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. 2022 Oct:29:100968.
doi: 10.1016/j.conctc.2022.100968. Epub 2022 Jul 20.

COVIDMED - An early pandemic randomized clinical trial of losartan treatment for hospitalized COVID-19 patients

Daniel Freilich  1 , Jennifer Victory  2 , Paul Jenkins  2 , Anne Gadomski  2
Affiliations

COVIDMED - An early pandemic randomized clinical trial of losartan treatment for hospitalized COVID-19 patients

Daniel Freilich et al. Contemp Clin Trials Commun. 2022 Oct.

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.

Keywords: Angiotensin II receptor Blocker (ARB); Angiotensin converting enzyme inhibitor (ACEi); COSS, COVID-19 Ordinal Severity Score; COVID-19; Losartan; Randomized clinical trial (RCT); SARS-CoV-2.

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Conflict of interest statement

The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.

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