Treatment of Middle East Respiratory Syndrome with a combination of lopinavir-ritonavir and interferon-β1b (MIRACLE trial): study protocol for a randomized controlled trial
Identifieur interne : 000770 ( Main/Exploration ); précédent : 000769; suivant : 000771Treatment of Middle East Respiratory Syndrome with a combination of lopinavir-ritonavir and interferon-β1b (MIRACLE trial): study protocol for a randomized controlled trial
Auteurs : Yaseen M. Arabi [Arabie saoudite] ; Adel Alothman [Arabie saoudite] ; Hanan H. Balkhy [Arabie saoudite] ; Abdulaziz Al-Dawood [Arabie saoudite] ; Sameera Aljohani [Arabie saoudite] ; Shmeylan Al Harbi [Arabie saoudite] ; Suleiman Kojan [Arabie saoudite] ; Majed Al Jeraisy [Arabie saoudite] ; Ahmad M. Deeb [Arabie saoudite] ; Abdullah M. Assiri [Arabie saoudite] ; Fahad Al-Hameed [Arabie saoudite] ; Asim Alsaedi [Arabie saoudite] ; Yasser Mandourah [Arabie saoudite] ; Ghaleb A. Almekhlafi [Arabie saoudite] ; Nisreen Murad Sherbeeni [Arabie saoudite] ; Fatehi Elnour Elzein [Arabie saoudite] ; Javed Memon [Arabie saoudite] ; Yusri Taha [Arabie saoudite] ; Abdullah Almotairi [Arabie saoudite] ; Khalid A. Maghrabi [Arabie saoudite] ; Ismael Qushmaq [Arabie saoudite] ; Ali Al Bshabshe [Arabie saoudite] ; Ayman Kharaba [Arabie saoudite] ; Sarah Shalhoub [Arabie saoudite] ; Jesna Jose [Arabie saoudite] ; Robert A. Fowler ; Frederick G. Hayden [États-Unis] ; Mohamed A. Hussein [Arabie saoudite]Source :
- Trials [ 1745-6215 ] ; 2018.
Descripteurs français
- KwdFr :
- Admission du patient, Antiviraux (effets indésirables), Antiviraux (usage thérapeutique), Arabie saoudite, Association de médicaments, Association médicamenteuse, Coronavirus du syndrome respiratoire du Moyen-Orient (), Coronavirus du syndrome respiratoire du Moyen-Orient (pathogénicité), Essais contrôlés randomisés comme sujet, Facteurs temps, Femelle, Humains, Infections à coronavirus (diagnostic), Infections à coronavirus (traitement médicamenteux), Infections à coronavirus (virologie), Interféron bêta-1b (effets indésirables), Interféron bêta-1b (usage thérapeutique), Lopinavir (effets indésirables), Lopinavir (usage thérapeutique), Mâle, Méthode en double aveugle, Ritonavir (effets indésirables), Ritonavir (usage thérapeutique), Résultat thérapeutique, Études multicentriques comme sujet.
- MESH :
- diagnostic : Infections à coronavirus.
- effets indésirables : Antiviraux, Interféron bêta-1b, Lopinavir, Ritonavir.
- pathogénicité : Coronavirus du syndrome respiratoire du Moyen-Orient.
- traitement médicamenteux : Infections à coronavirus.
- usage thérapeutique : Antiviraux, Interféron bêta-1b, Lopinavir, Ritonavir.
- virologie : Infections à coronavirus.
- Admission du patient, Arabie saoudite, Association de médicaments, Association médicamenteuse, Coronavirus du syndrome respiratoire du Moyen-Orient, Essais contrôlés randomisés comme sujet, Facteurs temps, Femelle, Humains, Mâle, Méthode en double aveugle, Résultat thérapeutique, Études multicentriques comme sujet.
- Wicri :
- geographic : Arabie saoudite.
English descriptors
- KwdEn :
- Antiviral Agents (adverse effects), Antiviral Agents (therapeutic use), Coronavirus Infections (diagnosis), Coronavirus Infections (drug therapy), Coronavirus Infections (virology), Double-Blind Method, Drug Combinations, Drug Therapy, Combination, Female, Humans, Interferon beta-1b (adverse effects), Interferon beta-1b (therapeutic use), Lopinavir (adverse effects), Lopinavir (therapeutic use), Male, Middle East Respiratory Syndrome Coronavirus (drug effects), Middle East Respiratory Syndrome Coronavirus (pathogenicity), Multicenter Studies as Topic, Patient Admission, Randomized Controlled Trials as Topic, Ritonavir (adverse effects), Ritonavir (therapeutic use), Saudi Arabia, Time Factors, Treatment Outcome.
- MESH :
- chemical , adverse effects : Antiviral Agents, Interferon beta-1b, Lopinavir, Ritonavir.
- chemical , therapeutic use : Antiviral Agents, Interferon beta-1b, Lopinavir, Ritonavir.
- geographic : Saudi Arabia.
- diagnosis : Coronavirus Infections.
- drug effects : Middle East Respiratory Syndrome Coronavirus.
- drug therapy : Coronavirus Infections.
- pathogenicity : Middle East Respiratory Syndrome Coronavirus.
- virology : Coronavirus Infections.
- Double-Blind Method, Drug Combinations, Drug Therapy, Combination, Female, Humans, Male, Multicenter Studies as Topic, Patient Admission, Randomized Controlled Trials as Topic, Time Factors, Treatment Outcome.
Abstract
It had been more than 5 years since the first case of Middle East Respiratory Syndrome coronavirus infection (MERS-CoV) was recorded, but no specific treatment has been investigated in randomized clinical trials. Results from in vitro and animal studies suggest that a combination of lopinavir/ritonavir and interferon-β1b (IFN-β1b) may be effective against MERS-CoV. The aim of this study is to investigate the efficacy of treatment with a combination of lopinavir/ritonavir and recombinant IFN-β1b provided with standard supportive care, compared to treatment with placebo provided with standard supportive care in patients with laboratory-confirmed MERS requiring hospital admission.
The protocol is prepared in accordance with the SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) guidelines. Hospitalized adult patients with laboratory-confirmed MERS will be enrolled in this recursive, two-stage, group sequential, multicenter, placebo-controlled, double-blind randomized controlled trial. The trial is initially designed to include 2 two-stage components. The first two-stage component is designed to adjust sample size and determine futility stopping, but not efficacy stopping. The second two-stage component is designed to determine efficacy stopping and possibly readjustment of sample size. The primary outcome is 90-day mortality.
