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

Phase 3

• Conditions: Coronavirus Infection; Covid19
• Interventions: Drug: Ivermectin Tablets; Other: Placebo

• Registration Number: NCT04834115
• Lead Sponsor: Universidad Nacional de Asunción

Brief Summary

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.

Detailed Description

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 Timeline

• Study Start: 2020-11-17
• Study First Submitted: 2021-03-28
• Status Verified: 2021-04
• Study First Submitted QC: 2021-04-04
• Last Update Submitted: 2021-04-04
• Study First Posted: 2021-04-06
• Last Update Posted: 2021-04-06
• Primary Completion: 2021-04-30
• Study Completion: 2021-05-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 400

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ivermectin	Ivermectin Tablets	Ivermectin 200mcg/kg single dose, maximum dose 18mg
Placebo	Placebo	Inactive medication tablets indistinguishable from ivermectin tablets

Primary Outcome Measures

Name	Time	Method
Proportion of patients with hospitalization criteria	30 days	Proportion of patients with hospitalization criteria at day 30

Secondary Outcome Measures

Name	Time	Method
Drug-related adverse events	30 days	Proportion of patients with ivermectin adverse events up to day 30
Proportion of patients with COVID-19 signs and symptoms	14 days	Proportion of patients with COVID-19 signs and symptoms up to day 14
Proportion of cohabitants who had COVID-19 after the index case	30 days	Proportion of cohabitants who had COVID-19 after the index case up to day 30
Levels of IgG for SARS-CoV-2	30-60 days	Quantitative levels of IgG for SARS-CoV-2 measured by ELISA immunoassay

Trial Locations

Locations (1)

Facultad de Ciencias Médicas - Universidad Nacional de Asunción; 🇵🇾 Asunción, Paraguay