Hydroxychloroquine in Nonhospitalized Adults With Early COVID-19 : A Randomized Trial.
Identifieur interne : 001129 ( Main/Curation ); précédent : 001128; suivant : 001130Hydroxychloroquine in Nonhospitalized Adults With Early COVID-19 : A Randomized Trial.
Auteurs : Caleb P. Skipper ; Katelyn A. Pastick ; Nicole W. Engen ; Ananta S. Bangdiwala ; Mahsa Abassi ; Sarah M. Lofgren ; Darlisha A. Williams ; Elizabeth C. Okafor ; Matthew F. Pullen ; Melanie R. Nicol ; Alanna A. Nascene ; Kathy H. Hullsiek ; Matthew P. Cheng ; Darlette Luke ; Sylvain A. Lother [Canada] ; Lauren J. Mackenzie [Canada] ; Glen Drobot [Canada] ; Lauren E. Kelly [Canada] ; Ilan S. Schwartz [Canada] ; Ryan Zarychanski [Canada] ; Emily G. Mcdonald ; Todd C. Lee ; Radha Rajasingham ; David R. BoulwareSource :
- Annals of internal medicine [ 1539-3704 ] ; 2020.
Descripteurs français
- KwdFr :
- Adulte (MeSH), Adulte d'âge moyen (MeSH), Antipaludiques (usage thérapeutique), Betacoronavirus (MeSH), Facteurs de risque (MeSH), Facteurs temps (MeSH), Femelle (MeSH), Humains (MeSH), Hydroxychloroquine (usage thérapeutique), Infections à coronavirus (traitement médicamenteux), Infections à coronavirus (épidémiologie), Mâle (MeSH), Méthode en double aveugle (MeSH), Pandémies (MeSH), Patients en consultation externe (MeSH), Pneumopathie virale (traitement médicamenteux), Pneumopathie virale (épidémiologie), Études de suivi (MeSH), Études rétrospectives (MeSH).
- MESH :
- traitement médicamenteux : Infections à coronavirus, Pneumopathie virale.
- usage thérapeutique : Antipaludiques, Hydroxychloroquine.
- épidémiologie : Infections à coronavirus, Pneumopathie virale.
- Adulte, Adulte d'âge moyen, Betacoronavirus, Facteurs de risque, Facteurs temps, Femelle, Humains, Mâle, Méthode en double aveugle, Pandémies, Patients en consultation externe, Études de suivi, Études rétrospectives.
English descriptors
- KwdEn :
- Adult (MeSH), Antimalarials (therapeutic use), Betacoronavirus (MeSH), COVID-19 (MeSH), Coronavirus Infections (drug therapy), Coronavirus Infections (epidemiology), Double-Blind Method (MeSH), Female (MeSH), Follow-Up Studies (MeSH), Humans (MeSH), Hydroxychloroquine (therapeutic use), Male (MeSH), Middle Aged (MeSH), Outpatients (MeSH), Pandemics (MeSH), Pneumonia, Viral (drug therapy), Pneumonia, Viral (epidemiology), Retrospective Studies (MeSH), Risk Factors (MeSH), SARS-CoV-2 (MeSH), Time Factors (MeSH).
- MESH :
- chemical , therapeutic use : Antimalarials, Hydroxychloroquine.
- drug therapy : Coronavirus Infections, Pneumonia, Viral.
- epidemiology : Coronavirus Infections, Pneumonia, Viral.
- Adult, Betacoronavirus, COVID-19, Double-Blind Method, Female, Follow-Up Studies, Humans, Male, Middle Aged, Outpatients, Pandemics, Retrospective Studies, Risk Factors, SARS-CoV-2, Time Factors.
Abstract
BACKGROUND
No effective oral therapy exists for early coronavirus disease 2019 (COVID-19).
OBJECTIVE
To investigate whether hydroxychloroquine could reduce COVID-19 severity in adult outpatients.
DESIGN
Randomized, double-blind, placebo-controlled trial conducted from 22 March through 20 May 2020. (ClinicalTrials.gov: NCT04308668).
SETTING
Internet-based trial across the United States and Canada (40 states and 3 provinces).
PARTICIPANTS
Symptomatic, nonhospitalized adults with laboratory-confirmed COVID-19 or probable COVID-19 and high-risk exposure within 4 days of symptom onset.
INTERVENTION
Oral hydroxychloroquine (800 mg once, followed by 600 mg in 6 to 8 hours, then 600 mg daily for 4 more days) or masked placebo.
MEASUREMENTS
Symptoms and severity at baseline and then at days 3, 5, 10, and 14 using a 10-point visual analogue scale. The primary end point was change in overall symptom severity over 14 days.
RESULTS
Of 491 patients randomly assigned to a group, 423 contributed primary end point data. Of these, 341 (81%) had laboratory-confirmed infection with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) or epidemiologically linked exposure to a person with laboratory-confirmed infection; 56% (236 of 423) were enrolled within 1 day of symptoms starting. Change in symptom severity over 14 days did not differ between the hydroxychloroquine and placebo groups (difference in symptom severity: relative, 12%; absolute, -0.27 point [95% CI, -0.61 to 0.07 point];
LIMITATION
Only 58% of participants received SARS-CoV-2 testing because of severe U.S. testing shortages.
CONCLUSION
Hydroxychloroquine did not substantially reduce symptom severity in outpatients with early, mild COVID-19.
PRIMARY FUNDING SOURCE
Private donors.
