Ivermectin vs. Placebo for the Treatment of Patients With Mild to Moderate COVID-19
1 other identifier
interventional
100
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable covid19
Started May 2020
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 12, 2020
CompletedFirst Submitted
Initial submission to the registry
May 24, 2020
CompletedFirst Posted
Study publicly available on registry
June 12, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
October 31, 2020
CompletedJune 16, 2020
June 1, 2020
5 months
May 24, 2020
June 14, 2020
Conditions
Outcome Measures
Primary Outcomes (3)
Viral clearance at day 6
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
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 between drug treatment and symptoms resolution
Outcome will be determined till 14 days post intervention
Study Arms (2)
IVERMECTIN
PLACEBO COMPARATORPLACEBO
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Sheba Medical Center
Ramat Gan, Israel
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Prinicipal Investigator
Study Record Dates
First Submitted
May 24, 2020
First Posted
June 12, 2020
Study Start
May 12, 2020
Primary Completion
September 30, 2020
Study Completion
October 31, 2020
Last Updated
June 16, 2020
Record last verified: 2020-06