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

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

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 Overview

• Status: Completed
• Conditions: COVID-19
• Intervention / Treatment: Drug: Ivermectin Oral Product; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 476
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Colombia
  • Valle
    • Cali, Valle, Colombia, 12345
      • Centro de Estudios en Infectología Pediátrica

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Ivermectin; Ivermectin, 300 micrograms / kg, once daily for 5 days	Drug: Ivermectin Oral Product; Ivermectin oral suspension, 6 mg/mL
PLACEBO_COMPARATOR: Placebo; Substance with similar physical and organoleptic characteristics as ivermectin, without the active drug ingredient	Drug: Placebo; Substance with similar physical and organoleptic characteristics as ivermectin, without the active drug ingredient

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to event	Time until resolution of symptoms	21 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical condition on day 2	Clinical condition in an ordinal scale of 7 points, on day 2. Higher scores indicate worse outcomes	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	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	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	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	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	On day 21 (± 1 day) after randomization
Proportion of subjects with additional care	Proportion of subjects who require hospitalization, use of supplementary oxygen for >24 hours or ICU admission	21 days
Proportion of subjects who die	Proportion of subjects who die	From randomization up to 21 days
Duration of additional care	Duration of supplementary oxygen, hospitalization, ICU stay	21 days
Adverse events	Proportion of subjects who develop solicited adverse events	21 days
Proportion of subjects who discontinue intervention	Proportion of subjects who required discontinuation of the intervention due to adverse events	21 days
Time to event	Time until deterioration of 2 or more points in an ordinal 7 points scale.	21 days
Duration of fever	Number of days with fever since randomization	21 days

Collaborators and Investigators

• Sponsor: Centro de Estudios en Infectogía Pediatrica
• Investigators: Principal Investigator: Eduardo López-Medina, MD MSc, Scientific Director of Centro de Estudios en Infectología Pediátrica --CEIP--

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 14, 2020
• Primary Completion (ACTUAL): December 21, 2020
• Study Completion (ACTUAL): December 21, 2020

Study Registration Dates

• First Submitted: May 23, 2020
• First Submitted That Met QC Criteria: May 26, 2020
• First Posted (ACTUAL): May 28, 2020

Study Record Updates

• Last Update Posted (ACTUAL): December 28, 2020
• Last Update Submitted That Met QC Criteria: December 24, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19; Anti-Infective Agents; Antiparasitic Agents; Ivermectin
• Other Study ID Numbers: ScDi823; IVE-PA (OTHER: INVIMA (Colombian Regulatory Agency))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No