DOI: 10.7326/M20-4207
PubMed: 32673060
PubMed Central: PMC7384270
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Caleb P. Skipper<affiliation><nlm:affiliation>University of Minnesota, Minneapolis, Minnesota (C.P.S., K.A.P., N.W.E., A.S.B., M.A., S.M.L., D.A.W., E.C.O., M.F.P., M.R.N., A.A.N., K.H.H., R.R., D.R.B.).</nlm:affiliation>
<wicri:noCountry code="subField">D.R.B.).</wicri:noCountry>
</affiliation>
<affiliation><nlm:affiliation>University of Minnesota, Minneapolis, Minnesota (C.P.S., K.A.P., N.W.E., A.S.B., M.A., S.M.L., D.A.W., E.C.O., M.F.P., M.R.N., A.A.N., K.H.H., R.R., D.R.B.).</nlm:affiliation>
<wicri:noCountry code="subField">D.R.B.).</wicri:noCountry>
</affiliation>
<affiliation><nlm:affiliation>University of Minnesota, Minneapolis, Minnesota (C.P.S., K.A.P., N.W.E., A.S.B., M.A., S.M.L., D.A.W., E.C.O., M.F.P., M.R.N., A.A.N., K.H.H., R.R., D.R.B.).</nlm:affiliation>
<wicri:noCountry code="subField">D.R.B.).</wicri:noCountry>
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<affiliation><nlm:affiliation>University of Minnesota, Minneapolis, Minnesota (C.P.S., K.A.P., N.W.E., A.S.B., M.A., S.M.L., D.A.W., E.C.O., M.F.P., M.R.N., A.A.N., K.H.H., R.R., D.R.B.).</nlm:affiliation>
<wicri:noCountry code="subField">D.R.B.).</wicri:noCountry>
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<affiliation><nlm:affiliation>University of Minnesota, Minneapolis, Minnesota (C.P.S., K.A.P., N.W.E., A.S.B., M.A., S.M.L., D.A.W., E.C.O., M.F.P., M.R.N., A.A.N., K.H.H., R.R., D.R.B.).</nlm:affiliation>
<wicri:noCountry code="subField">D.R.B.).</wicri:noCountry>
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<affiliation><nlm:affiliation>University of Minnesota, Minneapolis, Minnesota (C.P.S., K.A.P., N.W.E., A.S.B., M.A., S.M.L., D.A.W., E.C.O., M.F.P., M.R.N., A.A.N., K.H.H., R.R., D.R.B.).</nlm:affiliation>
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<affiliation><nlm:affiliation>University of Minnesota, Minneapolis, Minnesota (C.P.S., K.A.P., N.W.E., A.S.B., M.A., S.M.L., D.A.W., E.C.O., M.F.P., M.R.N., A.A.N., K.H.H., R.R., D.R.B.).</nlm:affiliation>
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<affiliation><nlm:affiliation>University of Minnesota, Minneapolis, Minnesota (C.P.S., K.A.P., N.W.E., A.S.B., M.A., S.M.L., D.A.W., E.C.O., M.F.P., M.R.N., A.A.N., K.H.H., R.R., D.R.B.).</nlm:affiliation>
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<affiliation><nlm:affiliation>University of Minnesota, Minneapolis, Minnesota (C.P.S., K.A.P., N.W.E., A.S.B., M.A., S.M.L., D.A.W., E.C.O., M.F.P., M.R.N., A.A.N., K.H.H., R.R., D.R.B.).</nlm:affiliation>
<wicri:noCountry code="subField">D.R.B.).</wicri:noCountry>
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<affiliation><nlm:affiliation>University of Minnesota, Minneapolis, Minnesota (C.P.S., K.A.P., N.W.E., A.S.B., M.A., S.M.L., D.A.W., E.C.O., M.F.P., M.R.N., A.A.N., K.H.H., R.R., D.R.B.).</nlm:affiliation>
<wicri:noCountry code="subField">D.R.B.).</wicri:noCountry>
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<affiliation><nlm:affiliation>University of Minnesota, Minneapolis, Minnesota (C.P.S., K.A.P., N.W.E., A.S.B., M.A., S.M.L., D.A.W., E.C.O., M.F.P., M.R.N., A.A.N., K.H.H., R.R., D.R.B.).</nlm:affiliation>
<wicri:noCountry code="subField">D.R.B.).</wicri:noCountry>
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<affiliation><nlm:affiliation>University of Minnesota, Minneapolis, Minnesota (C.P.S., K.A.P., N.W.E., A.S.B., M.A., S.M.L., D.A.W., E.C.O., M.F.P., M.R.N., A.A.N., K.H.H., R.R., D.R.B.).</nlm:affiliation>
<wicri:noCountry code="subField">D.R.B.).</wicri:noCountry>
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<affiliation><nlm:affiliation>Research Institute of the McGill University Health Centre and McGill University, Montréal, Quebec, Canada (M.P.C., E.G.M., T.C.L.).</nlm:affiliation>
<wicri:noCountry code="subField">T.C.L.).</wicri:noCountry>
</affiliation>
<affiliation><nlm:affiliation>M Health Fairview Investigational Drug Service Pharmacy, Minneapolis, Minnesota (D.L.).</nlm:affiliation>
<wicri:noCountry code="subField">Minnesota (D.L.).</wicri:noCountry>
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<affiliation><nlm:affiliation>Research Institute of the McGill University Health Centre and McGill University, Montréal, Quebec, Canada (M.P.C., E.G.M., T.C.L.).</nlm:affiliation>
<wicri:noCountry code="subField">T.C.L.).</wicri:noCountry>
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<affiliation><nlm:affiliation>Research Institute of the McGill University Health Centre and McGill University, Montréal, Quebec, Canada (M.P.C., E.G.M., T.C.L.).</nlm:affiliation>
<wicri:noCountry code="subField">T.C.L.).</wicri:noCountry>
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<affiliation><nlm:affiliation>University of Minnesota, Minneapolis, Minnesota (C.P.S., K.A.P., N.W.E., A.S.B., M.A., S.M.L., D.A.W., E.C.O., M.F.P., M.R.N., A.A.N., K.H.H., R.R., D.R.B.).</nlm:affiliation>
