Efficacy of Ivermectin in Adult Patients With Early Stages of COVID-19 (EPIC Trial)
NCT ID: NCT04405843
Last Updated: 2020-12-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2/PHASE3
476 participants
INTERVENTIONAL
2020-07-14
2020-12-21
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Ivermectin
Ivermectin, 300 micrograms / kg, once daily for 5 days
Ivermectin Oral Product
Ivermectin oral suspension, 6 mg/mL
Placebo
Substance with similar physical and organoleptic characteristics as ivermectin, without the active drug ingredient
Placebo
Substance with similar physical and organoleptic characteristics as ivermectin, without the active drug ingredient
Interventions
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Ivermectin Oral Product
Ivermectin oral suspension, 6 mg/mL
Placebo
Substance with similar physical and organoleptic characteristics as ivermectin, without the active drug ingredient
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Centro de Estudios en Infectogía Pediatrica
OTHER
Responsible Party
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Principal Investigators
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Eduardo López-Medina, MD MSc
Role: PRINCIPAL_INVESTIGATOR
Scientific Director of Centro de Estudios en Infectología Pediátrica --CEIP--
Locations
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Centro de Estudios en Infectología Pediátrica
Cali, Valle del Cauca Department, Colombia
Countries
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References
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Lopez-Medina E, Lopez P, Hurtado IC, Davalos DM, Ramirez O, Martinez E, Diazgranados JA, Onate JM, Chavarriaga H, Herrera S, Parra B, Libreros G, Jaramillo R, Avendano AC, Toro DF, Torres M, Lesmes MC, Rios CA, Caicedo I. Effect of Ivermectin on Time to Resolution of Symptoms Among Adults With Mild COVID-19: A Randomized Clinical Trial. JAMA. 2021 Apr 13;325(14):1426-1435. doi: 10.1001/jama.2021.3071.
Other Identifiers
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IVE-PA
Identifier Type: OTHER
Identifier Source: secondary_id
ScDi823
Identifier Type: -
Identifier Source: org_study_id