Efficacy of Ivermectin in Outpatients With Non-severe COVID-19

Universidad Nacional de Asunción400 enrolled

Overview

This is a randomized controlled trial to evaluate the efficacy of ivermectin in reducing the risk of progression to severe disease and hospitalizations in COVID-19 patients.

This is a randomized controlled trial to evaluate the efficacy of ivermectin in COVID-19 outpatients reducing the risk of progression to severe disease. Patients with COVID-19 infection are randomized to receive a single dose of 200mcg/kg of ivermectin or a placebo. The randomization code is generated by the trial statistician. The allocation is made after fulfilment of both inclusion and exclusion criteria.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

400

Conditions

Covid19 Coronavirus Infection

Interventions

Ivermectin TabletsDRUG

Oral ivermectin at a one time dose

PlaceboOTHER

Oral placebo at a one time dose

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Positive diagnostic RT-qPCR or antigen test for SARS-CoV-2 * Symptomatic patients with up to 8 days from the onset of symptoms, and asymptomatic cases with up to 5 days of positive test for SARS-CoV-2. * Patients who agree to participate in the study by signing the informed consent. Exclusion Criteria: * Patients with severity criteria defined in the Coronavirus Disease Epidemiological and Laboratory Surveillance Guide (Version 3/11/2020) * Pregnant or breastfeeding women * Women of childbearing age and without commitment to use contraceptive methods during the study time. * Inability to complete the study * Current treatment with drugs known to interact with ivermectin * Known intolerance to ivermectin, its derivate or any of its excipients. * Patients with known Child-Pugh C liver disease * Patients with prior ivermectin consumption in the 10 days prior to study entry.

Locations (1)

Facultad de Ciencias Médicas - Universidad Nacional de Asunción

Asunción, Paraguay

RECRUITING

Outcomes

Primary Outcomes

Proportion of patients with hospitalization criteria

Proportion of patients with hospitalization criteria at day 30

Time frame: 30 days

Secondary Outcomes

Proportion of patients with COVID-19 signs and symptoms

Proportion of patients with COVID-19 signs and symptoms up to day 14

Time frame: 14 days

Proportion of cohabitants who had COVID-19 after the index case

Proportion of cohabitants who had COVID-19 after the index case up to day 30

Time frame: 30 days

Drug-related adverse events

Proportion of patients with ivermectin adverse events up to day 30

Time frame: 30 days

Levels of IgG for SARS-CoV-2

Quantitative levels of IgG for SARS-CoV-2 measured by ELISA immunoassay

Time frame: 30-60 days

Central Contacts

Gabriela Avila, MD, MSc, PhD

CONTACT

+59521683930 mavila@med.una.py

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.