Hydroxychloroquine with or without azithromycin for treatment of early SARS-CoV-2 infection among high-risk outpatient adults: A randomized clinical trial.
Identifieur interne : 000262 ( Main/Corpus ); précédent : 000261; suivant : 000263Hydroxychloroquine with or without azithromycin for treatment of early SARS-CoV-2 infection among high-risk outpatient adults: A randomized clinical trial.
Auteurs : Christine Johnston ; Elizabeth R. Brown ; Jenell Stewart ; Helen C Stankiewicz Karita ; Patricia J. Kissinger ; John Dwyer ; Sybil Hosek ; Temitope Oyedele ; Michael K. Paasche-Orlow ; Kristopher Paolino ; Kate B. Heller ; Hannah Leingang ; Harald S. Haugen ; Tracy Q. Dong ; Anna Bershteyn ; Arun R. Sridhar ; Jeanne Poole ; Peter A. Noseworthy ; Michael J. Ackerman ; Susan Morrison ; Alexander L. Greninger ; Meei-Li Huang ; Keith R. Jerome ; Mark H. Wener ; Anna Wald ; Joshua T. Schiffer ; Connie Celum ; Helen Y. Chu ; Ruanne V. Barnabas ; Jared M. BaetenSource :
- EClinicalMedicine [ 2589-5370 ] ; 2021.
Abstract
Background
Treatment options for outpatients with COVID-19 could reduce morbidity and prevent SARS-CoV-2 transmission.
Methods
In this randomized, double-blind, three-arm (1:1:1) placebo-equivalent controlled trial conducted remotely throughout the United States, adult outpatients with laboratory-confirmed SARS-CoV-2 infection were recruited. Participants were randomly assigned to receive hydroxychloroquine (HCQ) (400 mg BID x1day, followed by 200 mg BID x9days) with or without azithromycin (AZ) (500 mg, then 250 mg daily x4days) or placebo-equivalent (ascorbic acid (HCQ) and folic acid (AZ)), stratified by risk for progression to severe COVID-19 (high-risk vs. low-risk). Self-collected nasal swabs for SARS-CoV-2 PCR, FLUPro symptom surveys, EKGs and vital signs were collected daily. Primary endpoints were: (a) 14-day progression to lower respiratory tract infection (LRTI), 28-day COVID-19 related hospitalization, or death; (b) 14-day time to viral clearance; secondary endpoints included time to symptom resolution (ClinicalTrials.gov: NCT04354428). Due to the low rate of clinical outcomes, the study was terminated for operational futility.
Findings
Between 15th April and 27th July 2020, 231 participants were enrolled and 219 initiated medication a median of 5.9 days after symptom onset. Among 129 high-risk participants, incident LRTI occurred in six (4.7%) participants (two control, four HCQ/AZ) and COVID-19 related hospitalization in seven (5.4%) (four control, one HCQ, two HCQ/AZ); no LRTI and two (2%) hospitalizations occurred in the 102 low-risk participants (one HCQ, one HCQ/AZ). There were no deaths. Among 152 participants with viral shedding at enrollment, median time to clearance was 5 days (95% CI=4-6) in HCQ, 6 days (95% CI=4-8) in HCQ/AZ, and 8 days (95% CI=6-10) in control. Viral clearance was faster in HCQ (HR=1.62, 95% CI=1.01-2.60,
Interpretation
Neither HCQ nor HCQ/AZ shortened the clinical course of outpatients with COVID-19, and HCQ, but not HCQ/AZ, had only a modest effect on SARS-CoV-2 viral shedding. HCQ and HCQ/AZ are not effective therapies for outpatient treatment of SARV-CoV-2 infection.
Funding
The COVID-19 Early Treatment Study was funded by the Bill & Melinda Gates Foundation (INV-017062) through the COVID-19 Therapeutics Accelerator. University of Washington Institute of Translational Health Science (ITHS) grant support (UL1 TR002319), KL2 TR002317, and TL1 TR002318 from NCATS/NIH funded REDCap. The content is solely the responsibility of the authors and does not necessarily represent the views, decisions, or policies of the institutions with which they are affiliated. PAN and MJA were supported by the Mayo Clinic Windland Smith Rice Comprehensive Sudden Cardiac Death Program.
DOI: 10.1016/j.eclinm.2021.100773
PubMed: 33681731
PubMed Central: PMC7912360
Links to Exploration step
pubmed:33681731Le document en format XML
<record><TEI><teiHeader><fileDesc><titleStmt><title xml:lang="en">Hydroxychloroquine with or without azithromycin for treatment of early SARS-CoV-2 infection among high-risk outpatient adults: A randomized clinical trial.</title><author><name sortKey="Johnston, Christine" sort="Johnston, Christine" uniqKey="Johnston C" first="Christine" last="Johnston">Christine Johnston</name><affiliation><nlm:affiliation>Division of Allergy and Infectious Diseases, University of Washington, United States.</nlm:affiliation></affiliation><affiliation><nlm:affiliation>Department of Laboratory Medicine and Pathology, University of Washington, United States.</nlm:affiliation></affiliation><affiliation><nlm:affiliation>Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, WA.</nlm:affiliation></affiliation></author><author><name sortKey="Brown, Elizabeth R" sort="Brown, Elizabeth R" uniqKey="Brown E" first="Elizabeth R" last="Brown">Elizabeth R. Brown</name><affiliation><nlm:affiliation>Department of Biostatistics, University of Washington, United States.</nlm:affiliation></affiliation><affiliation><nlm:affiliation>Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, WA.</nlm:affiliation></affiliation><affiliation><nlm:affiliation>Public Health Sciences Division, Fred Hutchinson Cancer Research Center, Seattle, WA, United States.</nlm:affiliation></affiliation></author><author><name sortKey="Stewart, Jenell" sort="Stewart, Jenell" uniqKey="Stewart J" first="Jenell" last="Stewart">Jenell Stewart</name><affiliation><nlm:affiliation>Division of Allergy and Infectious Diseases, University of Washington, United States.</nlm:affiliation></affiliation><affiliation><nlm:affiliation>Department of Global Health, University of Washington, United States.</nlm:affiliation></affiliation></author><author><name sortKey="Karita, Helen C Stankiewicz" sort="Karita, Helen C Stankiewicz" uniqKey="Karita H" first="Helen C Stankiewicz" last="Karita">Helen C Stankiewicz Karita</name><affiliation><nlm:affiliation>Division of Allergy and Infectious Diseases, University of Washington, United States.