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

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

Publication date: Jul 23, 2020

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.

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.

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.

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.).

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Concepts Keywords
Azithromycin Medical specialties
Brazil Organic compounds
Confidence Interval Quinolines
Coronavirus Chloroarenes
EMS Chemical compounds
Enzyme RTT
Hydroxychloroquine Hydroxychloroquine
Odds Ratio Azithromycin
Oxygen Coronavirus disease


Type Source Name
drug DRUGBANK Hydroxychloroquine
drug DRUGBANK Azithromycin
drug DRUGBANK Oxygen
disease MESH diagnosis
drug DRUGBANK Dacarbazine
drug DRUGBANK Coenzyme M
drug DRUGBANK Chloroquine
disease IDO antiviral
disease MESH viral load
disease VO effective
disease MESH ventricular tachycardia
disease MESH death
disease MESH complications
disease MESH acute kidney injury
disease MESH Hypertension
disease MESH renal
disease MESH Emergency
drug DRUGBANK Ranitidine
drug DRUGBANK Angiotensin II
disease MESH AIDS
disease MESH COPD
drug DRUGBANK Trestolone
disease MESH respiratory failure
disease MESH septic shock
disease MESH hemorrhage
disease MESH shock
disease MESH men
disease MESH tachycardia
disease MESH infarction
disease MESH embolism
disease MESH infection

Original Article