 1 Day 4-15: 250 mg x 1 If the patient is unable to take the medication orally by themselves, the medication will, if possible, be administered by either stomach-feeding tube, or alternatively, temporary be changed to clarithromycin 500 mg x 2 (this only in agreement with either study coordinator Pradeesh Sivapalan or principal investigator Jens-Ulrik Stæhr Jensen). This will also be done in the control group if necessary. The patient will switch back to azithromycin when possible. Hydroxychloroquine: Furthermore, the patient will be treated with hydroxychloroquine as follows: Day 1-15: 200 mg x 2 MAIN OUTCOMES: • Number of days alive and discharged from hospital within 14 days (summarises both whether the patient is alive and discharged from hospital) ("Days alive and out of hospital") RANDOMISATION: The sponsor (Chronic Obstructive Pulmonary Disease Trial Network, COP:TRIN) generates a randomisation sequence. Randomisation will be in blocks of unknown size and the final allocation will be via an encrypted website (REDCap). There will be stratification for age (>70 years vs. <=70 years), site of recruitment and whether the patient has any of the following chronic lung diseases: COPD, asthma, bronchiectasis, interstitial lung disease (Yes vs. No).
BLINDING (MASKING)
Participants and study personnel will both be blinded, i.e. neither will know which group the participant is allocated to.
NUMBERS TO BE RANDOMISED (SAMPLE SIZE)
This study requires 226 patients randomised 1:1 with 113 in each group.
TRIAL STATUS
Protocol version 1.8, from April 16, 2020. Recruitment is ongoing (first patient recruited April 6, 2020; final patient expected to be recruited October 31, 2020).
TRIAL REGISTRATION
ClinicalTrials.gov Identifier: NCT04322396 (registered March 26, 2020) FULL PROTOCOL: The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol. The study protocol has been reported in accordance with the Standard Protocol Items: Recommendations for Clinical Interventional Trials (SPIRIT) guidelines (Additional file 2).
DOI: 10.1186/s13063-020-04409-9
PubMed: 32522282
PubMed Central: PMC7284668
Affiliations:
Links toward previous steps (curation, corpus...)
Le document en format XML
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<affiliation wicri:level="1"><nlm:affiliation>Department of Internal Medicine, Zealand University Hospital, Roskilde, Denmark.</nlm:affiliation>
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<author><name sortKey="Ulrik, Charlotte Suppli" sort="Ulrik, Charlotte Suppli" uniqKey="Ulrik C" first="Charlotte Suppli" last="Ulrik">Charlotte Suppli Ulrik</name>
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<author><name sortKey="Bojesen, Rasmus Dahlin" sort="Bojesen, Rasmus Dahlin" uniqKey="Bojesen R" first="Rasmus Dahlin" last="Bojesen">Rasmus Dahlin Bojesen</name>
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<author><name sortKey="Lapperre, Therese Sophie" sort="Lapperre, Therese Sophie" uniqKey="Lapperre T" first="Therese Sophie" last="Lapperre">Therese Sophie Lapperre</name>
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<author><name sortKey="Eklof, Josefin Viktoria" sort="Eklof, Josefin Viktoria" uniqKey="Eklof J" first="Josefin Viktoria" last="Eklöf">Josefin Viktoria Eklöf</name>
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<author><name sortKey="H Kansson, Kjell Erik Julius" sort="H Kansson, Kjell Erik Julius" uniqKey="H Kansson K" first="Kjell Erik Julius" last="H Kansson">Kjell Erik Julius H Kansson</name>
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<author><name sortKey="Browatzki, Andrea" sort="Browatzki, Andrea" uniqKey="Browatzki A" first="Andrea" last="Browatzki">Andrea Browatzki</name>
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<author><name sortKey="Tidemansen, Casper" sort="Tidemansen, Casper" uniqKey="Tidemansen C" first="Casper" last="Tidemansen">Casper Tidemansen</name>
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<author><name sortKey="Wilcke, Jon Torgny" sort="Wilcke, Jon Torgny" uniqKey="Wilcke J" first="Jon Torgny" last="Wilcke">Jon Torgny Wilcke</name>
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<country xml:lang="fr">Danemark</country>
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<author><name sortKey="Janner, Julie" sort="Janner, Julie" uniqKey="Janner J" first="Julie" last="Janner">Julie Janner</name>
<affiliation wicri:level="1"><nlm:affiliation>Department of Respiratory Medicine, Amager and Hvidovre Hospital University of Copenhagen, Hvidovre, Denmark.</nlm:affiliation>
<country xml:lang="fr">Danemark</country>
<wicri:regionArea>Department of Respiratory Medicine, Amager and Hvidovre Hospital University of Copenhagen, Hvidovre</wicri:regionArea>
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<author><name sortKey="Gottlieb, Vibeke" sort="Gottlieb, Vibeke" uniqKey="Gottlieb V" first="Vibeke" last="Gottlieb">Vibeke Gottlieb</name>
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<country xml:lang="fr">Danemark</country>
<wicri:regionArea>Section of Respiratory Medicine, Department of Medicine, Herlev and Gentofte Hospital University of Copenhagen, Hellerup</wicri:regionArea>
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<author><name sortKey="Meteran, Howraman" sort="Meteran, Howraman" uniqKey="Meteran H" first="Howraman" last="Meteran">Howraman Meteran</name>
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<author><name sortKey="Porsbjerg, Celeste" sort="Porsbjerg, Celeste" uniqKey="Porsbjerg C" first="Celeste" last="Porsbjerg">Celeste Porsbjerg</name>
<affiliation wicri:level="3"><nlm:affiliation>Department of Respiratory Medicine, Bispebjerg and Frederiksberg Hospital University of Copenhagen, Copenhagen, Denmark.</nlm:affiliation>
<country xml:lang="fr">Danemark</country>
<wicri:regionArea>Department of Respiratory Medicine, Bispebjerg and Frederiksberg Hospital University of Copenhagen, Copenhagen</wicri:regionArea>
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<author><name sortKey="Madsen, Birgitte Lindegaard" sort="Madsen, Birgitte Lindegaard" uniqKey="Madsen B" first="Birgitte Lindegaard" last="Madsen">Birgitte Lindegaard Madsen</name>
<affiliation wicri:level="1"><nlm:affiliation>Department of Respiratory and Infectious Diseases, Nordsjællands Hospital University of Copenhagen, Hillerød, Denmark.</nlm:affiliation>
<country xml:lang="fr">Danemark</country>
<wicri:regionArea>Department of Respiratory and Infectious Diseases, Nordsjællands Hospital University of Copenhagen, Hillerød</wicri:regionArea>
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<author><name sortKey="Moberg, Mia" sort="Moberg, Mia" uniqKey="Moberg M" first="Mia" last="Moberg">Mia Moberg</name>
<affiliation wicri:level="1"><nlm:affiliation>Department of Respiratory Medicine, Amager and Hvidovre Hospital University of Copenhagen, Hvidovre, Denmark.</nlm:affiliation>
<country xml:lang="fr">Danemark</country>
<wicri:regionArea>Department of Respiratory Medicine, Amager and Hvidovre Hospital University of Copenhagen, Hvidovre</wicri:regionArea>
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<author><name sortKey="Pedersen, Lars" sort="Pedersen, Lars" uniqKey="Pedersen L" first="Lars" last="Pedersen">Lars Pedersen</name>
<affiliation wicri:level="3"><nlm:affiliation>Department of Respiratory Medicine, Bispebjerg and Frederiksberg Hospital University of Copenhagen, Copenhagen, Denmark.</nlm:affiliation>
<country xml:lang="fr">Danemark</country>
<wicri:regionArea>Department of Respiratory Medicine, Bispebjerg and Frederiksberg Hospital University of Copenhagen, Copenhagen</wicri:regionArea>
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</placeName>
</affiliation>
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<author><name sortKey="Benfield, Thomas Lars" sort="Benfield, Thomas Lars" uniqKey="Benfield T" first="Thomas Lars" last="Benfield">Thomas Lars Benfield</name>
<affiliation wicri:level="1"><nlm:affiliation>Dep. of Infectious Diseases, Amager and Hvidovre Hospital University of Copenhagen, Hvidovre, Denmark.</nlm:affiliation>
<country xml:lang="fr">Danemark</country>
<wicri:regionArea>Dep. of Infectious Diseases, Amager and Hvidovre Hospital University of Copenhagen, Hvidovre</wicri:regionArea>
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</affiliation>
</author>
<author><name sortKey="Lundgren, Jens Dilling" sort="Lundgren, Jens Dilling" uniqKey="Lundgren J" first="Jens Dilling" last="Lundgren">Jens Dilling Lundgren</name>
<affiliation wicri:level="3"><nlm:affiliation>Department of Infectious Diseases, Rigshospitalet University of Copenhagen, Copenhagen, Denmark.</nlm:affiliation>
<country xml:lang="fr">Danemark</country>
<wicri:regionArea>Department of Infectious Diseases, Rigshospitalet University of Copenhagen, Copenhagen</wicri:regionArea>
<placeName><settlement type="city">Copenhague</settlement>
<region type="région" nuts="2">Hovedstaden</region>
</placeName>
</affiliation>
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<author><name sortKey="Knop, Filip Krag" sort="Knop, Filip Krag" uniqKey="Knop F" first="Filip Krag" last="Knop">Filip Krag Knop</name>
<affiliation wicri:level="1"><nlm:affiliation>Department of Clinical Metabolic Research, Herlev and Gentofte Hospital University of Copenhagen, Hellerup, Denmark.</nlm:affiliation>
<country xml:lang="fr">Danemark</country>
<wicri:regionArea>Department of Clinical Metabolic Research, Herlev and Gentofte Hospital University of Copenhagen, Hellerup</wicri:regionArea>
<wicri:noRegion>Hellerup</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Biering S Rensen, Tor" sort="Biering S Rensen, Tor" uniqKey="Biering S Rensen T" first="Tor" last="Biering-S Rensen">Tor Biering-S Rensen</name>
<affiliation wicri:level="1"><nlm:affiliation>Department of Cardiology, Herlev and Gentofte Hospital University of Copenhagen, Hellerup, Denmark.</nlm:affiliation>
<country xml:lang="fr">Danemark</country>