</nlm:affiliation></affiliation></author><author><name sortKey="Kissinger, Patricia J" sort="Kissinger, Patricia J" uniqKey="Kissinger P" first="Patricia J" last="Kissinger">Patricia J. Kissinger</name><affiliation><nlm:affiliation>School of Public Health and Tropical Medicine, Tulane University, New Orleans, LA, United States.</nlm:affiliation></affiliation></author><author><name sortKey="Dwyer, John" sort="Dwyer, John" uniqKey="Dwyer J" first="John" last="Dwyer">John Dwyer</name><affiliation><nlm:affiliation>School of Medicine, Tulane University, New Orleans, LA, United States.</nlm:affiliation></affiliation></author><author><name sortKey="Hosek, Sybil" sort="Hosek, Sybil" uniqKey="Hosek S" first="Sybil" last="Hosek">Sybil Hosek</name><affiliation><nlm:affiliation>John H. Stroger, Jr., Hospital of Cook County, Chicago, IL, United States.</nlm:affiliation></affiliation><affiliation><nlm:affiliation>Rush University Medical Center, Chicago, IL, United States.</nlm:affiliation></affiliation></author><author><name sortKey="Oyedele, Temitope" sort="Oyedele, Temitope" uniqKey="Oyedele T" first="Temitope" last="Oyedele">Temitope Oyedele</name><affiliation><nlm:affiliation>John H. Stroger, Jr., Hospital of Cook County, Chicago, IL, United States.</nlm:affiliation></affiliation><affiliation><nlm:affiliation>Rush University Medical Center, Chicago, IL, United States.</nlm:affiliation></affiliation></author><author><name sortKey="Paasche Orlow, Michael K" sort="Paasche Orlow, Michael K" uniqKey="Paasche Orlow M" first="Michael K" last="Paasche-Orlow">Michael K. Paasche-Orlow</name><affiliation><nlm:affiliation>Boston University School of Medicine, Boston, MA, United States.</nlm:affiliation></affiliation><affiliation><nlm:affiliation>Boston Medical Center, Boston, MA, United States.</nlm:affiliation></affiliation></author><author><name sortKey="Paolino, Kristopher" sort="Paolino, Kristopher" uniqKey="Paolino K" first="Kristopher" last="Paolino">Kristopher Paolino</name><affiliation><nlm:affiliation>State University of New York Upstate Medical University, Syracuse, NY, United States.</nlm:affiliation></affiliation></author><author><name sortKey="Heller, Kate B" sort="Heller, Kate B" uniqKey="Heller K" first="Kate B" last="Heller">Kate B. Heller</name><affiliation><nlm:affiliation>Department of Global Health, University of Washington, United States.</nlm:affiliation></affiliation></author><author><name sortKey="Leingang, Hannah" sort="Leingang, Hannah" uniqKey="Leingang H" first="Hannah" last="Leingang">Hannah Leingang</name><affiliation><nlm:affiliation>Department of Global Health, University of Washington, United States.</nlm:affiliation></affiliation></author><author><name sortKey="Haugen, Harald S" sort="Haugen, Harald S" uniqKey="Haugen H" first="Harald S" last="Haugen">Harald S. Haugen</name><affiliation><nlm:affiliation>Department of Global Health, University of Washington, United States.</nlm:affiliation></affiliation></author><author><name sortKey="Dong, Tracy Q" sort="Dong, Tracy Q" uniqKey="Dong T" first="Tracy Q" last="Dong">Tracy Q. Dong</name><affiliation><nlm:affiliation>Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, WA.</nlm:affiliation></affiliation></author><author><name sortKey="Bershteyn, Anna" sort="Bershteyn, Anna" uniqKey="Bershteyn A" first="Anna" last="Bershteyn">Anna Bershteyn</name><affiliation><nlm:affiliation>New York University Grossman School of Medicine, NY, NY, United States.</nlm:affiliation></affiliation></author><author><name sortKey="Sridhar, Arun R" sort="Sridhar, Arun R" uniqKey="Sridhar A" first="Arun R" last="Sridhar">Arun R. Sridhar</name><affiliation><nlm:affiliation>Division of Cardiology, University of Washington, United States.</nlm:affiliation></affiliation></author><author><name sortKey="Poole, Jeanne" sort="Poole, Jeanne" uniqKey="Poole J" first="Jeanne" last="Poole">Jeanne Poole</name><affiliation><nlm:affiliation>Division of Cardiology, University of Washington, United States.</nlm:affiliation></affiliation></author><author><name sortKey="Noseworthy, Peter A" sort="Noseworthy, Peter A" uniqKey="Noseworthy P" first="Peter A" last="Noseworthy">Peter A. Noseworthy</name><affiliation><nlm:affiliation>Mayo Clinic, Rochester, MN, United States.</nlm:affiliation></affiliation></author><author><name sortKey="Ackerman, Michael J" sort="Ackerman, Michael J" uniqKey="Ackerman M" first="Michael J" last="Ackerman">Michael J. Ackerman</name><affiliation><nlm:affiliation>Mayo Clinic, Rochester, MN, United States.</nlm:affiliation></affiliation></author><author><name sortKey="Morrison, Susan" sort="Morrison, Susan" uniqKey="Morrison S" first="Susan" last="Morrison">Susan Morrison</name><affiliation><nlm:affiliation>Department of Global Health, University of Washington, United States.</nlm:affiliation></affiliation></author><author><name sortKey="Greninger, Alexander L" sort="Greninger, Alexander L" uniqKey="Greninger A" first="Alexander L" last="Greninger">Alexander L. Greninger</name><affiliation><nlm:affiliation>Department of Laboratory Medicine and Pathology, University of Washington, United States.</nlm:affiliation></affiliation><affiliation><nlm:affiliation>Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, WA.</nlm:affiliation></affiliation></author><author><name sortKey="Huang, Meei Li" sort="Huang, Meei Li" uniqKey="Huang M" first="Meei-Li" last="Huang">Meei-Li Huang</name><affiliation><nlm:affiliation>Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, WA.</nlm:affiliation></affiliation></author><author><name sortKey="Jerome, Keith R" sort="Jerome, Keith R" uniqKey="Jerome K" first="Keith R" last="Jerome">Keith R. Jerome</name><affiliation><nlm:affiliation>Department of Laboratory Medicine and Pathology, University of Washington, United States.</nlm:affiliation></affiliation><affiliation><nlm:affiliation>Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, WA.