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

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ClinicalTrials.gov Identifier: NCT04405843
Recruitment Status : Completed
First Posted : May 28, 2020
Last Update Posted : December 28, 2020
Sponsor:
Information provided by (Responsible Party):
Centro de Estudios en Infectogía Pediatrica

Tracking Information
First Submitted Date  ICMJE May 23, 2020
First Posted Date  ICMJE May 28, 2020
Last Update Posted Date December 28, 2020
Actual Study Start Date  ICMJE July 14, 2020
Actual Primary Completion Date December 21, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 12, 2020)
Time to event [ Time Frame: 21 days ]
Time until resolution of symptoms
Original Primary Outcome Measures  ICMJE
 (submitted: May 26, 2020)
Time to event [ Time Frame: 21 days ]
Time until deterioration of 2 or more points in an ordinal 7 points scale.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 1, 2020)
  • Clinical condition on day 2 [ Time Frame: On day 2 (± 1 day) after randomization ]
    Clinical condition in an ordinal scale of 7 points, on day 2. Higher scores indicate worse outcomes
  • Clinical condition on day 5 [ Time Frame: On day 5 (± 1 day) after randomization ]
    Clinical condition in an ordinal scale of 7 points, on day 5. Higher scores indicate worse outcomes
  • Clinical condition on day 8 [ Time Frame: On day 8 (± 1 day) after randomization ]
    Clinical condition in an ordinal scale of 7 points, on day 8. Higher scores indicate worse outcomes
  • Clinical condition on day 11 [ Time Frame: On day 11 (± 1 day) after randomization ]
    Clinical condition in an ordinal scale of 7 points, on day 11. Higher scores indicate worse outcomes
  • Clinical condition on day 15 [ Time Frame: On day 15 (± 1 day) after randomization ]
    Clinical condition in an ordinal scale of 7 points, on day 15. Higher scores indicate worse outcomes
  • Clinical condition on day 21 [ Time Frame: On day 21 (± 1 day) after randomization ]
    Clinical condition in an ordinal scale of 7 points, on day 21. Higher scores indicate worse outcomes
  • Proportion of subjects with additional care [ Time Frame: 21 days ]
    Proportion of subjects who require hospitalization, use of supplementary oxygen for >24 hours or ICU admission
  • Proportion of subjects who die [ Time Frame: From randomization up to 21 days ]
    Proportion of subjects who die
  • Duration of additional care [ Time Frame: 21 days ]
    Duration of supplementary oxygen, hospitalization, ICU stay
  • Adverse events [ Time Frame: 21 days ]
    Proportion of subjects who develop solicited adverse events
  • Proportion of subjects who discontinue intervention [ Time Frame: 21 days ]
    Proportion of subjects who required discontinuation of the intervention due to adverse events
  • Time to event [ Time Frame: 21 days ]
    Time until deterioration of 2 or more points in an ordinal 7 points scale.
  • Duration of fever [ Time Frame: 21 days ]
    Number of days with fever since randomization
Original Secondary Outcome Measures  ICMJE
 (submitted: May 26, 2020)
  • Clinical condition on day 2 [ Time Frame: On day 2 (± 1 day) after randomization ]
    Clinical condition in an ordinal scale of 7 points, on day 2. Higher scores indicate worse outcomes
  • Clinical condition on day 5 [ Time Frame: On day 5 (± 1 day) after randomization ]
    Clinical condition in an ordinal scale of 7 points, on day 5. Higher scores indicate worse outcomes
  • Clinical condition on day 8 [ Time Frame: On day 8 (± 1 day) after randomization ]
    Clinical condition in an ordinal scale of 7 points, on day 8. Higher scores indicate worse outcomes
  • Clinical condition on day 11 [ Time Frame: On day 11 (± 1 day) after randomization ]
    Clinical condition in an ordinal scale of 7 points, on day 11. Higher scores indicate worse outcomes
  • Clinical condition on day 15 [ Time Frame: On day 15 (± 1 day) after randomization ]
    Clinical condition in an ordinal scale of 7 points, on day 15. Higher scores indicate worse outcomes
  • Clinical condition on day 21 [ Time Frame: On day 21 (± 1 day) after randomization ]
    Clinical condition in an ordinal scale of 7 points, on day 21. Higher scores indicate worse outcomes
  • Proportion of subjects with additional care [ Time Frame: 21 days ]
    Proportion of subjects who require hospitalization, use of supplementary oxygen for >24 hours or ICU admission
  • Proportion of subjects who die [ Time Frame: From randomization up to 28 days ]
    Proportion of subjects who die
  • Duration of additional care [ Time Frame: 21 days ]
    Duration of supplementary oxygen, hospitalization, ICU stay
  • Adverse events [ Time Frame: 21 days ]
    Proportion of subjects who develop solicited adverse events
  • Proportion of subjects who discontinue intervention [ Time Frame: 21 days ]
    Proportion of subjects who required discontinuation of the trial due to adverse events
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy of Ivermectin in Adult Patients With Early Stages of COVID-19 (EPIC Trial)
Official Title  ICMJE 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
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
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE COVID-19
Intervention  ICMJE
  • Drug: Ivermectin Oral Product
    Ivermectin oral suspension, 6 mg/mL
  • Drug: Placebo
    Substance with similar physical and organoleptic characteristics as ivermectin, without the active drug ingredient
Study Arms  ICMJE
  • Experimental: Ivermectin
    Ivermectin, 300 micrograms / kg, once daily for 5 days
    Intervention: Drug: Ivermectin Oral Product
  • Placebo Comparator: Placebo
    Substance with similar physical and organoleptic characteristics as ivermectin, without the active drug ingredient
    Intervention: Drug: Placebo
Publications * López-Medina E, López P, Hurtado IC, Dávalos DM, Ramirez O, Martínez E, Díazgranados JA, Oñate JM, Chavarriaga H, Herrera S, Parra B, Libreros G, Jaramillo R, Avendaño 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 30, 2020)
476
Original Estimated Enrollment  ICMJE
 (submitted: May 26, 2020)
400
Actual Study Completion Date  ICMJE December 21, 2020
Actual Primary Completion Date December 21, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Colombia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04405843
Other Study ID Numbers  ICMJE ScDi823
IVE-PA ( Other Identifier: INVIMA (Colombian Regulatory Agency) )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Informed Consent Form (ICF)
Supporting Materials: Clinical Study Report (CSR)
Supporting Materials: Analytic Code
Responsible Party Centro de Estudios en Infectogía Pediatrica
Study Sponsor  ICMJE Centro de Estudios en Infectogía Pediatrica
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Eduardo López-Medina, MD MSc Scientific Director of Centro de Estudios en Infectología Pediátrica --CEIP--
PRS Account Centro de Estudios en Infectogía Pediatrica
Verification Date December 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP