Randomized double-blinded placebo-controlled trial of hydroxychloroquine with or without azithromycin for virologic cure of non-severe Covid-19

{ 'indexed': {'date-parts': [[2024, 1, 25]], 'date-time': '2024-01-25T15:46:37Z', 'timestamp': 1706197597142}, 'reference-count': 33, 'publisher': 'Elsevier BV', 'license': [ { 'start': { 'date-parts': [[2020, 12, 1]], 'date-time': '2020-12-01T00:00:00Z', 'timestamp': 1606780800000}, 'content-version': 'tdm', 'delay-in-days': 0, 'URL': 'https://www.elsevier.com/tdm/userlicense/1.0/'}, { 'start': { 'date-parts': [[2020, 11, 6]], 'date-time': '2020-11-06T00:00:00Z', 'timestamp': 1604620800000}, 'content-version': 'vor', 'delay-in-days': 0, 'URL': 'http://creativecommons.org/licenses/by-nc-nd/4.0/'}], 'funder': [ { 'DOI': '10.13039/100007833', 'name': 'Hamad Medical Corporation', 'doi-asserted-by': 'publisher'}], 'content-domain': {'domain': [], 'crossmark-restriction': False}, 'published-print': {'date-parts': [[2020, 12]]}, 'DOI': '10.1016/j.eclinm.2020.100645', 'type': 'journal-article', 'created': { 'date-parts': [[2020, 11, 20]], 'date-time': '2020-11-20T22:24:37Z', 'timestamp': 1605911077000}, 'page': '100645', 'source': 'Crossref', 'is-referenced-by-count': 42, 'title': 'Randomized double-blinded placebo-controlled trial of hydroxychloroquine with or without ' 'azithromycin for virologic cure of non-severe Covid-19', 'prefix': '10.1016', 'volume': '29-30', 'author': [ {'given': 'Ali S.', 'family': 'Omrani', 'sequence': 'first', 'affiliation': []}, {'given': 'Sameer A.', 'family': 'Pathan', 'sequence': 'additional', 'affiliation': []}, {'given': 'Sarah A.', 'family': 'Thomas', 'sequence': 'additional', 'affiliation': []}, {'given': 'Tim R.E.', 'family': 'Harris', 'sequence': 'additional', 'affiliation': []}, {'given': 'Peter V.', 'family': 'Coyle', 'sequence': 'additional', 'affiliation': []}, {'given': 'Caroline E.', 'family': 'Thomas', 'sequence': 'additional', 'affiliation': []}, {'given': 'Isma', 'family': 'Qureshi', 'sequence': 'additional', 'affiliation': []}, {'given': 'Zain A.', 'family': 'Bhutta', 'sequence': 'additional', 'affiliation': []}, {'given': 'Naema Al', 'family': 'Mawlawi', 'sequence': 'additional', 'affiliation': []}, {'given': 'Reham Al', 'family': 'Kahlout', 'sequence': 'additional', 'affiliation': []}, {'given': 'Ashraf', 'family': 'Elmalik', 'sequence': 'additional', 'affiliation': []}, {'given': 'Aftab M.', 'family': 'Azad', 'sequence': 'additional', 'affiliation': []}, {'given': 'Joanne', 'family': 'Daghfal', 'sequence': 'additional', 'affiliation': []}, {'given': 'Mulham', 'family': 'Mustafa', 'sequence': 'additional', 'affiliation': []}, {'given': 'Andrew', 'family': 'Jeremijenko', 'sequence': 'additional', 'affiliation': []}, {'given': 'Hussam Al', 'family': 'Soub', 'sequence': 'additional', 'affiliation': []}, {'given': 'Mohammed Abu', 'family': 'Khattab', 'sequence': 'additional', 'affiliation': []}, {'given': 'Muna Al', 'family': 'Maslamani', 'sequence': 'additional', 'affiliation': []}, {'given': 'Stephen H.', 'family': 'Thomas', 'sequence': 'additional', 'affiliation': []}], 'member': '78', 'reference': [ { 'key': '10.1016/j.eclinm.2020.100645_bib0001', 'doi-asserted-by': 'crossref', 'DOI': '10.1016/j.ijantimicag.2020.105949', 'article-title': 'Hydroxychloroquine and azithromycin as a treatment of COVID-19: results ' 'of an open-label non-randomized clinical trial', 'author': 'Gautret', 'year': '2020', 'journal-title': 'Int J Antimicrob Agents'}, { 'key': '10.1016/j.eclinm.2020.100645_bib0002', 'doi-asserted-by': 'crossref', 'DOI': '10.1016/j.tmaid.2020.101663', 'article-title': 'Clinical and microbiological effect of a combination of ' 'hydroxychloroquine and azithromycin in 80 COVID-19 patients with at ' 