This will be the first randomized controlled trial of a potential treatment for MERS. The study is sponsored by King Abdullah International Medical Research Center, Riyadh, Saudi Arabia. Enrollment for this study began in November 2016, and has enrolled thirteen patients as of Jan 24-2018.
ClinicalTrials.gov, ID:
The online version of this article (doi:10.1186/s13063-017-2427-0) contains supplementary material, which is available to authorized users.
Url:
DOI: 10.1186/s13063-017-2427-0
PubMed: 29382391
PubMed Central: 5791210
Affiliations:
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Arabi</name><affiliation wicri:level="1"><nlm:aff id="Aff1"><institution-wrap><institution-id institution-id-type="ISNI">0000 0004 0580 0891</institution-id><institution-id institution-id-type="GRID">grid.452607.2</institution-id><institution>College of Medicine, King Saud Bin Abdulaziz University for Health Sciences,</institution><institution>King Abdullah International Medical Research Center,</institution></institution-wrap>Riyadh, Saudi Arabia</nlm:aff><country xml:lang="fr">Arabie saoudite</country><wicri:regionArea>Riyadh</wicri:regionArea></affiliation><affiliation wicri:level="1"><nlm:aff id="Aff2"><institution-wrap><institution-id institution-id-type="ISNI">0000 0004 1790 7311</institution-id><institution-id institution-id-type="GRID">grid.415254.3</institution-id><institution>Intensive Care Department,</institution><institution>King Abdulaziz Medical City,</institution></institution-wrap>Riyadh, Saudi Arabia</nlm:aff><country xml:lang="fr">Arabie saoudite</country><wicri:regionArea>Riyadh</wicri:regionArea></affiliation><affiliation><nlm:aff id="Aff27"><institution-wrap><institution-id institution-id-type="ISNI">0000 0004 1936 8948</institution-id><institution-id institution-id-type="GRID">grid.4991.5</institution-id><institution>International Severe Acute Respiratory and Emerging Infection Consortium (ISARIC) University of Oxford, Old Road Campus, Roosevelt Drive,</institution></institution-wrap>Oxford, OX3 7FZ UK</nlm:aff><wicri:noCountry code="subfield">OX3 7FZ UK</wicri:noCountry></affiliation></author><author><name sortKey="Alothman, Adel" sort="Alothman, Adel" uniqKey="Alothman A" first="Adel" last="Alothman">Adel Alothman</name><affiliation wicri:level="1"><nlm:aff id="Aff1"><institution-wrap><institution-id institution-id-type="ISNI">0000 0004 0580 0891</institution-id><institution-id institution-id-type="GRID">grid.452607.2</institution-id><institution>College of Medicine, King Saud Bin Abdulaziz University for Health Sciences,</institution><institution>King Abdullah International Medical Research Center,</institution></institution-wrap>Riyadh, Saudi Arabia</nlm:aff><country xml:lang="fr">Arabie saoudite</country><wicri:regionArea>Riyadh</wicri:regionArea></affiliation><affiliation wicri:level="1"><nlm:aff id="Aff3"><institution-wrap><institution-id institution-id-type="ISNI">0000 0004 1790 7311</institution-id><institution-id institution-id-type="GRID">grid.415254.3</institution-id><institution>Department of Medicine,</institution><institution>King Abdulaziz Medical City,</institution></institution-wrap>Riyadh, Saudi Arabia</nlm:aff><country xml:lang="fr">Arabie saoudite</country><wicri:regionArea>Riyadh</wicri:regionArea></affiliation></author><author><name sortKey="Balkhy, Hanan H" sort="Balkhy, Hanan H" uniqKey="Balkhy H" first="Hanan H." last="Balkhy">Hanan H. Balkhy</name><affiliation wicri:level="1"><nlm:aff id="Aff1"><institution-wrap><institution-id institution-id-type="ISNI">0000 0004 0580 0891</institution-id><institution-id institution-id-type="GRID">grid.452607.2</institution-id><institution>College of Medicine, King Saud Bin Abdulaziz University for Health Sciences,</institution><institution>King Abdullah International Medical Research Center,</institution></institution-wrap>Riyadh, Saudi Arabia</nlm:aff><country xml:lang="fr">Arabie saoudite</country><wicri:regionArea>Riyadh</wicri:regionArea></affiliation><affiliation wicri:level="1"><nlm:aff id="Aff4"><institution-wrap><institution-id institution-id-type="ISNI">0000 0004 1790 7311</institution-id><institution-id institution-id-type="GRID">grid.415254.3</institution-id><institution>Department of Infection Prevention and Control,</institution><institution>King Abdulaziz Medical City,</institution></institution-wrap>Riyadh, Saudi Arabia</nlm:aff><country xml:lang="fr">Arabie saoudite</country><wicri:regionArea>Riyadh</wicri:regionArea></affiliation></author><author><name sortKey="Al Dawood, Abdulaziz" sort="Al Dawood, Abdulaziz" uniqKey="Al Dawood A" first="Abdulaziz" last="Al-Dawood">Abdulaziz Al-Dawood</name><affiliation wicri:level="1"><nlm:aff id="Aff1"><institution-wrap><institution-id institution-id-type="ISNI">0000 0004 0580 0891</institution-id><institution-id institution-id-type="GRID">grid.452607.2</institution-id><institution>College of Medicine, King Saud Bin Abdulaziz University for Health Sciences,</institution><institution>King Abdullah International Medical Research Center,</institution></institution-wrap>Riyadh, Saudi Arabia</nlm:aff><country xml:lang="fr">Arabie saoudite</country><wicri:regionArea>Riyadh</wicri:regionArea></affiliation><affiliation wicri:level="1"><nlm:aff id="Aff2"><institution-wrap><institution-id institution-id-type="ISNI">0000 0004 1790 7311</institution-id><institution-id institution-id-type="GRID">grid.415254.3</institution-id><institution>Intensive Care Department,</institution><institution>King Abdulaziz Medical City,</institution></institution-wrap>Riyadh, Saudi Arabia</nlm:aff><country