Efficacy, Safety and Tolerability of Ivermectin in Subjects Infected With SARS-CoV-2 With or Without Symptoms

Plain-language summary

This study evaluated the efficacy, safety and tolerability of the drug Ivermectin compared with placebo in people infected with SARS-CoV-2 (the novel coronavirus) who were asymptomatic or had mild symptoms. Adults receiving outpatient care and without severe COVID-19 were eligible. The study was conducted in Phase 2 and has been completed.

The summary above is a plain-language rendering of the official record. The original English title is shown for reference.

Trial details

Phase

Phase 2

Status

Completed

Sponsor

Investigacion Biomedica para el Desarrollo de Farmacos S.A. de C.V.

Intervention

Ivermectin, Placebo

Start date

7/1/2020

Estimated completion

1/29/2021

Countries

Mexico

Related genes

Locations

• Zapopan, Mexico

Eligibility criteria

Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.

Inclusion Criteria:

* Diagnosis of acute severe respiratory syndrome due to SARS-CoV-12 coronavirus infection defined by RT-PCR.
* Asymptomatic, or with mild symptoms who are taking outpatient treatment of the disease.
* Signed Informed Consent.

Exclusion Criteria:

1. Patients with severe disease COVID-19.
2. Positive to proof of infection by some other virus such as influenza H1N1, SARS, etc.
3. Recurrent urinary tract infections.
4. Alanine Aminotransferase (ALT) or Aspartate Aminotransferase (AST)\> 5 times above its normal limits.
5. Pregnant or lactating patients
6. Patients receiving antihypertensive medication verapamil, the immunosuppressant cyclosporin A and / or the antipsychotic trifluoperazine.
7. Patients with a known allergy or hypersensitivity to dewormers.
8. Patients who are using an antioxidant supplement.
9. Patients with a history of filariasis, strongyloidiasis, scabies, river blindness, or any parasitic disease in the last twelve months.