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Efficacy of Ivermectin in Adult Patients With Early Stages of COVID-19

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04405843
Recruitment Status : Not yet recruiting
First Posted : May 28, 2020
Last Update Posted : May 28, 2020
Sponsor:
Information provided by (Responsible Party):
Centro de Estudios en Infectogía Pediatrica

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 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 Cali, Colombia With Early Stages of SARS COV2 / COVID-19
Estimated Study Start Date : June 2020
Estimated Primary Completion Date : October 2020
Estimated Study Completion Date : November 1, 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Ivermectin

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
5% Dextrose in water
Drug: Placebo
5% Dextrose in water




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


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 28 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 trial due to adverse events



Information from the National Library of Medicine

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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 in a Colombian NIH-approved laboratory
  • Beginning of symptoms in the past 7 days
  • Mild disease
  • Informed consetn

Exclusion Criteria:

  • Preexisting liver disease
  • Hypersensitivity to ivermectin
  • Participants in other clinical trials for therapies against COVID-19
  • Severe pneumonia
  • Pregnancy
  • Concomitant use of warfarin, erdafitinib or quinidine
  • Use of ivermectin in the 48 hours prior to randomization
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Responsible Party: Centro de Estudios en Infectogía Pediatrica
ClinicalTrials.gov Identifier: NCT04405843    
Other Study ID Numbers: ScDi823
First Posted: May 28, 2020    Key Record Dates
Last Update Posted: May 28, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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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Ivermectin
Antiparasitic Agents
Anti-Infective Agents