xml:lang="fr">Arabie saoudite</country><wicri:regionArea>Riyadh</wicri:regionArea></affiliation></author><author><name sortKey="Aljohani, Sameera" sort="Aljohani, Sameera" uniqKey="Aljohani S" first="Sameera" last="Aljohani">Sameera Aljohani</name><affiliation wicri:level="1"><nlm:aff id="Aff1"><institution-wrap><institution-id institution-id-type="ISNI">0000 0004 0580 0891</institution-id><institution-id institution-id-type="GRID">grid.452607.2</institution-id><institution>College of Medicine, King Saud Bin Abdulaziz University for Health Sciences,</institution><institution>King Abdullah International Medical Research Center,</institution></institution-wrap>Riyadh, Saudi Arabia</nlm:aff><country xml:lang="fr">Arabie saoudite</country><wicri:regionArea>Riyadh</wicri:regionArea></affiliation><affiliation wicri:level="1"><nlm:aff id="Aff5"><institution-wrap><institution-id institution-id-type="ISNI">0000 0004 1790 7311</institution-id><institution-id institution-id-type="GRID">grid.415254.3</institution-id><institution>Department of Pathology and Laboratory Medicine,</institution><institution>King Abdulaziz Medical City,</institution></institution-wrap>Riyadh, Saudi Arabia</nlm:aff><country xml:lang="fr">Arabie saoudite</country><wicri:regionArea>Riyadh</wicri:regionArea></affiliation></author><author><name sortKey="Al Harbi, Shmeylan" sort="Al Harbi, Shmeylan" uniqKey="Al Harbi S" first="Shmeylan" last="Al Harbi">Shmeylan Al Harbi</name><affiliation wicri:level="1"><nlm:aff id="Aff6"><institution-wrap><institution-id institution-id-type="ISNI">0000 0004 0580 0891</institution-id><institution-id institution-id-type="GRID">grid.452607.2</institution-id><institution>College of Pharmacy, King Saud Bin Abdulaziz University for Health Sciences,</institution><institution>King Abdullah International Medical Research Center,</institution></institution-wrap>Riyadh, Saudi Arabia</nlm:aff><country xml:lang="fr">Arabie saoudite</country><wicri:regionArea>Riyadh</wicri:regionArea></affiliation><affiliation wicri:level="1"><nlm:aff id="Aff7"><institution-wrap><institution-id institution-id-type="ISNI">0000 0004 1790 7311</institution-id><institution-id institution-id-type="GRID">grid.415254.3</institution-id><institution>Pharmaceutical Care Department,</institution><institution>King Abdulaziz Medical City,</institution></institution-wrap>Riyadh, Saudi Arabia</nlm:aff><country xml:lang="fr">Arabie saoudite</country><wicri:regionArea>Riyadh</wicri:regionArea></affiliation></author><author><name sortKey="Kojan, Suleiman" sort="Kojan, Suleiman" uniqKey="Kojan S" first="Suleiman" last="Kojan">Suleiman Kojan</name><affiliation wicri:level="1"><nlm:aff id="Aff1"><institution-wrap><institution-id institution-id-type="ISNI">0000 0004 0580 0891</institution-id><institution-id institution-id-type="GRID">grid.452607.2</institution-id><institution>College of Medicine, King Saud Bin Abdulaziz University for Health Sciences,</institution><institution>King Abdullah International Medical Research Center,</institution></institution-wrap>Riyadh, Saudi Arabia</nlm:aff><country xml:lang="fr">Arabie saoudite</country><wicri:regionArea>Riyadh</wicri:regionArea></affiliation><affiliation wicri:level="1"><nlm:aff id="Aff3"><institution-wrap><institution-id institution-id-type="ISNI">0000 0004 1790 7311</institution-id><institution-id institution-id-type="GRID">grid.415254.3</institution-id><institution>Department of Medicine,</institution><institution>King Abdulaziz Medical City,</institution></institution-wrap>Riyadh, Saudi Arabia</nlm:aff><country xml:lang="fr">Arabie saoudite</country><wicri:regionArea>Riyadh</wicri:regionArea></affiliation></author><author><name sortKey="Al Jeraisy, Majed" sort="Al Jeraisy, Majed" uniqKey="Al Jeraisy M" first="Majed" last="Al Jeraisy">Majed Al Jeraisy</name><affiliation wicri:level="1"><nlm:aff id="Aff6"><institution-wrap><institution-id institution-id-type="ISNI">0000 0004 0580 0891</institution-id><institution-id institution-id-type="GRID">grid.452607.2</institution-id><institution>College of Pharmacy, King Saud Bin Abdulaziz University for Health Sciences,</institution><institution>King Abdullah International Medical Research Center,</institution></institution-wrap>Riyadh, Saudi Arabia</nlm:aff><country xml:lang="fr">Arabie saoudite</country><wicri:regionArea>Riyadh</wicri:regionArea></affiliation><affiliation wicri:level="1"><nlm:aff id="Aff7"><institution-wrap><institution-id institution-id-type="ISNI">0000 0004 1790 7311</institution-id><institution-id institution-id-type="GRID">grid.415254.3</institution-id><institution>Pharmaceutical Care Department,</institution><institution>King Abdulaziz Medical City,</institution></institution-wrap>Riyadh, Saudi Arabia</nlm:aff><country xml:lang="fr">Arabie saoudite</country><wicri:regionArea>Riyadh</wicri:regionArea></affiliation></author><author><name sortKey="Deeb, Ahmad M" sort="Deeb, Ahmad M" uniqKey="Deeb A" first="Ahmad M." last="Deeb">Ahmad M. Deeb</name><affiliation wicri:level="1"><nlm:aff id="Aff1"><institution-wrap><institution-id institution-id-type="ISNI">0000 0004 0580 0891</institution-id><institution-id institution-id-type="GRID">grid.452607.2</institution-id><institution>College of Medicine, King Saud Bin Abdulaziz University for Health Sciences,</institution><institution>King Abdullah International Medical Research Center,</institution></institution-wrap>Riyadh, Saudi Arabia</nlm:aff><country xml:lang="fr">Arabie saoudite</country><wicri:regionArea>Riyadh</wicri:regionArea></affiliation><affiliation wicri:level="1"><nlm:aff id="Aff2"><institution-wrap><institution-id