Efficacy of hydroxychloroquine for post-exposure prophylaxis to prevent severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection among adults exposed to coronavirus disease (COVID-19): a structured summary of a study protocol for a randomised controlled trial.
Identifieur interne : 001349 ( Main/Exploration ); précédent : 001348; suivant : 001350Efficacy of hydroxychloroquine for post-exposure prophylaxis to prevent severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection among adults exposed to coronavirus disease (COVID-19): a structured summary of a study protocol for a randomised controlled trial.
Auteurs : Ruanne V. Barnabas [États-Unis] ; Elizabeth Brown [États-Unis] ; Anna Bershteyn [États-Unis] ; R Scott Miller [États-Unis] ; Mark Wener [États-Unis] ; Connie Celum [États-Unis] ; Anna Wald [États-Unis] ; Helen Chu [États-Unis] ; David Wesche [États-Unis] ; Jared M. Baeten [États-Unis]Source :
- Trials [ 1745-6215 ] ; 2020.
Descripteurs français
- KwdFr :
- Acide ascorbique (administration et posologie), Adolescent (MeSH), Adulte (MeSH), Adulte d'âge moyen (MeSH), Antiviraux (administration et posologie), Antiviraux (effets indésirables), Appréciation des risques (MeSH), Betacoronavirus (effets des médicaments et des substances chimiques), Betacoronavirus (pathogénicité), Calendrier d'administration des médicaments (MeSH), Essais contrôlés randomisés comme sujet (MeSH), Excrétion virale (effets des médicaments et des substances chimiques), Exposition professionnelle (effets indésirables), Facteurs de risque (MeSH), Facteurs temps (MeSH), Femelle (MeSH), Humains (MeSH), Hydroxychloroquine (administration et posologie), Hydroxychloroquine (effets indésirables), Incidence (MeSH), Infections à coronavirus (diagnostic), Infections à coronavirus (transmission), Infections à coronavirus (virologie), Infections à coronavirus (épidémiologie), Jeune adulte (MeSH), Mâle (MeSH), Pandémies (MeSH), Pneumopathie virale (diagnostic), Pneumopathie virale (transmission), Pneumopathie virale (virologie), Pneumopathie virale (épidémiologie), Prophylaxie après exposition (MeSH), Résultat thérapeutique (MeSH), Santé au travail (MeSH), Sujet âgé (MeSH), Sujet âgé de 80 ans ou plus (MeSH), Traçage des contacts (MeSH), États-Unis (épidémiologie), Études multicentriques comme sujet (MeSH).
- MESH :
- administration et posologie : Acide ascorbique, Antiviraux, Hydroxychloroquine.
- diagnostic : Infections à coronavirus, Pneumopathie virale.
- effets des médicaments et des substances chimiques : Betacoronavirus, Excrétion virale.
- effets indésirables : Antiviraux, Exposition professionnelle, Hydroxychloroquine.
- pathogénicité : Betacoronavirus.
- virologie : Infections à coronavirus, Pneumopathie virale.
- épidémiologie : Infections à coronavirus, Pneumopathie virale, États-Unis.
- Adolescent, Adulte, Adulte d'âge moyen, Appréciation des risques, Calendrier d'administration des médicaments, Essais contrôlés randomisés comme sujet, Facteurs de risque, Facteurs temps, Femelle, Humains, Incidence, Jeune adulte, Mâle, Pandémies, Prophylaxie après exposition, Résultat thérapeutique, Santé au travail, Sujet âgé, Sujet âgé de 80 ans ou plus, Traçage des contacts, Études multicentriques comme sujet.
- Wicri :
- geographic : États-Unis.
English descriptors
- KwdEn :
- Adolescent (MeSH), Adult (MeSH), Aged (MeSH), Aged, 80 and over (MeSH), Antiviral Agents (administration & dosage), Antiviral Agents (adverse effects), Ascorbic Acid (administration & dosage), Betacoronavirus (drug effects), Betacoronavirus (pathogenicity), COVID-19 (MeSH), Contact Tracing (MeSH), Coronavirus Infections (diagnosis), Coronavirus Infections (epidemiology), Coronavirus Infections (transmission), Coronavirus Infections (virology), Drug Administration Schedule (MeSH), Female (MeSH), Humans (MeSH), Hydroxychloroquine (administration & dosage), Hydroxychloroquine (adverse effects), Incidence (MeSH), Male (MeSH), Middle Aged (MeSH), Multicenter Studies as Topic (MeSH), Occupational Exposure (adverse effects), Occupational Health (MeSH), Pandemics (MeSH), Pneumonia, Viral (diagnosis), Pneumonia, Viral (epidemiology), Pneumonia, Viral (transmission), Pneumonia, Viral (virology), Post-Exposure Prophylaxis (MeSH), Randomized Controlled Trials as Topic (MeSH), Risk Assessment (MeSH), Risk Factors (MeSH), SARS-CoV-2 (MeSH), Time Factors (MeSH), Treatment Outcome (MeSH), United States (epidemiology), Virus Shedding (drug effects), Young Adult (MeSH).
- MESH :
- chemical , administration & dosage : Antiviral Agents, Ascorbic Acid, Hydroxychloroquine.
- chemical , adverse effects : Antiviral Agents, Hydroxychloroquine.
- geographic , epidemiology : United States.
- adverse effects : Occupational Exposure.
- diagnosis : Coronavirus Infections, Pneumonia, Viral.
- drug effects : Betacoronavirus, Virus Shedding.
- epidemiology : Coronavirus Infections, Pneumonia, Viral.
- pathogenicity : Betacoronavirus.
- transmission : Coronavirus Infections, Pneumonia, Viral.
- virology : Coronavirus Infections, Pneumonia, Viral.
- Adolescent, Adult, Aged, Aged, 80 and over, COVID-19, Contact Tracing, Drug Administration Schedule, Female, Humans, Incidence, Male, Middle Aged, Multicenter Studies as Topic, Occupational Health, Pandemics, Post-Exposure Prophylaxis, Randomized Controlled Trials as Topic, Risk Assessment, Risk Factors, SARS-CoV-2, Time Factors, Treatment Outcome, Young Adult.
Abstract
OBJECTIVES
Primary Objective • To test the efficacy of Hydroxychloroquine (HCQ) (400 mg orally daily for 3 days then 200 mg orally daily for an additional 11 days, to complete 14 days) to prevent incident SARS-CoV-2 infection, compared to ascorbic acid among contacts of persons with SARS-CoV-2 infection Secondary objectives • To determine the safety and tolerability of HCQ as SARS-CoV-2 Post-exposure Prophylaxis (PEP) in adults • To test the efficacy of HCQ (400 mg orally daily for 3 days then 200 mg orally daily for an additional 11 days, to complete 14 days) to prevent incident SARS-CoV-2 infection 2 weeks after completing therapy, compared to ascorbic acid among contacts of persons with SARS-CoV-2 infection • To test the efficacy of HCQ to shorten the duration of SARS-CoV-2 shedding among those with SARS-CoV-2 infection in the HCQ PEP group • To test the efficacy of HCQ to prevent incident COVID-19 TRIAL DESIGN: This is a randomized, multi-center, placebo-equivalent (ascorbic acid) controlled, blinded study of HCQ PEP for the prevention of SARS-CoV-2 infection in adults exposed to the virus.