<wicri:noCountry code="subField">D.R.B.).</wicri:noCountry>
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<affiliation><nlm:affiliation>University of Minnesota, Minneapolis, Minnesota (C.P.S., K.A.P., N.W.E., A.S.B., M.A., S.M.L., D.A.W., E.C.O., M.F.P., M.R.N., A.A.N., K.H.H., R.R., D.R.B.).</nlm:affiliation>
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<author><name sortKey="Bangdiwala, Ananta S" sort="Bangdiwala, Ananta S" uniqKey="Bangdiwala A" first="Ananta S" last="Bangdiwala">Ananta S. Bangdiwala</name>
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<author><name sortKey="Abassi, Mahsa" sort="Abassi, Mahsa" uniqKey="Abassi M" first="Mahsa" last="Abassi">Mahsa Abassi</name>
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<author><name sortKey="Lofgren, Sarah M" sort="Lofgren, Sarah M" uniqKey="Lofgren S" first="Sarah M" last="Lofgren">Sarah M. Lofgren</name>
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<author><name sortKey="Williams, Darlisha A" sort="Williams, Darlisha A" uniqKey="Williams D" first="Darlisha A" last="Williams">Darlisha A. Williams</name>
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<author><name sortKey="Okafor, Elizabeth C" sort="Okafor, Elizabeth C" uniqKey="Okafor E" first="Elizabeth C" last="Okafor">Elizabeth C. Okafor</name>
<affiliation><nlm:affiliation>University of Minnesota, Minneapolis, Minnesota (C.P.S., K.A.P., N.W.E., A.S.B., M.A., S.M.L., D.A.W., E.C.O., M.F.P., M.R.N., A.A.N., K.H.H., R.R., D.R.B.).</nlm:affiliation>
<wicri:noCountry code="subField">D.R.B.).</wicri:noCountry>
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<author><name sortKey="Pullen, Matthew F" sort="Pullen, Matthew F" uniqKey="Pullen M" first="Matthew F" last="Pullen">Matthew F. Pullen</name>
<affiliation><nlm:affiliation>University of Minnesota, Minneapolis, Minnesota (C.P.S., K.A.P., N.W.E., A.S.B., M.A., S.M.L., D.A.W., E.C.O., M.F.P., M.R.N., A.A.N., K.H.H., R.R., D.R.B.).</nlm:affiliation>
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<author><name sortKey="Nicol, Melanie R" sort="Nicol, Melanie R" uniqKey="Nicol M" first="Melanie R" last="Nicol">Melanie R. Nicol</name>
<affiliation><nlm:affiliation>University of Minnesota, Minneapolis, Minnesota (C.P.S., K.A.P., N.W.E., A.S.B., M.A., S.M.L., D.A.W., E.C.O., M.F.P., M.R.N., A.A.N., K.H.H., R.R., D.R.B.).</nlm:affiliation>
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<author><name sortKey="Nascene, Alanna A" sort="Nascene, Alanna A" uniqKey="Nascene A" first="Alanna A" last="Nascene">Alanna A. Nascene</name>
<affiliation><nlm:affiliation>University of Minnesota, Minneapolis, Minnesota (C.P.S., K.A.P., N.W.E., A.S.B., M.A., S.M.L., D.A.W., E.C.O., M.F.P., M.R.N., A.A.N., K.H.H., R.R., D.R.B.).</nlm:affiliation>
<wicri:noCountry code="subField">D.R.B.).</wicri:noCountry>
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<author><name sortKey="Hullsiek, Kathy H" sort="Hullsiek, Kathy H" uniqKey="Hullsiek K" first="Kathy H" last="Hullsiek">Kathy H. Hullsiek</name>
<affiliation><nlm:affiliation>University of Minnesota, Minneapolis, Minnesota (C.P.S., K.A.P., N.W.E., A.S.B., M.A., S.M.L., D.A.W., E.C.O., M.F.P., M.R.N., A.A.N., K.H.H., R.R., D.R.B.).</nlm:affiliation>
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<author><name sortKey="Cheng, Matthew P" sort="Cheng, Matthew P" uniqKey="Cheng M" first="Matthew P" last="Cheng">Matthew P. Cheng</name>
<affiliation><nlm:affiliation>Research Institute of the McGill University Health Centre and McGill University, Montréal, Quebec, Canada (M.P.C., E.G.M., T.C.L.).</nlm:affiliation>
<wicri:noCountry code="subField">T.C.L.).</wicri:noCountry>
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<author><name sortKey="Luke, Darlette" sort="Luke, Darlette" uniqKey="Luke D" first="Darlette" last="Luke">Darlette Luke</name>
<affiliation><nlm:affiliation>M Health Fairview Investigational Drug Service Pharmacy, Minneapolis, Minnesota (D.L.).</nlm:affiliation>
<wicri:noCountry code="subField">Minnesota (D.L.).</wicri:noCountry>
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<author><name sortKey="Lother, Sylvain A" sort="Lother, Sylvain A" uniqKey="Lother S" first="Sylvain A" last="Lother">Sylvain A. Lother</name>
<affiliation wicri:level="4"><nlm:affiliation>University of Manitoba, Winnipeg, Manitoba, Canada (S.A.L., L.J.M., G.D., R.Z.).</nlm:affiliation>
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<country>Canada</country>
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<author><name sortKey="Mackenzie, Lauren J" sort="Mackenzie, Lauren J" uniqKey="Mackenzie L" first="Lauren J" last="Mackenzie">Lauren J. Mackenzie</name>
<affiliation wicri:level="4"><nlm:affiliation>University of Manitoba, Winnipeg, Manitoba, Canada (S.A.L., L.J.M., G.D., R.Z.).</nlm:affiliation>
<orgName type="university">Université du Manitoba</orgName>
