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

Universidad Nacional de Asunción

Status and phase: Unknown; Phase 3

Conditions: Covid19; Coronavirus Infection

Treatments: Drug: Ivermectin Tablets; Other: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT04834115

PINV20-387

Details and patient eligibility

About

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.

Full 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.

Enrollment: 400 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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400 participants in 2 patient groups, including a placebo group

Ivermectin

Experimental group

Description:

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

Treatment:

Drug: Ivermectin Tablets

Placebo

Placebo Comparator group

Description:

Inactive medication tablets indistinguishable from ivermectin tablets

Treatment:

Other: Placebo