'least a six-day follow up: a pilot observational study', 'volume': '34', 'author': 'Gautret', 'year': '2020', 'journal-title': 'Travel Med Infect Dis'}, { 'key': '10.1016/j.eclinm.2020.100645_bib0003', 'author': 'Molina', 'year': '2020', 'journal-title': 'Med Mal Infect'}, { 'key': '10.1016/j.eclinm.2020.100645_bib0004', 'unstructured': 'Ferner R.E., Aronson J.K... Hydroxychloroquine for Covid-19: what do the ' 'clinical trials tell us? 2020. ' 'https://www.cebm.net/covid-19/hydroxychloroquine-for-covid-19-what-do-the-clinical-trials-tell-us/ ' '(accessed 20 April 2020).'}, { 'key': '10.1016/j.eclinm.2020.100645_bib0005', 'unstructured': 'Q-PROTECT Research Protocol. 2020. ' 'https://www.hamad.qa/EN/Hospitals-and-services/Communicable-Disease-Center/Research-and-Education/Pages/Q-Protect.aspx ' '(accessed 1 August 2020).'}, { 'key': '10.1016/j.eclinm.2020.100645_bib0006', 'unstructured': 'Simpson T.F., Kovacs R.J., Stecker E.C.. Ventricular arrhythmia risk due ' 'to hydroxychloroquine-azithromycin treatment for Covid-19. 2020. ' 'https://www.acc.org/latest-in-cardiology/articles/2020/03/27/14/00/ventricular-arrhythmia-risk-due-to-hydroxychloroquine-azithromycin-treatment-for-covid-19 ' '(accessed 1 April 2020).'}, { 'issue': '12', 'key': '10.1016/j.eclinm.2020.100645_bib0007', 'doi-asserted-by': 'crossref', 'first-page': '1177', 'DOI': '10.1056/NEJMc2001737', 'article-title': 'SARS-CoV-2 viral load in upper respiratory specimens of infected ' 'patients', 'volume': '382', 'author': 'Zou', 'year': '2020', 'journal-title': 'N Engl J Med'}, { 'key': '10.1016/j.eclinm.2020.100645_bib0008', 'doi-asserted-by': 'crossref', 'first-page': '120', 'DOI': '10.1016/j.jclinepi.2020.04.016', 'article-title': 'COVID-19 coronavirus research has overall low methodological quality ' 'thus far: case in point for chloroquine/hydroxychloroquine', 'volume': '123', 'author': 'Alexander', 'year': '2020', 'journal-title': 'J Clin Epidemiol'}, { 'key': '10.1016/j.eclinm.2020.100645_bib0009', 'doi-asserted-by': 'crossref', 'DOI': '10.1056/NEJMoa2016638', 'article-title': 'A randomized trial of hydroxychloroquine as postexposure prophylaxis ' 'for covid-19', 'author': 'Boulware', 'year': '2020', 'journal-title': 'N Engl J Med'}, { 'key': '10.1016/j.eclinm.2020.100645_bib0010', 'doi-asserted-by': 'crossref', 'DOI': '10.1016/j.tmaid.2020.101738', 'article-title': 'Early treatment of COVID-19 patients with hydroxychloroquine and ' 'azithromycin: a retrospective analysis of 1061 cases in Marseille, ' 'France', 'volume': '35', 'author': 'Million', 'year': '2020', 'journal-title': 'Travel Med Infect Dis'}, { 'key': '10.1016/j.eclinm.2020.100645_bib0011', 'article-title': 'Hydroxychloroquine for early treatment of adults with mild covid-19: a ' 'randomized-controlled trial', 'author': 'Mitja', 'year': '2020', 'journal-title': 'Clin Infect Dis'}, { 'key': '10.1016/j.eclinm.2020.100645_bib0012', 'doi-asserted-by': 'crossref', 'DOI': '10.7326/M20-4207', 'article-title': 'Hydroxychloroquine in nonhospitalized adults with early COVID-19: a ' 'randomized trial', 'author': 'Skipper', 'year': '2020', 'journal-title': 'Ann Intern Med'}, { 'key': '10.1016/j.eclinm.2020.100645_bib0013', 'doi-asserted-by': 'crossref', 'first-page': 'm1849', 'DOI': '10.1136/bmj.m1849', 'article-title': 'Hydroxychloroquine in patients with mainly mild to moderate coronavirus ' 'disease 2019: open label, randomised controlled trial', 'volume': '369', 'author': 'Tang', 'year': '2020', 'journal-title': 'BMJ'}, { 'issue': '2', 'key': '10.1016/j.eclinm.2020.100645_bib0014', 'first-page': '215', 'article-title': 'A pilot study of hydroxychloroquine in treatment of patients with ' 'moderate COVID-19', 'volume': '49', 'author': 'Chen', 'year': '2020', 'journal-title': 