institution-id-type="ISNI">0000 0004 1790 7311</institution-id><institution-id institution-id-type="GRID">grid.415254.3</institution-id><institution>Intensive Care Department,</institution><institution>King Abdulaziz Medical City,</institution></institution-wrap>Riyadh, Saudi Arabia</nlm:aff><country xml:lang="fr">Arabie saoudite</country><wicri:regionArea>Riyadh</wicri:regionArea></affiliation></author><author><name sortKey="Assiri, Abdullah M" sort="Assiri, Abdullah M" uniqKey="Assiri A" first="Abdullah M." last="Assiri">Abdullah M. Assiri</name><affiliation wicri:level="1"><nlm:aff id="Aff8"><institution-wrap><institution-id institution-id-type="GRID">grid.415696.9</institution-id><institution>Infection Prevention and Control, Ministry of Health,</institution></institution-wrap>Riyadh, Saudi Arabia</nlm:aff><country xml:lang="fr">Arabie saoudite</country><wicri:regionArea>Riyadh</wicri:regionArea></affiliation></author><author><name sortKey="Al Hameed, Fahad" sort="Al Hameed, Fahad" uniqKey="Al Hameed F" first="Fahad" last="Al-Hameed">Fahad Al-Hameed</name><affiliation wicri:level="1"><nlm:aff id="Aff9"><institution-wrap><institution-id institution-id-type="ISNI">0000 0004 0580 0891</institution-id><institution-id institution-id-type="GRID">grid.452607.2</institution-id><institution>College of Medicine, King Saud Bin Abdulaziz University for Health Sciences,</institution><institution>King Abdullah International Medical Research Center,</institution></institution-wrap>Jeddah, Saudi Arabia</nlm:aff><country xml:lang="fr">Arabie saoudite</country><wicri:regionArea>Jeddah</wicri:regionArea></affiliation><affiliation wicri:level="1"><nlm:aff id="Aff10"><institution-wrap><institution-id institution-id-type="ISNI">0000 0004 1790 7311</institution-id><institution-id institution-id-type="GRID">grid.415254.3</institution-id><institution>Intensive Care Department,</institution><institution>King Abdulaziz Medical City,</institution></institution-wrap>Jeddah, Saudi Arabia</nlm:aff><country xml:lang="fr">Arabie saoudite</country><wicri:regionArea>Jeddah</wicri:regionArea></affiliation></author><author><name sortKey="Alsaedi, Asim" sort="Alsaedi, Asim" uniqKey="Alsaedi A" first="Asim" last="Alsaedi">Asim Alsaedi</name><affiliation wicri:level="1"><nlm:aff id="Aff9"><institution-wrap><institution-id institution-id-type="ISNI">0000 0004 0580 0891</institution-id><institution-id institution-id-type="GRID">grid.452607.2</institution-id><institution>College of Medicine, King Saud Bin Abdulaziz University for Health Sciences,</institution><institution>King Abdullah International Medical Research Center,</institution></institution-wrap>Jeddah, Saudi Arabia</nlm:aff><country xml:lang="fr">Arabie saoudite</country><wicri:regionArea>Jeddah</wicri:regionArea></affiliation><affiliation wicri:level="1"><nlm:aff id="Aff11"><institution-wrap><institution-id institution-id-type="ISNI">0000 0004 1790 7311</institution-id><institution-id institution-id-type="GRID">grid.415254.3</institution-id><institution>Department of Infection Prevention and Control,</institution><institution>King Abdulaziz Medical City,</institution></institution-wrap>Jeddah, Saudi Arabia</nlm:aff><country xml:lang="fr">Arabie saoudite</country><wicri:regionArea>Jeddah</wicri:regionArea></affiliation></author><author><name sortKey="Mandourah, Yasser" sort="Mandourah, Yasser" uniqKey="Mandourah Y" first="Yasser" last="Mandourah">Yasser Mandourah</name><affiliation wicri:level="1"><nlm:aff id="Aff12"><institution-wrap><institution-id institution-id-type="ISNI">0000 0000 9759 8141</institution-id><institution-id institution-id-type="GRID">grid.415989.8</institution-id><institution>Department of Intensive Care Services,</institution><institution>Prince Sultan Military Medical City,</institution></institution-wrap>Riyadh, Saudi Arabia</nlm:aff><country xml:lang="fr">Arabie saoudite</country><wicri:regionArea>Riyadh</wicri:regionArea></affiliation></author><author><name sortKey="Almekhlafi, Ghaleb A" sort="Almekhlafi, Ghaleb A" uniqKey="Almekhlafi G" first="Ghaleb A." last="Almekhlafi">Ghaleb A. Almekhlafi</name><affiliation wicri:level="1"><nlm:aff id="Aff12"><institution-wrap><institution-id institution-id-type="ISNI">0000 0000 9759 8141</institution-id><institution-id institution-id-type="GRID">grid.415989.8</institution-id><institution>Department of Intensive Care Services,</institution><institution>Prince Sultan Military Medical City,</institution></institution-wrap>Riyadh, Saudi Arabia</nlm:aff><country xml:lang="fr">Arabie saoudite</country><wicri:regionArea>Riyadh</wicri:regionArea></affiliation></author><author><name sortKey="Sherbeeni, Nisreen Murad" sort="Sherbeeni, Nisreen Murad" uniqKey="Sherbeeni N" first="Nisreen Murad" last="Sherbeeni">Nisreen Murad Sherbeeni</name><affiliation wicri:level="1"><nlm:aff id="Aff13"><institution-wrap><institution-id institution-id-type="ISNI">0000 0000 9759 8141</institution-id><institution-id institution-id-type="GRID">grid.415989.8</institution-id><institution>Infectious Diseases Division,</institution><institution>Prince Sultan Military Medical City,</institution></institution-wrap>Riyadh, Saudi Arabia</nlm:aff><country xml:lang="fr">Arabie saoudite</country><wicri:regionArea>Riyadh</wicri:regionArea></affiliation></author><author><name sortKey="Elzein, Fatehi Elnour" sort="Elzein, Fatehi Elnour" uniqKey="Elzein F" first="Fatehi Elnour" last="Elzein">Fatehi Elnour Elzein</name><affiliation wicri:level="1"><nlm:aff id="Aff13"><institution-wrap><institution-id institution-id-type="ISNI">0000 0000 9759 