Back to resultsIvermectin vs. Placebo for the Treatment of Patients With Mild to Moderate COVID-19
Primary Purpose
COVID-19
Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Ivermectin Oral Product
Sponsored by
About this trial
This is an interventional treatment trial for COVID-19
Eligibility Criteria
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.
Sites / Locations
- Sheba Medical CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Active Comparator
Arm Label
IVERMECTIN
PLACEBO
Arm Description
Outcomes
Primary Outcome Measures
Viral clearance at day 6
The primary outcome will be the viral clearance at day 6 in the intervention group compared to placebo.
Viral shedding duration
Secondary outcomes: viral shedding duration (time between first positive PCR to last of two consecutive negative tests)
Symptoms clearance time
Time between drug treatment and symptoms resolution
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04429711
Brief Title
Ivermectin vs. Placebo for the Treatment of Patients With Mild to Moderate COVID-19
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2020
Overall Recruitment Status
Unknown status
Study Start Date
May 12, 2020 (Actual)
Primary Completion Date
September 30, 2020 (Anticipated)
Study Completion Date
October 31, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sheba Medical Center
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Double blind randomized
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
IVERMECTIN
Arm Type
Placebo Comparator
Arm Title
PLACEBO
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Ivermectin Oral Product
Intervention Description
3mg Capsules, 12-15mg/ day for 3 days
Primary Outcome Measure Information:
Title
Viral clearance at day 6
Description
The primary outcome will be the viral clearance at day 6 in the intervention group compared to placebo.
Time Frame
Outcome will be determined till 6 days post intervention
Title
Viral shedding duration
Description
Secondary outcomes: viral shedding duration (time between first positive PCR to last of two consecutive negative tests)
Time Frame
Outcome will be determined till 14 days post intervention
Title
Symptoms clearance time
Description
Time between drug treatment and symptoms resolution
Time Frame
Outcome will be determined till 14 days post intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Eli Schwartz, Prof.
Phone
972 3 5308456
Email
Eli.schwartz@sheba.health.gov.il
First Name & Middle Initial & Last Name or Official Title & Degree
Asaf Biber, Dr.
Phone
972 50 7339184
Email
Asaf.Biber@sheba.health.gov.il
Facility Information:
Facility Name
Sheba Medical Center
City
Ramat-Gan
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eli Schwartz, M.D
Phone
+972-35308456
Email
Eli.schwartz@sheba.health.gov.il
12. IPD Sharing Statement
Learn more about this trial
Ivermectin vs. Placebo for the Treatment of Patients With Mild to Moderate COVID-19
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