</nlm:affiliation></affiliation></author><author><name sortKey="Wener, Mark H" sort="Wener, Mark H" uniqKey="Wener M" first="Mark H" last="Wener">Mark H. Wener</name><affiliation><nlm:affiliation>Department of Laboratory Medicine and Pathology, University of Washington, United States.</nlm:affiliation></affiliation><affiliation><nlm:affiliation>Division of Rheumatology, University of Washington, Seattle, WA, United States.</nlm:affiliation></affiliation></author><author><name sortKey="Wald, Anna" sort="Wald, Anna" uniqKey="Wald A" first="Anna" last="Wald">Anna Wald</name><affiliation><nlm:affiliation>Division of Allergy and Infectious Diseases, University of Washington, United States.</nlm:affiliation></affiliation><affiliation><nlm:affiliation>Department of Laboratory Medicine and Pathology, University of Washington, United States.</nlm:affiliation></affiliation><affiliation><nlm:affiliation>Department of Epidemiology, University of Washington, United States.</nlm:affiliation></affiliation><affiliation><nlm:affiliation>Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, WA.</nlm:affiliation></affiliation></author><author><name sortKey="Schiffer, Joshua T" sort="Schiffer, Joshua T" uniqKey="Schiffer J" first="Joshua T" last="Schiffer">Joshua T. Schiffer</name><affiliation><nlm:affiliation>Division of Allergy and Infectious Diseases, University of Washington, United States.</nlm:affiliation></affiliation><affiliation><nlm:affiliation>Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, WA.</nlm:affiliation></affiliation></author><author><name sortKey="Celum, Connie" sort="Celum, Connie" uniqKey="Celum C" first="Connie" last="Celum">Connie Celum</name><affiliation><nlm:affiliation>Division of Allergy and Infectious Diseases, University of Washington, United States.</nlm:affiliation></affiliation><affiliation><nlm:affiliation>Department of Epidemiology, University of Washington, United States.</nlm:affiliation></affiliation><affiliation><nlm:affiliation>Department of Global Health, University of Washington, United States.</nlm:affiliation></affiliation></author><author><name sortKey="Chu, Helen Y" sort="Chu, Helen Y" uniqKey="Chu H" first="Helen Y" last="Chu">Helen Y. Chu</name><affiliation><nlm:affiliation>Division of Allergy and Infectious Diseases, University of Washington, United States.</nlm:affiliation></affiliation><affiliation><nlm:affiliation>Department of Epidemiology, University of Washington, United States.</nlm:affiliation></affiliation><affiliation><nlm:affiliation>Department of Global Health, University of Washington, United States.</nlm:affiliation></affiliation></author><author><name sortKey="Barnabas, Ruanne V" sort="Barnabas, Ruanne V" uniqKey="Barnabas R" first="Ruanne V" last="Barnabas">Ruanne V. Barnabas</name><affiliation><nlm:affiliation>Division of Allergy and Infectious Diseases, University of Washington, United States.</nlm:affiliation></affiliation><affiliation><nlm:affiliation>Department of Laboratory Medicine and Pathology, University of Washington, United States.</nlm:affiliation></affiliation><affiliation><nlm:affiliation>Department of Epidemiology, University of Washington, United States.</nlm:affiliation></affiliation><affiliation><nlm:affiliation>Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, WA.</nlm:affiliation></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><nlm:affiliation>Division of Allergy and Infectious Diseases, University of Washington, United States.</nlm:affiliation></affiliation><affiliation><nlm:affiliation>Department of Epidemiology, University of Washington, United States.</nlm:affiliation></affiliation><affiliation><nlm:affiliation>Department of Global Health, University of Washington, United States.</nlm:affiliation></affiliation></author></titleStmt><publicationStmt><idno type="wicri:source">PubMed</idno><date when="2021">2021</date><idno type="RBID">pubmed:33681731</idno><idno type="pmid">33681731</idno><idno type="doi">10.1016/j.eclinm.2021.100773</idno><idno type="pmc">PMC7912360</idno><idno type="wicri:Area/Main/Corpus">000262</idno><idno type="wicri:explorRef" wicri:stream="Main" wicri:step="Corpus" wicri:corpus="PubMed">000262</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en">Hydroxychloroquine with or without azithromycin for treatment of early SARS-CoV-2 infection among high-risk outpatient adults: A randomized clinical trial.</title><author><name sortKey="Johnston, Christine" sort="Johnston, Christine" uniqKey="Johnston C" first="Christine" last="Johnston">Christine Johnston</name><affiliation><nlm:affiliation>Division of Allergy and Infectious Diseases, University of Washington, United States.</nlm:affiliation></affiliation><affiliation><nlm:affiliation>Department of Laboratory Medicine and Pathology, University of Washington, United States.</nlm:affiliation></affiliation><affiliation><nlm:affiliation>Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, WA.</nlm:affiliation></affiliation></author><author><name sortKey="Brown, Elizabeth R" sort="Brown, Elizabeth R" uniqKey="Brown E" first="Elizabeth R" last="Brown">Elizabeth R. Brown</name><affiliation><nlm:affiliation>Department of Biostatistics, University of Washington, United States.</nlm:affiliation></affiliation><affiliation><nlm:affiliation>Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, WA.</nlm:affiliation></affiliation><affiliation><nlm:affiliation>Public Health Sciences Division, Fred Hutchinson Cancer Research Center, Seattle, WA, United States.</nlm:affiliation></affiliation></author><author><name sortKey="Stewart, Jenell" sort="Stewart, Jenell" uniqKey="Stewart J" first="Jenell" last="Stewart">Jenell Stewart</name><affiliation><nlm:affiliation>Division of Allergy and Infectious Diseases, University of Washington, United States.</nlm:affiliation></affiliation><affiliation><nlm:affiliation>Department of Global Health, University of Washington, United States.