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<author><name sortKey="Drobot, Glen" sort="Drobot, Glen" uniqKey="Drobot G" first="Glen" last="Drobot">Glen Drobot</name>
<affiliation wicri:level="4"><nlm:affiliation>University of Manitoba, Winnipeg, Manitoba, Canada (S.A.L., L.J.M., G.D., R.Z.).</nlm:affiliation>
<orgName type="university">Université du Manitoba</orgName>
<country>Canada</country>
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<author><name sortKey="Kelly, Lauren E" sort="Kelly, Lauren E" uniqKey="Kelly L" first="Lauren E" last="Kelly">Lauren E. Kelly</name>
<affiliation wicri:level="1"><nlm:affiliation>George & Fay Yee Centre for Healthcare Innovation, Winnipeg, Manitoba, Canada (L.E.K.).</nlm:affiliation>
<country>Canada</country>
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<author><name sortKey="Schwartz, Ilan S" sort="Schwartz, Ilan S" uniqKey="Schwartz I" first="Ilan S" last="Schwartz">Ilan S. Schwartz</name>
<affiliation wicri:level="1"><nlm:affiliation>University of Alberta, Edmonton, Alberta, Canada (I.S.S.).</nlm:affiliation>
<country>Canada</country>
<wicri:regionArea>University of Alberta, Edmonton, Alberta</wicri:regionArea>
</affiliation>
</author>
<author><name sortKey="Zarychanski, Ryan" sort="Zarychanski, Ryan" uniqKey="Zarychanski R" first="Ryan" last="Zarychanski">Ryan Zarychanski</name>
<affiliation wicri:level="4"><nlm:affiliation>University of Manitoba, Winnipeg, Manitoba, Canada (S.A.L., L.J.M., G.D., R.Z.).</nlm:affiliation>
<orgName type="university">Université du Manitoba</orgName>
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<author><name sortKey="Mcdonald, Emily G" sort="Mcdonald, Emily G" uniqKey="Mcdonald E" first="Emily G" last="Mcdonald">Emily G. Mcdonald</name>
<affiliation><nlm:affiliation>Research Institute of the McGill University Health Centre and McGill University, Montréal, Quebec, Canada (M.P.C., E.G.M., T.C.L.).</nlm:affiliation>
<wicri:noCountry code="subField">T.C.L.).</wicri:noCountry>
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<author><name sortKey="Lee, Todd C" sort="Lee, Todd C" uniqKey="Lee T" first="Todd C" last="Lee">Todd C. Lee</name>
<affiliation><nlm:affiliation>Research Institute of the McGill University Health Centre and McGill University, Montréal, Quebec, Canada (M.P.C., E.G.M., T.C.L.).</nlm:affiliation>
<wicri:noCountry code="subField">T.C.L.).</wicri:noCountry>
</affiliation>
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<author><name sortKey="Rajasingham, Radha" sort="Rajasingham, Radha" uniqKey="Rajasingham R" first="Radha" last="Rajasingham">Radha Rajasingham</name>
<affiliation><nlm:affiliation>University of Minnesota, Minneapolis, Minnesota (C.P.S., K.A.P., N.W.E., A.S.B., M.A., S.M.L., D.A.W., E.C.O., M.F.P., M.R.N., A.A.N., K.H.H., R.R., D.R.B.).</nlm:affiliation>
<wicri:noCountry code="subField">D.R.B.).</wicri:noCountry>
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<author><name sortKey="Boulware, David R" sort="Boulware, David R" uniqKey="Boulware D" first="David R" last="Boulware">David R. Boulware</name>
<affiliation><nlm:affiliation>University of Minnesota, Minneapolis, Minnesota (C.P.S., K.A.P., N.W.E., A.S.B., M.A., S.M.L., D.A.W., E.C.O., M.F.P., M.R.N., A.A.N., K.H.H., R.R., D.R.B.).</nlm:affiliation>
<wicri:noCountry code="subField">D.R.B.).</wicri:noCountry>
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</titleStmt>
<publicationStmt><idno type="wicri:source">PubMed</idno>
<date when="2020">2020</date>
<idno type="RBID">pubmed:32673060</idno>
<idno type="pmid">32673060</idno>
<idno type="doi">10.7326/M20-4207</idno>
<idno type="pmc">PMC7384270</idno>
<idno type="wicri:Area/Main/Corpus">001129</idno>
<idno type="wicri:explorRef" wicri:stream="Main" wicri:step="Corpus" wicri:corpus="PubMed">001129</idno>
<idno type="wicri:Area/Main/Curation">001129</idno>
<idno type="wicri:explorRef" wicri:stream="Main" wicri:step="Curation">001129</idno>
</publicationStmt>
<sourceDesc><biblStruct><analytic><title xml:lang="en">Hydroxychloroquine in Nonhospitalized Adults With Early COVID-19 : A Randomized Trial.</title>
<author><name sortKey="Skipper, Caleb P" sort="Skipper, Caleb P" uniqKey="Skipper C" first="Caleb P" last="Skipper">Caleb P. Skipper</name>
<affiliation><nlm:affiliation>University of Minnesota, Minneapolis, Minnesota (C.P.S., K.A.P., N.W.E., A.S.B., M.A., S.M.L., D.A.W., E.C.O., M.F.P., M.R.N., A.A.N., K.H.H., R.R., D.R.B.).</nlm:affiliation>
<wicri:noCountry code="subField">D.R.B.).</wicri:noCountry>
</affiliation>
</author>
<author><name sortKey="Pastick, Katelyn A" sort="Pastick, Katelyn A" uniqKey="Pastick K" first="Katelyn A" last="Pastick">Katelyn A. Pastick</name>
<affiliation><nlm:affiliation>University of Minnesota, Minneapolis, Minnesota (C.P.S., K.A.P., N.W.E., A.S.B., M.A., S.M.L., D.A.W., E.C.O., M.F.P., M.R.N., A.A.N., K.H.H., R.R., D.R.B.).</nlm:affiliation>
<wicri:noCountry code="subField">D.R.B.).</wicri:noCountry>