PARTICIPANTS
This study will enroll up to 2000 asymptomatic adults 18 to 80 years of age (inclusive) at baseline who are close contacts of persons with polymerase chain reaction (PCR)-confirmed SARS-CoV-2 or clinically suspected COVID-19 and a pending SARS-CoV-2 PCR test. This multisite trial will be conducted at seven sites in Seattle (UW), Los Angeles (UCLA), New Orleans (Tulane), Baltimore (UMB), New York City (NYU), Syracuse (SUNY-Upstate), and Boston (BMC). Inclusion criteria Participants are eligible to be included in the study only if all of the following criteria apply: 1.Men or women 18 to 80 years of age inclusive, at the time of signing the informed consent2.Willing and able to provide informed consent3.Had a close contact of a person (index) with known PCR-confirmed SARS-CoV-2 infection or index who is currently being assessed for COVID-19 Close contact is defined as: a.Household contact (i.e., residing with the index case in the 14 days prior to index diagnosis or prolonged exposure within a residence/vehicle/enclosed space without maintaining social distance)b.Medical staff, first responders, or other care persons who cared for the index case without personal protection (mask and gloves)4.Less than 4 days since last exposure (close contact with a person with SARS-CoV-2 infection) to the index case5.Access to device and internet for Telehealth visits6.Not planning to take HCQ in addition to the study medication Exclusion criteria Participants are excluded from the study if any of the following criteria apply: 1.Known hypersensitivity to HCQ or other 4-aminoquinoline compounds2.Currently hospitalized3.Symptomatic with subjective fever, cough, or shortness of breath4.Current medications exclude concomitant use of HCQ5.Concomitant use of other anti-malarial treatment or chemoprophylaxis, including chloroquine, mefloquine, artemether, or lumefantrine.6.History of retinopathy of any etiology7.Psoriasis8.Porphyria9.Known bone marrow disorders with significant neutropenia (polymorphonuclear leukocytes <1500) or thrombocytopenia (<100 K)10.Concomitant use of digoxin, cyclosporin, cimetidine, amiodarone, or tamoxifen11.Known moderate or severe liver disease12.Known long QT syndrome13.Severe renal impairment14.Use of any investigational or non-registered drug or vaccine within 30 days preceding the first dose of the study drugs or planned use during the study period INTERVENTION AND COMPARATOR: Households will be randomized 1:1 (at the level of household), with close contact participants receiving one of the following therapies: •HCQ 400 mg orally daily for 3 days then 200 mg orally daily for an additional 11 days •Placebo-like control (ascorbic acid) 500 mg orally daily for 3 days then 250 mg orally daily for 11 days MAIN OUTCOMES: The primary outcome of the study is the incidence of SARS-CoV-2 infection through day 14 among participants who are SARS-CoV-2 negative at baseline by randomization group.
RANDOMISATION
Participants will be randomized in a 1:1 ratio to HCQ or ascorbic acid at the level of the household (all eligible participants in 1 household will receive the same intervention). The randomization code and resulting allocation list will be generated and maintained by the Study Statistician. The list will be blocked and stratified by site and contact type (household versus healthcare worker).
BLINDING (MASKING)
This is a blinded study. HCQ and ascorbic acid will appear similar, and taste will be partially masked as HCQ can be bitter and ascorbic acid will be sour. The participants will be blinded to their randomization group once assigned. Study team members, apart from the Study Pharmacist and the unblinded statistical staff, will be blinded. Laboratory staff are blinded to the group allocation.
NUMBERS TO BE RANDOMISED (SAMPLE SIZE)
The sample size for the study is N=2 000 participants randomized 1:1 to either HCZ (n=1 000) and ascorbic acid (n=1 000).
TRIAL STATUS
Protocol version: 1.2 05 April 2020 Recruitment is ongoing, started March 31 and anticipated end date is September 30, 2020.
TRIAL REGISTRATION
ClinicalTrials.gov, Protocol Registry Number: NCT04328961 Date of registration: April 1, 2020, retrospectively registered 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.
DOI: 10.1186/s13063-020-04446-4
PubMed: 32493478
PubMed Central: PMC7268961
Affiliations:
Links toward previous steps (curation, corpus...)
Le document en format XML
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<sourceDesc><biblStruct><analytic><title xml:lang="en">Efficacy of hydroxychloroquine for post-exposure prophylaxis to prevent severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection among adults exposed to coronavirus disease (COVID-19): a structured summary of a study protocol for a randomised controlled trial.</title>
<author><name sortKey="Barnabas, Ruanne V" sort="Barnabas, Ruanne V" uniqKey="Barnabas R" first="Ruanne V" last="Barnabas">Ruanne V. Barnabas</name>
<affiliation wicri:level="4"><nlm:affiliation>Department of Global Health,International Clinical Research Center (ICRC), University of Washington, UW Box 359927, 325 Ninth Avenue, Seattle, WA, 98104, USA. rbarnaba@uw.edu.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>Department of Global Health,International Clinical Research Center (ICRC), University of Washington, UW Box 359927, 325 Ninth Avenue, Seattle, WA, 98104</wicri:regionArea>
<orgName type="university">Université de Washington</orgName>
<placeName><settlement type="city">Seattle</settlement>
<region type="state">Washington (État)</region>
</placeName>
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<affiliation wicri:level="4"><nlm:affiliation>Division of Allergy and Infectious Diseases, University of Washington, Seattle, WA, USA. rbarnaba@uw.edu.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>Division of Allergy and Infectious Diseases, University of Washington, Seattle, WA</wicri:regionArea>
<placeName><region type="state">Washington (État)</region>
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<affiliation wicri:level="2"><nlm:affiliation>Vaccine and Infectious Diseases Division, Fred Hutchinson Cancer Research Center, Seattle, WA, USA. rbarnaba@uw.edu.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>Vaccine and Infectious Diseases Division, Fred Hutchinson Cancer Research Center, Seattle, WA</wicri:regionArea>
<placeName><region type="state">Washington (État)</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Brown, Elizabeth" sort="Brown, Elizabeth" uniqKey="Brown E" first="Elizabeth" last="Brown">Elizabeth Brown</name>
<affiliation wicri:level="2"><nlm:affiliation>Vaccine and Infectious Diseases Division, Fred Hutchinson Cancer Research Center, Seattle, WA, USA.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>Vaccine and Infectious Diseases Division, Fred Hutchinson Cancer Research Center, Seattle, WA</wicri:regionArea>
<placeName><region type="state">Washington (État)</region>
</placeName>
</affiliation>
