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Ivermectin vs. Placebo for the Treatment of Patients With Mild to Moderate 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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04429711
Recruitment Status : Unknown
Verified June 2020 by Prof. Eli Schwartz MD, DTMH, Sheba Medical Center.
Recruitment status was:  Recruiting
First Posted : June 12, 2020
Last Update Posted : June 16, 2020
Sponsor:
Information provided by (Responsible Party):
Prof. Eli Schwartz MD, DTMH, Sheba Medical Center

Tracking Information
First Submitted Date  ICMJE May 24, 2020
First Posted Date  ICMJE June 12, 2020
Last Update Posted Date June 16, 2020
Actual Study Start Date  ICMJE May 12, 2020
Estimated Primary Completion Date September 30, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 11, 2020)
  • Viral clearance at day 6 [ Time Frame: Outcome will be determined till 6 days post intervention ]
    The primary outcome will be the viral clearance at day 6 in the intervention group compared to placebo.
  • Viral shedding duration [ Time Frame: Outcome will be determined till 14 days post intervention ]
    Secondary outcomes: viral shedding duration (time between first positive PCR to last of two consecutive negative tests)
  • Symptoms clearance time [ Time Frame: Outcome will be determined till 14 days post intervention ]
    Time between drug treatment and symptoms resolution
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Ivermectin vs. Placebo for the Treatment of Patients With Mild to Moderate COVID-19
Official Title  ICMJE Ivermectin vs. Placebo for the Treatment of Patients With Mild to Moderate COVID-19 to Prevent Progression to Severe Infection and to Decrease Viral Shedding - A Double Blind , Randomized Controlled Trial
Brief Summary

Ivermectin which is an FDA-approved broad spectrum anti-parasitic agent, has also anti-viral activity. In vitro study have shown its activity against SARS-CoV-2, however its clinical effect on patients with COVID-19 never been tested.

In this RCT we would like to evaluate the effect of Ivermectin on reduction of viral shedding among mild to moderate COVID-19 patients, and in shortening the symptom resolution time.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Double blind randomized
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE COVID-19
Intervention  ICMJE Drug: Ivermectin Oral Product
3mg Capsules, 12-15mg/ day for 3 days
Study Arms  ICMJE
  • Placebo Comparator: IVERMECTIN
    Intervention: Drug: Ivermectin Oral Product
  • Active Comparator: PLACEBO
    Intervention: Drug: Ivermectin Oral Product
Publications * Not Provided

*   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 Unknown status
Estimated Enrollment  ICMJE
 (submitted: June 11, 2020)
100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 31, 2020
Estimated Primary Completion Date September 30, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

Participants eligible for inclusion will include non-pregnant adult (>18 years old) with molecular confirmation of COVID-19. [Participants will be eligible in a period of no longer than 72 hours after exposure].

Exclusion Criteria:

  • Severe infection ( defined as need for invasive or non-invasive ventilator support, ECMO or shock requiring vasopressor support).
  • Weight below 40Kg or above 100Kg
  • Unable to take oral medication
  • Known allergy to the drugs
  • Pregnancy or breast feeding
  • Participating in another RCT for treatment of COVID-19.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (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 Israel
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04429711
Other Study ID Numbers  ICMJE SHEBA-20-7156-ES-CTIL
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Prof. Eli Schwartz MD, DTMH, Sheba Medical Center
Original Responsible Party Prof. Eli Schwartz MD, DTMH, Sheba Medical Center, The Institute of Tropical Medicine Secondary IDs:
Current Study Sponsor  ICMJE Sheba Medical Center
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Sheba Medical Center
Verification Date June 2020

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