</affiliation>
</author>
<author><name sortKey="Engen, Nicole W" sort="Engen, Nicole W" uniqKey="Engen N" first="Nicole W" last="Engen">Nicole W. Engen</name>
<affiliation><nlm:affiliation>University of Minnesota, Minneapolis, Minnesota (C.P.S., K.A.P., N.W.E., A.S.B., M.A., S.M.L., D.A.W., E.C.O., M.F.P., M.R.N., A.A.N., K.H.H., R.R., D.R.B.).</nlm:affiliation>
<wicri:noCountry code="subField">D.R.B.).</wicri:noCountry>
</affiliation>
</author>
<author><name sortKey="Bangdiwala, Ananta S" sort="Bangdiwala, Ananta S" uniqKey="Bangdiwala A" first="Ananta S" last="Bangdiwala">Ananta S. Bangdiwala</name>
<affiliation><nlm:affiliation>University of Minnesota, Minneapolis, Minnesota (C.P.S., K.A.P., N.W.E., A.S.B., M.A., S.M.L., D.A.W., E.C.O., M.F.P., M.R.N., A.A.N., K.H.H., R.R., D.R.B.).</nlm:affiliation>
<wicri:noCountry code="subField">D.R.B.).</wicri:noCountry>
</affiliation>
</author>
<author><name sortKey="Abassi, Mahsa" sort="Abassi, Mahsa" uniqKey="Abassi M" first="Mahsa" last="Abassi">Mahsa Abassi</name>
<affiliation><nlm:affiliation>University of Minnesota, Minneapolis, Minnesota (C.P.S., K.A.P., N.W.E., A.S.B., M.A., S.M.L., D.A.W., E.C.O., M.F.P., M.R.N., A.A.N., K.H.H., R.R., D.R.B.).</nlm:affiliation>
<wicri:noCountry code="subField">D.R.B.).</wicri:noCountry>
</affiliation>
</author>
<author><name sortKey="Lofgren, Sarah M" sort="Lofgren, Sarah M" uniqKey="Lofgren S" first="Sarah M" last="Lofgren">Sarah M. Lofgren</name>
<affiliation><nlm:affiliation>University of Minnesota, Minneapolis, Minnesota (C.P.S., K.A.P., N.W.E., A.S.B., M.A., S.M.L., D.A.W., E.C.O., M.F.P., M.R.N., A.A.N., K.H.H., R.R., D.R.B.).</nlm:affiliation>
<wicri:noCountry code="subField">D.R.B.).</wicri:noCountry>
</affiliation>
</author>
<author><name sortKey="Williams, Darlisha A" sort="Williams, Darlisha A" uniqKey="Williams D" first="Darlisha A" last="Williams">Darlisha A. Williams</name>
<affiliation><nlm:affiliation>University of Minnesota, Minneapolis, Minnesota (C.P.S., K.A.P., N.W.E., A.S.B., M.A., S.M.L., D.A.W., E.C.O., M.F.P., M.R.N., A.A.N., K.H.H., R.R., D.R.B.).</nlm:affiliation>
<wicri:noCountry code="subField">D.R.B.).</wicri:noCountry>
</affiliation>
</author>
<author><name sortKey="Okafor, Elizabeth C" sort="Okafor, Elizabeth C" uniqKey="Okafor E" first="Elizabeth C" last="Okafor">Elizabeth C. Okafor</name>
<affiliation><nlm:affiliation>University of Minnesota, Minneapolis, Minnesota (C.P.S., K.A.P., N.W.E., A.S.B., M.A., S.M.L., D.A.W., E.C.O., M.F.P., M.R.N., A.A.N., K.H.H., R.R., D.R.B.).</nlm:affiliation>
<wicri:noCountry code="subField">D.R.B.).</wicri:noCountry>
</affiliation>
</author>
<author><name sortKey="Pullen, Matthew F" sort="Pullen, Matthew F" uniqKey="Pullen M" first="Matthew F" last="Pullen">Matthew F. Pullen</name>
<affiliation><nlm:affiliation>University of Minnesota, Minneapolis, Minnesota (C.P.S., K.A.P., N.W.E., A.S.B., M.A., S.M.L., D.A.W., E.C.O., M.F.P., M.R.N., A.A.N., K.H.H., R.R., D.R.B.).</nlm:affiliation>
<wicri:noCountry code="subField">D.R.B.).</wicri:noCountry>
</affiliation>
</author>
<author><name sortKey="Nicol, Melanie R" sort="Nicol, Melanie R" uniqKey="Nicol M" first="Melanie R" last="Nicol">Melanie R. Nicol</name>
<affiliation><nlm:affiliation>University of Minnesota, Minneapolis, Minnesota (C.P.S., K.A.P., N.W.E., A.S.B., M.A., S.M.L., D.A.W., E.C.O., M.F.P., M.R.N., A.A.N., K.H.H., R.R., D.R.B.).</nlm:affiliation>
<wicri:noCountry code="subField">D.R.B.).</wicri:noCountry>
</affiliation>
</author>
<author><name sortKey="Nascene, Alanna A" sort="Nascene, Alanna A" uniqKey="Nascene A" first="Alanna A" last="Nascene">Alanna A. Nascene</name>
<affiliation><nlm:affiliation>University of Minnesota, Minneapolis, Minnesota (C.P.S., K.A.P., N.W.E., A.S.B., M.A., S.M.L., D.A.W., E.C.O., M.F.P., M.R.N., A.A.N., K.H.H., R.R., D.R.B.).</nlm:affiliation>
<wicri:noCountry code="subField">D.R.B.).</wicri:noCountry>
</affiliation>
</author>
<author><name sortKey="Hullsiek, Kathy H" sort="Hullsiek, Kathy H" uniqKey="Hullsiek K" first="Kathy H" last="Hullsiek">Kathy H. Hullsiek</name>
<affiliation><nlm:affiliation>University of Minnesota, Minneapolis, Minnesota (C.P.S., K.A.P., N.W.E., A.S.B., M.A., S.M.L., D.A.W., E.C.O., M.F.P., M.R.N., A.A.N., K.H.H., R.R., D.R.B.).</nlm:affiliation>
<wicri:noCountry code="subField">D.R.B.).</wicri:noCountry>
</affiliation>
</author>
<author><name sortKey="Cheng, Matthew P" sort="Cheng, Matthew P" uniqKey="Cheng M" first="Matthew P" last="Cheng">Matthew P. Cheng</name>
<affiliation><nlm:affiliation>Research Institute of the McGill University Health Centre and McGill University, Montréal, Quebec, Canada (M.P.C., E.G.M., T.C.L.).</nlm:affiliation>
<wicri:noCountry code="subField">T.C.L.).</wicri:noCountry>
</affiliation>
</author>
<author><name sortKey="Luke, Darlette" sort="Luke, Darlette" uniqKey="Luke D" first="Darlette" last="Luke">Darlette Luke</name>