'Zhejiang Da Xue Xue Bao Yi Xue Ban'}, { 'key': '10.1016/j.eclinm.2020.100645_bib0015', 'article-title': 'Low dose of hydroxychloroquine reduces fatality of critically ill ' 'patients with COVID-19', 'author': 'Yu', 'year': '2020', 'journal-title': 'Sci China Life Sci'}, { 'key': '10.1016/j.eclinm.2020.100645_bib0016', 'doi-asserted-by': 'crossref', 'DOI': '10.1056/NEJMoa2012410', 'article-title': 'Observational study of hydroxychloroquine in hospitalized patients with ' 'covid-19', 'author': 'Geleris', 'year': '2020', 'journal-title': 'N Engl J Med'}, { 'key': '10.1016/j.eclinm.2020.100645_bib0017', 'doi-asserted-by': 'crossref', 'DOI': '10.1001/jama.2020.8630', 'article-title': 'Association of treatment with hydroxychloroquine or azithromycin with ' 'in-hospital mortality in patients with COVID-19 in New York State', 'author': 'Rosenberg', 'year': '2020', 'journal-title': 'JAMA'}, { 'key': '10.1016/j.eclinm.2020.100645_bib0018', 'doi-asserted-by': 'crossref', 'first-page': 'm1844', 'DOI': '10.1136/bmj.m1844', 'article-title': 'Clinical efficacy of hydroxychloroquine in patients with covid-19 ' 'pneumonia who require oxygen: observational comparative study using ' 'routine care data', 'volume': '369', 'author': 'Mahevas', 'year': '2020', 'journal-title': 'BMJ'}, { 'key': '10.1016/j.eclinm.2020.100645_bib0019', 'doi-asserted-by': 'crossref', 'DOI': '10.1001/jamacardio.2020.1782', 'article-title': 'Hydroxychloroquine, coronavirus disease 2019, and QT prolongation', 'author': 'Bonow', 'year': '2020', 'journal-title': 'JAMA Cardiol'}, { 'key': '10.1016/j.eclinm.2020.100645_bib0020', 'article-title': 'Hydroxychloroquine or chloroquine with or without a macrolide for ' 'treatment of COVID-19: a multinational registry analysis', 'author': 'Mehra', 'year': '2020', 'journal-title': 'Lancet'}, { 'key': '10.1016/j.eclinm.2020.100645_bib0021', 'unstructured': 'Horby P., Landray M.J... No clinical benefit from use of ' 'hydroxychloroquine in hospitalised patients with Covid-19. 2020. ' 'https://www.recoverytrial.net/news/statement-from-the-chief-investigators-of-the-randomised-evaluation-of-covid-19-therapy-recovery-trial-on-hydroxychloroquine-5-june-2020-no-clinical-benefit-from-use-of-hydroxychloroquine-in-hospitalised-patients-with-covid-19 ' '(accessed 1 July 2020).'}, { 'key': '10.1016/j.eclinm.2020.100645_bib0022', 'unstructured': 'FDA cautions against use of hydroxychloroquine or chloroquine for ' 'COVID-19 outside of the hospital setting or a clinical trial due to risk ' 'of heart rhythm problems. 2020. ' 'https://www.fda.gov/drugs/drug-safety-and-availability/fda-cautions-against-use-hydroxychloroquine-or-chloroquine-covid-19-outside-hospital-setting-or ' '(accessed 15 July 2020).'}, { 'key': '10.1016/j.eclinm.2020.100645_bib0023', 'unstructured': 'WHO. "Solidarity" clinical trial for Covid-19 treatments. 2020. ' 'https://www.who.int/emergencies/diseases/novel-coronavirus-2019/global-research-on-novel-coronavirus-2019-ncov/solidarity-clinical-trial-for-covid-19-treatments ' '(accessed 15 July 2020).'}, { 'key': '10.1016/j.eclinm.2020.100645_bib0024', 'doi-asserted-by': 'crossref', 'DOI': '10.1056/NEJMoa2019014', 'article-title': 'Hydroxychloroquine with or without azithromycin in mild-to-moderate ' 'covid-19', 'author': 'Cavalcanti', 'year': '2020', 'journal-title': 'N Engl J Med'}, { 'key': '10.1016/j.eclinm.2020.100645_bib0025', 'doi-asserted-by': 'crossref', 'first-page': '396', 'DOI': '10.1016/j.ijid.2020.06.099', 'article-title': 'Treatment with hydroxychloroquine, azithromycin, and combination in ' 'patients hospitalized with COVID-19', 'volume': '97', 'author': 'Arshad', 'year': '2020', 'journal-title': 'Int J Infect Dis'}, { 'key': '10.1016/j.eclinm.2020.100645_bib0026', 