- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04429711
Ivermectin vs. Placebo for the Treatment of Patients With Mild to Moderate COVID-19
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
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.
Study Overview
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Eli Schwartz, Prof.
- Phone Number: 972 3 5308456
- Email: Eli.schwartz@sheba.health.gov.il
Study Contact Backup
- Name: Asaf Biber, Dr.
- Phone Number: 972 50 7339184
- Email: Asaf.Biber@sheba.health.gov.il
Study Locations
-
-
-
Ramat-Gan, Israel
- Recruiting
- Sheba Medical Center
-
Contact:
- Eli Schwartz, M.D
- Phone Number: +972-35308456
- Email: Eli.schwartz@sheba.health.gov.il
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: IVERMECTIN
|
3mg Capsules, 12-15mg/ day for 3 days
|
Active Comparator: PLACEBO
|
3mg Capsules, 12-15mg/ day for 3 days
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Outcome will be determined till 6 days post intervention
|
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)
|
Outcome will be determined till 14 days post intervention
|
Symptoms clearance time
Time Frame: Outcome will be determined till 14 days post intervention
|
Time between drug treatment and symptoms resolution
|
Outcome will be determined till 14 days post intervention
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SHEBA-20-7156-ES-CTIL
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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