<affiliation><nlm:affiliation>M Health Fairview Investigational Drug Service Pharmacy, Minneapolis, Minnesota (D.L.).</nlm:affiliation>
<wicri:noCountry code="subField">Minnesota (D.L.).</wicri:noCountry>
</affiliation>
</author>
<author><name sortKey="Lother, Sylvain A" sort="Lother, Sylvain A" uniqKey="Lother S" first="Sylvain A" last="Lother">Sylvain A. Lother</name>
<affiliation wicri:level="4"><nlm:affiliation>University of Manitoba, Winnipeg, Manitoba, Canada (S.A.L., L.J.M., G.D., R.Z.).</nlm:affiliation>
<orgName type="university">Université du Manitoba</orgName>
<country>Canada</country>
<placeName><settlement type="city">Winnipeg</settlement>
<region type="state">Manitoba</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Mackenzie, Lauren J" sort="Mackenzie, Lauren J" uniqKey="Mackenzie L" first="Lauren J" last="Mackenzie">Lauren J. Mackenzie</name>
<affiliation wicri:level="4"><nlm:affiliation>University of Manitoba, Winnipeg, Manitoba, Canada (S.A.L., L.J.M., G.D., R.Z.).</nlm:affiliation>
<orgName type="university">Université du Manitoba</orgName>
<country>Canada</country>
<placeName><settlement type="city">Winnipeg</settlement>
<region type="state">Manitoba</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Drobot, Glen" sort="Drobot, Glen" uniqKey="Drobot G" first="Glen" last="Drobot">Glen Drobot</name>
<affiliation wicri:level="4"><nlm:affiliation>University of Manitoba, Winnipeg, Manitoba, Canada (S.A.L., L.J.M., G.D., R.Z.).</nlm:affiliation>
<orgName type="university">Université du Manitoba</orgName>
<country>Canada</country>
<placeName><settlement type="city">Winnipeg</settlement>
<region type="state">Manitoba</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Kelly, Lauren E" sort="Kelly, Lauren E" uniqKey="Kelly L" first="Lauren E" last="Kelly">Lauren E. Kelly</name>
<affiliation wicri:level="1"><nlm:affiliation>George & Fay Yee Centre for Healthcare Innovation, Winnipeg, Manitoba, Canada (L.E.K.).</nlm:affiliation>
<country>Canada</country>
<wicri:regionArea>George & Fay Yee Centre for Healthcare Innovation, Winnipeg, Manitoba</wicri:regionArea>
</affiliation>
</author>
<author><name sortKey="Schwartz, Ilan S" sort="Schwartz, Ilan S" uniqKey="Schwartz I" first="Ilan S" last="Schwartz">Ilan S. Schwartz</name>
<affiliation wicri:level="1"><nlm:affiliation>University of Alberta, Edmonton, Alberta, Canada (I.S.S.).</nlm:affiliation>
<country>Canada</country>
<wicri:regionArea>University of Alberta, Edmonton, Alberta</wicri:regionArea>
</affiliation>
</author>
<author><name sortKey="Zarychanski, Ryan" sort="Zarychanski, Ryan" uniqKey="Zarychanski R" first="Ryan" last="Zarychanski">Ryan Zarychanski</name>
<affiliation wicri:level="4"><nlm:affiliation>University of Manitoba, Winnipeg, Manitoba, Canada (S.A.L., L.J.M., G.D., R.Z.).</nlm:affiliation>
<orgName type="university">Université du Manitoba</orgName>
<country>Canada</country>
<placeName><settlement type="city">Winnipeg</settlement>
<region type="state">Manitoba</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Mcdonald, Emily G" sort="Mcdonald, Emily G" uniqKey="Mcdonald E" first="Emily G" last="Mcdonald">Emily G. Mcdonald</name>
<affiliation><nlm:affiliation>Research Institute of the McGill University Health Centre and McGill University, Montréal, Quebec, Canada (M.P.C., E.G.M., T.C.L.).</nlm:affiliation>
<wicri:noCountry code="subField">T.C.L.).</wicri:noCountry>
</affiliation>
</author>
<author><name sortKey="Lee, Todd C" sort="Lee, Todd C" uniqKey="Lee T" first="Todd C" last="Lee">Todd C. Lee</name>
<affiliation><nlm:affiliation>Research Institute of the McGill University Health Centre and McGill University, Montréal, Quebec, Canada (M.P.C., E.G.M., T.C.L.).</nlm:affiliation>
<wicri:noCountry code="subField">T.C.L.).</wicri:noCountry>
</affiliation>
</author>
<author><name sortKey="Rajasingham, Radha" sort="Rajasingham, Radha" uniqKey="Rajasingham R" first="Radha" last="Rajasingham">Radha Rajasingham</name>
<affiliation><nlm:affiliation>University of Minnesota, Minneapolis, Minnesota (C.P.S., K.A.P., N.W.E., A.S.B., M.A., S.M.L., D.A.W., E.C.O., M.F.P., M.R.N., A.A.N., K.H.H., R.R., D.R.B.).</nlm:affiliation>
<wicri:noCountry code="subField">D.R.B.).</wicri:noCountry>
</affiliation>
</author>
<author><name sortKey="Boulware, David R" sort="Boulware, David R" uniqKey="Boulware D" first="David R" last="Boulware">David R. Boulware</name>
<affiliation><nlm:affiliation>University of Minnesota, Minneapolis, Minnesota (C.P.S., K.A.P., N.W.E., A.S.B., M.A., S.M.L., D.A.W., E.C.O., M.F.P., M.R.N., A.A.N., K.H.H., R.R., D.R.B.).</nlm:affiliation>
<wicri:noCountry code="subField">D.R.B.).</wicri:noCountry>
</affiliation>
</author>
</analytic>
<series><title level="j">Annals of internal medicine</title>
<idno type="eISSN">1539-3704</idno>
<imprint><date when="2020" type="published">2020</date>
</imprint>
</series>
</biblStruct>
</sourceDesc>
</fileDesc>
<profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Adult (MeSH)</term>