<affiliation wicri:level="4"><nlm:affiliation>Department of Biostatistics, University of Washington, Seattle, WA, USA.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>Department of Biostatistics, University of Washington, Seattle, WA</wicri:regionArea>
<placeName><region type="state">Washington (État)</region>
<settlement type="city">Seattle</settlement>
</placeName>
<orgName type="university">Université de Washington</orgName>
</affiliation>
</author>
<author><name sortKey="Bershteyn, Anna" sort="Bershteyn, Anna" uniqKey="Bershteyn A" first="Anna" last="Bershteyn">Anna Bershteyn</name>
<affiliation wicri:level="2"><nlm:affiliation>New York University School of Medicine, New York, NY, USA.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>New York University School of Medicine, New York, NY</wicri:regionArea>
<placeName><region type="state">État de New York</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Miller, R Scott" sort="Miller, R Scott" uniqKey="Miller R" first="R Scott" last="Miller">R Scott Miller</name>
<affiliation wicri:level="2"><nlm:affiliation>Bill and Melinda Gates Foundation, Seattle, WA, USA.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>Bill and Melinda Gates Foundation, Seattle, WA</wicri:regionArea>
<placeName><region type="state">Washington (État)</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Wener, Mark" sort="Wener, Mark" uniqKey="Wener M" first="Mark" last="Wener">Mark Wener</name>
<affiliation wicri:level="4"><nlm:affiliation>Department of Laboratory Medicine, University of Washington, Seattle, WA, USA.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>Department of Laboratory Medicine, University of Washington, Seattle, WA</wicri:regionArea>
<placeName><region type="state">Washington (État)</region>
<settlement type="city">Seattle</settlement>
</placeName>
<orgName type="university">Université de Washington</orgName>
</affiliation>
</author>
<author><name sortKey="Celum, Connie" sort="Celum, Connie" uniqKey="Celum C" first="Connie" last="Celum">Connie Celum</name>
<affiliation wicri:level="4"><nlm:affiliation>Department of Global Health,International Clinical Research Center (ICRC), University of Washington, UW Box 359927, 325 Ninth Avenue, Seattle, WA, 98104, USA.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>Department of Global Health,International Clinical Research Center (ICRC), University of Washington, UW Box 359927, 325 Ninth Avenue, Seattle, WA, 98104</wicri:regionArea>
<orgName type="university">Université de Washington</orgName>
<placeName><settlement type="city">Seattle</settlement>
<region type="state">Washington (État)</region>
</placeName>
</affiliation>
<affiliation wicri:level="4"><nlm:affiliation>Division of Allergy and Infectious Diseases, University of Washington, Seattle, WA, USA.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>Division of Allergy and Infectious Diseases, University of Washington, Seattle, WA</wicri:regionArea>
<placeName><region type="state">Washington (État)</region>
<settlement type="city">Seattle</settlement>
</placeName>
<orgName type="university">Université de Washington</orgName>
</affiliation>
<affiliation wicri:level="4"><nlm:affiliation>Department of Epidemiolog, University of Washington, Seattle, WA, USA.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>Department of Epidemiolog, University of Washington, Seattle, WA</wicri:regionArea>
<placeName><region type="state">Washington (État)</region>
<settlement type="city">Seattle</settlement>
</placeName>
<orgName type="university">Université de Washington</orgName>
</affiliation>
</author>
<author><name sortKey="Wald, Anna" sort="Wald, Anna" uniqKey="Wald A" first="Anna" last="Wald">Anna Wald</name>
<affiliation wicri:level="4"><nlm:affiliation>Division of Allergy and Infectious Diseases, University of Washington, Seattle, WA, USA.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>Division of Allergy and Infectious Diseases, University of Washington, Seattle, WA</wicri:regionArea>
<placeName><region type="state">Washington (État)</region>
<settlement type="city">Seattle</settlement>
</placeName>
<orgName type="university">Université de Washington</orgName>
</affiliation>
<affiliation wicri:level="4"><nlm:affiliation>Department of Epidemiolog, University of Washington, Seattle, WA, USA.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>Department of Epidemiolog, University of Washington, Seattle, WA</wicri:regionArea>
<placeName><region type="state">Washington (État)</region>
<settlement type="city">Seattle</settlement>
</placeName>
<orgName type="university">Université de Washington</orgName>
</affiliation>
<affiliation wicri:level="2"><nlm:affiliation>Vaccine and Infectious Diseases Division, Fred Hutchinson Cancer Research Center, Seattle, WA, USA.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>Vaccine and Infectious Diseases Division, Fred Hutchinson Cancer Research Center, Seattle, WA</wicri:regionArea>
<placeName><region type="state">Washington (État)</region>
</placeName>
</affiliation>
<affiliation wicri:level="4"><nlm:affiliation>Department of Laboratory Medicine, University of Washington, Seattle, WA, USA.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>Department of Laboratory Medicine, University of Washington, Seattle, WA</wicri:regionArea>
<placeName><region type="state">Washington (État)</region>
<settlement type="city">Seattle</settlement>
</placeName>
<orgName type="university">Université de Washington</orgName>
</affiliation>
</author>
<author><name sortKey="Chu, Helen" sort="Chu, Helen" uniqKey="Chu H" first="Helen" last="Chu">Helen Chu</name>
<affiliation wicri:level="4"><nlm:affiliation>Department of Global Health,International Clinical Research Center (ICRC), University of Washington, UW Box 359927, 325 Ninth Avenue, Seattle, WA, 98104, USA.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>Department of Global Health,International Clinical Research Center (ICRC), University of Washington, UW Box 359927, 325 Ninth Avenue, Seattle, WA, 98104</wicri:regionArea>
<orgName type="university">Université de Washington</orgName>
<placeName><settlement type="city">Seattle</settlement>
<region type="state">Washington (État)</region>
</placeName>
</affiliation>
<affiliation wicri:level="4"><nlm:affiliation>Division of Allergy and Infectious Diseases, University of Washington, Seattle, WA, USA.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>Division of Allergy and Infectious Diseases, University of Washington, Seattle, WA</wicri:regionArea>
<placeName><region type="state">Washington (État)</region>
<settlement type="city">Seattle</settlement>
</placeName>
<orgName type="university">Université de Washington</orgName>
</affiliation>
<affiliation wicri:level="4"><nlm:affiliation>Department of Epidemiolog, University of Washington, Seattle, WA, USA.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>Department of Epidemiolog, University of Washington, Seattle, WA</wicri:regionArea>
<placeName><region type="state">Washington (État)</region>
<settlement type="city">Seattle</settlement>
</placeName>
<orgName type="university">Université de Washington</orgName>
</affiliation>
</author>