<wicri:regionArea>Department of Cardiology, Herlev and Gentofte Hospital University of Copenhagen, Hellerup</wicri:regionArea>
<wicri:noRegion>Hellerup</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Ghanizada, Muzhda" sort="Ghanizada, Muzhda" uniqKey="Ghanizada M" first="Muzhda" last="Ghanizada">Muzhda Ghanizada</name>
<affiliation wicri:level="3"><nlm:affiliation>Department of Respiratory Medicine, Bispebjerg and Frederiksberg Hospital University of Copenhagen, Copenhagen, Denmark.</nlm:affiliation>
<country xml:lang="fr">Danemark</country>
<wicri:regionArea>Department of Respiratory Medicine, Bispebjerg and Frederiksberg Hospital University of Copenhagen, Copenhagen</wicri:regionArea>
<placeName><settlement type="city">Copenhague</settlement>
<region type="région" nuts="2">Hovedstaden</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Sonne, Tine Peick" sort="Sonne, Tine Peick" uniqKey="Sonne T" first="Tine Peick" last="Sonne">Tine Peick Sonne</name>
<affiliation wicri:level="1"><nlm:affiliation>Section of Respiratory Medicine, Department of Medicine, Herlev and Gentofte Hospital University of Copenhagen, Hellerup, Denmark.</nlm:affiliation>
<country xml:lang="fr">Danemark</country>
<wicri:regionArea>Section of Respiratory Medicine, Department of Medicine, Herlev and Gentofte Hospital University of Copenhagen, Hellerup</wicri:regionArea>
<wicri:noRegion>Hellerup</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="B Dtger, Uffe Christian Steinholtz" sort="B Dtger, Uffe Christian Steinholtz" uniqKey="B Dtger U" first="Uffe Christian Steinholtz" last="B Dtger">Uffe Christian Steinholtz B Dtger</name>
<affiliation wicri:level="1"><nlm:affiliation>Department of Internal Medicine, Zealand University Hospital, Roskilde, Denmark.</nlm:affiliation>
<country xml:lang="fr">Danemark</country>
<wicri:regionArea>Department of Internal Medicine, Zealand University Hospital, Roskilde</wicri:regionArea>
<wicri:noRegion>Roskilde</wicri:noRegion>
</affiliation>
<affiliation wicri:level="1"><nlm:affiliation>Department of Respiratory Medicine, Næstved-Slagelse-Ringsted Hospitals University of Southern Denmark, Slagelse, Denmark.</nlm:affiliation>
<country xml:lang="fr">Danemark</country>
<wicri:regionArea>Department of Respiratory Medicine, Næstved-Slagelse-Ringsted Hospitals University of Southern Denmark, Slagelse</wicri:regionArea>
<wicri:noRegion>Slagelse</wicri:noRegion>
</affiliation>
<affiliation wicri:level="1"><nlm:affiliation>Institute for Regional Health Research University of Southern Denmark, Odense, Denmark.</nlm:affiliation>
<country xml:lang="fr">Danemark</country>
<wicri:regionArea>Institute for Regional Health Research University of Southern Denmark, Odense</wicri:regionArea>
<wicri:noRegion>Odense</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Jensen, Sidse Graff" sort="Jensen, Sidse Graff" uniqKey="Jensen S" first="Sidse Graff" last="Jensen">Sidse Graff Jensen</name>
<affiliation wicri:level="1"><nlm:affiliation>Section of Respiratory Medicine, Department of Medicine, Herlev and Gentofte Hospital University of Copenhagen, Hellerup, Denmark.</nlm:affiliation>
<country xml:lang="fr">Danemark</country>
<wicri:regionArea>Section of Respiratory Medicine, Department of Medicine, Herlev and Gentofte Hospital University of Copenhagen, Hellerup</wicri:regionArea>
<wicri:noRegion>Hellerup</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Rasmussen, Daniel Bech" sort="Rasmussen, Daniel Bech" uniqKey="Rasmussen D" first="Daniel Bech" last="Rasmussen">Daniel Bech Rasmussen</name>
<affiliation wicri:level="1"><nlm:affiliation>Department of Respiratory Medicine, Næstved-Slagelse-Ringsted Hospitals University of Southern Denmark, Slagelse, Denmark.</nlm:affiliation>
<country xml:lang="fr">Danemark</country>
<wicri:regionArea>Department of Respiratory Medicine, Næstved-Slagelse-Ringsted Hospitals University of Southern Denmark, Slagelse</wicri:regionArea>
<wicri:noRegion>Slagelse</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Br Ndum, Eva" sort="Br Ndum, Eva" uniqKey="Br Ndum E" first="Eva" last="Br Ndum">Eva Br Ndum</name>
<affiliation wicri:level="1"><nlm:affiliation>Department of Respiratory Medicine, Amager and Hvidovre Hospital University of Copenhagen, Hvidovre, Denmark.</nlm:affiliation>
<country xml:lang="fr">Danemark</country>
<wicri:regionArea>Department of Respiratory Medicine, Amager and Hvidovre Hospital University of Copenhagen, Hvidovre</wicri:regionArea>
<wicri:noRegion>Hvidovre</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Tupper, Oliver Djurhuus" sort="Tupper, Oliver Djurhuus" uniqKey="Tupper O" first="Oliver Djurhuus" last="Tupper">Oliver Djurhuus Tupper</name>
<affiliation wicri:level="1"><nlm:affiliation>Department of Respiratory Medicine, Amager and Hvidovre Hospital University of Copenhagen, Hvidovre, Denmark.</nlm:affiliation>
<country xml:lang="fr">Danemark</country>
<wicri:regionArea>Department of Respiratory Medicine, Amager and Hvidovre Hospital University of Copenhagen, Hvidovre</wicri:regionArea>
<wicri:noRegion>Hvidovre</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="S Rensen, Susanne Wiemann" sort="S Rensen, Susanne Wiemann" uniqKey="S Rensen S" first="Susanne Wiemann" last="S Rensen">Susanne Wiemann S Rensen</name>
<affiliation wicri:level="1"><nlm:affiliation>Department of Respiratory Medicine, Amager and Hvidovre Hospital University of Copenhagen, Hvidovre, Denmark.</nlm:affiliation>
<country xml:lang="fr">Danemark</country>
<wicri:regionArea>Department of Respiratory Medicine, Amager and Hvidovre Hospital University of Copenhagen, Hvidovre</wicri:regionArea>
<wicri:noRegion>Hvidovre</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Alstrup, Gitte" sort="Alstrup, Gitte" uniqKey="Alstrup G" first="Gitte" last="Alstrup">Gitte Alstrup</name>
<affiliation wicri:level="1"><nlm:affiliation>Department of Respiratory Medicine, Næstved-Slagelse-Ringsted Hospitals University of Southern Denmark, Slagelse, Denmark.</nlm:affiliation>
<country xml:lang="fr">Danemark</country>
<wicri:regionArea>Department of Respiratory Medicine, Næstved-Slagelse-Ringsted Hospitals University of Southern Denmark, Slagelse</wicri:regionArea>
<wicri:noRegion>Slagelse</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Laursen, Christian Borbjerg" sort="Laursen, Christian Borbjerg" uniqKey="Laursen C" first="Christian Borbjerg" last="Laursen">Christian Borbjerg Laursen</name>
<affiliation wicri:level="1"><nlm:affiliation>Department of Respiratory Medicine, Odense University Hospital University of Southern Denmark, Odense, Denmark.</nlm:affiliation>
<country xml:lang="fr">Danemark</country>
<wicri:regionArea>Department of Respiratory Medicine, Odense University Hospital University of Southern Denmark, Odense</wicri:regionArea>
<wicri:noRegion>Odense</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="M Ller, Ulla Weinrich" sort="M Ller, Ulla Weinrich" uniqKey="M Ller U" first="Ulla Weinrich" last="M Ller">Ulla Weinrich M Ller</name>
<affiliation wicri:level="1"><nlm:affiliation>Department of Respiratory Medicine, Aalborg University Hospital University of Aalborg, Aalborg, Denmark.</nlm:affiliation>
<country xml:lang="fr">Danemark</country>
<wicri:regionArea>Department of Respiratory Medicine, Aalborg University Hospital University of Aalborg, Aalborg</wicri:regionArea>
<wicri:noRegion>Aalborg</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Sverrild, Asger" sort="Sverrild, Asger" uniqKey="Sverrild A" first="Asger" last="Sverrild">Asger Sverrild</name>
<affiliation wicri:level="3"><nlm:affiliation>Department of Respiratory Medicine, Bispebjerg and Frederiksberg Hospital University of Copenhagen, Copenhagen, Denmark.</nlm:affiliation>
<country xml:lang="fr">Danemark</country>
<wicri:regionArea>Department of Respiratory Medicine, Bispebjerg and Frederiksberg Hospital University of Copenhagen, Copenhagen</wicri:regionArea>
<placeName><settlement type="city">Copenhague</settlement>
<region type="région" nuts="2">Hovedstaden</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Jensen, Jens Ulrik St Hr" sort="Jensen, Jens Ulrik St Hr" uniqKey="Jensen J" first="Jens-Ulrik St Hr" last="Jensen">Jens-Ulrik St Hr Jensen</name>
<affiliation wicri:level="1"><nlm:affiliation>Section of Respiratory Medicine, Department of Medicine, Herlev and Gentofte Hospital University of Copenhagen, Hellerup, Denmark. jens.ulrik.jensen@regionh.dk.</nlm:affiliation>
<country xml:lang="fr">Danemark</country>
<wicri:regionArea>Section of Respiratory Medicine, Department of Medicine, Herlev and Gentofte Hospital University of Copenhagen, Hellerup</wicri:regionArea>
<wicri:noRegion>Hellerup</wicri:noRegion>
</affiliation>
</author>
</titleStmt>
<publicationStmt><idno type="wicri:source">PubMed</idno>
<date when="2020">2020</date>
<idno type="RBID">pubmed:32522282</idno>
<idno type="pmid">32522282</idno>
<idno type="doi">10.1186/s13063-020-04409-9</idno>
<idno type="pmc">PMC7284668</idno>
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<sourceDesc><biblStruct><analytic><title xml:lang="en">Proactive Prophylaxis With Azithromycin and HydroxyChloroquine in Hospitalised Patients With COVID-19 (ProPAC-COVID): A structured summary of a study protocol for a randomised controlled trial.</title>
<author><name sortKey="Sivapalan, Pradeesh" sort="Sivapalan, Pradeesh" uniqKey="Sivapalan P" first="Pradeesh" last="Sivapalan">Pradeesh Sivapalan</name>
<affiliation wicri:level="1"><nlm:affiliation>Section of Respiratory Medicine, Department of Medicine, Herlev and Gentofte Hospital University of Copenhagen, Hellerup, Denmark.</nlm:affiliation>
<country xml:lang="fr">Danemark</country>
<wicri:regionArea>Section of Respiratory Medicine, Department of Medicine, Herlev and Gentofte Hospital University of Copenhagen, Hellerup</wicri:regionArea>
<wicri:noRegion>Hellerup</wicri:noRegion>
</affiliation>
<affiliation wicri:level="1"><nlm:affiliation>Department of Internal Medicine, Zealand University Hospital, Roskilde, Denmark.</nlm:affiliation>