<term>Antimalarials (therapeutic use)</term>
<term>Betacoronavirus (MeSH)</term>
<term>COVID-19 (MeSH)</term>
<term>Coronavirus Infections (drug therapy)</term>
<term>Coronavirus Infections (epidemiology)</term>
<term>Double-Blind Method (MeSH)</term>
<term>Female (MeSH)</term>
<term>Follow-Up Studies (MeSH)</term>
<term>Humans (MeSH)</term>
<term>Hydroxychloroquine (therapeutic use)</term>
<term>Male (MeSH)</term>
<term>Middle Aged (MeSH)</term>
<term>Outpatients (MeSH)</term>
<term>Pandemics (MeSH)</term>
<term>Pneumonia, Viral (drug therapy)</term>
<term>Pneumonia, Viral (epidemiology)</term>
<term>Retrospective Studies (MeSH)</term>
<term>Risk Factors (MeSH)</term>
<term>SARS-CoV-2 (MeSH)</term>
<term>Time Factors (MeSH)</term>
</keywords>
<keywords scheme="KwdFr" xml:lang="fr"><term>Adulte (MeSH)</term>
<term>Adulte d'âge moyen (MeSH)</term>
<term>Antipaludiques (usage thérapeutique)</term>
<term>Betacoronavirus (MeSH)</term>
<term>Facteurs de risque (MeSH)</term>
<term>Facteurs temps (MeSH)</term>
<term>Femelle (MeSH)</term>
<term>Humains (MeSH)</term>
<term>Hydroxychloroquine (usage thérapeutique)</term>
<term>Infections à coronavirus (traitement médicamenteux)</term>
<term>Infections à coronavirus (épidémiologie)</term>
<term>Mâle (MeSH)</term>
<term>Méthode en double aveugle (MeSH)</term>
<term>Pandémies (MeSH)</term>
<term>Patients en consultation externe (MeSH)</term>
<term>Pneumopathie virale (traitement médicamenteux)</term>
<term>Pneumopathie virale (épidémiologie)</term>
<term>Études de suivi (MeSH)</term>
<term>Études rétrospectives (MeSH)</term>
</keywords>
<keywords scheme="MESH" type="chemical" qualifier="therapeutic use" xml:lang="en"><term>Antimalarials</term>
<term>Hydroxychloroquine</term>
</keywords>
<keywords scheme="MESH" qualifier="drug therapy" xml:lang="en"><term>Coronavirus Infections</term>
<term>Pneumonia, Viral</term>
</keywords>
<keywords scheme="MESH" qualifier="epidemiology" xml:lang="en"><term>Coronavirus Infections</term>
<term>Pneumonia, Viral</term>
</keywords>
<keywords scheme="MESH" qualifier="traitement médicamenteux" xml:lang="fr"><term>Infections à coronavirus</term>
<term>Pneumopathie virale</term>
</keywords>
<keywords scheme="MESH" qualifier="usage thérapeutique" xml:lang="fr"><term>Antipaludiques</term>
<term>Hydroxychloroquine</term>
</keywords>
<keywords scheme="MESH" qualifier="épidémiologie" xml:lang="fr"><term>Infections à coronavirus</term>
<term>Pneumopathie virale</term>
</keywords>
<keywords scheme="MESH" xml:lang="en"><term>Adult</term>
<term>Betacoronavirus</term>
<term>COVID-19</term>
<term>Double-Blind Method</term>
<term>Female</term>
<term>Follow-Up Studies</term>
<term>Humans</term>
<term>Male</term>
<term>Middle Aged</term>
<term>Outpatients</term>
<term>Pandemics</term>
<term>Retrospective Studies</term>
<term>Risk Factors</term>
<term>SARS-CoV-2</term>
<term>Time Factors</term>
</keywords>
<keywords scheme="MESH" xml:lang="fr"><term>Adulte</term>
<term>Adulte d'âge moyen</term>
<term>Betacoronavirus</term>
<term>Facteurs de risque</term>
<term>Facteurs temps</term>
<term>Femelle</term>
<term>Humains</term>
<term>Mâle</term>
<term>Méthode en double aveugle</term>
<term>Pandémies</term>
<term>Patients en consultation externe</term>
<term>Études de suivi</term>
<term>Études rétrospectives</term>
</keywords>
</textClass>
</profileDesc>
</teiHeader>
<front><div type="abstract" xml:lang="en"><p><b>BACKGROUND</b>
</p>
<p>No effective oral therapy exists for early coronavirus disease 2019 (COVID-19).</p>
</div>
<div type="abstract" xml:lang="en"><p><b>OBJECTIVE</b>
</p>
<p>To investigate whether hydroxychloroquine could reduce COVID-19 severity in adult outpatients.</p>
</div>
<div type="abstract" xml:lang="en"><p><b>DESIGN</b>
</p>
<p>Randomized, double-blind, placebo-controlled trial conducted from 22 March through 20 May 2020. (ClinicalTrials.gov: NCT04308668).</p>
</div>
<div type="abstract" xml:lang="en"><p><b>SETTING</b>
</p>
<p>Internet-based trial across the United States and Canada (40 states and 3 provinces).</p>
</div>
<div type="abstract" xml:lang="en"><p><b>PARTICIPANTS</b>
</p>
<p>Symptomatic, nonhospitalized adults with laboratory-confirmed COVID-19 or probable COVID-19 and high-risk exposure within 4 days of symptom onset.</p>
</div>
<div type="abstract" xml:lang="en"><p><b>INTERVENTION</b>
</p>
<p>Oral hydroxychloroquine (800 mg once, followed by 600 mg in 6 to 8 hours, then 600 mg daily for 4 more days) or masked placebo.</p>
</div>
<div type="abstract" xml:lang="en"><p><b>MEASUREMENTS</b>
</p>
<p>Symptoms and severity at baseline and then at days 3, 5, 10, and 14 using a 10-point visual analogue scale. The primary end point was change in overall symptom severity over 14 days.</p>
</div>
<div type="abstract" xml:lang="en"><p><b>RESULTS</b>
</p>
