Dataset Information

Hydroxychloroquine with or without Azithromycin in Mild-to-Moderate Covid-19.

ABSTRACT: Background: Hydroxychloroquine and azithromycin have been used to treat patients with coronavirus disease 2019 (Covid-19). However, evidence on the safety and efficacy of these therapies is limited.

Methods: We conducted a multicenter, randomized, open-label, three-group, controlled trial involving hospitalized patients with suspected or confirmed Covid-19 who were receiving either no supplemental oxygen or a maximum of 4 liters per minute of supplemental oxygen. Patients were randomly assigned in a 1:1:1 ratio to receive standard care, standard care plus hydroxychloroquine at a dose of 400 mg twice daily, or standard care plus hydroxychloroquine at a dose of 400 mg twice daily plus azithromycin at a dose of 500 mg once daily for 7 days. The primary outcome was clinical status at 15 days as assessed with the use of a seven-level ordinal scale (with levels ranging from one to seven and higher scores indicating a worse condition) in the modified intention-to-treat population (patients with a confirmed diagnosis of Covid-19). Safety was also assessed.

Results: A total of 667 patients underwent randomization; 504 patients had confirmed Covid-19 and were included in the modified intention-to-treat analysis. As compared with standard care, the proportional odds of having a higher score on the seven-point ordinal scale at 15 days was not affected by either hydroxychloroquine alone (odds ratio, 1.21; 95% confidence interval [CI], 0.69 to 2.11; P?=?1.00) or hydroxychloroquine plus azithromycin (odds ratio, 0.99; 95% CI, 0.57 to 1.73; P?=?1.00). Prolongation of the corrected QT interval and elevation of liver-enzyme levels were more frequent in patients receiving hydroxychloroquine, alone or with azithromycin, than in those who were not receiving either agent.

Conclusions: Among patients hospitalized with mild-to-moderate Covid-19, the use of hydroxychloroquine, alone or with azithromycin, did not improve clinical status at 15 days as compared with standard care. (Funded by the Coalition Covid-19 Brazil and EMS Pharma; ClinicalTrials.gov number, NCT04322123.).

SUBMITTER: Cavalcanti AB

PROVIDER: S-EPMC7397242 | biostudies-literature | 2020 Nov

REPOSITORIES: biostudies-literature

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Hydroxychloroquine with or without Azithromycin in Mild-to-Moderate Covid-19.

Cavalcanti Alexandre B AB Zampieri Fernando G FG Rosa Regis G RG Azevedo Luciano C P LCP Veiga Viviane C VC Avezum Alvaro A Damiani Lucas P LP Marcadenti Aline A Kawano-Dourado Letícia L Lisboa Thiago T Junqueira Debora L M DLM de Barros E Silva Pedro G M PGM Tramujas Lucas L Abreu-Silva Erlon O EO Laranjeira Ligia N LN Soares Aline T AT Echenique Leandro S LS Pereira Adriano J AJ Freitas Flávio G R FGR Gebara Otávio C E OCE Dantas Vicente C S VCS Furtado Remo H M RHM Milan Eveline P EP Golin Nicole A NA Cardoso Fábio F FF Maia Israel S IS Hoffmann Filho Conrado R CR Kormann Adrian P M APM Amazonas Roberto B RB Bocchi de Oliveira Monalisa F MF Serpa-Neto Ary A Falavigna Maicon M Lopes Renato D RD Machado Flávia R FR Berwanger Otavio O

The New England journal of medicine 20200723 21

<h4>Background</h4>Hydroxychloroquine and azithromycin have been used to treat patients with coronavirus disease 2019 (Covid-19). However, evidence on the safety and efficacy of these therapies is limited.<h4>Methods</h4>We conducted a multicenter, randomized, open-label, three-group, controlled trial involving hospitalized patients with suspected or confirmed Covid-19 who were receiving either no supplemental oxygen or a maximum of 4 liters per minute of supplemental oxygen. Patients were rando ...[more]

PMID: 32706953

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Project description:BackgroundThe antibacterial, anti-inflammatory, and antiviral properties of azithromycin suggest therapeutic potential against COVID-19. Randomised data in mild-to-moderate disease are not available. We assessed whether azithromycin is effective in reducing hospital admission in patients with mild-to-moderate COVID-19.MethodsThis prospective, open-label, randomised superiority trial was done at 19 hospitals in the UK. We enrolled adults aged at least 18 years presenting to hospitals with clinically diagnosed, highly probable or confirmed COVID-19 infection, with fewer than 14 days of symptoms, who were considered suitable for initial ambulatory management. Patients were randomly assigned (1:1) to azithromycin (500 mg once daily orally for 14 days) plus standard care or to standard care alone. The primary outcome was death or hospital admission from any cause over the 28 days from randomisation. The primary and safety outcomes were assessed according to the intention-to-treat principle. This trial is registered at ClinicalTrials.gov (NCT04381962) and recruitment is closed.Findings298 participants were enrolled from June 3, 2020, to Jan 29, 2021. Three participants withdrew consent and requested removal of all data, and three further participants withdrew consent after randomisation, thus, the primary outcome was assessed in 292 participants (145 in the azithromycin group and 147 in the standard care group). The mean age of the participants was 45·9 years (SD 14·9). 15 (10%) participants in the azithromycin group and 17 (12%) in the standard care group were admitted to hospital or died during the study (adjusted OR 0·91 [95% CI 0·43-1·92], p=0·80). No serious adverse events were reported.InterpretationIn patients with mild-to-moderate COVID-19 managed without hospital admission, adding azithromycin to standard care treatment did not reduce the risk of subsequent hospital admission or death. Our findings do not support the use of azithromycin in patients with mild-to-moderate COVID-19.FundingNational Institute for Health Research Oxford Biomedical Research Centre, University of Oxford and Pfizer.

Dataset Information

Hydroxychloroquine with or without Azithromycin in Mild-to-Moderate Covid-19.

Publications

Hydroxychloroquine with or without Azithromycin in Mild-to-Moderate Covid-19.

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