Status:
COMPLETED
Efficacy of Ivermectin in Adult Patients With Early Stages of COVID-19 (EPIC Trial)
Lead Sponsor:
Centro de Estudios en Infectogía Pediatrica
Conditions:
COVID-19
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
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
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 14 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 21 2020
Estimated Enrollment :
476 Patients enrolled
Trial Details
Trial ID
NCT04405843
Start Date
July 14 2020
End Date
December 21 2020
Last Update
December 28 2020
Active Locations (1)
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1
Centro de Estudios en Infectología Pediátrica
Cali, Valle del Cauca Department, Colombia, 12345