</nlm:affiliation></affiliation></author><author><name sortKey="Karita, Helen C Stankiewicz" sort="Karita, Helen C Stankiewicz" uniqKey="Karita H" first="Helen C Stankiewicz" last="Karita">Helen C Stankiewicz Karita</name><affiliation><nlm:affiliation>Division of Allergy and Infectious Diseases, University of Washington, United States.</nlm:affiliation></affiliation></author><author><name sortKey="Kissinger, Patricia J" sort="Kissinger, Patricia J" uniqKey="Kissinger P" first="Patricia J" last="Kissinger">Patricia J. Kissinger</name><affiliation><nlm:affiliation>School of Public Health and Tropical Medicine, Tulane University, New Orleans, LA, United States.</nlm:affiliation></affiliation></author><author><name sortKey="Dwyer, John" sort="Dwyer, John" uniqKey="Dwyer J" first="John" last="Dwyer">John Dwyer</name><affiliation><nlm:affiliation>School of Medicine, Tulane University, New Orleans, LA, United States.</nlm:affiliation></affiliation></author><author><name sortKey="Hosek, Sybil" sort="Hosek, Sybil" uniqKey="Hosek S" first="Sybil" last="Hosek">Sybil Hosek</name><affiliation><nlm:affiliation>John H. Stroger, Jr., Hospital of Cook County, Chicago, IL, United States.</nlm:affiliation></affiliation><affiliation><nlm:affiliation>Rush University Medical Center, Chicago, IL, United States.</nlm:affiliation></affiliation></author><author><name sortKey="Oyedele, Temitope" sort="Oyedele, Temitope" uniqKey="Oyedele T" first="Temitope" last="Oyedele">Temitope Oyedele</name><affiliation><nlm:affiliation>John H. Stroger, Jr., Hospital of Cook County, Chicago, IL, United States.</nlm:affiliation></affiliation><affiliation><nlm:affiliation>Rush University Medical Center, Chicago, IL, United States.</nlm:affiliation></affiliation></author><author><name sortKey="Paasche Orlow, Michael K" sort="Paasche Orlow, Michael K" uniqKey="Paasche Orlow M" first="Michael K" last="Paasche-Orlow">Michael K. Paasche-Orlow</name><affiliation><nlm:affiliation>Boston University School of Medicine, Boston, MA, United States.</nlm:affiliation></affiliation><affiliation><nlm:affiliation>Boston Medical Center, Boston, MA, United States.</nlm:affiliation></affiliation></author><author><name sortKey="Paolino, Kristopher" sort="Paolino, Kristopher" uniqKey="Paolino K" first="Kristopher" last="Paolino">Kristopher Paolino</name><affiliation><nlm:affiliation>State University of New York Upstate Medical University, Syracuse, NY, United States.</nlm:affiliation></affiliation></author><author><name sortKey="Heller, Kate B" sort="Heller, Kate B" uniqKey="Heller K" first="Kate B" last="Heller">Kate B. Heller</name><affiliation><nlm:affiliation>Department of Global Health, University of Washington, United States.</nlm:affiliation></affiliation></author><author><name sortKey="Leingang, Hannah" sort="Leingang, Hannah" uniqKey="Leingang H" first="Hannah" last="Leingang">Hannah Leingang</name><affiliation><nlm:affiliation>Department of Global Health, University of Washington, United States.</nlm:affiliation></affiliation></author><author><name sortKey="Haugen, Harald S" sort="Haugen, Harald S" uniqKey="Haugen H" first="Harald S" last="Haugen">Harald S. Haugen</name><affiliation><nlm:affiliation>Department of Global Health, University of Washington, United States.</nlm:affiliation></affiliation></author><author><name sortKey="Dong, Tracy Q" sort="Dong, Tracy Q" uniqKey="Dong T" first="Tracy Q" last="Dong">Tracy Q. Dong</name><affiliation><nlm:affiliation>Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, WA.</nlm:affiliation></affiliation></author><author><name sortKey="Bershteyn, Anna" sort="Bershteyn, Anna" uniqKey="Bershteyn A" first="Anna" last="Bershteyn">Anna Bershteyn</name><affiliation><nlm:affiliation>New York University Grossman School of Medicine, NY, NY, United States.</nlm:affiliation></affiliation></author><author><name sortKey="Sridhar, Arun R" sort="Sridhar, Arun R" uniqKey="Sridhar A" first="Arun R" last="Sridhar">Arun R. Sridhar</name><affiliation><nlm:affiliation>Division of Cardiology, University of Washington, United States.</nlm:affiliation></affiliation></author><author><name sortKey="Poole, Jeanne" sort="Poole, Jeanne" uniqKey="Poole J" first="Jeanne" last="Poole">Jeanne Poole</name><affiliation><nlm:affiliation>Division of Cardiology, University of Washington, United States.</nlm:affiliation></affiliation></author><author><name sortKey="Noseworthy, Peter A" sort="Noseworthy, Peter A" uniqKey="Noseworthy P" first="Peter A" last="Noseworthy">Peter A. Noseworthy</name><affiliation><nlm:affiliation>Mayo Clinic, Rochester, MN, United States.</nlm:affiliation></affiliation></author><author><name sortKey="Ackerman, Michael J" sort="Ackerman, Michael J" uniqKey="Ackerman M" first="Michael J" last="Ackerman">Michael J. Ackerman</name><affiliation><nlm:affiliation>Mayo Clinic, Rochester, MN, United States.</nlm:affiliation></affiliation></author><author><name sortKey="Morrison, Susan" sort="Morrison, Susan" uniqKey="Morrison S" first="Susan" last="Morrison">Susan Morrison</name><affiliation><nlm:affiliation>Department of Global Health, University of Washington, United States.</nlm:affiliation></affiliation></author><author><name sortKey="Greninger, Alexander L" sort="Greninger, Alexander L" uniqKey="Greninger A" first="Alexander L" last="Greninger">Alexander L. Greninger</name><affiliation><nlm:affiliation>Department of Laboratory Medicine and Pathology, University of Washington, United States.</nlm:affiliation></affiliation><affiliation><nlm:affiliation>Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, WA.</nlm:affiliation></affiliation></author><author><name sortKey="Huang, Meei Li" sort="Huang, Meei Li" uniqKey="Huang M" first="Meei-Li" last="Huang">Meei-Li Huang</name><affiliation><nlm:affiliation>Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, WA.