<country xml:lang="fr">Danemark</country>
<wicri:regionArea>Department of Internal Medicine, Zealand University Hospital, Roskilde</wicri:regionArea>
<wicri:noRegion>Roskilde</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Ulrik, Charlotte Suppli" sort="Ulrik, Charlotte Suppli" uniqKey="Ulrik C" first="Charlotte Suppli" last="Ulrik">Charlotte Suppli Ulrik</name>
<affiliation wicri:level="1"><nlm:affiliation>Department of Respiratory Medicine, Amager and Hvidovre Hospital University of Copenhagen, Hvidovre, Denmark.</nlm:affiliation>
<country xml:lang="fr">Danemark</country>
<wicri:regionArea>Department of Respiratory Medicine, Amager and Hvidovre Hospital University of Copenhagen, Hvidovre</wicri:regionArea>
<wicri:noRegion>Hvidovre</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Bojesen, Rasmus Dahlin" sort="Bojesen, Rasmus Dahlin" uniqKey="Bojesen R" first="Rasmus Dahlin" last="Bojesen">Rasmus Dahlin Bojesen</name>
<affiliation wicri:level="1"><nlm:affiliation>Department of Surgery, Næstved-Slagelse- Ringsted Hospitals University of Southern Denmark, Slagelse, Denmark.</nlm:affiliation>
<country xml:lang="fr">Danemark</country>
<wicri:regionArea>Department of Surgery, Næstved-Slagelse- Ringsted Hospitals University of Southern Denmark, Slagelse</wicri:regionArea>
<wicri:noRegion>Slagelse</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Lapperre, Therese Sophie" sort="Lapperre, Therese Sophie" uniqKey="Lapperre T" first="Therese Sophie" last="Lapperre">Therese Sophie Lapperre</name>
<affiliation wicri:level="3"><nlm:affiliation>Department of Respiratory Medicine, Bispebjerg and Frederiksberg Hospital University of Copenhagen, Copenhagen, Denmark.</nlm:affiliation>
<country xml:lang="fr">Danemark</country>
<wicri:regionArea>Department of Respiratory Medicine, Bispebjerg and Frederiksberg Hospital University of Copenhagen, Copenhagen</wicri:regionArea>
<placeName><settlement type="city">Copenhague</settlement>
<region type="région" nuts="2">Hovedstaden</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Eklof, Josefin Viktoria" sort="Eklof, Josefin Viktoria" uniqKey="Eklof J" first="Josefin Viktoria" last="Eklöf">Josefin Viktoria Eklöf</name>
<affiliation wicri:level="1"><nlm:affiliation>Section of Respiratory Medicine, Department of Medicine, Herlev and Gentofte Hospital University of Copenhagen, Hellerup, Denmark.</nlm:affiliation>
<country xml:lang="fr">Danemark</country>
<wicri:regionArea>Section of Respiratory Medicine, Department of Medicine, Herlev and Gentofte Hospital University of Copenhagen, Hellerup</wicri:regionArea>
<wicri:noRegion>Hellerup</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="H Kansson, Kjell Erik Julius" sort="H Kansson, Kjell Erik Julius" uniqKey="H Kansson K" first="Kjell Erik Julius" last="H Kansson">Kjell Erik Julius H Kansson</name>
<affiliation wicri:level="1"><nlm:affiliation>Department of Respiratory Medicine, Amager and Hvidovre Hospital University of Copenhagen, Hvidovre, Denmark.</nlm:affiliation>
<country xml:lang="fr">Danemark</country>
<wicri:regionArea>Department of Respiratory Medicine, Amager and Hvidovre Hospital University of Copenhagen, Hvidovre</wicri:regionArea>
<wicri:noRegion>Hvidovre</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Browatzki, Andrea" sort="Browatzki, Andrea" uniqKey="Browatzki A" first="Andrea" last="Browatzki">Andrea Browatzki</name>
<affiliation wicri:level="1"><nlm:affiliation>Department of Respiratory and Infectious Diseases, Nordsjællands Hospital University of Copenhagen, Hillerød, Denmark.</nlm:affiliation>
<country xml:lang="fr">Danemark</country>
<wicri:regionArea>Department of Respiratory and Infectious Diseases, Nordsjællands Hospital University of Copenhagen, Hillerød</wicri:regionArea>
<wicri:noRegion>Hillerød</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Tidemansen, Casper" sort="Tidemansen, Casper" uniqKey="Tidemansen C" first="Casper" last="Tidemansen">Casper Tidemansen</name>
<affiliation wicri:level="1"><nlm:affiliation>Department of Respiratory Medicine, Amager and Hvidovre Hospital University of Copenhagen, Hvidovre, Denmark.</nlm:affiliation>
<country xml:lang="fr">Danemark</country>
<wicri:regionArea>Department of Respiratory Medicine, Amager and Hvidovre Hospital University of Copenhagen, Hvidovre</wicri:regionArea>
<wicri:noRegion>Hvidovre</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Wilcke, Jon Torgny" sort="Wilcke, Jon Torgny" uniqKey="Wilcke J" first="Jon Torgny" last="Wilcke">Jon Torgny Wilcke</name>
<affiliation wicri:level="1"><nlm:affiliation>Section of Respiratory Medicine, Department of Medicine, Herlev and Gentofte Hospital University of Copenhagen, Hellerup, Denmark.</nlm:affiliation>
<country xml:lang="fr">Danemark</country>
<wicri:regionArea>Section of Respiratory Medicine, Department of Medicine, Herlev and Gentofte Hospital University of Copenhagen, Hellerup</wicri:regionArea>
<wicri:noRegion>Hellerup</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Janner, Julie" sort="Janner, Julie" uniqKey="Janner J" first="Julie" last="Janner">Julie Janner</name>
<affiliation wicri:level="1"><nlm:affiliation>Department of Respiratory Medicine, Amager and Hvidovre Hospital University of Copenhagen, Hvidovre, Denmark.</nlm:affiliation>
<country xml:lang="fr">Danemark</country>
<wicri:regionArea>Department of Respiratory Medicine, Amager and Hvidovre Hospital University of Copenhagen, Hvidovre</wicri:regionArea>
<wicri:noRegion>Hvidovre</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Gottlieb, Vibeke" sort="Gottlieb, Vibeke" uniqKey="Gottlieb V" first="Vibeke" last="Gottlieb">Vibeke Gottlieb</name>
<affiliation wicri:level="1"><nlm:affiliation>Section of Respiratory Medicine, Department of Medicine, Herlev and Gentofte Hospital University of Copenhagen, Hellerup, Denmark.</nlm:affiliation>
<country xml:lang="fr">Danemark</country>
<wicri:regionArea>Section of Respiratory Medicine, Department of Medicine, Herlev and Gentofte Hospital University of Copenhagen, Hellerup</wicri:regionArea>
<wicri:noRegion>Hellerup</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Meteran, Howraman" sort="Meteran, Howraman" uniqKey="Meteran H" first="Howraman" last="Meteran">Howraman Meteran</name>
<affiliation wicri:level="1"><nlm:affiliation>Section of Respiratory Medicine, Department of Medicine, Herlev and Gentofte Hospital University of Copenhagen, Hellerup, Denmark.</nlm:affiliation>
<country xml:lang="fr">Danemark</country>
<wicri:regionArea>Section of Respiratory Medicine, Department of Medicine, Herlev and Gentofte Hospital University of Copenhagen, Hellerup</wicri:regionArea>
<wicri:noRegion>Hellerup</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Porsbjerg, Celeste" sort="Porsbjerg, Celeste" uniqKey="Porsbjerg C" first="Celeste" last="Porsbjerg">Celeste Porsbjerg</name>
<affiliation wicri:level="3"><nlm:affiliation>Department of Respiratory Medicine, Bispebjerg and Frederiksberg Hospital University of Copenhagen, Copenhagen, Denmark.</nlm:affiliation>
<country xml:lang="fr">Danemark</country>
<wicri:regionArea>Department of Respiratory Medicine, Bispebjerg and Frederiksberg Hospital University of Copenhagen, Copenhagen</wicri:regionArea>
<placeName><settlement type="city">Copenhague</settlement>
<region type="région" nuts="2">Hovedstaden</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Madsen, Birgitte Lindegaard" sort="Madsen, Birgitte Lindegaard" uniqKey="Madsen B" first="Birgitte Lindegaard" last="Madsen">Birgitte Lindegaard Madsen</name>
<affiliation wicri:level="1"><nlm:affiliation>Department of Respiratory and Infectious Diseases, Nordsjællands Hospital University of Copenhagen, Hillerød, Denmark.</nlm:affiliation>
<country xml:lang="fr">Danemark</country>
<wicri:regionArea>Department of Respiratory and Infectious Diseases, Nordsjællands Hospital University of Copenhagen, Hillerød</wicri:regionArea>
<wicri:noRegion>Hillerød</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Moberg, Mia" sort="Moberg, Mia" uniqKey="Moberg M" first="Mia" last="Moberg">Mia Moberg</name>
<affiliation wicri:level="1"><nlm:affiliation>Department of Respiratory Medicine, Amager and Hvidovre Hospital University of Copenhagen, Hvidovre, Denmark.</nlm:affiliation>
<country xml:lang="fr">Danemark</country>
<wicri:regionArea>Department of Respiratory Medicine, Amager and Hvidovre Hospital University of Copenhagen, Hvidovre</wicri:regionArea>
<wicri:noRegion>Hvidovre</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Pedersen, Lars" sort="Pedersen, Lars" uniqKey="Pedersen L" first="Lars" last="Pedersen">Lars Pedersen</name>
<affiliation wicri:level="3"><nlm:affiliation>Department of Respiratory Medicine, Bispebjerg and Frederiksberg Hospital University of Copenhagen, Copenhagen, Denmark.</nlm:affiliation>
<country xml:lang="fr">Danemark</country>
<wicri:regionArea>Department of Respiratory Medicine, Bispebjerg and Frederiksberg Hospital University of Copenhagen, Copenhagen</wicri:regionArea>
<placeName><settlement type="city">Copenhague</settlement>
<region type="région" nuts="2">Hovedstaden</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Benfield, Thomas Lars" sort="Benfield, Thomas Lars" uniqKey="Benfield T" first="Thomas Lars" last="Benfield">Thomas Lars Benfield</name>
<affiliation wicri:level="1"><nlm:affiliation>Dep. of Infectious Diseases, Amager and Hvidovre Hospital University of Copenhagen, Hvidovre, Denmark.</nlm:affiliation>
<country xml:lang="fr">Danemark</country>
<wicri:regionArea>Dep. of Infectious Diseases, Amager and Hvidovre Hospital University of Copenhagen, Hvidovre</wicri:regionArea>
<wicri:noRegion>Hvidovre</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Lundgren, Jens Dilling" sort="Lundgren, Jens Dilling" uniqKey="Lundgren J" first="Jens Dilling" last="Lundgren">Jens Dilling Lundgren</name>
