Results of a multicenter, double-blinded, randomized controlled trial found no evidence to support the use of hydroxychloroquine for COVID-19 infection in the outpatient setting. These findings were published in The Lancet Regional Health — Americas.
Data for this study were sourced from the COPE-COALITION V trial, which was conducted at 56 centers in Brazil between May 2020 and July 2021. Eligible patients included adults with mild to moderate COVID-19-like symptoms within the 7 days prior to enrollment who had at least 1 risk factor for clinical deterioration. Patients randomly assigned in a 1:1 fashion to receive either 2 doses of hydroxychloroquine 400 mg on day 1 followed by a daily 400-mg dose for a total of 7 days (n=689) or placebo (n=683). The primary outcome was hospitalization for COVID-19 infection up to day 30; secondary outcomes included pneumonia, otitis, worsening of asthma, intensive care unit (ICU) admission, and need for invasive mechanical ventilation (IMV). In addition, a meta-analysis of all published data was performed.
Among patients in the intervention and control cohorts, 52.2% and 54.0% were women, 52.2% and 52.3% were aged 45 years and older, 71.9% and 68.1% were White, 69.4% and 69.0% tested positive for COVID-19 infection, and 61.2% and 62.7% were enrolled at least4 days after symptom onset, respectively.
At 30 days, 6.4% of patients who received hydroxychloroquine and 8.3% of those who received placebo were hospitalized for COVID-19 infection (relative risk [RR], 0.77; 95% CI, 0.52-1.12; P =.1646).
For the secondary outcomes, no significant differences between the cohorts were observed for pneumonia (RR, 0.63; 95% CI, 0.34-1.14; P =.1194), otitis (RR, 0.25; 95% CI, 0.03-2.22; P =.2167), worsening of asthma (RR, 0.82; 95% CI, 0.45-1.49; P =.5119), ICU admission (RR, 0.84; 95% CI, 0.43-1. 61; P =.5922), need for IMV (RR, 1.32; 95% CI, 0.46-3.79; P =.6006), or death (hazard ratio [HR], 1.56; 95% CI, 0.42-6.72; P =.540).
In subgroup analyses, no significant differences were observed between cohorts on the basis of sex, age, days since symptom onset, smoking status, BMI, and comorbidities.
In the meta-analysis, data from 5 previous studies representing 1222 patients assigned to hydroxychloroquine and 1189 assigned to placebo were combined with these data. Results showed that treatment with hydroxychloroquine did not decrease the risk for hospitalization due to COVID-19 infection (RR, 0.77; 95% CI, 0.57-1.04; I2, 0%).
This study was limited by its small sample size and had insufficient power to detect a clinically meaningful benefit in regard to a decreased hospitalization risk, which motivated the study authors to perform the meta-analysis.
The researchers concluded “there is no evidence of benefit to support the routine use of [hydroxychloroquine] in the clinical management of COVID-19 [infection].”
Disclosure: Multiple authors declared affiliations with industry. Please see the original article for a full list of disclosures.
Avezum Á, Oliveira GBF, Oliveira H, et al. Hydroxychloroquine versus placebo in the treatment of non-hospitalised patients with COVID-19 (COPE-Coalition V): A double-blind, multicentre, randomized, controlled trial. Lancet Reg Health Am. 2022;11:100243. doi:10.1016/j.lana.2022.100243