<author><name sortKey="Wesche, David" sort="Wesche, David" uniqKey="Wesche D" first="David" last="Wesche">David Wesche</name>
<affiliation wicri:level="2"><nlm:affiliation>Certara, Princeton, NJ, USA.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>Certara, Princeton, NJ</wicri:regionArea>
<placeName><region type="state">New Jersey</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Baeten, Jared M" sort="Baeten, Jared M" uniqKey="Baeten J" first="Jared M" last="Baeten">Jared M. Baeten</name>
<affiliation wicri:level="4"><nlm:affiliation>Department of Global Health,International Clinical Research Center (ICRC), University of Washington, UW Box 359927, 325 Ninth Avenue, Seattle, WA, 98104, USA.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>Department of Global Health,International Clinical Research Center (ICRC), University of Washington, UW Box 359927, 325 Ninth Avenue, Seattle, WA, 98104</wicri:regionArea>
<orgName type="university">Université de Washington</orgName>
<placeName><settlement type="city">Seattle</settlement>
<region type="state">Washington (État)</region>
</placeName>
</affiliation>
<affiliation wicri:level="4"><nlm:affiliation>Division of Allergy and Infectious Diseases, University of Washington, Seattle, WA, USA.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>Division of Allergy and Infectious Diseases, University of Washington, Seattle, WA</wicri:regionArea>
<placeName><region type="state">Washington (État)</region>
<settlement type="city">Seattle</settlement>
</placeName>
<orgName type="university">Université de Washington</orgName>
</affiliation>
<affiliation wicri:level="4"><nlm:affiliation>Department of Epidemiolog, University of Washington, Seattle, WA, USA.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>Department of Epidemiolog, University of Washington, Seattle, WA</wicri:regionArea>
<placeName><region type="state">Washington (État)</region>
<settlement type="city">Seattle</settlement>
</placeName>
<orgName type="university">Université de Washington</orgName>
</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>Adolescent (MeSH)</term>
<term>Adult (MeSH)</term>
<term>Aged (MeSH)</term>
<term>Aged, 80 and over (MeSH)</term>
<term>Antiviral Agents (administration & dosage)</term>
<term>Antiviral Agents (adverse effects)</term>
<term>Ascorbic Acid (administration & dosage)</term>
<term>Betacoronavirus (drug effects)</term>
<term>Betacoronavirus (pathogenicity)</term>
<term>COVID-19 (MeSH)</term>
<term>Contact Tracing (MeSH)</term>
<term>Coronavirus Infections (diagnosis)</term>
<term>Coronavirus Infections (epidemiology)</term>
<term>Coronavirus Infections (transmission)</term>
<term>Coronavirus Infections (virology)</term>
<term>Drug Administration Schedule (MeSH)</term>
<term>Female (MeSH)</term>
<term>Humans (MeSH)</term>
<term>Hydroxychloroquine (administration & dosage)</term>
<term>Hydroxychloroquine (adverse effects)</term>
<term>Incidence (MeSH)</term>
<term>Male (MeSH)</term>
<term>Middle Aged (MeSH)</term>
<term>Multicenter Studies as Topic (MeSH)</term>
<term>Occupational Exposure (adverse effects)</term>
<term>Occupational Health (MeSH)</term>
<term>Pandemics (MeSH)</term>
<term>Pneumonia, Viral (diagnosis)</term>
<term>Pneumonia, Viral (epidemiology)</term>
<term>Pneumonia, Viral (transmission)</term>
<term>Pneumonia, Viral (virology)</term>
<term>Post-Exposure Prophylaxis (MeSH)</term>
<term>Randomized Controlled Trials as Topic (MeSH)</term>
<term>Risk Assessment (MeSH)</term>
<term>Risk Factors (MeSH)</term>
<term>SARS-CoV-2 (MeSH)</term>
<term>Time Factors (MeSH)</term>
<term>Treatment Outcome (MeSH)</term>
<term>United States (epidemiology)</term>
<term>Virus Shedding (drug effects)</term>
<term>Young Adult (MeSH)</term>
</keywords>
<keywords scheme="KwdFr" xml:lang="fr"><term>Acide ascorbique (administration et posologie)</term>
<term>Adolescent (MeSH)</term>
<term>Adulte (MeSH)</term>
<term>Adulte d'âge moyen (MeSH)</term>
<term>Antiviraux (administration et posologie)</term>
<term>Antiviraux (effets indésirables)</term>
<term>Appréciation des risques (MeSH)</term>
<term>Betacoronavirus (effets des médicaments et des substances chimiques)</term>
<term>Betacoronavirus (pathogénicité)</term>
<term>Calendrier d'administration des médicaments (MeSH)</term>
<term>Essais contrôlés randomisés comme sujet (MeSH)</term>
<term>Excrétion virale (effets des médicaments et des substances chimiques)</term>
<term>Exposition professionnelle (effets indésirables)</term>
<term>Facteurs de risque (MeSH)</term>
<term>Facteurs temps (MeSH)</term>
<term>Femelle (MeSH)</term>
<term>Humains (MeSH)</term>
<term>Hydroxychloroquine (administration et posologie)</term>
<term>Hydroxychloroquine (effets indésirables)</term>
<term>Incidence (MeSH)</term>
<term>Infections à coronavirus (diagnostic)</term>
<term>Infections à coronavirus (transmission)</term>
<term>Infections à coronavirus (virologie)</term>
<term>Infections à coronavirus (épidémiologie)</term>
<term>Jeune adulte (MeSH)</term>
<term>Mâle (MeSH)</term>
<term>Pandémies (MeSH)</term>
<term>Pneumopathie virale (diagnostic)</term>
<term>Pneumopathie virale (transmission)</term>
<term>Pneumopathie virale (virologie)</term>
<term>Pneumopathie virale (épidémiologie)</term>
<term>Prophylaxie après exposition (MeSH)</term>
<term>Résultat thérapeutique (MeSH)</term>
<term>Santé au travail (MeSH)</term>
<term>Sujet âgé (MeSH)</term>
<term>Sujet âgé de 80 ans ou plus (MeSH)</term>
<term>Traçage des contacts (MeSH)</term>
<term>États-Unis (épidémiologie)</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>Ascorbic Acid</term>
<term>Hydroxychloroquine</term>
</keywords>
<keywords scheme="MESH" type="chemical" qualifier="adverse effects" xml:lang="en"><term>Antiviral Agents</term>
<term>Hydroxychloroquine</term>
</keywords>
<keywords scheme="MESH" type="geographic" qualifier="epidemiology" xml:lang="en"><term>United States</term>
</keywords>
<keywords scheme="MESH" qualifier="administration et posologie" xml:lang="fr"><term>Acide ascorbique</term>
<term>Antiviraux</term>
<term>Hydroxychloroquine</term>
</keywords>
<keywords scheme="MESH" qualifier="adverse effects" xml:lang="en"><term>Occupational Exposure</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>
<term>Virus Shedding</term>
</keywords>
<keywords scheme="MESH" qualifier="effets des médicaments et des substances chimiques" xml:lang="fr"><term>Betacoronavirus</term>
<term>Excrétion virale</term>
</keywords>
<keywords scheme="MESH" qualifier="effets indésirables" xml:lang="fr"><term>Antiviraux</term>
<term>Exposition professionnelle</term>
<term>Hydroxychloroquine</term>
</keywords>
<keywords scheme="MESH" qualifier="epidemiology" xml:lang="en"><term>Coronavirus Infections</term>
<term>Pneumonia, Viral</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="transmission" xml:lang="en"><term>Coronavirus Infections</term>
<term>Pneumonia, Viral</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" qualifier="épidémiologie" xml:lang="fr"><term>Infections à coronavirus</term>
<term>Pneumopathie virale</term>
<term>États-Unis</term>
</keywords>
<keywords scheme="MESH" xml:lang="en"><term>Adolescent</term>