</nlm:affiliation></affiliation></author><author><name sortKey="Jerome, Keith R" sort="Jerome, Keith R" uniqKey="Jerome K" first="Keith R" last="Jerome">Keith R. Jerome</name><affiliation><nlm:affiliation>Department of Laboratory Medicine and Pathology, University of Washington, United States.</nlm:affiliation></affiliation><affiliation><nlm:affiliation>Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, WA.</nlm:affiliation></affiliation></author><author><name sortKey="Wener, Mark H" sort="Wener, Mark H" uniqKey="Wener M" first="Mark H" last="Wener">Mark H. Wener</name><affiliation><nlm:affiliation>Department of Laboratory Medicine and Pathology, University of Washington, United States.</nlm:affiliation></affiliation><affiliation><nlm:affiliation>Division of Rheumatology, University of Washington, Seattle, WA, United States.</nlm:affiliation></affiliation></author><author><name sortKey="Wald, Anna" sort="Wald, Anna" uniqKey="Wald A" first="Anna" last="Wald">Anna Wald</name><affiliation><nlm:affiliation>Division of Allergy and Infectious Diseases, University of Washington, United States.</nlm:affiliation></affiliation><affiliation><nlm:affiliation>Department of Laboratory Medicine and Pathology, University of Washington, United States.</nlm:affiliation></affiliation><affiliation><nlm:affiliation>Department of Epidemiology, University of Washington, United States.</nlm:affiliation></affiliation><affiliation><nlm:affiliation>Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, WA.</nlm:affiliation></affiliation></author><author><name sortKey="Schiffer, Joshua T" sort="Schiffer, Joshua T" uniqKey="Schiffer J" first="Joshua T" last="Schiffer">Joshua T. Schiffer</name><affiliation><nlm:affiliation>Division of Allergy and Infectious Diseases, University of Washington, United States.</nlm:affiliation></affiliation><affiliation><nlm:affiliation>Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, WA.</nlm:affiliation></affiliation></author><author><name sortKey="Celum, Connie" sort="Celum, Connie" uniqKey="Celum C" first="Connie" last="Celum">Connie Celum</name><affiliation><nlm:affiliation>Division of Allergy and Infectious Diseases, University of Washington, United States.</nlm:affiliation></affiliation><affiliation><nlm:affiliation>Department of Epidemiology, University of Washington, United States.</nlm:affiliation></affiliation><affiliation><nlm:affiliation>Department of Global Health, University of Washington, United States.</nlm:affiliation></affiliation></author><author><name sortKey="Chu, Helen Y" sort="Chu, Helen Y" uniqKey="Chu H" first="Helen Y" last="Chu">Helen Y. Chu</name><affiliation><nlm:affiliation>Division of Allergy and Infectious Diseases, University of Washington, United States.</nlm:affiliation></affiliation><affiliation><nlm:affiliation>Department of Epidemiology, University of Washington, United States.</nlm:affiliation></affiliation><affiliation><nlm:affiliation>Department of Global Health, University of Washington, United States.</nlm:affiliation></affiliation></author><author><name sortKey="Barnabas, Ruanne V" sort="Barnabas, Ruanne V" uniqKey="Barnabas R" first="Ruanne V" last="Barnabas">Ruanne V. Barnabas</name><affiliation><nlm:affiliation>Division of Allergy and Infectious Diseases, University of Washington, United States.</nlm:affiliation></affiliation><affiliation><nlm:affiliation>Department of Laboratory Medicine and Pathology, University of Washington, United States.</nlm:affiliation></affiliation><affiliation><nlm:affiliation>Department of Epidemiology, University of Washington, United States.</nlm:affiliation></affiliation><affiliation><nlm:affiliation>Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, WA.</nlm:affiliation></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><nlm:affiliation>Division of Allergy and Infectious Diseases, University of Washington, United States.</nlm:affiliation></affiliation><affiliation><nlm:affiliation>Department of Epidemiology, University of Washington, United States.</nlm:affiliation></affiliation><affiliation><nlm:affiliation>Department of Global Health, University of Washington, United States.</nlm:affiliation></affiliation></author></analytic><series><title level="j">EClinicalMedicine</title><idno type="eISSN">2589-5370</idno><imprint><date when="2021" type="published">2021</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en"><p><b>Background</b></p><p>Treatment options for outpatients with COVID-19 could reduce morbidity and prevent SARS-CoV-2 transmission.</p></div><div type="abstract" xml:lang="en"><p><b>Methods</b></p><p>In this randomized, double-blind, three-arm (1:1:1) placebo-equivalent controlled trial conducted remotely throughout the United States, adult outpatients with laboratory-confirmed SARS-CoV-2 infection were recruited. Participants were randomly assigned to receive hydroxychloroquine (HCQ) (400 mg BID x1day, followed by 200 mg BID x9days) with or without azithromycin (AZ) (500 mg, then 250 mg daily x4days) or placebo-equivalent (ascorbic acid (HCQ) and folic acid (AZ)), stratified by risk for progression to severe COVID-19 (high-risk vs. low-risk). Self-collected nasal swabs for SARS-CoV-2 PCR, FLUPro symptom surveys, EKGs and vital signs were collected daily. Primary endpoints were: (a) 14-day progression to lower respiratory tract infection (LRTI), 28-day COVID-19 related hospitalization, or death; (b) 14-day time to viral clearance; secondary endpoints included time to symptom resolution (ClinicalTrials.gov: NCT04354428). Due to the low rate of clinical outcomes, the study was terminated for operational futility.