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

• Status: Completed
• Trial end date: 2021-01-29
• Target enrollment: 0
• Participant gender: All

Summary

This study aims to evaluate the efficacy, safety and tolerability of Ivermectin in patients with mild SARS-CoV-2 infection, in the rate of progression to severe 2019 novel coronavirus disease (COVID-19).

The primary efficacy endpoint is the proportion of participants with a disease control status defined as no progression of severe disease Hypothesis (H0): There is no difference between group A (ivermectin + paracetamol) and group B (ivermectin + paracetamol) in terms of the primary endpoint on day 14.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Investigacion Biomedica para el Desarrollo de Farmacos S.A. de C.V.
• Treatments: Ivermectin

Criteria

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.