<term>Adult</term>
<term>Aged</term>
<term>Aged, 80 and over</term>
<term>COVID-19</term>
<term>Contact Tracing</term>
<term>Drug Administration Schedule</term>
<term>Female</term>
<term>Humans</term>
<term>Incidence</term>
<term>Male</term>
<term>Middle Aged</term>
<term>Multicenter Studies as Topic</term>
<term>Occupational Health</term>
<term>Pandemics</term>
<term>Post-Exposure Prophylaxis</term>
<term>Randomized Controlled Trials as Topic</term>
<term>Risk Assessment</term>
<term>Risk Factors</term>
<term>SARS-CoV-2</term>
<term>Time Factors</term>
<term>Treatment Outcome</term>
<term>Young Adult</term>
</keywords>
<keywords scheme="MESH" xml:lang="fr"><term>Adolescent</term>
<term>Adulte</term>
<term>Adulte d'âge moyen</term>
<term>Appréciation des risques</term>
<term>Calendrier d'administration des médicaments</term>
<term>Essais contrôlés randomisés comme sujet</term>
<term>Facteurs de risque</term>
<term>Facteurs temps</term>
<term>Femelle</term>
<term>Humains</term>
<term>Incidence</term>
<term>Jeune adulte</term>
<term>Mâle</term>
<term>Pandémies</term>
<term>Prophylaxie après exposition</term>
<term>Résultat thérapeutique</term>
<term>Santé au travail</term>
<term>Sujet âgé</term>
<term>Sujet âgé de 80 ans ou plus</term>
<term>Traçage des contacts</term>
<term>Études multicentriques comme sujet</term>
</keywords>
<keywords scheme="Wicri" type="geographic" xml:lang="fr"><term>États-Unis</term>
</keywords>
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</teiHeader>
<front><div type="abstract" xml:lang="en"><p><b>OBJECTIVES</b>
</p>
<p>Primary Objective • To test the efficacy of Hydroxychloroquine (HCQ) (400 mg orally daily for 3 days then 200 mg orally daily for an additional 11 days, to complete 14 days) to prevent incident SARS-CoV-2 infection, compared to ascorbic acid among contacts of persons with SARS-CoV-2 infection Secondary objectives • To determine the safety and tolerability of HCQ as SARS-CoV-2 Post-exposure Prophylaxis (PEP) in adults • To test the efficacy of HCQ (400 mg orally daily for 3 days then 200 mg orally daily for an additional 11 days, to complete 14 days) to prevent incident SARS-CoV-2 infection 2 weeks after completing therapy, compared to ascorbic acid among contacts of persons with SARS-CoV-2 infection • To test the efficacy of HCQ to shorten the duration of SARS-CoV-2 shedding among those with SARS-CoV-2 infection in the HCQ PEP group • To test the efficacy of HCQ to prevent incident COVID-19 TRIAL DESIGN: This is a randomized, multi-center, placebo-equivalent (ascorbic acid) controlled, blinded study of HCQ PEP for the prevention of SARS-CoV-2 infection in adults exposed to the virus.</p>
</div>
<div type="abstract" xml:lang="en"><p><b>PARTICIPANTS</b>
</p>
<p>This study will enroll up to 2000 asymptomatic adults 18 to 80 years of age (inclusive) at baseline who are close contacts of persons with polymerase chain reaction (PCR)-confirmed SARS-CoV-2 or clinically suspected COVID-19 and a pending SARS-CoV-2 PCR test. This multisite trial will be conducted at seven sites in Seattle (UW), Los Angeles (UCLA), New Orleans (Tulane), Baltimore (UMB), New York City (NYU), Syracuse (SUNY-Upstate), and Boston (BMC). Inclusion criteria Participants are eligible to be included in the study only if all of the following criteria apply: 1.Men or women 18 to 80 years of age inclusive, at the time of signing the informed consent2.Willing and able to provide informed consent3.Had a close contact of a person (index) with known PCR-confirmed SARS-CoV-2 infection or index who is currently being assessed for COVID-19 Close contact is defined as: a.Household contact (i.e., residing with the index case in the 14 days prior to index diagnosis or prolonged exposure within a residence/vehicle/enclosed space without maintaining social distance)b.Medical staff, first responders, or other care persons who cared for the index case without personal protection (mask and gloves)4.Less than 4 days since last exposure (close contact with a person with SARS-CoV-2 infection) to the index case5.Access to device and internet for Telehealth visits6.Not planning to take HCQ in addition to the study medication Exclusion criteria Participants are excluded from the study if any of the following criteria apply: 1.Known hypersensitivity to HCQ or other 4-aminoquinoline compounds2.Currently hospitalized3.Symptomatic with subjective fever, cough, or shortness of breath4.Current medications exclude concomitant use of HCQ5.Concomitant use of other anti-malarial treatment or chemoprophylaxis, including chloroquine, mefloquine, artemether, or lumefantrine.6.History of retinopathy of any etiology7.Psoriasis8.Porphyria9.Known bone marrow disorders with significant neutropenia (polymorphonuclear leukocytes <1500) or thrombocytopenia (<100 K)10.Concomitant use of digoxin, cyclosporin, cimetidine, amiodarone, or tamoxifen11.Known moderate or severe liver disease12.Known long QT syndrome13.Severe renal impairment14.Use of any investigational or non-registered drug or vaccine within 30 days preceding the first dose of the study drugs or planned use during the study period INTERVENTION AND COMPARATOR: Households will be randomized 1:1 (at the level of household), with close contact participants receiving one of the following therapies: •HCQ 400 mg orally daily for 3 days then 200 mg orally daily for an additional 11 days •Placebo-like control (ascorbic acid) 500 mg orally daily for 3 days then 250 mg orally daily for 11 days MAIN OUTCOMES: The primary outcome of the study is the incidence of SARS-CoV-2 infection through day 14 among participants who are SARS-CoV-2 negative at baseline by randomization group.</p>
</div>
<div type="abstract" xml:lang="en"><p><b>RANDOMISATION</b>
</p>
<p>Participants will be randomized in a 1:1 ratio to HCQ or ascorbic acid at the level of the household (all eligible participants in 1 household will receive the same intervention). The randomization code and resulting allocation list will be generated and maintained by the Study Statistician. The list will be blocked and stratified by site and contact type (household versus healthcare worker).</p>
</div>
<div type="abstract" xml:lang="en"><p><b>BLINDING (MASKING)</b>
</p>
<p>This is a blinded study. HCQ and ascorbic acid will appear similar, and taste will be partially masked as HCQ can be bitter and ascorbic acid will be sour. The participants will be blinded to their randomization group once assigned. Study team members, apart from the Study Pharmacist and the unblinded statistical staff, will be blinded. Laboratory staff are blinded to the group allocation.</p>
</div>
<div type="abstract" xml:lang="en"><p><b>NUMBERS TO BE RANDOMISED (SAMPLE SIZE)</b>
</p>
<p>The sample size for the study is N=2 000 participants randomized 1:1 to either HCZ (n=1 000) and ascorbic acid (n=1 000).</p>
</div>
<div type="abstract" xml:lang="en"><p><b>TRIAL STATUS</b>
</p>
<p>Protocol version: 1.2 05 April 2020 Recruitment is ongoing, started March 31 and anticipated end date is September 30, 2020.</p>
</div>
<div type="abstract" xml:lang="en"><p><b>TRIAL REGISTRATION</b>