</p></div><div type="abstract" xml:lang="en"><p><b>Findings</b></p><p>Between 15th April and 27th July 2020, 231 participants were enrolled and 219 initiated medication a median of 5.9 days after symptom onset. Among 129 high-risk participants, incident LRTI occurred in six (4.7%) participants (two control, four HCQ/AZ) and COVID-19 related hospitalization in seven (5.4%) (four control, one HCQ, two HCQ/AZ); no LRTI and two (2%) hospitalizations occurred in the 102 low-risk participants (one HCQ, one HCQ/AZ). There were no deaths. Among 152 participants with viral shedding at enrollment, median time to clearance was 5 days (95% CI=4-6) in HCQ, 6 days (95% CI=4-8) in HCQ/AZ, and 8 days (95% CI=6-10) in control. Viral clearance was faster in HCQ (HR=1.62, 95% CI=1.01-2.60, </p></div><div type="abstract" xml:lang="en"><p><b>Interpretation</b></p><p>Neither HCQ nor HCQ/AZ shortened the clinical course of outpatients with COVID-19, and HCQ, but not HCQ/AZ, had only a modest effect on SARS-CoV-2 viral shedding. HCQ and HCQ/AZ are not effective therapies for outpatient treatment of SARV-CoV-2 infection.</p></div><div type="abstract" xml:lang="en"><p><b>Funding</b></p><p>The COVID-19 Early Treatment Study was funded by the Bill & Melinda Gates Foundation (INV-017062) through the COVID-19 Therapeutics Accelerator. University of Washington Institute of Translational Health Science (ITHS) grant support (UL1 TR002319), KL2 TR002317, and TL1 TR002318 from NCATS/NIH funded REDCap. The content is solely the responsibility of the authors and does not necessarily represent the views, decisions, or policies of the institutions with which they are affiliated. PAN and MJA were supported by the Mayo Clinic Windland Smith Rice Comprehensive Sudden Cardiac Death Program.</p></div></front></TEI><pubmed><MedlineCitation Status="PubMed-not-MEDLINE" Owner="NLM"><PMID Version="1">33681731</PMID><DateRevised><Year>2021</Year><Month>04</Month><Day>02</Day></DateRevised><Article PubModel="Print-Electronic"><Journal><ISSN IssnType="Electronic">2589-5370</ISSN><JournalIssue CitedMedium="Internet"><Volume>33</Volume><PubDate><Year>2021</Year><Month>Mar</Month></PubDate></JournalIssue><Title>EClinicalMedicine</Title><ISOAbbreviation>EClinicalMedicine</ISOAbbreviation></Journal><ArticleTitle>Hydroxychloroquine with or without azithromycin for treatment of early SARS-CoV-2 infection among high-risk outpatient adults: A randomized clinical trial.</ArticleTitle><Pagination><MedlinePgn>100773</MedlinePgn></Pagination><ELocationID EIdType="doi" ValidYN="Y">10.1016/j.eclinm.2021.100773</ELocationID><Abstract><AbstractText Label="Background" NlmCategory="UNASSIGNED">Treatment options for outpatients with COVID-19 could reduce morbidity and prevent SARS-CoV-2 transmission.</AbstractText><AbstractText Label="Methods" NlmCategory="UNASSIGNED">In this randomized, double-blind, three-arm (1:1:1) placebo-equivalent controlled trial conducted remotely throughout the United States, adult outpatients with laboratory-confirmed SARS-CoV-2 infection were recruited. Participants were randomly assigned to receive hydroxychloroquine (HCQ) (400 mg BID x1day, followed by 200 mg BID x9days) with or without azithromycin (AZ) (500 mg, then 250 mg daily x4days) or placebo-equivalent (ascorbic acid (HCQ) and folic acid (AZ)), stratified by risk for progression to severe COVID-19 (high-risk vs. low-risk). Self-collected nasal swabs for SARS-CoV-2 PCR, FLUPro symptom surveys, EKGs and vital signs were collected daily. Primary endpoints were: (a) 14-day progression to lower respiratory tract infection (LRTI), 28-day COVID-19 related hospitalization, or death; (b) 14-day time to viral clearance; secondary endpoints included time to symptom resolution (ClinicalTrials.gov: NCT04354428). Due to the low rate of clinical outcomes, the study was terminated for operational futility.</AbstractText><AbstractText Label="Findings" NlmCategory="UNASSIGNED">Between 15th April and 27th July 2020, 231 participants were enrolled and 219 initiated medication a median of 5.9 days after symptom onset. Among 129 high-risk participants, incident LRTI occurred in six (4.7%) participants (two control, four HCQ/AZ) and COVID-19 related hospitalization in seven (5.4%) (four control, one HCQ, two HCQ/AZ); no LRTI and two (2%) hospitalizations occurred in the 102 low-risk participants (one HCQ, one HCQ/AZ). There were no deaths. Among 152 participants with viral shedding at enrollment, median time to clearance was 5 days (95% CI=4-6) in HCQ, 6 days (95% CI=4-8) in HCQ/AZ, and 8 days (95% CI=6-10) in control. Viral clearance was faster in HCQ (HR=1.62, 95% CI=1.01-2.60, <i>p</i> = 0.047) but not HCQ/AZ (HR=1.25, <i>p</i> = 0.39) compared to control. Among 197 participants who met the COVID-19 definition at enrollment, time to symptom resolution did not differ by group (HCQ: HR=1.02, 95% CI-0.63-1.64, <i>p</i> = 0.95, HCQ/AZ: HR=0.91, 95% CI=0.57-1.45, <i>p</i> = 0.70).</AbstractText><AbstractText Label="Interpretation" NlmCategory="UNASSIGNED">Neither HCQ nor HCQ/AZ shortened the clinical course of outpatients with COVID-19, and HCQ, but not HCQ/AZ, had only a modest effect on SARS-CoV-2 viral shedding. HCQ and HCQ/AZ are not effective therapies for outpatient treatment of SARV-CoV-2 infection.</AbstractText><AbstractText Label="Funding" NlmCategory="UNASSIGNED">The COVID-19 Early Treatment Study was funded by the Bill & Melinda Gates Foundation (INV-017062) through the COVID-19 Therapeutics Accelerator. University of Washington Institute of Translational Health Science (ITHS) grant support (UL1 TR002319), KL2 TR002317, and TL1 TR002318 from NCATS/NIH funded REDCap. The content is solely the responsibility of the authors and does not necessarily represent the views, decisions, or policies of the institutions with which they are affiliated. PAN and MJA were supported by the Mayo Clinic Windland Smith Rice Comprehensive Sudden Cardiac Death Program.<b>Trial registration</b> ClinicalTrials.gov number NCT04354428.</AbstractText><CopyrightInformation>© 2021 The Author(s).</CopyrightInformation></Abstract><AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Johnston</LastName><ForeName>Christine</ForeName><Initials>C</Initials><AffiliationInfo><Affiliation>Division of Allergy and Infectious Diseases, University of Washington, United States.