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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-11-17

Study Completion Date

2021-05-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Covid19 Coronavirus Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This is a double blind, randomized controlled trial with two parallel groups that evaluates the efficacy of ivermectin in reducing hospitalization in outpatients with COVID-19.

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Triple (Participant, Investigator, Outcomes Assessor)

Study Groups

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Ivermectin

Ivermectin 200mcg/kg single dose, maximum dose 18mg

Group Type EXPERIMENTAL

Ivermectin Tablets

Intervention Type DRUG

Oral ivermectin at a one time dose

Placebo

Inactive medication tablets indistinguishable from ivermectin tablets

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Oral placebo at a one time dose

Interventions

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Ivermectin Tablets

Oral ivermectin at a one time dose

Intervention Type DRUG

Placebo

Oral placebo at a one time dose

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No