8141</institution-id><institution-id institution-id-type="GRID">grid.415989.8</institution-id><institution>Infectious Diseases Division,</institution><institution>Prince Sultan Military Medical City,</institution></institution-wrap>Riyadh, Saudi Arabia</nlm:aff><country xml:lang="fr">Arabie saoudite</country><wicri:regionArea>Riyadh</wicri:regionArea></affiliation></author><author><name sortKey="Memon, Javed" sort="Memon, Javed" uniqKey="Memon J" first="Javed" last="Memon">Javed Memon</name><affiliation wicri:level="1"><nlm:aff id="Aff14"><institution-wrap><institution-id institution-id-type="GRID">grid.415252.5</institution-id><institution>Intensive Care Section, Department of Medicine,</institution><institution>King Abdulaziz Hospital,</institution></institution-wrap>Alahsa, Saudi Arabia</nlm:aff><country xml:lang="fr">Arabie saoudite</country><wicri:regionArea>Alahsa</wicri:regionArea></affiliation></author><author><name sortKey="Taha, Yusri" sort="Taha, Yusri" uniqKey="Taha Y" first="Yusri" last="Taha">Yusri Taha</name><affiliation wicri:level="1"><nlm:aff id="Aff15"><institution-wrap><institution-id institution-id-type="GRID">grid.415252.5</institution-id><institution>Department of Medicine,</institution><institution>King Abdulaziz Hospital,</institution></institution-wrap>Alahsa, Saudi Arabia</nlm:aff><country xml:lang="fr">Arabie saoudite</country><wicri:regionArea>Alahsa</wicri:regionArea></affiliation></author><author><name sortKey="Almotairi, Abdullah" sort="Almotairi, Abdullah" uniqKey="Almotairi A" first="Abdullah" last="Almotairi">Abdullah Almotairi</name><affiliation wicri:level="1"><nlm:aff id="Aff16"><institution-wrap><institution-id institution-id-type="ISNI">0000 0004 0593 1832</institution-id><institution-id institution-id-type="GRID">grid.415277.2</institution-id><institution>Department of Critical Care Medicine,</institution><institution>King Fahad Medical City,</institution></institution-wrap>Riyadh, Saudi Arabia</nlm:aff><country xml:lang="fr">Arabie saoudite</country><wicri:regionArea>Riyadh</wicri:regionArea></affiliation></author><author><name sortKey="Maghrabi, Khalid A" sort="Maghrabi, Khalid A" uniqKey="Maghrabi K" first="Khalid A." last="Maghrabi">Khalid A. Maghrabi</name><affiliation wicri:level="1"><nlm:aff id="Aff17"><institution-wrap><institution-id institution-id-type="ISNI">0000 0001 2191 4301</institution-id><institution-id institution-id-type="GRID">grid.415310.2</institution-id><institution>Department of Critical Care Medicine,</institution><institution>King Faisal Specialist Hospital and Research,</institution></institution-wrap>Riyadh, Saudi Arabia</nlm:aff><country xml:lang="fr">Arabie saoudite</country><wicri:regionArea>Riyadh</wicri:regionArea></affiliation></author><author><name sortKey="Qushmaq, Ismael" sort="Qushmaq, Ismael" uniqKey="Qushmaq I" first="Ismael" last="Qushmaq">Ismael Qushmaq</name><affiliation wicri:level="1"><nlm:aff id="Aff18"><institution-wrap><institution-id institution-id-type="ISNI">0000 0001 2191 4301</institution-id><institution-id institution-id-type="GRID">grid.415310.2</institution-id><institution>Department of Medicine,</institution><institution>King Faisal Specialist Hospital and Research Center,</institution></institution-wrap>Jeddah, Saudi Arabia</nlm:aff><country xml:lang="fr">Arabie saoudite</country><wicri:regionArea>Jeddah</wicri:regionArea></affiliation></author><author><name sortKey="Al Bshabshe, Ali" sort="Al Bshabshe, Ali" uniqKey="Al Bshabshe A" first="Ali" last="Al Bshabshe">Ali Al Bshabshe</name><affiliation wicri:level="1"><nlm:aff id="Aff19">Department of Critical Care Medicine, King Khalid University, Aseer Central Hospital, Abha, Saudi Arabia</nlm:aff><country xml:lang="fr">Arabie saoudite</country><wicri:regionArea>Department of Critical Care Medicine, King Khalid University, Aseer Central Hospital, Abha</wicri:regionArea><wicri:noRegion>Abha</wicri:noRegion></affiliation></author><author><name sortKey="Kharaba, Ayman" sort="Kharaba, Ayman" uniqKey="Kharaba A" first="Ayman" last="Kharaba">Ayman Kharaba</name><affiliation wicri:level="1"><nlm:aff id="Aff20">Department of Critical Care, King Fahad Hospital, Ohoud Hospital, Al-Madinah Al-Monawarah, Saudi Arabia</nlm:aff><country xml:lang="fr">Arabie saoudite</country><wicri:regionArea>Department of Critical Care, King Fahad Hospital, Ohoud Hospital, Al-Madinah Al-Monawarah</wicri:regionArea><wicri:noRegion>Al-Madinah Al-Monawarah</wicri:noRegion></affiliation></author><author><name sortKey="Shalhoub, Sarah" sort="Shalhoub, Sarah" uniqKey="Shalhoub S" first="Sarah" last="Shalhoub">Sarah Shalhoub</name><affiliation wicri:level="1"><nlm:aff id="Aff21"><institution-wrap><institution-id institution-id-type="ISNI">0000 0004 0573 8987</institution-id><institution-id institution-id-type="GRID">grid.415271.4</institution-id><institution>Department of Medicine,</institution><institution>King Fahad Armed Forces Hospital,</institution></institution-wrap>Jeddah, Saudi Arabia</nlm:aff><country xml:lang="fr">Arabie saoudite</country><wicri:regionArea>Jeddah</wicri:regionArea></affiliation></author><author><name sortKey="Jose, Jesna" sort="Jose, Jesna" uniqKey="Jose J" first="Jesna" last="Jose">Jesna Jose</name><affiliation wicri:level="1"><nlm:aff id="Aff22"><institution-wrap><institution-id institution-id-type="ISNI">0000 0004 0580 0891</institution-id><institution-id institution-id-type="GRID">grid.452607.2</institution-id><institution>Department of Biostatistics and Bioinformatics, King Saud Bin Abdulaziz University for Health Sciences,</institution><institution>King Abdullah International Medical