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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Study Description
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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

Condition or disease Intervention/treatment Phase
COVID-19 Drug: Ivermectin Oral Product Drug: Placebo Phase 2 Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 476 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : July 14, 2020
Actual Primary Completion Date : December 21, 2020
Actual Study Completion Date : December 21, 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Ivermectin

Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Time to event [ Time Frame: 21 days ]
    Time until resolution of symptoms


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. Proportion of subjects who die [ Time Frame: From randomization up to 21 days ]
    Proportion of subjects who die

  9. Duration of additional care [ Time Frame: 21 days ]
    Duration of supplementary oxygen, hospitalization, ICU stay

  10. Adverse events [ Time Frame: 21 days ]
    Proportion of subjects who develop solicited adverse events

  11. Proportion of subjects who discontinue intervention [ Time Frame: 21 days ]
    Proportion of subjects who required discontinuation of the intervention due to adverse events

  12. Time to event [ Time Frame: 21 days ]
    Time until deterioration of 2 or more points in an ordinal 7 points scale.

  13. Duration of fever [ Time Frame: 21 days ]
    Number of days with fever since randomization


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04405843


Locations
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Colombia
Centro de Estudios en Infectología Pediátrica
Cali, Valle, Colombia, 12345
Sponsors and Collaborators
Centro de Estudios en Infectogía Pediatrica
Investigators
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Principal Investigator: Eduardo López-Medina, MD MSc Scientific Director of Centro de Estudios en Infectología Pediátrica --CEIP--
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Centro de Estudios en Infectogía Pediatrica
ClinicalTrials.gov Identifier: NCT04405843    
Other Study ID Numbers: ScDi823
IVE-PA ( Other Identifier: INVIMA (Colombian Regulatory Agency) )
First Posted: May 28, 2020    Key Record Dates
Last Update Posted: December 28, 2020
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
 Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Ivermectin
Antiparasitic Agents
Anti-Infective Agents