</Affiliation></AffiliationInfo><AffiliationInfo><Affiliation>Department of Laboratory Medicine and Pathology, University of Washington, United States.</Affiliation></AffiliationInfo><AffiliationInfo><Affiliation>Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, WA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Brown</LastName><ForeName>Elizabeth R</ForeName><Initials>ER</Initials><AffiliationInfo><Affiliation>Department of Biostatistics, University of Washington, United States.</Affiliation></AffiliationInfo><AffiliationInfo><Affiliation>Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, WA.</Affiliation></AffiliationInfo><AffiliationInfo><Affiliation>Public Health Sciences Division, Fred Hutchinson Cancer Research Center, Seattle, WA, United States.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Stewart</LastName><ForeName>Jenell</ForeName><Initials>J</Initials><AffiliationInfo><Affiliation>Division of Allergy and Infectious Diseases, University of Washington, United States.</Affiliation></AffiliationInfo><AffiliationInfo><Affiliation>Department of Global Health, University of Washington, United States.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Karita</LastName><ForeName>Helen C Stankiewicz</ForeName><Initials>HCS</Initials><AffiliationInfo><Affiliation>Division of Allergy and Infectious Diseases, University of Washington, United States.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Kissinger</LastName><ForeName>Patricia J</ForeName><Initials>PJ</Initials><AffiliationInfo><Affiliation>School of Public Health and Tropical Medicine, Tulane University, New Orleans, LA, United States.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Dwyer</LastName><ForeName>John</ForeName><Initials>J</Initials><AffiliationInfo><Affiliation>School of Medicine, Tulane University, New Orleans, LA, United States.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Hosek</LastName><ForeName>Sybil</ForeName><Initials>S</Initials><AffiliationInfo><Affiliation>John H. Stroger, Jr., Hospital of Cook County, Chicago, IL, United States.</Affiliation></AffiliationInfo><AffiliationInfo><Affiliation>Rush University Medical Center, Chicago, IL, United States.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Oyedele</LastName><ForeName>Temitope</ForeName><Initials>T</Initials><AffiliationInfo><Affiliation>John H. Stroger, Jr., Hospital of Cook County, Chicago, IL, United States.</Affiliation></AffiliationInfo><AffiliationInfo><Affiliation>Rush University Medical Center, Chicago, IL, United States.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Paasche-Orlow</LastName><ForeName>Michael K</ForeName><Initials>MK</Initials><AffiliationInfo><Affiliation>Boston University School of Medicine, Boston, MA, United States.</Affiliation></AffiliationInfo><AffiliationInfo><Affiliation>Boston Medical Center, Boston, MA, United States.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Paolino</LastName><ForeName>Kristopher</ForeName><Initials>K</Initials><AffiliationInfo><Affiliation>State University of New York Upstate Medical University, Syracuse, NY, United States.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Heller</LastName><ForeName>Kate B</ForeName><Initials>KB</Initials><AffiliationInfo><Affiliation>Department of Global Health, University of Washington, United States.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Leingang</LastName><ForeName>Hannah</ForeName><Initials>H</Initials><AffiliationInfo><Affiliation>Department of Global Health, University of Washington, United States.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Haugen</LastName><ForeName>Harald S</ForeName><Initials>HS</Initials><AffiliationInfo><Affiliation>Department of Global Health, University of Washington, United States.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Dong</LastName><ForeName>Tracy Q</ForeName><Initials>TQ</Initials><AffiliationInfo><Affiliation>Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, WA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Bershteyn</LastName><ForeName>Anna</ForeName><Initials>A</Initials><AffiliationInfo><Affiliation>New York University Grossman School of Medicine, NY, NY, United States.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Sridhar</LastName><ForeName>Arun R</ForeName><Initials>AR</Initials><AffiliationInfo><Affiliation>Division of Cardiology, University of Washington, United States.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Poole</LastName><ForeName>Jeanne</ForeName><Initials>J</Initials><AffiliationInfo><Affiliation>Division of Cardiology, University of Washington, United States.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Noseworthy</LastName><ForeName>Peter A</ForeName><Initials>PA</Initials><AffiliationInfo><Affiliation>Mayo Clinic, Rochester, MN, United States.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Ackerman</LastName><ForeName>Michael J</ForeName><Initials>MJ</Initials><AffiliationInfo><Affiliation>Mayo Clinic, Rochester, MN, United States.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Morrison</LastName><ForeName>Susan</ForeName><Initials>S</Initials><AffiliationInfo><Affiliation>Department of Global Health, University of Washington, United States.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Greninger</LastName><ForeName>Alexander L</ForeName><Initials>AL</Initials><AffiliationInfo><Affiliation>Department of Laboratory Medicine and Pathology, University of Washington, United States.</Affiliation></AffiliationInfo><AffiliationInfo><Affiliation>Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, WA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Huang</LastName><ForeName>Meei-Li</ForeName><Initials>ML</Initials><AffiliationInfo><Affiliation>Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, WA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Jerome</LastName><ForeName>Keith R</ForeName><Initials>KR</Initials><AffiliationInfo><Affiliation>Department of Laboratory Medicine and Pathology, University of Washington, United States.