The effect of early treatment with ivermectin on viral load, symptoms and humoral response in patients with mild COVID-19: a pilot, double-blind, placebo-controlled, randomized clinical trial
Abstract Ivermectin inhibits the replication of SARS-CoV-2 in vitro at concentrations not readily achievable with currently approved doses. There is limited evidence to support its clinical use in COVID-19 patients. We conducted a Pilot, randomized, double-blind, placebo-controlled trial to determine the efficacy of a single dose of ivermectin to reduce the proportion of PCR positives, viral load at day 7 post treatment.Consecutive patients with confirmed severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection and mild COVID-19 (no pneumonia) and no risk factors for complicated disease attending the emergency room of the Clínica Universidad de Navarra. Patients were randomized 1:1 to receive ivermectin, 400 mcg/kg, single dose (n = 12) or placebo (n = 12). The primary outcome measure was the proportion of patients with detectable SARS-CoV-2 RNA by PCR from nasopharyngeal swab at day 7 post-treatment. The primary outcome was supported by determination of the viral load and infectivity of each sample. The differences between ivermectin and placebo were calculated using Fisher’s exact test and presented as a relative risk ratio.All patients recruited completed the trial (median age, 26 [range, 18-54] years; 12 [50%] women; 100% had symptoms at recruitment, 70% reported headache, 62% reported fever, 50% reported general malaise and 25% reported cough). At day 7, there was no difference in the proportion of PCR positive patients (RR 0.92, 95% CI: 0.77-1.09, p = 1.0). The ivermectin group had lower median viral loads at days 4 and 7 post treatment as well as lower median IgG titers at day 21 post treatment. Hyposmia/anosmia (76 vs 158 patient-days) and cough (68 vs 97 patient-days) were less frequent in the ivermectin group.Among patients with mild COVID-19 and no risk factors for severe disease receiving a single 400 mcg/kg dose of ivermectin within 48 hours of fever or cough onset there was no difference in the proportion of PCR positives. There was however a marked reduction of anosmia/hyposmia, a reduction of cough and a tendency to lower viral loads and lower IgG titers which warrants assessment in larger trials.Trial registration ClinicalTrials.gov Identifier: NCT04390022 https://clinicaltrials.gov/ct2/show/NCT04390022
