Abstract
Objectives
To assess the efficacy and safety of losartan for COVID-19 patients.
Methods
COVIDMED was a double-blinded, placebo-controlled platform RCT. Enrollees were randomized to standard care plus hydroxychloroquine, lopinavir/ritonavir, losartan, or placebo. Hydroxychloroquine and lopinavir/ritonavir arms were discontinued early. We report losartan data vs. combined (lopinavir-ritonavir and placebo) and prespecified placebo-only controls. The primary endpoint was the mean COVID-19 Ordinal Severity Score (COSS) slope of change. Slow enrollment prompted early termination.
Results
Fourteen patients were included in our final analysis (losartan [N = 9] vs. control [N = 5] [lopinavir/ritonavir [N = 2], placebo [N = 3]]). Most baseline parameters were balanced. Losartan treatment was not associated with a difference in mean COSS slope of change vs. combined (p = 0.4) or placebo-only control (p = 0.05) (trend favoring placebo). 60-day mortality and overall AE/SAE rates were insignificantly higher with losartan.
Conclusion
In this small RCT in hospitalized COVID-19 patients, losartan did not improve outcome and was associated with adverse safety signals.
【저자키워드】 COVID-19, SARS-CoV-2, losartan, Angiotensin converting enzyme inhibitor (ACEi), Angiotensin II receptor Blocker (ARB), Randomized clinical trial (RCT), 【초록키워드】 Treatment, Mortality, Hydroxychloroquine, outcome, RCT, Randomized, Patient, Efficacy and safety, Placebo, platform, placebo-controlled, score, COVID-19 patients, Lopinavir-ritonavir, primary endpoint, Analysis, Enrollment, hospitalized COVID-19 patients, standard care, double-blinded, Final, MOST, slow, parameter, Arm, objective, controls, IMPROVE, Result, the mean, AE/SAE, baseline, 【제목키워드】 Treatment, randomized clinical trial, pandemic, hospitalized COVID-19 patient,