<affiliation wicri:level="3"><nlm:affiliation>Department of Infectious Diseases, Rigshospitalet University of Copenhagen, Copenhagen, Denmark.</nlm:affiliation>
<country xml:lang="fr">Danemark</country>
<wicri:regionArea>Department of Infectious Diseases, Rigshospitalet University of Copenhagen, Copenhagen</wicri:regionArea>
<placeName><settlement type="city">Copenhague</settlement>
<region type="région" nuts="2">Hovedstaden</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Knop, Filip Krag" sort="Knop, Filip Krag" uniqKey="Knop F" first="Filip Krag" last="Knop">Filip Krag Knop</name>
<affiliation wicri:level="1"><nlm:affiliation>Department of Clinical Metabolic Research, Herlev and Gentofte Hospital University of Copenhagen, Hellerup, Denmark.</nlm:affiliation>
<country xml:lang="fr">Danemark</country>
<wicri:regionArea>Department of Clinical Metabolic Research, Herlev and Gentofte Hospital University of Copenhagen, Hellerup</wicri:regionArea>
<wicri:noRegion>Hellerup</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Biering S Rensen, Tor" sort="Biering S Rensen, Tor" uniqKey="Biering S Rensen T" first="Tor" last="Biering-S Rensen">Tor Biering-S Rensen</name>
<affiliation wicri:level="1"><nlm:affiliation>Department of Cardiology, Herlev and Gentofte Hospital University of Copenhagen, Hellerup, Denmark.</nlm:affiliation>
<country xml:lang="fr">Danemark</country>
<wicri:regionArea>Department of Cardiology, Herlev and Gentofte Hospital University of Copenhagen, Hellerup</wicri:regionArea>
<wicri:noRegion>Hellerup</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Ghanizada, Muzhda" sort="Ghanizada, Muzhda" uniqKey="Ghanizada M" first="Muzhda" last="Ghanizada">Muzhda Ghanizada</name>
<affiliation wicri:level="3"><nlm:affiliation>Department of Respiratory Medicine, Bispebjerg and Frederiksberg Hospital University of Copenhagen, Copenhagen, Denmark.</nlm:affiliation>
<country xml:lang="fr">Danemark</country>
<wicri:regionArea>Department of Respiratory Medicine, Bispebjerg and Frederiksberg Hospital University of Copenhagen, Copenhagen</wicri:regionArea>
<placeName><settlement type="city">Copenhague</settlement>
<region type="région" nuts="2">Hovedstaden</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Sonne, Tine Peick" sort="Sonne, Tine Peick" uniqKey="Sonne T" first="Tine Peick" last="Sonne">Tine Peick Sonne</name>
<affiliation wicri:level="1"><nlm:affiliation>Section of Respiratory Medicine, Department of Medicine, Herlev and Gentofte Hospital University of Copenhagen, Hellerup, Denmark.</nlm:affiliation>
<country xml:lang="fr">Danemark</country>
<wicri:regionArea>Section of Respiratory Medicine, Department of Medicine, Herlev and Gentofte Hospital University of Copenhagen, Hellerup</wicri:regionArea>
<wicri:noRegion>Hellerup</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="B Dtger, Uffe Christian Steinholtz" sort="B Dtger, Uffe Christian Steinholtz" uniqKey="B Dtger U" first="Uffe Christian Steinholtz" last="B Dtger">Uffe Christian Steinholtz B Dtger</name>
<affiliation wicri:level="1"><nlm:affiliation>Department of Internal Medicine, Zealand University Hospital, Roskilde, Denmark.</nlm:affiliation>
<country xml:lang="fr">Danemark</country>
<wicri:regionArea>Department of Internal Medicine, Zealand University Hospital, Roskilde</wicri:regionArea>
<wicri:noRegion>Roskilde</wicri:noRegion>
</affiliation>
<affiliation wicri:level="1"><nlm:affiliation>Department of Respiratory Medicine, Næstved-Slagelse-Ringsted Hospitals University of Southern Denmark, Slagelse, Denmark.</nlm:affiliation>
<country xml:lang="fr">Danemark</country>
<wicri:regionArea>Department of Respiratory Medicine, Næstved-Slagelse-Ringsted Hospitals University of Southern Denmark, Slagelse</wicri:regionArea>
<wicri:noRegion>Slagelse</wicri:noRegion>
</affiliation>
<affiliation wicri:level="1"><nlm:affiliation>Institute for Regional Health Research University of Southern Denmark, Odense, Denmark.</nlm:affiliation>
<country xml:lang="fr">Danemark</country>
<wicri:regionArea>Institute for Regional Health Research University of Southern Denmark, Odense</wicri:regionArea>
<wicri:noRegion>Odense</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Jensen, Sidse Graff" sort="Jensen, Sidse Graff" uniqKey="Jensen S" first="Sidse Graff" last="Jensen">Sidse Graff Jensen</name>
<affiliation wicri:level="1"><nlm:affiliation>Section of Respiratory Medicine, Department of Medicine, Herlev and Gentofte Hospital University of Copenhagen, Hellerup, Denmark.</nlm:affiliation>
<country xml:lang="fr">Danemark</country>
<wicri:regionArea>Section of Respiratory Medicine, Department of Medicine, Herlev and Gentofte Hospital University of Copenhagen, Hellerup</wicri:regionArea>
<wicri:noRegion>Hellerup</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Rasmussen, Daniel Bech" sort="Rasmussen, Daniel Bech" uniqKey="Rasmussen D" first="Daniel Bech" last="Rasmussen">Daniel Bech Rasmussen</name>
<affiliation wicri:level="1"><nlm:affiliation>Department of Respiratory Medicine, Næstved-Slagelse-Ringsted Hospitals University of Southern Denmark, Slagelse, Denmark.</nlm:affiliation>
<country xml:lang="fr">Danemark</country>
<wicri:regionArea>Department of Respiratory Medicine, Næstved-Slagelse-Ringsted Hospitals University of Southern Denmark, Slagelse</wicri:regionArea>
<wicri:noRegion>Slagelse</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Br Ndum, Eva" sort="Br Ndum, Eva" uniqKey="Br Ndum E" first="Eva" last="Br Ndum">Eva Br Ndum</name>
<affiliation wicri:level="1"><nlm:affiliation>Department of Respiratory Medicine, Amager and Hvidovre Hospital University of Copenhagen, Hvidovre, Denmark.</nlm:affiliation>
<country xml:lang="fr">Danemark</country>
<wicri:regionArea>Department of Respiratory Medicine, Amager and Hvidovre Hospital University of Copenhagen, Hvidovre</wicri:regionArea>
<wicri:noRegion>Hvidovre</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Tupper, Oliver Djurhuus" sort="Tupper, Oliver Djurhuus" uniqKey="Tupper O" first="Oliver Djurhuus" last="Tupper">Oliver Djurhuus Tupper</name>
<affiliation wicri:level="1"><nlm:affiliation>Department of Respiratory Medicine, Amager and Hvidovre Hospital University of Copenhagen, Hvidovre, Denmark.</nlm:affiliation>
<country xml:lang="fr">Danemark</country>
<wicri:regionArea>Department of Respiratory Medicine, Amager and Hvidovre Hospital University of Copenhagen, Hvidovre</wicri:regionArea>
<wicri:noRegion>Hvidovre</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="S Rensen, Susanne Wiemann" sort="S Rensen, Susanne Wiemann" uniqKey="S Rensen S" first="Susanne Wiemann" last="S Rensen">Susanne Wiemann S Rensen</name>
<affiliation wicri:level="1"><nlm:affiliation>Department of Respiratory Medicine, Amager and Hvidovre Hospital University of Copenhagen, Hvidovre, Denmark.</nlm:affiliation>
<country xml:lang="fr">Danemark</country>
<wicri:regionArea>Department of Respiratory Medicine, Amager and Hvidovre Hospital University of Copenhagen, Hvidovre</wicri:regionArea>
<wicri:noRegion>Hvidovre</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Alstrup, Gitte" sort="Alstrup, Gitte" uniqKey="Alstrup G" first="Gitte" last="Alstrup">Gitte Alstrup</name>
<affiliation wicri:level="1"><nlm:affiliation>Department of Respiratory Medicine, Næstved-Slagelse-Ringsted Hospitals University of Southern Denmark, Slagelse, Denmark.</nlm:affiliation>
<country xml:lang="fr">Danemark</country>
<wicri:regionArea>Department of Respiratory Medicine, Næstved-Slagelse-Ringsted Hospitals University of Southern Denmark, Slagelse</wicri:regionArea>
<wicri:noRegion>Slagelse</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Laursen, Christian Borbjerg" sort="Laursen, Christian Borbjerg" uniqKey="Laursen C" first="Christian Borbjerg" last="Laursen">Christian Borbjerg Laursen</name>
<affiliation wicri:level="1"><nlm:affiliation>Department of Respiratory Medicine, Odense University Hospital University of Southern Denmark, Odense, Denmark.</nlm:affiliation>
<country xml:lang="fr">Danemark</country>
<wicri:regionArea>Department of Respiratory Medicine, Odense University Hospital University of Southern Denmark, Odense</wicri:regionArea>
<wicri:noRegion>Odense</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="M Ller, Ulla Weinrich" sort="M Ller, Ulla Weinrich" uniqKey="M Ller U" first="Ulla Weinrich" last="M Ller">Ulla Weinrich M Ller</name>
<affiliation wicri:level="1"><nlm:affiliation>Department of Respiratory Medicine, Aalborg University Hospital University of Aalborg, Aalborg, Denmark.</nlm:affiliation>
<country xml:lang="fr">Danemark</country>
<wicri:regionArea>Department of Respiratory Medicine, Aalborg University Hospital University of Aalborg, Aalborg</wicri:regionArea>
<wicri:noRegion>Aalborg</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Sverrild, Asger" sort="Sverrild, Asger" uniqKey="Sverrild A" first="Asger" last="Sverrild">Asger Sverrild</name>
<affiliation wicri:level="3"><nlm:affiliation>Department of Respiratory Medicine, Bispebjerg and Frederiksberg Hospital University of Copenhagen, Copenhagen, Denmark.</nlm:affiliation>
<country xml:lang="fr">Danemark</country>
<wicri:regionArea>Department of Respiratory Medicine, Bispebjerg and Frederiksberg Hospital University of Copenhagen, Copenhagen</wicri:regionArea>
<placeName><settlement type="city">Copenhague</settlement>
<region type="région" nuts="2">Hovedstaden</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Jensen, Jens Ulrik St Hr" sort="Jensen, Jens Ulrik St Hr" uniqKey="Jensen J" first="Jens-Ulrik St Hr" last="Jensen">Jens-Ulrik St Hr Jensen</name>
<affiliation wicri:level="1"><nlm:affiliation>Section of Respiratory Medicine, Department of Medicine, Herlev and Gentofte Hospital University of Copenhagen, Hellerup, Denmark. jens.ulrik.jensen@regionh.dk.</nlm:affiliation>
<country xml:lang="fr">Danemark</country>
<wicri:regionArea>Section of Respiratory Medicine, Department of Medicine, Herlev and Gentofte Hospital University of Copenhagen, Hellerup</wicri:regionArea>
<wicri:noRegion>Hellerup</wicri:noRegion>
