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

Centro de Estudios en Infectogía Pediatrica476 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

476

Conditions

COVID-19

Interventions

Ivermectin Oral ProductDRUG

Ivermectin oral suspension, 6 mg/mL

PlaceboDRUG

Substance with similar physical and organoleptic characteristics as ivermectin, without the active drug ingredient

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Centro de Estudios en Infectología Pediátrica

Cali, Valle del Cauca Department, Colombia

Outcomes

Primary Outcomes

Time to event

Time until resolution of symptoms

Time frame: 21 days

Secondary Outcomes

Clinical condition on day 2

Clinical condition in an ordinal scale of 7 points, on day 2. Higher scores indicate worse outcomes

Time frame: On day 2 (± 1 day) after randomization

Clinical condition on day 5

Clinical condition in an ordinal scale of 7 points, on day 5. Higher scores indicate worse outcomes

Time frame: On day 5 (± 1 day) after randomization

Clinical condition on day 8

Clinical condition in an ordinal scale of 7 points, on day 8. Higher scores indicate worse outcomes

Time frame: On day 8 (± 1 day) after randomization

Clinical condition on day 11

Clinical condition in an ordinal scale of 7 points, on day 11. Higher scores indicate worse outcomes

Time frame: On day 11 (± 1 day) after randomization

Clinical condition on day 15

Clinical condition in an ordinal scale of 7 points, on day 15. Higher scores indicate worse outcomes

Time frame: On day 15 (± 1 day) after randomization

Clinical condition on day 21

Clinical condition in an ordinal scale of 7 points, on day 21. Higher scores indicate worse outcomes

Time frame: On day 21 (± 1 day) after randomization

Proportion of subjects with additional care

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.