The SARS-CoV-2 Ivermectin Navarra-ISGlobal Trial (SAINT) to Evaluate the Potential of Ivermectin to Reduce COVID-19 Transmission in low risk, non-severe COVID-19 patients in the first 48 hours after symptoms onset: A structured summary of a study protocol for a randomized control pilot trial

Abstract

Objectives: The primary objective is to determine the efficacy of a single dose of ivermectin, administered to low risk, non-severe COVID-19 patients in the first 48 hours after symptom onset to reduce the proportion of patients with detectable SARS-CoV-2 RNA by Polymerase Chain Reaction (PCR) test from nasopharyngeal swab at day 7 post-treatment. The secondary objectives are: 1. To assess the efficacy of ivermectin to reduce the SARS-CoV-2 viral load in the nasopharyngeal swab at day 7 post treatment. 2. To assess the efficacy of ivermectin to improve symptom progression in treated patients. 3. To assess the proportion of seroconversions in treated patients at day 21. 4. To assess the safety of ivermectin at the proposed dose. 5. To determine the magnitude of immune response against SARS-CoV-2. 6. To assess the early kinetics of immunity against SARS-CoV-2.

The effect of early treatment with ivermectin on viral load, symptoms and humoral response in patients with non-severe COVID-19: A pilot, double-blind, placebo-controlled, randomized clinical trial

“…This was a pilot, double-blind, placebo-controlled, single-center, parallel-arm, superiority, randomized clinical trial that compared a single dose of ivermectin with placebo in patients with non-severe COVID-19 and no risk factors. The trial protocol was published [14] , the last version of the protocol and statistical analysis plan are available as supplementary files. The protocol was approved by the Spanish national ethics committee for drug research (Hospital Puerta de Hierro Majadahonda) and by the Spanish Agency of Medicines and Medical Devices.…”

Treatment of children with COVID-19: position paper of the Italian Society of Pediatric Infectious Disease

“…Ivermectin, an FDA-approved anti-parasitic, seems to have broad-spectrum anti-viral activity in vitro, is an inhibitor of the causative virus (SARS-CoV-2), 2 h post infection with SARS-CoV-2 able to effect 5000-fold reduction in viral RNA at 48 h [ 46 ]. A single center, double-blind, randomized, placebo-controlled trial is ongoing on ivermectin efficacy in reducing SARS-CoV-2 viral load in adult patients with low risk, non-severe COVID-19 [ 47 ].…”

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

“…This was a pilot, double-blind, placebo-controlled, single-center, parallel-arm, superiority, randomized clinical trial that compared a single dose of ivermectin with placebo in patients with mild COVID-19 and no risk factors. The trial protocol was published 9 , the last version of the protocol and statistical analysis plan are available as supplementary les. The protocol was approved by the Spanish national ethics committee for drug research (Hospital Puerta de Hierro Majadahonda) and by the Spanish Agency of Medicines and Medical Devices.…”