</affiliation>
</author>
</analytic>
<series><title level="j">Trials</title>
<idno type="eISSN">1745-6215</idno>
<imprint><date when="2020" type="published">2020</date>
</imprint>
</series>
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<profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Antiviral Agents (administration & dosage)</term>
<term>Antiviral Agents (adverse effects)</term>
<term>Azithromycin (administration & dosage)</term>
<term>Azithromycin (adverse effects)</term>
<term>Betacoronavirus (drug effects)</term>
<term>Betacoronavirus (pathogenicity)</term>
<term>COVID-19 (MeSH)</term>
<term>Coronavirus Infections (diagnosis)</term>
<term>Coronavirus Infections (drug therapy)</term>
<term>Coronavirus Infections (mortality)</term>
<term>Coronavirus Infections (virology)</term>
<term>Critical Care (MeSH)</term>
<term>Denmark (MeSH)</term>
<term>Double-Blind Method (MeSH)</term>
<term>Drug Administration Schedule (MeSH)</term>
<term>Hospital Mortality (MeSH)</term>
<term>Host-Pathogen Interactions (MeSH)</term>
<term>Humans (MeSH)</term>
<term>Hydroxychloroquine (administration & dosage)</term>
<term>Hydroxychloroquine (adverse effects)</term>
<term>Inpatients (MeSH)</term>
<term>Length of Stay (MeSH)</term>
<term>Multicenter Studies as Topic (MeSH)</term>
<term>Noninvasive Ventilation (MeSH)</term>
<term>Pandemics (MeSH)</term>
<term>Patient Admission (MeSH)</term>
<term>Pneumonia, Viral (diagnosis)</term>
<term>Pneumonia, Viral (drug therapy)</term>
<term>Pneumonia, Viral (mortality)</term>
<term>Pneumonia, Viral (virology)</term>
<term>Randomized Controlled Trials as Topic (MeSH)</term>
<term>SARS-CoV-2 (MeSH)</term>
<term>Severity of Illness Index (MeSH)</term>
<term>Time Factors (MeSH)</term>
<term>Treatment Outcome (MeSH)</term>
</keywords>
<keywords scheme="KwdFr" xml:lang="fr"><term>Admission du patient (MeSH)</term>
<term>Antiviraux (administration et posologie)</term>
<term>Antiviraux (effets indésirables)</term>
<term>Azithromycine (administration et posologie)</term>
<term>Azithromycine (effets indésirables)</term>
<term>Betacoronavirus (effets des médicaments et des substances chimiques)</term>
<term>Betacoronavirus (pathogénicité)</term>
<term>Calendrier d'administration des médicaments (MeSH)</term>
<term>Danemark (MeSH)</term>
<term>Durée du séjour (MeSH)</term>
<term>Essais contrôlés randomisés comme sujet (MeSH)</term>
<term>Facteurs temps (MeSH)</term>
<term>Humains (MeSH)</term>
<term>Hydroxychloroquine (administration et posologie)</term>
<term>Hydroxychloroquine (effets indésirables)</term>
<term>Indice de gravité de la maladie (MeSH)</term>
<term>Infections à coronavirus (diagnostic)</term>
<term>Infections à coronavirus (mortalité)</term>
<term>Infections à coronavirus (traitement médicamenteux)</term>
<term>Infections à coronavirus (virologie)</term>
<term>Interactions hôte-pathogène (MeSH)</term>
<term>Mortalité hospitalière (MeSH)</term>
<term>Méthode en double aveugle (MeSH)</term>
<term>Pandémies (MeSH)</term>
<term>Patients hospitalisés (MeSH)</term>
<term>Pneumopathie virale (diagnostic)</term>
<term>Pneumopathie virale (mortalité)</term>
<term>Pneumopathie virale (traitement médicamenteux)</term>
<term>Pneumopathie virale (virologie)</term>
<term>Résultat thérapeutique (MeSH)</term>
<term>Soins de réanimation (MeSH)</term>
<term>Ventilation non effractive (MeSH)</term>
<term>Études multicentriques comme sujet (MeSH)</term>
</keywords>
<keywords scheme="MESH" type="chemical" qualifier="administration & dosage" xml:lang="en"><term>Antiviral Agents</term>
<term>Azithromycin</term>
<term>Hydroxychloroquine</term>
</keywords>
<keywords scheme="MESH" type="chemical" qualifier="adverse effects" xml:lang="en"><term>Antiviral Agents</term>
<term>Azithromycin</term>
<term>Hydroxychloroquine</term>
</keywords>
<keywords scheme="MESH" type="geographic" xml:lang="en"><term>Denmark</term>
</keywords>
<keywords scheme="MESH" qualifier="administration et posologie" xml:lang="fr"><term>Antiviraux</term>
<term>Azithromycine</term>
<term>Hydroxychloroquine</term>
</keywords>
<keywords scheme="MESH" qualifier="diagnosis" xml:lang="en"><term>Coronavirus Infections</term>
<term>Pneumonia, Viral</term>
</keywords>
<keywords scheme="MESH" qualifier="diagnostic" xml:lang="fr"><term>Infections à coronavirus</term>
<term>Pneumopathie virale</term>
</keywords>
<keywords scheme="MESH" qualifier="drug effects" xml:lang="en"><term>Betacoronavirus</term>
</keywords>
<keywords scheme="MESH" qualifier="drug therapy" xml:lang="en"><term>Coronavirus Infections</term>
<term>Pneumonia, Viral</term>
</keywords>
<keywords scheme="MESH" qualifier="effets des médicaments et des substances chimiques" xml:lang="fr"><term>Betacoronavirus</term>
</keywords>
<keywords scheme="MESH" qualifier="effets indésirables" xml:lang="fr"><term>Antiviraux</term>
<term>Azithromycine</term>
<term>Hydroxychloroquine</term>
</keywords>
<keywords scheme="MESH" qualifier="mortality" xml:lang="en"><term>Coronavirus Infections</term>
<term>Pneumonia, Viral</term>
</keywords>
<keywords scheme="MESH" qualifier="mortalité" xml:lang="fr"><term>Infections à coronavirus</term>
<term>Pneumopathie virale</term>
</keywords>
<keywords scheme="MESH" qualifier="pathogenicity" xml:lang="en"><term>Betacoronavirus</term>
</keywords>
<keywords scheme="MESH" qualifier="pathogénicité" xml:lang="fr"><term>Betacoronavirus</term>
</keywords>
<keywords scheme="MESH" qualifier="traitement médicamenteux" xml:lang="fr"><term>Infections à coronavirus</term>
<term>Pneumopathie virale</term>
</keywords>
<keywords scheme="MESH" qualifier="virologie" xml:lang="fr"><term>Infections à coronavirus</term>
<term>Pneumopathie virale</term>
</keywords>
<keywords scheme="MESH" qualifier="virology" xml:lang="en"><term>Coronavirus Infections</term>
<term>Pneumonia, Viral</term>
</keywords>
<keywords scheme="MESH" xml:lang="en"><term>COVID-19</term>
<term>Critical Care</term>
<term>Double-Blind Method</term>
<term>Drug Administration Schedule</term>
<term>Hospital Mortality</term>
<term>Host-Pathogen Interactions</term>
<term>Humans</term>
<term>Inpatients</term>
<term>Length of Stay</term>
<term>Multicenter Studies as Topic</term>
<term>Noninvasive Ventilation</term>
<term>Pandemics</term>
<term>Patient Admission</term>
<term>Randomized Controlled Trials as Topic</term>
<term>SARS-CoV-2</term>
<term>Severity of Illness Index</term>
<term>Time Factors</term>
<term>Treatment Outcome</term>
</keywords>
<keywords scheme="MESH" xml:lang="fr"><term>Admission du patient</term>
<term>Calendrier d'administration des médicaments</term>
<term>Danemark</term>
<term>Durée du séjour</term>
<term>Essais contrôlés randomisés comme sujet</term>
<term>Facteurs temps</term>
<term>Humains</term>
<term>Indice de gravité de la maladie</term>
<term>Interactions hôte-pathogène</term>
<term>Mortalité hospitalière</term>
<term>Méthode en double aveugle</term>
<term>Pandémies</term>
<term>Patients hospitalisés</term>
<term>Résultat thérapeutique</term>
<term>Soins de réanimation</term>
<term>Ventilation non effractive</term>
<term>Études multicentriques comme sujet</term>
</keywords>
<keywords scheme="Wicri" type="geographic" xml:lang="fr"><term>Danemark</term>
</keywords>
</textClass>
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</teiHeader>
<front><div type="abstract" xml:lang="en"><p><b>OBJECTIVES</b>
</p>
<p>The aim of this randomised GCP-controlled trial is to clarify whether combination therapy with the antibiotic azithromycin and hydroxychloroquine via anti-inflammation/immune modulation, antiviral efficacy and pre-emptive treatment of supra-infections can shorten hospitalisation duration for patients with COVID-19 (measured as "days alive and out of hospital" as the primary outcome), reduce the risk of non- invasive ventilation, treatment in the intensive care unit and death.</p>
</div>
<div type="abstract" xml:lang="en"><p><b>TRIAL DESIGN</b>
</p>
<p>This is a multi-centre, randomised, Placebo-controlled, 2-arm ratio 1:1, parallel group double-blind study.</p>
</div>
<div type="abstract" xml:lang="en"><p><b>PARTICIPANTS</b>
</p>
<p>226 participants are recruited at the trial sites/hospitals, where the study will take place in Denmark: Aalborg, Bispebjerg, Gentofte, Herlev, Hillerød, Hvidovre, Odense and Slagelse hospitals.</p>
</div>
<div type="abstract" xml:lang="en"><p><b>INCLUSION CRITERIA</b>
</p>
<p>• Patient admitted to Danish emergency departments, respiratory medicine departments or internal medicine departments • Age≥ 18 years • Hospitalized ≤48 hours • Positive COVID-19 test / diagnosis during the hospitalization (confirmed). • Men or non-fertile women. Fertile women* must not be pregnant, i.e. negative pregnancy test must be available at inclusion • Informed consent signed by the patient *Defined as after menarche and until postmenopausal (no menstruation for 12 months) Exclusion criteria: • At the time of recruitment, the patient uses >5 LO2/min (equivalent to 40% FiO2 if measured) • Known intolerance/allergy to azithromycin or hydroxychloroquine or hypersensitivity to quinine or 4-aminoquinoline derivatives • Neurogenic hearing loss • Psoriasis • Retinopathy • Maculopathy • Visual field changes • Breastfeeding • Severe liver diseases other than amoebiasis (INR> 1.5 spontaneously) • Severe gastrointestinal, neurological and hematological disorders (investigator-assessed) • eGFR <45 ml/min/1.73 m2 • Clinically significant cardiac conduction disorders/arrhythmias or prolonged QTc interval (QTc (f) of> 480/470 ms). • Myasthenia gravis • Treatment with digoxin* • Glucose-6-phosphate dehydrogenase deficiency • Porphyria • Hypoglycaemia (Blood glucose at any time since hospitalization of <3.0 mmol/L) • Severe mental illness which significantly impedes cooperation • Severe linguistic problems that significantly hinder cooperation • Treatment with ergot alkaloids *The patient must not be treated with digoxin for the duration of the intervention. For atrial fibrillation/flutter, select according to the Cardiovascular National Treatment Guide (NBV): Calcium antagonist, Beta blocker, direct current (DC) conversion or amiodarone. In case of urgent need for digoxin treatment (contraindication for the aforementioned equal alternatives), the test drug should be paused, and ECG should be taken daily.</p>
