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

Primary Purpose

COVID-19

Status
Completed
Phase
Phase 2
Locations
Colombia
Study Type
Interventional
Intervention
Ivermectin Oral Product
Placebo
Sponsored by
Centro de Estudios en Infectogía Pediatrica
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for COVID-19

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Centro de Estudios en Infectología Pediátrica

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Ivermectin

Placebo

Arm Description

Ivermectin, 300 micrograms / kg, once daily for 5 days

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

Outcomes

Primary Outcome Measures

Time to event
Time until resolution of symptoms

Secondary Outcome Measures

Clinical condition on day 2
Clinical condition in an ordinal scale of 7 points, on day 2. Higher scores indicate worse outcomes
Clinical condition on day 5
Clinical condition in an ordinal scale of 7 points, on day 5. Higher scores indicate worse outcomes
Clinical condition on day 8
Clinical condition in an ordinal scale of 7 points, on day 8. Higher scores indicate worse outcomes
Clinical condition on day 11
Clinical condition in an ordinal scale of 7 points, on day 11. Higher scores indicate worse outcomes
Clinical condition on day 15
Clinical condition in an ordinal scale of 7 points, on day 15. Higher scores indicate worse outcomes
Clinical condition on day 21
Clinical condition in an ordinal scale of 7 points, on day 21. Higher scores indicate worse outcomes
Proportion of subjects with additional care
Proportion of subjects who require hospitalization, use of supplementary oxygen for >24 hours or ICU admission
Proportion of subjects who die
Proportion of subjects who die
Duration of additional care
Duration of supplementary oxygen, hospitalization, ICU stay
Adverse events
Proportion of subjects who develop solicited adverse events
Proportion of subjects who discontinue intervention
Proportion of subjects who required discontinuation of the intervention due to adverse events
Time to event
Time until deterioration of 2 or more points in an ordinal 7 points scale.
Duration of fever
Number of days with fever since randomization

Full Information

First Posted
May 23, 2020
Last Updated
December 24, 2020
Sponsor
Centro de Estudios en Infectogía Pediatrica
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1. Study Identification

Unique Protocol Identification Number
NCT04405843
Brief Title
Efficacy of Ivermectin in Adult Patients With Early Stages of COVID-19 (EPIC Trial)
Acronym
EPIC
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

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
July 14, 2020 (Actual)
Primary Completion Date
December 21, 2020 (Actual)
Study Completion Date
December 21, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centro de Estudios en Infectogía Pediatrica

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
476 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ivermectin
Arm Type
Experimental
Arm Description
Ivermectin, 300 micrograms / kg, once daily for 5 days
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Substance with similar physical and organoleptic characteristics as ivermectin, without the active drug ingredient
Intervention Type
Drug
Intervention Name(s)
Ivermectin Oral Product
Intervention Description
Ivermectin oral suspension, 6 mg/mL
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Substance with similar physical and organoleptic characteristics as ivermectin, without the active drug ingredient
Primary Outcome Measure Information:
Title
Time to event
Description
Time until resolution of symptoms
Time Frame
21 days
Secondary Outcome Measure Information:
Title
Clinical condition on day 2
Description
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
Title
Clinical condition on day 5
Description
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
Title
Clinical condition on day 8
Description
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
Title
Clinical condition on day 11
Description
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
Title
Clinical condition on day 15
Description
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
Title
Clinical condition on day 21
Description
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
Title
Proportion of subjects with additional care
Description
Proportion of subjects who require hospitalization, use of supplementary oxygen for >24 hours or ICU admission
Time Frame
21 days
Title
Proportion of subjects who die
Description
Proportion of subjects who die
Time Frame
From randomization up to 21 days
Title
Duration of additional care
Description
Duration of supplementary oxygen, hospitalization, ICU stay
Time Frame
21 days
Title
Adverse events
Description
Proportion of subjects who develop solicited adverse events
Time Frame
21 days
Title
Proportion of subjects who discontinue intervention
Description
Proportion of subjects who required discontinuation of the intervention due to adverse events
Time Frame
21 days
Title
Time to event
Description
Time until deterioration of 2 or more points in an ordinal 7 points scale.
Time Frame
21 days
Title
Duration of fever
Description
Number of days with fever since randomization
Time Frame
21 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eduardo López-Medina, MD MSc
Organizational Affiliation
Scientific Director of Centro de Estudios en Infectología Pediátrica --CEIP--
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centro de Estudios en Infectología Pediátrica
City
Cali
State/Province
Valle
ZIP/Postal Code
12345
Country
Colombia

12. IPD Sharing Statement

Plan to Share IPD
Yes
Citations:
PubMed Identifier
33662102
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.
Results Reference
derived

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

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