Research Center,</institution></institution-wrap>Riyadh, Saudi Arabia</nlm:aff><country xml:lang="fr">Arabie saoudite</country><wicri:regionArea>Riyadh</wicri:regionArea></affiliation></author><author><name sortKey="Fowler, Robert A" sort="Fowler, Robert A" uniqKey="Fowler R" first="Robert A." last="Fowler">Robert A. Fowler</name><affiliation><nlm:aff id="Aff23"><institution-wrap><institution-id institution-id-type="ISNI">0000 0001 2157 2938</institution-id><institution-id institution-id-type="GRID">grid.17063.33</institution-id><institution>AMR Infection Control and Publications AIP/PED/HSE/HQ, Institute of Health Policy Management and Evaluation,</institution><institution>University of Toronto,</institution></institution-wrap>Toronto, ON Canada</nlm:aff><wicri:noCountry code="subfield">ON Canada</wicri:noCountry></affiliation><affiliation><nlm:aff id="Aff24"><institution-wrap><institution-id institution-id-type="GRID">grid.416745.5</institution-id><institution>Department of Critical Care Medicine,</institution><institution>Sunnybrook Hospital,</institution></institution-wrap>2075 Bayview Avenue, Room D478, Toronto, ON Canada</nlm:aff><wicri:noCountry code="subfield">ON Canada</wicri:noCountry></affiliation><affiliation><nlm:aff id="Aff25"><institution-wrap><institution-id institution-id-type="GRID">grid.416745.5</institution-id><institution>Department of Medicine,</institution><institution>Sunnybrook Hospital,</institution></institution-wrap>2075 Bayview Avenue, Room D478, Toronto, ON Canada</nlm:aff><wicri:noCountry code="subfield">ON Canada</wicri:noCountry></affiliation></author><author><name sortKey="Hayden, Frederick G" sort="Hayden, Frederick G" uniqKey="Hayden F" first="Frederick G." last="Hayden">Frederick G. Hayden</name><affiliation wicri:level="2"><nlm:aff id="Aff26"><institution-wrap><institution-id institution-id-type="ISNI">0000 0000 9136 933X</institution-id><institution-id institution-id-type="GRID">grid.27755.32</institution-id><institution>Department of Medicine, Division of Infectious Diseases and International Health,</institution><institution>University of Virginia School of Medicine,</institution></institution-wrap>Charlottesville, VA USA</nlm:aff><country>États-Unis</country><placeName><region type="state">Virginie</region></placeName><wicri:cityArea>Charlottesville</wicri:cityArea></affiliation></author><author><name sortKey="Hussein, Mohamed A" sort="Hussein, Mohamed A" uniqKey="Hussein M" first="Mohamed A." last="Hussein">Mohamed A. Hussein</name><affiliation wicri:level="1"><nlm:aff id="Aff22"><institution-wrap><institution-id institution-id-type="ISNI">0000 0004 0580 0891</institution-id><institution-id institution-id-type="GRID">grid.452607.2</institution-id><institution>Department of Biostatistics and Bioinformatics, King Saud Bin Abdulaziz University for Health Sciences,</institution><institution>King Abdullah International Medical Research Center,</institution></institution-wrap>Riyadh, Saudi Arabia</nlm:aff><country xml:lang="fr">Arabie saoudite</country><wicri:regionArea>Riyadh</wicri:regionArea></affiliation></author></analytic><series><title level="j">Trials</title><idno type="eISSN">1745-6215</idno><imprint><date when="2018">2018</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Antiviral Agents (adverse effects)</term><term>Antiviral Agents (therapeutic use)</term><term>Coronavirus Infections (diagnosis)</term><term>Coronavirus Infections (drug therapy)</term><term>Coronavirus Infections (virology)</term><term>Double-Blind Method</term><term>Drug Combinations</term><term>Drug Therapy, Combination</term><term>Female</term><term>Humans</term><term>Interferon beta-1b (adverse effects)</term><term>Interferon beta-1b (therapeutic use)</term><term>Lopinavir (adverse effects)</term><term>Lopinavir (therapeutic use)</term><term>Male</term><term>Middle East Respiratory Syndrome Coronavirus (drug effects)</term><term>Middle East Respiratory Syndrome Coronavirus (pathogenicity)</term><term>Multicenter Studies as Topic</term><term>Patient Admission</term><term>Randomized Controlled Trials as Topic</term><term>Ritonavir (adverse effects)</term><term>Ritonavir (therapeutic use)</term><term>Saudi Arabia</term><term>Time Factors</term><term>Treatment Outcome</term></keywords><keywords scheme="KwdFr" xml:lang="fr"><term>Admission du patient</term><term>Antiviraux (effets indésirables)</term><term>Antiviraux (usage thérapeutique)</term><term>Arabie saoudite</term><term>Association de médicaments</term><term>Association médicamenteuse</term><term>Coronavirus du syndrome respiratoire du Moyen-Orient ()</term><term>Coronavirus du syndrome respiratoire du Moyen-Orient (pathogénicité)</term><term>Essais contrôlés randomisés comme sujet</term><term>Facteurs temps</term><term>Femelle</term><term>Humains</term><term>Infections à coronavirus (diagnostic)</term><term>Infections à coronavirus (traitement médicamenteux)</term><term>Infections à coronavirus (virologie)</term><term>Interféron bêta-1b (effets indésirables)</term><term>Interféron bêta-1b (usage thérapeutique)</term><term>Lopinavir (effets indésirables)</term><term>Lopinavir (usage thérapeutique)</term><term>Mâle</term><term>Méthode en double aveugle</term><term>Ritonavir (effets indésirables)</term><term>Ritonavir (usage thérapeutique)</term><term>Résultat thérapeutique</term><term>Études multicentriques comme sujet</term></keywords><keywords scheme="MESH" type="chemical" qualifier="adverse effects" xml:lang="en"><term>Antiviral Agents</term><term>Interferon beta-1b</term><term>Lopinavir</term><term>Ritonavir</term></keywords><keywords