</div>
<div type="abstract" xml:lang="en"><p><b>INTERVENTION AND COMPARATOR</b>
</p>
<p>Control group: The control group will receive the standard treatment + placebo for both types of intervention medication at all times. If part or all the intervention therapy being investigated becomes standard treatment during the study, this may also be offered to the control group. Intervention group: The patients in the intervention group will also receive standard care. Immediately after randomisation to the intervention group, the patient will begin treatment with: Azithromycin: Day 1-3: 500 mg x 1 Day 4-15: 250 mg x 1 If the patient is unable to take the medication orally by themselves, the medication will, if possible, be administered by either stomach-feeding tube, or alternatively, temporary be changed to clarithromycin 500 mg x 2 (this only in agreement with either study coordinator Pradeesh Sivapalan or principal investigator Jens-Ulrik Stæhr Jensen). This will also be done in the control group if necessary. The patient will switch back to azithromycin when possible. Hydroxychloroquine: Furthermore, the patient will be treated with hydroxychloroquine as follows: Day 1-15: 200 mg x 2 MAIN OUTCOMES: • Number of days alive and discharged from hospital within 14 days (summarises both whether the patient is alive and discharged from hospital) ("Days alive and out of hospital") RANDOMISATION: The sponsor (Chronic Obstructive Pulmonary Disease Trial Network, COP:TRIN) generates a randomisation sequence. Randomisation will be in blocks of unknown size and the final allocation will be via an encrypted website (REDCap). There will be stratification for age (>70 years vs. <=70 years), site of recruitment and whether the patient has any of the following chronic lung diseases: COPD, asthma, bronchiectasis, interstitial lung disease (Yes vs. No).</p>
</div>
<div type="abstract" xml:lang="en"><p><b>BLINDING (MASKING)</b>
</p>
<p>Participants and study personnel will both be blinded, i.e. neither will know which group the participant is allocated to.</p>
</div>
<div type="abstract" xml:lang="en"><p><b>NUMBERS TO BE RANDOMISED (SAMPLE SIZE)</b>
</p>
<p>This study requires 226 patients randomised 1:1 with 113 in each group.</p>
</div>
<div type="abstract" xml:lang="en"><p><b>TRIAL STATUS</b>
</p>
<p>Protocol version 1.8, from April 16, 2020. Recruitment is ongoing (first patient recruited April 6, 2020; final patient expected to be recruited October 31, 2020).</p>
</div>
<div type="abstract" xml:lang="en"><p><b>TRIAL REGISTRATION</b>
</p>
<p>ClinicalTrials.gov Identifier: NCT04322396 (registered March 26, 2020) FULL PROTOCOL: The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol. The study protocol has been reported in accordance with the Standard Protocol Items: Recommendations for Clinical Interventional Trials (SPIRIT) guidelines (Additional file 2).</p>
</div>
</front>
</TEI>
<pubmed><MedlineCitation Status="MEDLINE" Owner="NLM"><PMID Version="1">32522282</PMID>
<DateCompleted><Year>2020</Year>
<Month>06</Month>
<Day>17</Day>
</DateCompleted>
<DateRevised><Year>2020</Year>
<Month>12</Month>
<Day>10</Day>
</DateRevised>
<Article PubModel="Electronic"><Journal><ISSN IssnType="Electronic">1745-6215</ISSN>
<JournalIssue CitedMedium="Internet"><Volume>21</Volume>
<Issue>1</Issue>
<PubDate><Year>2020</Year>
<Month>Jun</Month>
<Day>10</Day>
</PubDate>
</JournalIssue>
<Title>Trials</Title>
<ISOAbbreviation>Trials</ISOAbbreviation>
</Journal>
<ArticleTitle>Proactive Prophylaxis With Azithromycin and HydroxyChloroquine in Hospitalised Patients With COVID-19 (ProPAC-COVID): A structured summary of a study protocol for a randomised controlled trial.</ArticleTitle>
<Pagination><MedlinePgn>513</MedlinePgn>
</Pagination>
<ELocationID EIdType="doi" ValidYN="Y">10.1186/s13063-020-04409-9</ELocationID>
<Abstract><AbstractText Label="OBJECTIVES" NlmCategory="OBJECTIVE">The aim of this randomised GCP-controlled trial is to clarify whether combination therapy with the antibiotic azithromycin and hydroxychloroquine via anti-inflammation/immune modulation, antiviral efficacy and pre-emptive treatment of supra-infections can shorten hospitalisation duration for patients with COVID-19 (measured as "days alive and out of hospital" as the primary outcome), reduce the risk of non- invasive ventilation, treatment in the intensive care unit and death.</AbstractText>
<AbstractText Label="TRIAL DESIGN" NlmCategory="METHODS">This is a multi-centre, randomised, Placebo-controlled, 2-arm ratio 1:1, parallel group double-blind study.</AbstractText>
<AbstractText Label="PARTICIPANTS" NlmCategory="METHODS">226 participants are recruited at the trial sites/hospitals, where the study will take place in Denmark: Aalborg, Bispebjerg, Gentofte, Herlev, Hillerød, Hvidovre, Odense and Slagelse hospitals.</AbstractText>
<AbstractText Label="INCLUSION CRITERIA" NlmCategory="METHODS">• Patient admitted to Danish emergency departments, respiratory medicine departments or internal medicine departments • Age≥ 18 years • Hospitalized ≤48 hours • Positive COVID-19 test / diagnosis during the hospitalization (confirmed). • Men or non-fertile women. Fertile women* must not be pregnant, i.e. negative pregnancy test must be available at inclusion • Informed consent signed by the patient *Defined as after menarche and until postmenopausal (no menstruation for 12 months) Exclusion criteria: • At the time of recruitment, the patient uses >5 LO2/min (equivalent to 40% FiO2 if measured) • Known intolerance/allergy to azithromycin or hydroxychloroquine or hypersensitivity to quinine or 4-aminoquinoline derivatives • Neurogenic hearing loss • Psoriasis • Retinopathy • Maculopathy • Visual field changes • Breastfeeding • Severe liver diseases other than amoebiasis (INR> 1.5 spontaneously) • Severe gastrointestinal, neurological and hematological disorders (investigator-assessed) • eGFR <45 ml/min/1.73 m2 • Clinically significant cardiac conduction disorders/arrhythmias or prolonged QTc interval (QTc (f) of> 480/470 ms). • Myasthenia gravis • Treatment with digoxin* • Glucose-6-phosphate dehydrogenase deficiency • Porphyria • Hypoglycaemia (Blood glucose at any time since hospitalization of <3.0 mmol/L) • Severe mental illness which significantly impedes cooperation • Severe linguistic problems that significantly hinder cooperation • Treatment with ergot alkaloids *The patient must not be treated with digoxin for the duration of the intervention. For atrial fibrillation/flutter, select according to the Cardiovascular National Treatment Guide (NBV): Calcium antagonist, Beta blocker, direct current (DC) conversion or amiodarone. In case of urgent need for digoxin treatment (contraindication for the aforementioned equal alternatives), the test drug should be paused, and ECG should be taken daily.</AbstractText>
<AbstractText Label="INTERVENTION AND COMPARATOR" NlmCategory="UNASSIGNED">Control group: The control group will receive the standard treatment + placebo for both types of intervention medication at all times. If part or all the intervention therapy being investigated becomes standard treatment during the study, this may also be offered to the control group. Intervention group: The patients in the intervention group will also receive standard care. Immediately after randomisation to the intervention group, the patient will begin treatment with: Azithromycin: Day 1-3: 500 mg x 1 Day 4-15: 250 mg x 1 If the patient is unable to take the medication orally by themselves, the medication will, if possible, be administered by either stomach-feeding tube, or alternatively, temporary be changed to clarithromycin 500 mg x 2 (this only in agreement with either study coordinator Pradeesh Sivapalan or principal investigator Jens-Ulrik Stæhr Jensen). This will also be done in the control group if necessary. The patient will switch back to azithromycin when possible. Hydroxychloroquine: Furthermore, the patient will be treated with hydroxychloroquine as follows: Day 1-15: 200 mg x 2 MAIN OUTCOMES: • Number of days alive and discharged from hospital within 14 days (summarises both whether the patient is alive and discharged from hospital) ("Days alive and out of hospital") RANDOMISATION: The sponsor (Chronic Obstructive Pulmonary Disease Trial Network, COP:TRIN) generates a randomisation sequence. Randomisation will be in blocks of unknown size and the final allocation will be via an encrypted website (REDCap). There will be stratification for age (>70 years vs. <=70 years), site of recruitment and whether the patient has any of the following chronic lung diseases: COPD, asthma, bronchiectasis, interstitial lung disease (Yes vs. No).</AbstractText>
<AbstractText Label="BLINDING (MASKING)" NlmCategory="UNASSIGNED">Participants and study personnel will both be blinded, i.e. neither will know which group the participant is allocated to.</AbstractText>
<AbstractText Label="NUMBERS TO BE RANDOMISED (SAMPLE SIZE)" NlmCategory="UNASSIGNED">This study requires 226 patients randomised 1:1 with 113 in each group.</AbstractText>
<AbstractText Label="TRIAL STATUS" NlmCategory="UNASSIGNED">Protocol version 1.8, from April 16, 2020. Recruitment is ongoing (first patient recruited April 6, 2020; final patient expected to be recruited October 31, 2020).</AbstractText>
<AbstractText Label="TRIAL REGISTRATION" NlmCategory="BACKGROUND">ClinicalTrials.gov Identifier: NCT04322396 (registered March 26, 2020) FULL PROTOCOL: The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol. The study protocol has been reported in accordance with the Standard Protocol Items: Recommendations for Clinical Interventional Trials (SPIRIT) guidelines (Additional file 2).</AbstractText>
