NCT04405843
Completed
Phase 2
Randomized, Placebo Controlled, Double Blind Clinical Trial to Evaluate the Efficacy of Molecule D11AX22 in Adults Patients From Valle Del Cauca, Colombia With Early Stages of SARS COV2 / COVID-19
Centro de Estudios en Infectogía Pediatrica1 site in 1 country476 target enrollmentJuly 14, 2020
Overview
- Phase
- Phase 2
- Intervention
- Ivermectin Oral Product
- Conditions
- COVID-19
- Sponsor
- Centro de Estudios en Infectogía Pediatrica
- Enrollment
- 476
- Locations
- 1
- Primary Endpoint
- Time to event
- Status
- Completed
- Last Updated
- 5 years ago
Overview
Brief Summary
Double blind, placebo controlled, randomized clinical trial to evaluate the efficacy of ivermectin in preventing progression of disease in adult patients with early stages of COVID-19
Investigators
Eligibility Criteria
Inclusion Criteria
- •At least 18 years of age
- •Confirmed SARS-CoV-2 by RT-PCR or antigen detection in a Colombian NIH-approved laboratory
- •Beginning of symptoms in the past 7 days
- •Mild disease
- •Informed consent
Exclusion Criteria
- •Preexisting liver disease
- •Hypersensitivity to ivermectin
- •Participants in other clinical trials for therapies against COVID-19
- •Severe pneumonia
- •Pregnant or breastfeeding women
- •Concomitant use of warfarin, erdafitinib or quinidine
- •Use of ivermectin in the 5 days prior to randomization
- •Inability to obtain a blood sample needed to assess liver transaminases
- •Elevation of transaminases \>1.5 times the normal level
- •Participant whose first contact with the study personnel occurs between days 5 and 7 and at that time manifests significant and progressive resolution of COVID-19 related signs and symptoms
Arms & Interventions
Ivermectin
Ivermectin, 300 micrograms / kg, once daily for 5 days
Intervention: Ivermectin Oral Product
Placebo
Substance with similar physical and organoleptic characteristics as ivermectin, without the active drug ingredient
Intervention: Placebo
Outcomes
Primary Outcomes
Time to event
Time Frame: 21 days
Time until resolution of symptoms
Secondary Outcomes
- Clinical condition on day 5(On day 5 (± 1 day) after randomization)
- Proportion of subjects who discontinue intervention(21 days)
- Time to event(21 days)
- Duration of fever(21 days)
- Clinical condition on day 2(On day 2 (± 1 day) after randomization)
- Clinical condition on day 8(On day 8 (± 1 day) after randomization)
- Clinical condition on day 11(On day 11 (± 1 day) after randomization)
- Clinical condition on day 15(On day 15 (± 1 day) after randomization)
- Clinical condition on day 21(On day 21 (± 1 day) after randomization)
- Proportion of subjects with additional care(21 days)
- Proportion of subjects who die(From randomization up to 21 days)
- Duration of additional care(21 days)
- Adverse events(21 days)
Study Sites (1)
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