</Affiliation></AffiliationInfo><AffiliationInfo><Affiliation>Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, WA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Wener</LastName><ForeName>Mark H</ForeName><Initials>MH</Initials><AffiliationInfo><Affiliation>Department of Laboratory Medicine and Pathology, University of Washington, United States.</Affiliation></AffiliationInfo><AffiliationInfo><Affiliation>Division of Rheumatology, University of Washington, Seattle, WA, United States.</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, United States.</Affiliation></AffiliationInfo><AffiliationInfo><Affiliation>Department of Laboratory Medicine and Pathology, University of Washington, United States.</Affiliation></AffiliationInfo><AffiliationInfo><Affiliation>Department of Epidemiology, University of Washington, United States.</Affiliation></AffiliationInfo><AffiliationInfo><Affiliation>Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, WA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Schiffer</LastName><ForeName>Joshua T</ForeName><Initials>JT</Initials><AffiliationInfo><Affiliation>Division of Allergy and Infectious Diseases, University of Washington, United States.</Affiliation></AffiliationInfo><AffiliationInfo><Affiliation>Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, WA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Celum</LastName><ForeName>Connie</ForeName><Initials>C</Initials><AffiliationInfo><Affiliation>Division of Allergy and Infectious Diseases, University of Washington, United States.</Affiliation></AffiliationInfo><AffiliationInfo><Affiliation>Department of Epidemiology, University of Washington, United States.</Affiliation></AffiliationInfo><AffiliationInfo><Affiliation>Department of Global Health, University of Washington, United States.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Chu</LastName><ForeName>Helen Y</ForeName><Initials>HY</Initials><AffiliationInfo><Affiliation>Division of Allergy and Infectious Diseases, University of Washington, United States.</Affiliation></AffiliationInfo><AffiliationInfo><Affiliation>Department of Epidemiology, University of Washington, United States.</Affiliation></AffiliationInfo><AffiliationInfo><Affiliation>Department of Global Health, University of Washington, United States.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Barnabas</LastName><ForeName>Ruanne V</ForeName><Initials>RV</Initials><AffiliationInfo><Affiliation>Division of Allergy and Infectious Diseases, University of Washington, United States.</Affiliation></AffiliationInfo><AffiliationInfo><Affiliation>Department of Laboratory Medicine and Pathology, University of Washington, United States.</Affiliation></AffiliationInfo><AffiliationInfo><Affiliation>Department of Epidemiology, University of Washington, United States.</Affiliation></AffiliationInfo><AffiliationInfo><Affiliation>Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, WA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Baeten</LastName><ForeName>Jared M</ForeName><Initials>JM</Initials><AffiliationInfo><Affiliation>Division of Allergy and Infectious Diseases, University of Washington, United States.</Affiliation></AffiliationInfo><AffiliationInfo><Affiliation>Department of Epidemiology, University of Washington, United States.</Affiliation></AffiliationInfo><AffiliationInfo><Affiliation>Department of Global Health, University of Washington, United States.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><CollectiveName>COVID-19 Early Treatment Study Team</CollectiveName></Author></AuthorList><Language>eng</Language><DataBankList CompleteYN="Y"><DataBank><DataBankName>ClinicalTrials.gov</DataBankName><AccessionNumberList><AccessionNumber>NCT04354428</AccessionNumber></AccessionNumberList></DataBank></DataBankList><GrantList CompleteYN="Y"><Grant><GrantID>R01 CA213130</GrantID><Acronym>CA</Acronym><Agency>NCI NIH HHS</Agency><Country>United States</Country></Grant></GrantList><PublicationTypeList><PublicationType UI="D016428">Journal Article</PublicationType></PublicationTypeList><ArticleDate DateType="Electronic"><Year>2021</Year><Month>02</Month><Day>27</Day></ArticleDate></Article><MedlineJournalInfo><Country>England</Country><MedlineTA>EClinicalMedicine</MedlineTA><NlmUniqueID>101733727</NlmUniqueID><ISSNLinking>2589-5370</ISSNLinking></MedlineJournalInfo><KeywordList Owner="NOTNLM"><Keyword MajorTopicYN="N">Azithromycin</Keyword><Keyword MajorTopicYN="N">COVID-19</Keyword><Keyword MajorTopicYN="N">Coronavirus</Keyword><Keyword MajorTopicYN="N">Early treatment</Keyword><Keyword MajorTopicYN="N">Hydroxychloroquine</Keyword><Keyword MajorTopicYN="N">Randomized controlled trial</Keyword><Keyword MajorTopicYN="N">Remote enrollment</Keyword><Keyword MajorTopicYN="N">SARS-CoV-2</Keyword></KeywordList></MedlineCitation><PubmedData><History><PubMedPubDate PubStatus="received"><Year>2020</Year><Month>12</Month><Day>23</Day></PubMedPubDate><PubMedPubDate PubStatus="revised"><Year>2021</Year><Month>02</Month><Day>08</Day></PubMedPubDate><PubMedPubDate PubStatus="accepted"><Year>2021</Year><Month>02</Month><Day>10</Day></PubMedPubDate><PubMedPubDate PubStatus="pubmed"><Year>2021</Year><Month>3</Month><Day>9</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="medline"><Year>2021</Year><Month>3</Month><Day>9</Day><Hour>6</Hour><Minute>1</Minute></PubMedPubDate><PubMedPubDate PubStatus="entrez"><Year>2021</Year><Month>3</Month><Day>8</Day><Hour>5</Hour><Minute>57</Minute></PubMedPubDate></History><PublicationStatus>ppublish</PublicationStatus><ArticleIdList><ArticleId IdType="pubmed">33681731</ArticleId><ArticleId IdType="doi">10.1016/j.eclinm.2021.100773</ArticleId><ArticleId IdType="pii">S2589-5370(21)00053-5</ArticleId><ArticleId IdType="pmc">PMC7912360</ArticleId></ArticleIdList><pmc-dir>pmcsd</pmc-dir>
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