</Abstract>
<AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Sivapalan</LastName>
<ForeName>Pradeesh</ForeName>
<Initials>P</Initials>
<AffiliationInfo><Affiliation>Section of Respiratory Medicine, Department of Medicine, Herlev and Gentofte Hospital University of Copenhagen, Hellerup, Denmark.</Affiliation>
</AffiliationInfo>
<AffiliationInfo><Affiliation>Department of Internal Medicine, Zealand University Hospital, Roskilde, Denmark.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Ulrik</LastName>
<ForeName>Charlotte Suppli</ForeName>
<Initials>CS</Initials>
<AffiliationInfo><Affiliation>Department of Respiratory Medicine, Amager and Hvidovre Hospital University of Copenhagen, Hvidovre, Denmark.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Bojesen</LastName>
<ForeName>Rasmus Dahlin</ForeName>
<Initials>RD</Initials>
<AffiliationInfo><Affiliation>Department of Surgery, Næstved-Slagelse- Ringsted Hospitals University of Southern Denmark, Slagelse, Denmark.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Lapperre</LastName>
<ForeName>Therese Sophie</ForeName>
<Initials>TS</Initials>
<AffiliationInfo><Affiliation>Department of Respiratory Medicine, Bispebjerg and Frederiksberg Hospital University of Copenhagen, Copenhagen, Denmark.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Eklöf</LastName>
<ForeName>Josefin Viktoria</ForeName>
<Initials>JV</Initials>
<AffiliationInfo><Affiliation>Section of Respiratory Medicine, Department of Medicine, Herlev and Gentofte Hospital University of Copenhagen, Hellerup, Denmark.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Håkansson</LastName>
<ForeName>Kjell Erik Julius</ForeName>
<Initials>KEJ</Initials>
<AffiliationInfo><Affiliation>Department of Respiratory Medicine, Amager and Hvidovre Hospital University of Copenhagen, Hvidovre, Denmark.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Browatzki</LastName>
<ForeName>Andrea</ForeName>
<Initials>A</Initials>
<AffiliationInfo><Affiliation>Department of Respiratory and Infectious Diseases, Nordsjællands Hospital University of Copenhagen, Hillerød, Denmark.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Tidemansen</LastName>
<ForeName>Casper</ForeName>
<Initials>C</Initials>
<AffiliationInfo><Affiliation>Department of Respiratory Medicine, Amager and Hvidovre Hospital University of Copenhagen, Hvidovre, Denmark.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Wilcke</LastName>
<ForeName>Jon Torgny</ForeName>
<Initials>JT</Initials>
<AffiliationInfo><Affiliation>Section of Respiratory Medicine, Department of Medicine, Herlev and Gentofte Hospital University of Copenhagen, Hellerup, Denmark.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Janner</LastName>
<ForeName>Julie</ForeName>
<Initials>J</Initials>
<AffiliationInfo><Affiliation>Department of Respiratory Medicine, Amager and Hvidovre Hospital University of Copenhagen, Hvidovre, Denmark.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Gottlieb</LastName>
<ForeName>Vibeke</ForeName>
<Initials>V</Initials>
<AffiliationInfo><Affiliation>Section of Respiratory Medicine, Department of Medicine, Herlev and Gentofte Hospital University of Copenhagen, Hellerup, Denmark.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Meteran</LastName>
<ForeName>Howraman</ForeName>
<Initials>H</Initials>
<AffiliationInfo><Affiliation>Section of Respiratory Medicine, Department of Medicine, Herlev and Gentofte Hospital University of Copenhagen, Hellerup, Denmark.</Affiliation>
</AffiliationInfo>
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<Initials>C</Initials>
<AffiliationInfo><Affiliation>Department of Respiratory Medicine, Bispebjerg and Frederiksberg Hospital University of Copenhagen, Copenhagen, Denmark.</Affiliation>
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</Author>
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<AffiliationInfo><Affiliation>Department of Respiratory and Infectious Diseases, Nordsjællands Hospital University of Copenhagen, Hillerød, Denmark.</Affiliation>
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<AffiliationInfo><Affiliation>Department of Respiratory Medicine, Bispebjerg and Frederiksberg Hospital University of Copenhagen, Copenhagen, Denmark.</Affiliation>
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<AffiliationInfo><Affiliation>Dep. of Infectious Diseases, Amager and Hvidovre Hospital University of Copenhagen, Hvidovre, Denmark.</Affiliation>
</AffiliationInfo>
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<AffiliationInfo><Affiliation>Department of Infectious Diseases, Rigshospitalet University of Copenhagen, Copenhagen, Denmark.</Affiliation>
</AffiliationInfo>
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<AffiliationInfo><Affiliation>Department of Clinical Metabolic Research, Herlev and Gentofte Hospital University of Copenhagen, Hellerup, Denmark.</Affiliation>
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</Author>
<Author ValidYN="Y"><LastName>Biering-Sørensen</LastName>
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<Initials>T</Initials>
<AffiliationInfo><Affiliation>Department of Cardiology, Herlev and Gentofte Hospital University of Copenhagen, Hellerup, Denmark.</Affiliation>
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<ForeName>Muzhda</ForeName>
<Initials>M</Initials>
<AffiliationInfo><Affiliation>Department of Respiratory Medicine, Bispebjerg and Frederiksberg Hospital University of Copenhagen, Copenhagen, Denmark.</Affiliation>
</AffiliationInfo>
</Author>
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<ForeName>Tine Peick</ForeName>
<Initials>TP</Initials>
<AffiliationInfo><Affiliation>Section of Respiratory Medicine, Department of Medicine, Herlev and Gentofte Hospital University of Copenhagen, Hellerup, Denmark.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Bødtger</LastName>
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<Initials>UCS</Initials>
<AffiliationInfo><Affiliation>Department of Internal Medicine, Zealand University Hospital, Roskilde, Denmark.</Affiliation>
</AffiliationInfo>
<AffiliationInfo><Affiliation>Department of Respiratory Medicine, Næstved-Slagelse-Ringsted Hospitals University of Southern Denmark, Slagelse, Denmark.</Affiliation>
</AffiliationInfo>
<AffiliationInfo><Affiliation>Institute for Regional Health Research University of Southern Denmark, Odense, Denmark.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Jensen</LastName>
<ForeName>Sidse Graff</ForeName>
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<AffiliationInfo><Affiliation>Section of Respiratory Medicine, Department of Medicine, Herlev and Gentofte Hospital University of Copenhagen, Hellerup, Denmark.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Rasmussen</LastName>
<ForeName>Daniel Bech</ForeName>
<Initials>DB</Initials>
<AffiliationInfo><Affiliation>Department of Respiratory Medicine, Næstved-Slagelse-Ringsted Hospitals University of Southern Denmark, Slagelse, Denmark.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Brøndum</LastName>
<ForeName>Eva</ForeName>
<Initials>E</Initials>
<AffiliationInfo><Affiliation>Department of Respiratory Medicine, Amager and Hvidovre Hospital University of Copenhagen, Hvidovre, Denmark.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Tupper</LastName>
<ForeName>Oliver Djurhuus</ForeName>
<Initials>OD</Initials>
<AffiliationInfo><Affiliation>Department of Respiratory Medicine, Amager and Hvidovre Hospital University of Copenhagen, Hvidovre, Denmark.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Sørensen</LastName>
<ForeName>Susanne Wiemann</ForeName>
<Initials>SW</Initials>
<AffiliationInfo><Affiliation>Department of Respiratory Medicine, Amager and Hvidovre Hospital University of Copenhagen, Hvidovre, Denmark.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Alstrup</LastName>
<ForeName>Gitte</ForeName>
<Initials>G</Initials>
<AffiliationInfo><Affiliation>Department of Respiratory Medicine, Næstved-Slagelse-Ringsted Hospitals University of Southern Denmark, Slagelse, Denmark.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Laursen</LastName>
<ForeName>Christian Borbjerg</ForeName>
<Initials>CB</Initials>
<AffiliationInfo><Affiliation>Department of Respiratory Medicine, Odense University Hospital University of Southern Denmark, Odense, Denmark.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Møller</LastName>
<ForeName>Ulla Weinrich</ForeName>
<Initials>UW</Initials>
<AffiliationInfo><Affiliation>Department of Respiratory Medicine, Aalborg University Hospital University of Aalborg, Aalborg, Denmark.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Sverrild</LastName>
<ForeName>Asger</ForeName>
<Initials>A</Initials>
<AffiliationInfo><Affiliation>Department of Respiratory Medicine, Bispebjerg and Frederiksberg Hospital University of Copenhagen, Copenhagen, Denmark.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Jensen</LastName>
<ForeName>Jens-Ulrik Stæhr</ForeName>
<Initials>JS</Initials>
<Identifier Source="ORCID">http://orcid.org/0000-0003-4036-0521</Identifier>
<AffiliationInfo><Affiliation>Section of Respiratory Medicine, Department of Medicine, Herlev and Gentofte Hospital University of Copenhagen, Hellerup, Denmark. jens.ulrik.jensen@regionh.dk.</Affiliation>
</AffiliationInfo>
</Author>
</AuthorList>
<Language>eng</Language>
<DataBankList CompleteYN="Y"><DataBank><DataBankName>ClinicalTrials.gov</DataBankName>
<AccessionNumberList><AccessionNumber>NCT04322396</AccessionNumber>
</AccessionNumberList>
</DataBank>
</DataBankList>
<GrantList CompleteYN="Y"><Grant><GrantID>NNF20SA0062834</GrantID>
<Agency>Novo Nordisk Fonden</Agency>
<Country></Country>
</Grant>
</GrantList>
<PublicationTypeList><PublicationType UI="D000078325">Clinical Trial Protocol</PublicationType>