</p>
<p>ClinicalTrials.gov, Protocol Registry Number: NCT04328961 Date of registration: April 1, 2020, retrospectively registered 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.</p>
</div>
</front>
</TEI>
<pubmed><MedlineCitation Status="MEDLINE" Owner="NLM"><PMID Version="1">32493478</PMID>
<DateCompleted><Year>2020</Year>
<Month>06</Month>
<Day>10</Day>
</DateCompleted>
<DateRevised><Year>2020</Year>
<Month>12</Month>
<Day>18</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>03</Day>
</PubDate>
</JournalIssue>
<Title>Trials</Title>
<ISOAbbreviation>Trials</ISOAbbreviation>
</Journal>
<ArticleTitle>Efficacy of hydroxychloroquine for post-exposure prophylaxis to prevent severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection among adults exposed to coronavirus disease (COVID-19): a structured summary of a study protocol for a randomised controlled trial.</ArticleTitle>
<Pagination><MedlinePgn>475</MedlinePgn>
</Pagination>
<ELocationID EIdType="doi" ValidYN="Y">10.1186/s13063-020-04446-4</ELocationID>
<Abstract><AbstractText Label="OBJECTIVES" NlmCategory="OBJECTIVE">Primary Objective • To test the efficacy of Hydroxychloroquine (HCQ) (400 mg orally daily for 3 days then 200 mg orally daily for an additional 11 days, to complete 14 days) to prevent incident SARS-CoV-2 infection, compared to ascorbic acid among contacts of persons with SARS-CoV-2 infection Secondary objectives • To determine the safety and tolerability of HCQ as SARS-CoV-2 Post-exposure Prophylaxis (PEP) in adults • To test the efficacy of HCQ (400 mg orally daily for 3 days then 200 mg orally daily for an additional 11 days, to complete 14 days) to prevent incident SARS-CoV-2 infection 2 weeks after completing therapy, compared to ascorbic acid among contacts of persons with SARS-CoV-2 infection • To test the efficacy of HCQ to shorten the duration of SARS-CoV-2 shedding among those with SARS-CoV-2 infection in the HCQ PEP group • To test the efficacy of HCQ to prevent incident COVID-19 TRIAL DESIGN: This is a randomized, multi-center, placebo-equivalent (ascorbic acid) controlled, blinded study of HCQ PEP for the prevention of SARS-CoV-2 infection in adults exposed to the virus.</AbstractText>
<AbstractText Label="PARTICIPANTS" NlmCategory="METHODS">This study will enroll up to 2000 asymptomatic adults 18 to 80 years of age (inclusive) at baseline who are close contacts of persons with polymerase chain reaction (PCR)-confirmed SARS-CoV-2 or clinically suspected COVID-19 and a pending SARS-CoV-2 PCR test. This multisite trial will be conducted at seven sites in Seattle (UW), Los Angeles (UCLA), New Orleans (Tulane), Baltimore (UMB), New York City (NYU), Syracuse (SUNY-Upstate), and Boston (BMC). Inclusion criteria Participants are eligible to be included in the study only if all of the following criteria apply: 1.Men or women 18 to 80 years of age inclusive, at the time of signing the informed consent2.Willing and able to provide informed consent3.Had a close contact of a person (index) with known PCR-confirmed SARS-CoV-2 infection or index who is currently being assessed for COVID-19 Close contact is defined as: a.Household contact (i.e., residing with the index case in the 14 days prior to index diagnosis or prolonged exposure within a residence/vehicle/enclosed space without maintaining social distance)b.Medical staff, first responders, or other care persons who cared for the index case without personal protection (mask and gloves)4.Less than 4 days since last exposure (close contact with a person with SARS-CoV-2 infection) to the index case5.Access to device and internet for Telehealth visits6.Not planning to take HCQ in addition to the study medication Exclusion criteria Participants are excluded from the study if any of the following criteria apply: 1.Known hypersensitivity to HCQ or other 4-aminoquinoline compounds2.Currently hospitalized3.Symptomatic with subjective fever, cough, or shortness of breath4.Current medications exclude concomitant use of HCQ5.Concomitant use of other anti-malarial treatment or chemoprophylaxis, including chloroquine, mefloquine, artemether, or lumefantrine.6.History of retinopathy of any etiology7.Psoriasis8.Porphyria9.Known bone marrow disorders with significant neutropenia (polymorphonuclear leukocytes <1500) or thrombocytopenia (<100 K)10.Concomitant use of digoxin, cyclosporin, cimetidine, amiodarone, or tamoxifen11.Known moderate or severe liver disease12.Known long QT syndrome13.Severe renal impairment14.Use of any investigational or non-registered drug or vaccine within 30 days preceding the first dose of the study drugs or planned use during the study period INTERVENTION AND COMPARATOR: Households will be randomized 1:1 (at the level of household), with close contact participants receiving one of the following therapies: •HCQ 400 mg orally daily for 3 days then 200 mg orally daily for an additional 11 days •Placebo-like control (ascorbic acid) 500 mg orally daily for 3 days then 250 mg orally daily for 11 days MAIN OUTCOMES: The primary outcome of the study is the incidence of SARS-CoV-2 infection through day 14 among participants who are SARS-CoV-2 negative at baseline by randomization group.</AbstractText>
<AbstractText Label="RANDOMISATION" NlmCategory="UNASSIGNED">Participants will be randomized in a 1:1 ratio to HCQ or ascorbic acid at the level of the household (all eligible participants in 1 household will receive the same intervention). The randomization code and resulting allocation list will be generated and maintained by the Study Statistician. The list will be blocked and stratified by site and contact type (household versus healthcare worker).</AbstractText>
<AbstractText Label="BLINDING (MASKING)" NlmCategory="UNASSIGNED">This is a blinded study. HCQ and ascorbic acid will appear similar, and taste will be partially masked as HCQ can be bitter and ascorbic acid will be sour. The participants will be blinded to their randomization group once assigned. Study team members, apart from the Study Pharmacist and the unblinded statistical staff, will be blinded. Laboratory staff are blinded to the group allocation.</AbstractText>
<AbstractText Label="NUMBERS TO BE RANDOMISED (SAMPLE SIZE)" NlmCategory="UNASSIGNED">The sample size for the study is N=2 000 participants randomized 1:1 to either HCZ (n=1 000) and ascorbic acid (n=1 000).</AbstractText>
<AbstractText Label="TRIAL STATUS" NlmCategory="UNASSIGNED">Protocol version: 1.2 05 April 2020 Recruitment is ongoing, started March 31 and anticipated end date is September 30, 2020.</AbstractText>
<AbstractText Label="TRIAL REGISTRATION" NlmCategory="BACKGROUND">ClinicalTrials.gov, Protocol Registry Number: NCT04328961 Date of registration: April 1, 2020, retrospectively registered 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.</AbstractText>
</Abstract>
<AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Barnabas</LastName>
<ForeName>Ruanne V</ForeName>
<Initials>RV</Initials>
<Identifier Source="ORCID">http://orcid.org/0000-0002-1793-6003</Identifier>
