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Hydroxychloroquine with or without Azithromycin in Mild-to-Moderate Covid-19
dc.contributor.author | Cavalcanti, Alexandre B. et al. | |
dc.date.accessioned | 2020-08-18T14:16:06Z | |
dc.date.available | 2020-08-18T14:16:06Z | |
dc.date.issued | 2020-07-03 | |
dc.identifier.uri | http://doi.org/10.1056/NEJMoa2019014 | en_US |
dc.identifier.uri | https://hdl.handle.net/20.500.12663/2146 | |
dc.description.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. opens in new tab.) | en_US |
dc.language | English | en_US |
dc.subject | COVID-19 | en_US |
dc.subject | Coronavirus | en_US |
dc.subject | Coronavirus Infections | en_US |
dc.subject | Infectious Diseases | en_US |
dc.subject | Hydroxychloroquine | en_US |
dc.subject | Azithromycin | en_US |
dc.subject | Betacoronavirus | en_US |
dc.subject | SARS-CoV-2 | en_US |
dc.title | Hydroxychloroquine with or without Azithromycin in Mild-to-Moderate Covid-19 | en_US |
eihealth.country | Others | en_US |
eihealth.category | Candidate therapeutics RD | en_US |
eihealth.type | Published Article | en_US |
eihealth.maincategory | Save Lives / Salvar Vidas | en_US |
dc.relation.ispartofjournal | The New England Journal of Medicine | en_US |
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