Ivermectin as an adjunct treatment for hospitalized adult COVID-19 patients: A randomized multi-center clinical trial

Abstract

<title>Abstract</title> <bold>Background: </bold>It appears that ivermectin can potentially act against COVID-19 infection. Today, it is an urgent need to evaluate the efficacy and safety of ivermectin. The effect of ivermectin therapy on mild to severe COVID-19 patients was investigated.<bold>Methods:</bold> A 45-days randomized, double-blind, placebo-controlled, multicenter, phase 2 clinical trial was designed at five hospitals. A total number of 180 mild to severe hospitalized patients with confirmed PCR and chest image tests were enrolled. The radiographic findings, hospitalization and low O₂ saturation duration, and clinical outcomes such as mortality and variables of blood samples were analyzed using standard statistical analyses in SPSS (V20).<bold>Results</bold>: Average age of the participants was 56 years (45-67) and 50% were women. The primary and secondary results showed significant changes between day zero and day five of admission (∆ 0/5) in terms of ΔALC5/0, ΔPLT5/0, ΔESR5/0, ΔCRP5/0, duration of low O₂ saturation, and duration of hospitalization (CI = 95% ). Risk of mortality was also decreased significantly in the study groups.<bold>Conclusion:</bold> Ivermectin as an adjunct reduced the rate of mortality, low O₂ duration, and duration of hospitalization in adult COVID 19 patients. The improvement of other clinical parameters showed that the ivermectin, with a wide margin of safety, had a high therapeutic effect on COVID-19.<bold>Trial Registration</bold>: This trial was registered with the Iranian Registry of Clinical Trials website (registration ID IRCT20200408046987N1).