Phase 2
N=66
Efficacy, Safety and Tolerability of Ivermectin in Subjects Infected With SARS-CoV-2 With or Without Symptoms
COVID-19
Bottom Line
View on ClinicalTrials.gov: NCT04407507 ↗Enrolled (actual)
66
Serious AEs
1.5%
Results posted
May 2021
Primary outcome: Primary: Participants With a Disease Control Status Defined as no Disease Progression to Severe. — 30; 26 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Ivermectin (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Investigacion Biomedica para el Desarrollo de Farmacos S.A. de C.V.
- Primary completion
- Jan 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Participants With a Disease Control Status Defined as no Disease Progression to Severe. |
30; 26 | — |
| SECONDARY SARS-CoV-2 Viral Load, at 5 and 14 Days |
26.17; 23.3; 30.52; 28.5; 33.74; 32.94 | — |
| SECONDARY Presence and Frequency of Symptoms Associated With the COVID-19 Disease |
7.67; 5.44; 51.7; 34.1; 29.5; 24.6 | — |
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.
Eligibility 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
- Patients with severe disease COVID-19.
- Positive to proof of infection by some other virus such as influenza H1N1, SARS, etc.
- Recurrent urinary tract infections.
- Alanine Aminotransferase (ALT) or Aspartate Aminotransferase (AST)> 5 times above its normal limits.
- Pregnant or lactating patients
- Patients receiving antihypertensive medication verapamil, the immunosuppressant cyclosporin A and / or the antipsychotic trifluoperazine.
- Patients with a known allergy or hypersensitivity to dewormers.
- Patients who are using an antioxidant supplement.
- Patients with a history of filariasis, strongyloidiasis, scabies, river blindness, or any parasitic disease in the last twelve months.
Data sourced from ClinicalTrials.gov (NCT04407507). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.