scheme="MESH" type="chemical" qualifier="therapeutic use" xml:lang="en"><term>Antiviral Agents</term><term>Interferon beta-1b</term><term>Lopinavir</term><term>Ritonavir</term></keywords><keywords scheme="MESH" type="geographic" xml:lang="en"><term>Saudi Arabia</term></keywords><keywords scheme="MESH" qualifier="diagnosis" xml:lang="en"><term>Coronavirus Infections</term></keywords><keywords scheme="MESH" qualifier="diagnostic" xml:lang="fr"><term>Infections à coronavirus</term></keywords><keywords scheme="MESH" qualifier="drug effects" xml:lang="en"><term>Middle East Respiratory Syndrome Coronavirus</term></keywords><keywords scheme="MESH" qualifier="drug therapy" xml:lang="en"><term>Coronavirus Infections</term></keywords><keywords scheme="MESH" qualifier="effets indésirables" xml:lang="fr"><term>Antiviraux</term><term>Interféron bêta-1b</term><term>Lopinavir</term><term>Ritonavir</term></keywords><keywords scheme="MESH" qualifier="pathogenicity" xml:lang="en"><term>Middle East Respiratory Syndrome Coronavirus</term></keywords><keywords scheme="MESH" qualifier="pathogénicité" xml:lang="fr"><term>Coronavirus du syndrome respiratoire du Moyen-Orient</term></keywords><keywords scheme="MESH" qualifier="traitement médicamenteux" xml:lang="fr"><term>Infections à coronavirus</term></keywords><keywords scheme="MESH" qualifier="usage thérapeutique" xml:lang="fr"><term>Antiviraux</term><term>Interféron bêta-1b</term><term>Lopinavir</term><term>Ritonavir</term></keywords><keywords scheme="MESH" qualifier="virologie" xml:lang="fr"><term>Infections à coronavirus</term></keywords><keywords scheme="MESH" qualifier="virology" xml:lang="en"><term>Coronavirus Infections</term></keywords><keywords scheme="MESH" xml:lang="en"><term>Double-Blind Method</term><term>Drug Combinations</term><term>Drug Therapy, Combination</term><term>Female</term><term>Humans</term><term>Male</term><term>Multicenter Studies as Topic</term><term>Patient Admission</term><term>Randomized Controlled Trials as Topic</term><term>Time Factors</term><term>Treatment Outcome</term></keywords><keywords scheme="MESH" xml:lang="fr"><term>Admission du patient</term><term>Arabie saoudite</term><term>Association de médicaments</term><term>Association médicamenteuse</term><term>Coronavirus du syndrome respiratoire du Moyen-Orient</term><term>Essais contrôlés randomisés comme sujet</term><term>Facteurs temps</term><term>Femelle</term><term>Humains</term><term>Mâle</term><term>Méthode en double aveugle</term><term>Résultat thérapeutique</term><term>Études multicentriques comme sujet</term></keywords><keywords scheme="Wicri" type="geographic" xml:lang="fr"><term>Arabie saoudite</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en"><sec><title>Background</title><p id="Par1">It had been more than 5 years since the first case of Middle East Respiratory Syndrome coronavirus infection (MERS-CoV) was recorded, but no specific treatment has been investigated in randomized clinical trials. Results from in vitro and animal studies suggest that a combination of lopinavir/ritonavir and interferon-β1b (IFN-β1b) may be effective against MERS-CoV. The aim of this study is to investigate the efficacy of treatment with a combination of lopinavir/ritonavir and recombinant IFN-β1b provided with standard supportive care, compared to treatment with placebo provided with standard supportive care in patients with laboratory-confirmed MERS requiring hospital admission.</p></sec><sec><title>Methods</title><p id="Par2">The protocol is prepared in accordance with the SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) guidelines. Hospitalized adult patients with laboratory-confirmed MERS will be enrolled in this recursive, two-stage, group sequential, multicenter, placebo-controlled, double-blind randomized controlled trial. The trial is initially designed to include 2 two-stage components. The first two-stage component is designed to adjust sample size and determine futility stopping, but not efficacy stopping. The second two-stage component is designed to determine efficacy stopping and possibly readjustment of sample size. The primary outcome is 90-day mortality.</p></sec><sec><title>Discussion</title><p id="Par3">This will be the first randomized controlled trial of a potential treatment for MERS. The study is sponsored by King Abdullah International Medical Research Center, Riyadh, Saudi Arabia. Enrollment for this study began in November 2016, and has enrolled thirteen patients as of Jan 24-2018.</p></sec><sec><title>Trial registration</title><p id="Par4">ClinicalTrials.gov, ID: <ext-link ext-link-type="uri" xlink:href="https://clinicaltrials.gov/ct2/show/NCT02845843">NCT02845843</ext-link>. Registered on 27 July 2016.</p></sec><sec><title>Electronic supplementary material</title><p>The online version of this article (doi:10.1186/s13063-017-2427-0) contains supplementary material, which is available to authorized users.