Ivermectin as an adjunct treatment for hospitalized adult COVID-19 patients: A randomized multi-center clinical trial
Nematollah Gheibi, Morteza Shakhsi Niaee, Peyman Namdar, Abbas Allami, Leila Zolghadr, Amir Javadi, Amin Karampour, Mehran Varnaseri, Behzad Bijani, Fatemeh Cheraghi, Yazdan Naderi, Fatemeh Amini, Masoumeh Karamyan, Mohammadjafar Yadyad, Ramin Jamshidian
Asian Pacific Journal of Tropical Medicine, doi:10.4103/1995-7645.318304
To evaluate different doses of ivermectin in adult patients with mild COVID-19 and to evaluate the effect of ivermectin on mortality and clinical consequences. Methods: A randomized, double-blind, placebo-controlled, multicenter clinical trial was performed at five hospitals. A total of 180 mild hospitalized patients with COVID-19 confirmed by PCR or chest image tests were enrolled and allocated to six arms including hydroxychloroquine 200 mg twice per day, placebo plus hydroxychloroquine 200 mg twice per day, single dose ivermectin (200 µg/kg), three low interval doses of ivermectin (200, 200, 200 µg/kg), single dose ivermectin (400 µg/kg), and three high interval doses of ivermectin (400, 200, 200 µg/kg). The primary endpoint of this trial was all-cause of mortality or clinical recovery. The radiographic findings, hospitalization and low O 2 saturation duration, and hematological variables of blood samples were analyzed. Results: A total of 16.7% (5/30) and 20.0% (6/30) patients died in arms treated with hydroxychloroquine 200 mg twice per day and placebo plus hydroxychloroquine 200 mg twice per day, respectively, and a reduction in mortality rate in patients receiving ivermectin treatment to 0%, 10%, 0% and 3.3% for arms 1-4 were observed. Risk of mortality was also decreased about 15% in the ivermectin treated arms. Conclusions: Ivermectin as an adjunct reduces the rate of mortality, time of low O 2 saturation, and duration of hospitalization in adult COVID-19 patients. The improvement of other clinical parameters shows that ivermectin, with a wide margin of safety, had a high therapeutic effect on COVID-19.
Conflict of interest statement We declare that we have no conflict of interest.
Authors' contributions GN, NMS, NP, AA designed the study. BB,VM,YYMJ, KA, FA, KM and JR were responsible for overall data collection and clinical studies. ZL, JA, AA conducted data analysis and interpretation. ZL drafted the first manuscript and has designed Figure1. GN and AA revised the manuscript critically. NY and ZL were in charge of drug formulation. All authors read and approved the final manuscript. NMS,GN,CHF and NP supervised the project.
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