Efficacy of Ivermectin in Adult Patients With Early Stages of COVID-19 (EPIC Trial)

Centro de Estudios en Infectogía Pediatrica

Status and phase

Completed

Phase 3

Phase 2

Conditions

COVID-19

Treatments

Drug: Placebo

Drug: Ivermectin Oral Product

Study type

Interventional

Funder types

Other

Identifiers

NCT04405843

ScDi823

IVE-PA (Other Identifier)

Details and patient eligibility

About

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

Enrollment

476 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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