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

2020; Research Square (United States); Linguagem: Inglês

10.21203/rs.3.rs-109670/v1

Morteza Shakhsi Niaee, Nematollah Gheibi, Peyman Namdar, Abbas Allami, Leila Zolghadr, Amir Javadi, Amin Karampour, Mehran Varnaseri, Behzad Bizhani, Fatemeh Cheraghi, Yazdan Naderi, Fatemeh Amini, Masoumeh Karamyan, Mohammad Jaafar Yadyad, Ramin Jamshidian,

COVID-19 Clinical Research Studies

Abstract Background: 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. Methods: 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 O 2 saturation duration, and clinical outcomes such as mortality and variables of blood samples were analyzed using standard statistical analyses in SPSS (V20). Results : 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 O 2 saturation, and duration of hospitalization (CI = 95% ). Risk of mortality was also decreased significantly in the study groups. Conclusion: Ivermectin as an adjunct reduced the rate of mortality, low O 2 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. Trial Registration : This trial was registered with the Iranian Registry of Clinical Trials website (registration ID IRCT20200408046987N1).