</p></sec></div></front><back><div1 type="bibliography"><listBibl><biblStruct></biblStruct><biblStruct><analytic><author><name sortKey="Arabi, Ym" uniqKey="Arabi Y">YM Arabi</name></author><author><name sortKey="Balkhy, Hh" uniqKey="Balkhy H">HH Balkhy</name></author><author><name sortKey="Hayden, Fg" uniqKey="Hayden F">FG Hayden</name></author><author><name sortKey="Bouchama, A" uniqKey="Bouchama A">A Bouchama</name></author><author><name sortKey="Luke, T" uniqKey="Luke T">T Luke</name></author><author><name sortKey="Baillie, Jk" uniqKey="Baillie J">JK Baillie</name></author><author><name sortKey="Al Omari, A" uniqKey="Al Omari A">A Al-Omari</name></author><author><name sortKey="Hajeer, Ah" uniqKey="Hajeer A">AH Hajeer</name></author><author><name 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saoudite</li><li>États-Unis</li></country><region><li>Virginie</li></region></list><tree><noCountry><name sortKey="Fowler, Robert A" sort="Fowler, Robert A" uniqKey="Fowler R" first="Robert A." last="Fowler">Robert A. Fowler</name></noCountry><country name="Arabie saoudite"><noRegion><name sortKey="Arabi, Yaseen M" sort="Arabi, Yaseen M" uniqKey="Arabi Y" first="Yaseen M." last="Arabi">Yaseen M. Arabi</name></noRegion><name sortKey="Al Bshabshe, Ali" sort="Al Bshabshe, Ali" uniqKey="Al Bshabshe A" first="Ali" last="Al Bshabshe">Ali Al Bshabshe</name><name sortKey="Al Dawood, Abdulaziz" sort="Al Dawood, Abdulaziz" uniqKey="Al Dawood A" first="Abdulaziz" last="Al-Dawood">Abdulaziz Al-Dawood</name><name sortKey="Al Dawood, Abdulaziz" sort="Al Dawood, Abdulaziz" uniqKey="Al Dawood A" first="Abdulaziz" last="Al-Dawood">Abdulaziz Al-Dawood</name><name sortKey="Al Hameed, Fahad" sort="Al Hameed, Fahad" uniqKey="Al Hameed F" first="Fahad" last="Al-Hameed">Fahad Al-Hameed</name><name sortKey="Al Hameed, Fahad" sort="Al Hameed, Fahad" uniqKey="Al Hameed F" first="Fahad" last="Al-Hameed">Fahad Al-Hameed</name><name sortKey="Al Harbi, Shmeylan" sort="Al Harbi, Shmeylan" uniqKey="Al Harbi S" first="Shmeylan" last="Al Harbi">Shmeylan Al Harbi</name><name sortKey="Al Harbi, Shmeylan" sort="Al Harbi, Shmeylan" uniqKey="Al Harbi S" first="Shmeylan" last="Al Harbi">Shmeylan Al Harbi</name><name sortKey="Al Jeraisy, Majed" sort="Al Jeraisy, Majed" uniqKey="Al Jeraisy M" first="Majed" last="Al Jeraisy">Majed Al Jeraisy</name><name sortKey="Al Jeraisy, Majed" sort="Al Jeraisy, Majed" uniqKey="Al Jeraisy M" first="Majed" last="Al Jeraisy">Majed Al Jeraisy</name><name sortKey="Aljohani, Sameera" sort="Aljohani, Sameera" uniqKey="Aljohani S" first="Sameera" last="Aljohani">Sameera Aljohani</name><name sortKey="Aljohani, Sameera" sort="Aljohani, Sameera" uniqKey="Aljohani S" first="Sameera" last="Aljohani">Sameera Aljohani</name><name sortKey="Almekhlafi, Ghaleb A" sort="Almekhlafi, Ghaleb A" uniqKey="Almekhlafi G" first="Ghaleb A." last="Almekhlafi">Ghaleb A. Almekhlafi</name><name sortKey="Almotairi, Abdullah" sort="Almotairi, Abdullah" uniqKey="Almotairi A" first="Abdullah" last="Almotairi">Abdullah Almotairi</name><name sortKey="Alothman, Adel" sort="Alothman, Adel" uniqKey="Alothman A" first="Adel" last="Alothman">Adel Alothman</name><name sortKey="Alothman, Adel" sort="Alothman, Adel" uniqKey="Alothman A" first="Adel" last="Alothman">Adel Alothman</name><name sortKey="Alsaedi, Asim" sort="Alsaedi, Asim" uniqKey="Alsaedi A" first="Asim" last="Alsaedi">Asim Alsaedi</name><name sortKey="Alsaedi, Asim" sort="Alsaedi, Asim" uniqKey="Alsaedi A" first="Asim" last="Alsaedi">Asim Alsaedi</name><name sortKey="Arabi, Yaseen M" sort="Arabi, Yaseen M" uniqKey="Arabi Y" first="Yaseen M." last="Arabi">Yaseen M. Arabi</name><name sortKey="Assiri, Abdullah M" sort="Assiri, Abdullah M" uniqKey="Assiri A" first="Abdullah M." last="Assiri">Abdullah M. Assiri</name><name sortKey="Balkhy, Hanan H" sort="Balkhy, Hanan H" uniqKey="Balkhy H" first="Hanan H." last="Balkhy">Hanan H. Balkhy</name><name sortKey="Balkhy, Hanan H" sort="Balkhy, Hanan H" uniqKey="Balkhy H" first="Hanan H." last="Balkhy">Hanan H. Balkhy</name><name sortKey="Deeb, Ahmad M" sort="Deeb, Ahmad M" uniqKey="Deeb A" first="Ahmad M." last="Deeb">Ahmad M. Deeb</name><name sortKey="Deeb, Ahmad M" sort="Deeb, Ahmad M" uniqKey="Deeb A" first="Ahmad M." last="Deeb">Ahmad M. Deeb</name><name sortKey="Elzein, Fatehi Elnour" sort="Elzein, Fatehi Elnour" uniqKey="Elzein F" first="Fatehi Elnour" last="Elzein">Fatehi Elnour Elzein</name><name sortKey="Hussein, Mohamed A" sort="Hussein, Mohamed A" uniqKey="Hussein M" first="Mohamed A." last="Hussein">Mohamed A. Hussein</name><name sortKey="Jose, Jesna" sort="Jose, Jesna" uniqKey="Jose J" first="Jesna" last="Jose">Jesna Jose</name><name sortKey="Kharaba, Ayman" sort="Kharaba, Ayman" uniqKey="Kharaba A" first="Ayman" last="Kharaba">Ayman Kharaba</name><name sortKey="Kojan, Suleiman" sort="Kojan, Suleiman" uniqKey="Kojan S" first="Suleiman" last="Kojan">Suleiman Kojan</name><name sortKey="Kojan, Suleiman" sort="Kojan, Suleiman" uniqKey="Kojan S" first="Suleiman" last="Kojan">Suleiman Kojan</name><name sortKey="Maghrabi, Khalid A" sort="Maghrabi, Khalid A" uniqKey="Maghrabi K" first="Khalid A." last="Maghrabi">Khalid A. Maghrabi</name><name sortKey="Mandourah, Yasser" sort="Mandourah, Yasser" uniqKey="Mandourah Y" first="Yasser" last="Mandourah">Yasser Mandourah</name><name sortKey="Memon, Javed" sort="Memon, Javed" uniqKey="Memon J" first="Javed" last="Memon">Javed Memon</name><name sortKey="Qushmaq, Ismael" sort="Qushmaq, Ismael" uniqKey="Qushmaq I" first="Ismael" last="Qushmaq">Ismael Qushmaq</name><name sortKey="Shalhoub, Sarah" sort="Shalhoub, Sarah" uniqKey="Shalhoub S" first="Sarah" last="Shalhoub">Sarah Shalhoub</name><name sortKey="Sherbeeni, Nisreen Murad" sort="Sherbeeni, Nisreen Murad" uniqKey="Sherbeeni N" first="Nisreen Murad" last="Sherbeeni">Nisreen Murad Sherbeeni</name><name sortKey="Taha, Yusri" sort="Taha, Yusri" uniqKey="Taha Y" first="Yusri" last="Taha">Yusri Taha</name></country><country name="États-Unis"><region name="Virginie"><name sortKey="Hayden, Frederick G" sort="Hayden, Frederick G" uniqKey="Hayden F" first="Frederick G." last="Hayden">Frederick G. Hayden</name></region></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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