<p>Of 491 patients randomly assigned to a group, 423 contributed primary end point data. Of these, 341 (81%) had laboratory-confirmed infection with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) or epidemiologically linked exposure to a person with laboratory-confirmed infection; 56% (236 of 423) were enrolled within 1 day of symptoms starting. Change in symptom severity over 14 days did not differ between the hydroxychloroquine and placebo groups (difference in symptom severity: relative, 12%; absolute, -0.27 point [95% CI, -0.61 to 0.07 point]; </p>
</div>
<div type="abstract" xml:lang="en"><p><b>LIMITATION</b>
</p>
<p>Only 58% of participants received SARS-CoV-2 testing because of severe U.S. testing shortages.</p>
</div>
<div type="abstract" xml:lang="en"><p><b>CONCLUSION</b>
</p>
<p>Hydroxychloroquine did not substantially reduce symptom severity in outpatients with early, mild COVID-19.</p>
</div>
<div type="abstract" xml:lang="en"><p><b>PRIMARY FUNDING SOURCE</b>
</p>
<p>Private donors.</p>
</div>
</front>
</TEI>
<pubmed><MedlineCitation Status="MEDLINE" Owner="NLM"><PMID Version="1">32673060</PMID>
<DateCompleted><Year>2020</Year>
<Month>10</Month>
<Day>27</Day>
</DateCompleted>
<DateRevised><Year>2021</Year>
<Month>03</Month>
<Day>16</Day>
</DateRevised>
<Article PubModel="Print-Electronic"><Journal><ISSN IssnType="Electronic">1539-3704</ISSN>
<JournalIssue CitedMedium="Internet"><Volume>173</Volume>
<Issue>8</Issue>
<PubDate><Year>2020</Year>
<Month>10</Month>
<Day>20</Day>
</PubDate>
</JournalIssue>
<Title>Annals of internal medicine</Title>
<ISOAbbreviation>Ann Intern Med</ISOAbbreviation>
</Journal>
<ArticleTitle>Hydroxychloroquine in Nonhospitalized Adults With Early COVID-19 : A Randomized Trial.</ArticleTitle>
<Pagination><MedlinePgn>623-631</MedlinePgn>
</Pagination>
<ELocationID EIdType="doi" ValidYN="Y">10.7326/M20-4207</ELocationID>
<Abstract><AbstractText Label="BACKGROUND">No effective oral therapy exists for early coronavirus disease 2019 (COVID-19).</AbstractText>
<AbstractText Label="OBJECTIVE">To investigate whether hydroxychloroquine could reduce COVID-19 severity in adult outpatients.</AbstractText>
<AbstractText Label="DESIGN">Randomized, double-blind, placebo-controlled trial conducted from 22 March through 20 May 2020. (ClinicalTrials.gov: NCT04308668).</AbstractText>
<AbstractText Label="SETTING">Internet-based trial across the United States and Canada (40 states and 3 provinces).</AbstractText>
<AbstractText Label="PARTICIPANTS">Symptomatic, nonhospitalized adults with laboratory-confirmed COVID-19 or probable COVID-19 and high-risk exposure within 4 days of symptom onset.</AbstractText>
<AbstractText Label="INTERVENTION">Oral hydroxychloroquine (800 mg once, followed by 600 mg in 6 to 8 hours, then 600 mg daily for 4 more days) or masked placebo.</AbstractText>
<AbstractText Label="MEASUREMENTS">Symptoms and severity at baseline and then at days 3, 5, 10, and 14 using a 10-point visual analogue scale. The primary end point was change in overall symptom severity over 14 days.</AbstractText>
<AbstractText Label="RESULTS">Of 491 patients randomly assigned to a group, 423 contributed primary end point data. Of these, 341 (81%) had laboratory-confirmed infection with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) or epidemiologically linked exposure to a person with laboratory-confirmed infection; 56% (236 of 423) were enrolled within 1 day of symptoms starting. Change in symptom severity over 14 days did not differ between the hydroxychloroquine and placebo groups (difference in symptom severity: relative, 12%; absolute, -0.27 point [95% CI, -0.61 to 0.07 point]; <i>P</i>
= 0.117). At 14 days, 24% (49 of 201) of participants receiving hydroxychloroquine had ongoing symptoms compared with 30% (59 of 194) receiving placebo (<i>P</i>
= 0.21). Medication adverse effects occurred in 43% (92 of 212) of participants receiving hydroxychloroquine versus 22% (46 of 211) receiving placebo (<i>P</i>
< 0.001). With placebo, 10 hospitalizations occurred (2 non-COVID-19-related), including 1 hospitalized death. With hydroxychloroquine, 4 hospitalizations occurred plus 1 nonhospitalized death (<i>P</i>
= 0.29).</AbstractText>
<AbstractText Label="LIMITATION">Only 58% of participants received SARS-CoV-2 testing because of severe U.S. testing shortages.</AbstractText>
<AbstractText Label="CONCLUSION">Hydroxychloroquine did not substantially reduce symptom severity in outpatients with early, mild COVID-19.</AbstractText>
<AbstractText Label="PRIMARY FUNDING SOURCE">Private donors.</AbstractText>
</Abstract>
<AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Skipper</LastName>
<ForeName>Caleb P</ForeName>
<Initials>CP</Initials>
<Identifier Source="ORCID">0000-0002-0000-8876</Identifier>
<AffiliationInfo><Affiliation>University of Minnesota, Minneapolis, Minnesota (C.P.S., K.A.P., N.W.E., A.S.B., M.A., S.M.L., D.A.W., E.C.O., M.F.P., M.R.N., A.A.N., K.H.H., R.R., D.R.B.).</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Pastick</LastName>
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