<AffiliationInfo><Affiliation>Department of Global Health,International Clinical Research Center (ICRC), University of Washington, UW Box 359927, 325 Ninth Avenue, Seattle, WA, 98104, USA. rbarnaba@uw.edu.</Affiliation>
</AffiliationInfo>
<AffiliationInfo><Affiliation>Division of Allergy and Infectious Diseases, University of Washington, Seattle, WA, USA. rbarnaba@uw.edu.</Affiliation>
</AffiliationInfo>
<AffiliationInfo><Affiliation>Department of Epidemiolog, University of Washington, Seattle, WA, USA. rbarnaba@uw.edu.</Affiliation>
</AffiliationInfo>
<AffiliationInfo><Affiliation>Vaccine and Infectious Diseases Division, Fred Hutchinson Cancer Research Center, Seattle, WA, USA. rbarnaba@uw.edu.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Brown</LastName>
<ForeName>Elizabeth</ForeName>
<Initials>E</Initials>
<AffiliationInfo><Affiliation>Vaccine and Infectious Diseases Division, Fred Hutchinson Cancer Research Center, Seattle, WA, USA.</Affiliation>
</AffiliationInfo>
<AffiliationInfo><Affiliation>Department of Biostatistics, University of Washington, Seattle, WA, USA.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Bershteyn</LastName>
<ForeName>Anna</ForeName>
<Initials>A</Initials>
<AffiliationInfo><Affiliation>New York University School of Medicine, New York, NY, USA.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Miller</LastName>
<ForeName>R Scott</ForeName>
<Initials>RS</Initials>
<AffiliationInfo><Affiliation>Bill and Melinda Gates Foundation, Seattle, WA, USA.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Wener</LastName>
<ForeName>Mark</ForeName>
<Initials>M</Initials>
<AffiliationInfo><Affiliation>Department of Laboratory Medicine, University of Washington, Seattle, WA, USA.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Celum</LastName>
<ForeName>Connie</ForeName>
<Initials>C</Initials>
<AffiliationInfo><Affiliation>Department of Global Health,International Clinical Research Center (ICRC), University of Washington, UW Box 359927, 325 Ninth Avenue, Seattle, WA, 98104, USA.</Affiliation>
</AffiliationInfo>
<AffiliationInfo><Affiliation>Division of Allergy and Infectious Diseases, University of Washington, Seattle, WA, USA.</Affiliation>
</AffiliationInfo>
<AffiliationInfo><Affiliation>Department of Epidemiolog, University of Washington, Seattle, WA, USA.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Wald</LastName>
<ForeName>Anna</ForeName>
<Initials>A</Initials>
<AffiliationInfo><Affiliation>Division of Allergy and Infectious Diseases, University of Washington, Seattle, WA, USA.</Affiliation>
</AffiliationInfo>
<AffiliationInfo><Affiliation>Department of Epidemiolog, University of Washington, Seattle, WA, USA.</Affiliation>
</AffiliationInfo>
<AffiliationInfo><Affiliation>Vaccine and Infectious Diseases Division, Fred Hutchinson Cancer Research Center, Seattle, WA, USA.</Affiliation>
</AffiliationInfo>
<AffiliationInfo><Affiliation>Department of Laboratory Medicine, University of Washington, Seattle, WA, USA.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Chu</LastName>
<ForeName>Helen</ForeName>
<Initials>H</Initials>
<AffiliationInfo><Affiliation>Department of Global Health,International Clinical Research Center (ICRC), University of Washington, UW Box 359927, 325 Ninth Avenue, Seattle, WA, 98104, USA.</Affiliation>
</AffiliationInfo>
<AffiliationInfo><Affiliation>Division of Allergy and Infectious Diseases, University of Washington, Seattle, WA, USA.</Affiliation>
</AffiliationInfo>
<AffiliationInfo><Affiliation>Department of Epidemiolog, University of Washington, Seattle, WA, USA.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Wesche</LastName>
<ForeName>David</ForeName>
<Initials>D</Initials>
<AffiliationInfo><Affiliation>Certara, Princeton, NJ, USA.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Baeten</LastName>
<ForeName>Jared M</ForeName>
<Initials>JM</Initials>
<AffiliationInfo><Affiliation>Department of Global Health,International Clinical Research Center (ICRC), University of Washington, UW Box 359927, 325 Ninth Avenue, Seattle, WA, 98104, USA.</Affiliation>
</AffiliationInfo>
<AffiliationInfo><Affiliation>Division of Allergy and Infectious Diseases, University of Washington, Seattle, WA, USA.</Affiliation>
</AffiliationInfo>
<AffiliationInfo><Affiliation>Department of Epidemiolog, University of Washington, Seattle, WA, USA.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><CollectiveName>Hydroxychloroquine COVID-19 PEP Study Team</CollectiveName>
</Author>
</AuthorList>
<Language>eng</Language>
<DataBankList CompleteYN="Y"><DataBank><DataBankName>ClinicalTrials.gov</DataBankName>
<AccessionNumberList><AccessionNumber>NCT04328961</AccessionNumber>
</AccessionNumberList>
</DataBank>
</DataBankList>
<GrantList CompleteYN="Y"><Grant><GrantID>INV-016204</GrantID>
<Agency>Bill and Melinda Gates Foundation</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>03</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>PQ6CK8PD0R</RegistryNumber>
<NameOfSubstance UI="D001205">Ascorbic Acid</NameOfSubstance>
</Chemical>
</ChemicalList>
<CitationSubset>IM</CitationSubset>
<MeshHeadingList><MeshHeading><DescriptorName UI="D000293" MajorTopicYN="N">Adolescent</DescriptorName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D000328" MajorTopicYN="N">Adult</DescriptorName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D000368" MajorTopicYN="N">Aged</DescriptorName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D000369" MajorTopicYN="N">Aged, 80 and over</DescriptorName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D000998" MajorTopicYN="N">Antiviral Agents</DescriptorName>
<QualifierName UI="Q000008" MajorTopicYN="Y">administration & dosage</QualifierName>
<QualifierName UI="Q000009" MajorTopicYN="N">adverse effects</QualifierName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D001205" MajorTopicYN="N">Ascorbic Acid</DescriptorName>
<QualifierName UI="Q000008" MajorTopicYN="N">administration & dosage</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="D016358" MajorTopicYN="N">Contact Tracing</DescriptorName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D018352" MajorTopicYN="N">Coronavirus Infections</DescriptorName>
<QualifierName UI="Q000175" MajorTopicYN="N">diagnosis</QualifierName>
<QualifierName UI="Q000453" MajorTopicYN="N">epidemiology</QualifierName>
<QualifierName UI="Q000635" MajorTopicYN="N">transmission</QualifierName>
<QualifierName UI="Q000821" MajorTopicYN="N">virology</QualifierName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D004334" MajorTopicYN="N">Drug Administration Schedule</DescriptorName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D005260" MajorTopicYN="N">Female</DescriptorName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D006801" MajorTopicYN="N">Humans</DescriptorName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D006886" MajorTopicYN="N">Hydroxychloroquine</DescriptorName>
<QualifierName UI="Q000008" MajorTopicYN="Y">administration & dosage</QualifierName>
