High-dose ivermectin for early treatment of COVID-19 (COVER study): a randomised, double-blind, multicentre, phase II, dose-finding, proof-of-concept clinical trial

Autor: Buonfrate D, Chesini F, Martini D, Roncaglioni MC, Ojeda Fernandez ML, Alvisi MF, De Simone I, Rulli E, Nobili A, Casalini G, Antinori S, Gobbi M, Campoli C, Deiana M, Pomari E, Lunardi G, Tessari R, Bisoffi Z
Rok vydání: 2022
Předmět:
Popis: High concentrations of ivermectin demonstrated antiviral activity against SARS-CoV-2 in vitro. The aim of this study was to assess the safety and efficacy of high-dose ivermectin in reducing viral load in individuals with early SARS-CoV-2 infection. This was a randomised, double-blind, multicentre, phase II, dose-finding, proof-of-concept clinical trial. Participants were adults recently diagnosed with asymptomatic/oligosymptomatic SARS-CoV-2 infection. Exclusion criteria were: pregnant or lactating women; CNS disease; dialysis; severe medical condition with prognosis 10viral load reduction was 2.9 (1.6) in arm C, 2.5 (2.2) in arm B and 2.0 (2.1) in arm A, with no significant differences (P = 0.099 and 0.122 for C vs. A and B vs. A, respectively). High-dose ivermectin was safe but did not show efficacy to reduce viral load. For anonymization purpose, the dates of recruitment have been shifted of an unspecifiednumber of days. However, timeframe between follow up visits remains fixed.
Databáze: OpenAIRE