'doi-asserted-by': 'crossref', 'DOI': '10.1016/j.tmaid.2020.101791', 'article-title': 'Outcomes of 3,737 COVID-19 patients treated with ' 'hydroxychloroquine/azithromycin and other regimens in Marseille, ' 'France: a retrospective analysis', 'author': 'Lagier', 'year': '2020', 'journal-title': 'Travel Med Infect Dis'}, { 'issue': '6', 'key': '10.1016/j.eclinm.2020.100645_bib0027', 'doi-asserted-by': 'crossref', 'first-page': '585', 'DOI': '10.1056/NEJMe2020388', 'article-title': 'Hydroxychloroquine for the prevention of Covid-19 – searching for ' 'evidence', 'volume': '383', 'author': 'Cohen', 'year': '2020', 'journal-title': 'N Engl J Med'}, { 'key': '10.1016/j.eclinm.2020.100645_bib0028', 'doi-asserted-by': 'crossref', 'DOI': '10.1016/j.jinf.2020.06.034', 'article-title': 'Low transmission risk of 9 asymptomatic carriers tested positive for ' 'both SARS-CoV-2 nucleic acid and serum IgG', 'author': 'Chen', 'year': '2020', 'journal-title': 'J Infect'}, { 'key': '10.1016/j.eclinm.2020.100645_bib0029', 'article-title': 'Temporal dynamics in viral shedding and transmissibility of COVID-19', 'author': 'He', 'year': '2020', 'journal-title': 'Nat Med'}, { 'issue': '4', 'key': '10.1016/j.eclinm.2020.100645_bib0030', 'doi-asserted-by': 'crossref', 'first-page': 'ofaa130', 'DOI': '10.1093/ofid/ofaa130', 'article-title': 'Review: hydroxychloroquine and chloroquine for treatment of SARS-CoV-2 ' '(COVID-19)', 'volume': '7', 'author': 'Pastick', 'year': '2020', 'journal-title': 'Open Forum Infect Dis'}, { 'issue': '15', 'key': '10.1016/j.eclinm.2020.100645_bib0031', 'doi-asserted-by': 'crossref', 'first-page': '732', 'DOI': '10.1093/cid/ciaa237', 'article-title': 'In vitro antiviral activity and projection of optimized dosing design ' 'of hydroxychloroquine for the treatment of Severe Acute Respiratory ' 'Syndrome Coronavirus 2 (SARS-CoV-2)', 'volume': '71', 'author': 'Yao', 'year': '2020', 'journal-title': 'Clin Infect Dis'}, { 'issue': '3', 'key': '10.1016/j.eclinm.2020.100645_bib0032', 'doi-asserted-by': 'crossref', 'first-page': '287', 'DOI': '10.2174/1573403X10666140514103612', 'article-title': 'The measurement of the QT interval', 'volume': '10', 'author': 'Postema', 'year': '2014', 'journal-title': 'Curr Cardiol Rev'}, { 'key': '10.1016/j.eclinm.2020.100645_bib0033', 'doi-asserted-by': 'crossref', 'DOI': '10.1001/jamacardio.2020.1787', 'article-title': 'Assessment of QT intervals in a case series of patients with ' 'coronavirus disease 2019 (COVID-19) infection treated with ' 'hydroxychloroquine alone or in combination with azithromycin in an ' 'intensive care unit', 'author': 'Bessiere', 'year': '2020', 'journal-title': 'JAMA Cardiol'}], 'container-title': 'EClinicalMedicine', 'original-title': [], 'language': 'en', 'link': [ { 'URL': 'https://api.elsevier.com/content/article/PII:S2589537020303898?httpAccept=text/xml', 'content-type': 'text/xml', 'content-version': 'vor', 'intended-application': 'text-mining'}, { 'URL': 'https://api.elsevier.com/content/article/PII:S2589537020303898?httpAccept=text/plain', 'content-type': 'text/plain', 'content-version': 'vor', 'intended-application': 'text-mining'}], 'deposited': { 'date-parts': [[2021, 5, 13]], 'date-time': '2021-05-13T12:00:34Z', 'timestamp': 1620907234000}, 'score': 1, 'resource': {'primary': {'URL': 'https://linkinghub.elsevier.com/retrieve/pii/S2589537020303898'}}, 'subtitle': [], 'short-title': [], 'issued': {'date-parts': [[2020, 12]]}, 'references-count': 33, 'alternative-id': ['S2589537020303898'], 'URL': 'http://dx.doi.org/10.1016/j.eclinm.2020.100645', 'relation': {}, 'ISSN': ['2589-5370'], 'subject': ['General Medicine'], 'container-title-short': 'EClinicalMedicine', 'published': {'date-parts': [[2020, 12]]}, 'article-number': '100645'}