<QualifierName UI="Q000009" MajorTopicYN="N">adverse effects</QualifierName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D015994" MajorTopicYN="N">Incidence</DescriptorName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D008297" MajorTopicYN="N">Male</DescriptorName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D008875" MajorTopicYN="N">Middle Aged</DescriptorName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D015337" MajorTopicYN="N">Multicenter Studies as Topic</DescriptorName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D016273" MajorTopicYN="N">Occupational Exposure</DescriptorName>
<QualifierName UI="Q000009" MajorTopicYN="Y">adverse effects</QualifierName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D016272" MajorTopicYN="N">Occupational Health</DescriptorName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D058873" MajorTopicYN="N">Pandemics</DescriptorName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D011024" MajorTopicYN="N">Pneumonia, Viral</DescriptorName>
<QualifierName UI="Q000175" MajorTopicYN="N">diagnosis</QualifierName>
<QualifierName UI="Q000453" MajorTopicYN="N">epidemiology</QualifierName>
<QualifierName UI="Q000635" MajorTopicYN="N">transmission</QualifierName>
<QualifierName UI="Q000821" MajorTopicYN="N">virology</QualifierName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D056990" MajorTopicYN="Y">Post-Exposure Prophylaxis</DescriptorName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D016032" MajorTopicYN="N">Randomized Controlled Trials as Topic</DescriptorName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D018570" MajorTopicYN="N">Risk Assessment</DescriptorName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D012307" MajorTopicYN="N">Risk Factors</DescriptorName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D000086402" MajorTopicYN="N">SARS-CoV-2</DescriptorName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D013997" MajorTopicYN="N">Time Factors</DescriptorName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D016896" MajorTopicYN="N">Treatment Outcome</DescriptorName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D014481" MajorTopicYN="N" Type="Geographic">United States</DescriptorName>
<QualifierName UI="Q000453" MajorTopicYN="N">epidemiology</QualifierName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D017201" MajorTopicYN="N">Virus Shedding</DescriptorName>
<QualifierName UI="Q000187" MajorTopicYN="N">drug effects</QualifierName>
</MeshHeading>
<MeshHeading><DescriptorName UI="D055815" MajorTopicYN="N">Young Adult</DescriptorName>
</MeshHeading>
</MeshHeadingList>
<KeywordList Owner="NOTNLM"><Keyword MajorTopicYN="N">COVID-19</Keyword>
<Keyword MajorTopicYN="N">Randomised controlled trial</Keyword>
<Keyword MajorTopicYN="N">health care worker</Keyword>
<Keyword MajorTopicYN="N">household contact</Keyword>
<Keyword MajorTopicYN="N">hydroxychloroquine</Keyword>
<Keyword MajorTopicYN="N">post-exposure prophylaxis</Keyword>
<Keyword MajorTopicYN="N">protocol</Keyword>
</KeywordList>
</MedlineCitation>
<PubmedData><History><PubMedPubDate PubStatus="received"><Year>2020</Year>
<Month>04</Month>
<Day>29</Day>
</PubMedPubDate>
<PubMedPubDate PubStatus="accepted"><Year>2020</Year>
<Month>05</Month>
<Day>23</Day>
</PubMedPubDate>
<PubMedPubDate PubStatus="entrez"><Year>2020</Year>
<Month>6</Month>
<Day>5</Day>
<Hour>6</Hour>
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<PubMedPubDate PubStatus="pubmed"><Year>2020</Year>
<Month>6</Month>
<Day>5</Day>
<Hour>6</Hour>
<Minute>0</Minute>
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<PubMedPubDate PubStatus="medline"><Year>2020</Year>
<Month>6</Month>
<Day>11</Day>
<Hour>6</Hour>
<Minute>0</Minute>
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<PublicationStatus>epublish</PublicationStatus>
<ArticleIdList><ArticleId IdType="pubmed">32493478</ArticleId>
<ArticleId IdType="doi">10.1186/s13063-020-04446-4</ArticleId>
<ArticleId IdType="pii">10.1186/s13063-020-04446-4</ArticleId>
<ArticleId IdType="pmc">PMC7268961</ArticleId>
</ArticleIdList>
</PubmedData>
</pubmed>
<affiliations><list><country><li>États-Unis</li>
</country>
<region><li>New Jersey</li>
<li>Washington (État)</li>
<li>État de New York</li>
</region>
<settlement><li>Seattle</li>
</settlement>
<orgName><li>Université de Washington</li>
</orgName>
</list>
<tree><country name="États-Unis"><region name="Washington (État)"><name sortKey="Barnabas, Ruanne V" sort="Barnabas, Ruanne V" uniqKey="Barnabas R" first="Ruanne V" last="Barnabas">Ruanne V. Barnabas</name>
</region>
<name sortKey="Baeten, Jared M" sort="Baeten, Jared M" uniqKey="Baeten J" first="Jared M" last="Baeten">Jared M. Baeten</name>
<name sortKey="Baeten, Jared M" sort="Baeten, Jared M" uniqKey="Baeten J" first="Jared M" last="Baeten">Jared M. Baeten</name>
<name sortKey="Baeten, Jared M" sort="Baeten, Jared M" uniqKey="Baeten J" first="Jared M" last="Baeten">Jared M. Baeten</name>
<name sortKey="Barnabas, Ruanne V" sort="Barnabas, Ruanne V" uniqKey="Barnabas R" first="Ruanne V" last="Barnabas">Ruanne V. Barnabas</name>
<name sortKey="Barnabas, Ruanne V" sort="Barnabas, Ruanne V" uniqKey="Barnabas R" first="Ruanne V" last="Barnabas">Ruanne V. Barnabas</name>
<name sortKey="Barnabas, Ruanne V" sort="Barnabas, Ruanne V" uniqKey="Barnabas R" first="Ruanne V" last="Barnabas">Ruanne V. Barnabas</name>
<name sortKey="Bershteyn, Anna" sort="Bershteyn, Anna" uniqKey="Bershteyn A" first="Anna" last="Bershteyn">Anna Bershteyn</name>
<name sortKey="Brown, Elizabeth" sort="Brown, Elizabeth" uniqKey="Brown E" first="Elizabeth" last="Brown">Elizabeth Brown</name>
<name sortKey="Brown, Elizabeth" sort="Brown, Elizabeth" uniqKey="Brown E" first="Elizabeth" last="Brown">Elizabeth Brown</name>
<name sortKey="Celum, Connie" sort="Celum, Connie" uniqKey="Celum C" first="Connie" last="Celum">Connie Celum</name>
<name sortKey="Celum, Connie" sort="Celum, Connie" uniqKey="Celum C" first="Connie" last="Celum">Connie Celum</name>
<name sortKey="Celum, Connie" sort="Celum, Connie" uniqKey="Celum C" first="Connie" last="Celum">Connie Celum</name>
<name sortKey="Chu, Helen" sort="Chu, Helen" uniqKey="Chu H" first="Helen" last="Chu">Helen Chu</name>
<name sortKey="Chu, Helen" sort="Chu, Helen" uniqKey="Chu H" first="Helen" last="Chu">Helen Chu</name>
<name sortKey="Chu, Helen" sort="Chu, Helen" uniqKey="Chu H" first="Helen" last="Chu">Helen Chu</name>
<name sortKey="Miller, R Scott" sort="Miller, R Scott" uniqKey="Miller R" first="R Scott" last="Miller">R Scott Miller</name>
<name sortKey="Wald, Anna" sort="Wald, Anna" uniqKey="Wald A" first="Anna" last="Wald">Anna Wald</name>
<name sortKey="Wald, Anna" sort="Wald, Anna" uniqKey="Wald A" first="Anna" last="Wald">Anna Wald</name>
<name sortKey="Wald, Anna" sort="Wald, Anna" uniqKey="Wald A" first="Anna" last="Wald">Anna Wald</name>
<name sortKey="Wald, Anna" sort="Wald, Anna" uniqKey="Wald A" first="Anna" last="Wald">Anna Wald</name>
<name sortKey="Wener, Mark" sort="Wener, Mark" uniqKey="Wener M" first="Mark" last="Wener">Mark Wener</name>
<name sortKey="Wesche, David" sort="Wesche, David" uniqKey="Wesche D" first="David" last="Wesche">David Wesche</name>
</country>
</tree>
</affiliations>
</record>
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