<PublicationType UI="D016422">Letter</PublicationType>
</PublicationTypeList>
<ArticleDate DateType="Electronic"><Year>2020</Year>
<Month>06</Month>
<Day>10</Day>
</ArticleDate>
</Article>
<MedlineJournalInfo><Country>England</Country>
<MedlineTA>Trials</MedlineTA>
<NlmUniqueID>101263253</NlmUniqueID>
<ISSNLinking>1745-6215</ISSNLinking>
</MedlineJournalInfo>
<ChemicalList><Chemical><RegistryNumber>0</RegistryNumber>
<NameOfSubstance UI="D000998">Antiviral Agents</NameOfSubstance>
</Chemical>
<Chemical><RegistryNumber>4QWG6N8QKH</RegistryNumber>
<NameOfSubstance UI="D006886">Hydroxychloroquine</NameOfSubstance>
</Chemical>
<Chemical><RegistryNumber>83905-01-5</RegistryNumber>
<NameOfSubstance UI="D017963">Azithromycin</NameOfSubstance>
</Chemical>
</ChemicalList>
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<QualifierName UI="Q000008" MajorTopicYN="Y">administration & dosage</QualifierName>
<QualifierName UI="Q000009" MajorTopicYN="N">adverse effects</QualifierName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D017963" MajorTopicYN="N">Azithromycin</DescriptorName>
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<QualifierName UI="Q000009" MajorTopicYN="N">adverse effects</QualifierName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D000073640" MajorTopicYN="N">Betacoronavirus</DescriptorName>
<QualifierName UI="Q000187" MajorTopicYN="Y">drug effects</QualifierName>
<QualifierName UI="Q000472" MajorTopicYN="N">pathogenicity</QualifierName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D000086382" MajorTopicYN="N">COVID-19</DescriptorName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D018352" MajorTopicYN="N">Coronavirus Infections</DescriptorName>
<QualifierName UI="Q000175" MajorTopicYN="N">diagnosis</QualifierName>
<QualifierName UI="Q000188" MajorTopicYN="Y">drug therapy</QualifierName>
<QualifierName UI="Q000401" MajorTopicYN="N">mortality</QualifierName>
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</MeshHeading>
<MeshHeading><DescriptorName UI="D004334" MajorTopicYN="N">Drug Administration Schedule</DescriptorName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D017052" MajorTopicYN="N">Hospital Mortality</DescriptorName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D054884" MajorTopicYN="N">Host-Pathogen Interactions</DescriptorName>
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<MeshHeading><DescriptorName UI="D006801" MajorTopicYN="N">Humans</DescriptorName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D006886" MajorTopicYN="N">Hydroxychloroquine</DescriptorName>
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</MeshHeading>
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<MeshHeading><DescriptorName UI="D015337" MajorTopicYN="N">Multicenter Studies as Topic</DescriptorName>
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<QualifierName UI="Q000401" MajorTopicYN="N">mortality</QualifierName>
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</MeshHeading>
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<KeywordList Owner="NOTNLM"><Keyword MajorTopicYN="N">COVID-19</Keyword>
<Keyword MajorTopicYN="N">Randomised controlled trial</Keyword>
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<Keyword MajorTopicYN="N">hydroxychloroquine</Keyword>
<Keyword MajorTopicYN="N">protocol</Keyword>
<Keyword MajorTopicYN="N">respiratory infections</Keyword>
</KeywordList>
</MedlineCitation>
<PubmedData><History><PubMedPubDate PubStatus="received"><Year>2020</Year>
<Month>05</Month>
<Day>07</Day>
</PubMedPubDate>
<PubMedPubDate PubStatus="accepted"><Year>2020</Year>
<Month>05</Month>
<Day>14</Day>
</PubMedPubDate>
<PubMedPubDate PubStatus="entrez"><Year>2020</Year>
<Month>6</Month>
<Day>12</Day>
<Hour>6</Hour>
<Minute>0</Minute>
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<PubMedPubDate PubStatus="pubmed"><Year>2020</Year>
<Month>6</Month>
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<Hour>6</Hour>
<Minute>0</Minute>
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<PubMedPubDate PubStatus="medline"><Year>2020</Year>
<Month>6</Month>
<Day>18</Day>
<Hour>6</Hour>
<Minute>0</Minute>
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<ArticleIdList><ArticleId IdType="pubmed">32522282</ArticleId>
<ArticleId IdType="doi">10.1186/s13063-020-04409-9</ArticleId>
<ArticleId IdType="pii">10.1186/s13063-020-04409-9</ArticleId>
<ArticleId IdType="pmc">PMC7284668</ArticleId>
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</pubmed>
<affiliations><list><country><li>Danemark</li>
</country>
<region><li>Hovedstaden</li>
</region>
<settlement><li>Copenhague</li>
</settlement>
</list>
<tree><country name="Danemark"><noRegion><name sortKey="Sivapalan, Pradeesh" sort="Sivapalan, Pradeesh" uniqKey="Sivapalan P" first="Pradeesh" last="Sivapalan">Pradeesh Sivapalan</name>
</noRegion>
<name sortKey="Alstrup, Gitte" sort="Alstrup, Gitte" uniqKey="Alstrup G" first="Gitte" last="Alstrup">Gitte Alstrup</name>
<name sortKey="B Dtger, Uffe Christian Steinholtz" sort="B Dtger, Uffe Christian Steinholtz" uniqKey="B Dtger U" first="Uffe Christian Steinholtz" last="B Dtger">Uffe Christian Steinholtz B Dtger</name>
<name sortKey="B Dtger, Uffe Christian Steinholtz" sort="B Dtger, Uffe Christian Steinholtz" uniqKey="B Dtger U" first="Uffe Christian Steinholtz" last="B Dtger">Uffe Christian Steinholtz B Dtger</name>
<name sortKey="B Dtger, Uffe Christian Steinholtz" sort="B Dtger, Uffe Christian Steinholtz" uniqKey="B Dtger U" first="Uffe Christian Steinholtz" last="B Dtger">Uffe Christian Steinholtz B Dtger</name>
<name sortKey="Benfield, Thomas Lars" sort="Benfield, Thomas Lars" uniqKey="Benfield T" first="Thomas Lars" last="Benfield">Thomas Lars Benfield</name>
<name sortKey="Biering S Rensen, Tor" sort="Biering S Rensen, Tor" uniqKey="Biering S Rensen T" first="Tor" last="Biering-S Rensen">Tor Biering-S Rensen</name>
<name sortKey="Bojesen, Rasmus Dahlin" sort="Bojesen, Rasmus Dahlin" uniqKey="Bojesen R" first="Rasmus Dahlin" last="Bojesen">Rasmus Dahlin Bojesen</name>
<name sortKey="Br Ndum, Eva" sort="Br Ndum, Eva" uniqKey="Br Ndum E" first="Eva" last="Br Ndum">Eva Br Ndum</name>
<name sortKey="Browatzki, Andrea" sort="Browatzki, Andrea" uniqKey="Browatzki A" first="Andrea" last="Browatzki">Andrea Browatzki</name>
<name sortKey="Eklof, Josefin Viktoria" sort="Eklof, Josefin Viktoria" uniqKey="Eklof J" first="Josefin Viktoria" last="Eklöf">Josefin Viktoria Eklöf</name>
<name sortKey="Ghanizada, Muzhda" sort="Ghanizada, Muzhda" uniqKey="Ghanizada M" first="Muzhda" last="Ghanizada">Muzhda Ghanizada</name>
<name sortKey="Gottlieb, Vibeke" sort="Gottlieb, Vibeke" uniqKey="Gottlieb V" first="Vibeke" last="Gottlieb">Vibeke Gottlieb</name>
<name sortKey="H Kansson, Kjell Erik Julius" sort="H Kansson, Kjell Erik Julius" uniqKey="H Kansson K" first="Kjell Erik Julius" last="H Kansson">Kjell Erik Julius H Kansson</name>
<name sortKey="Janner, Julie" sort="Janner, Julie" uniqKey="Janner J" first="Julie" last="Janner">Julie Janner</name>
<name sortKey="Jensen, Jens Ulrik St Hr" sort="Jensen, Jens Ulrik St Hr" uniqKey="Jensen J" first="Jens-Ulrik St Hr" last="Jensen">Jens-Ulrik St Hr Jensen</name>
<name sortKey="Jensen, Sidse Graff" sort="Jensen, Sidse Graff" uniqKey="Jensen S" first="Sidse Graff" last="Jensen">Sidse Graff Jensen</name>
<name sortKey="Knop, Filip Krag" sort="Knop, Filip Krag" uniqKey="Knop F" first="Filip Krag" last="Knop">Filip Krag Knop</name>
<name sortKey="Lapperre, Therese Sophie" sort="Lapperre, Therese Sophie" uniqKey="Lapperre T" first="Therese Sophie" last="Lapperre">Therese Sophie Lapperre</name>
<name sortKey="Laursen, Christian Borbjerg" sort="Laursen, Christian Borbjerg" uniqKey="Laursen C" first="Christian Borbjerg" last="Laursen">Christian Borbjerg Laursen</name>
<name sortKey="Lundgren, Jens Dilling" sort="Lundgren, Jens Dilling" uniqKey="Lundgren J" first="Jens Dilling" last="Lundgren">Jens Dilling Lundgren</name>
<name sortKey="M Ller, Ulla Weinrich" sort="M Ller, Ulla Weinrich" uniqKey="M Ller U" first="Ulla Weinrich" last="M Ller">Ulla Weinrich M Ller</name>
<name sortKey="Madsen, Birgitte Lindegaard" sort="Madsen, Birgitte Lindegaard" uniqKey="Madsen B" first="Birgitte Lindegaard" last="Madsen">Birgitte Lindegaard Madsen</name>
<name sortKey="Meteran, Howraman" sort="Meteran, Howraman" uniqKey="Meteran H" first="Howraman" last="Meteran">Howraman Meteran</name>
<name sortKey="Moberg, Mia" sort="Moberg, Mia" uniqKey="Moberg M" first="Mia" last="Moberg">Mia Moberg</name>
<name sortKey="Pedersen, Lars" sort="Pedersen, Lars" uniqKey="Pedersen L" first="Lars" last="Pedersen">Lars Pedersen</name>
<name sortKey="Porsbjerg, Celeste" sort="Porsbjerg, Celeste" uniqKey="Porsbjerg C" first="Celeste" last="Porsbjerg">Celeste Porsbjerg</name>
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<name sortKey="S Rensen, Susanne Wiemann" sort="S Rensen, Susanne Wiemann" uniqKey="S Rensen S" first="Susanne Wiemann" last="S Rensen">Susanne Wiemann S Rensen</name>
<name sortKey="Sivapalan, Pradeesh" sort="Sivapalan, Pradeesh" uniqKey="Sivapalan P" first="Pradeesh" last="Sivapalan">Pradeesh Sivapalan</name>
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<name sortKey="Sverrild, Asger" sort="Sverrild, Asger" uniqKey="Sverrild A" first="Asger" last="Sverrild">Asger Sverrild</name>
<name sortKey="Tidemansen, Casper" sort="Tidemansen, Casper" uniqKey="Tidemansen C" first="Casper" last="Tidemansen">Casper Tidemansen</name>
<name sortKey="Tupper, Oliver Djurhuus" sort="Tupper, Oliver Djurhuus" uniqKey="Tupper O" first="Oliver Djurhuus" last="Tupper">Oliver Djurhuus Tupper</name>
<name sortKey="Ulrik, Charlotte Suppli" sort="Ulrik, Charlotte Suppli" uniqKey="Ulrik C" first="Charlotte Suppli" last="Ulrik">Charlotte Suppli Ulrik</name>
<name sortKey="Wilcke, Jon Torgny" sort="Wilcke, Jon Torgny" uniqKey="Wilcke J" first="Jon Torgny" last="Wilcke">Jon Torgny Wilcke</name>
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