Clinical trial NCT04405843: Efficacy of Ivermectin in Adult Patients With Early Stages of COVID-19 (EPIC Trial)
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: COVID-19
Lead sponsor: Centro de Estudios en Infectogía Pediatrica
Sponsor class: OTHER
First posted: 2020-05-28
Enrollment: 476
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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

Primary outcomes:
measure: Time to event
timeFrame: 21 days
Secondary outcomes:
measure: Clinical condition on day 2
timeFrame: On day 2 (± 1 day) after randomization
measure: Clinical condition on day 5
timeFrame: On day 5 (± 1 day) after randomization
measure: Clinical condition on day 8
timeFrame: On day 8 (± 1 day) after randomization
measure: Clinical condition on day 11
timeFrame: On day 11 (± 1 day) after randomization
measure: Clinical condition on day 15
timeFrame: On day 15 (± 1 day) after randomization
measure: Clinical condition on day 21
timeFrame: On day 21 (± 1 day) after randomization
measure: Proportion of subjects with additional care
timeFrame: 21 days
measure: Proportion of subjects who die
timeFrame: From randomization up to 21 days
measure: Duration of additional care
timeFrame: 21 days
measure: Adverse events
timeFrame: 21 days
measure: Proportion of subjects who discontinue intervention
timeFrame: 21 days
measure: Time to event
timeFrame: 21 days
measure: Duration of fever
timeFrame: 21 days
Other outcomes:
Locations:
city: Cali
country: Colombia
facility: Centro de Estudios en Infectología Pediátrica
state: Valle
Study officials:
affiliation: Scientific Director of Centro de Estudios en Infectología Pediátrica --CEIP--
name: Eduardo López-Medina, MD MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.