Ivermectin vs. Placebo for the Treatment of Patients With Mild to Moderate COVID-19

Not Applicable

• Conditions: COVID-19
• Interventions: Drug: Ivermectin Oral Product

• Registration Number: NCT04429711
• Lead Sponsor: Sheba Medical Center

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 available

Study Timeline

• Study Start: 2020-05-12
• Study First Submitted: 2020-05-24
• Status Verified: 2020-06
• Study First Submitted QC: 2020-06-11
• Study First Posted: 2020-06-12
• Last Update Submitted: 2020-06-14
• Last Update Posted: 2020-06-16
• Primary Completion: 2020-09-30
• Study Completion: 2020-10-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
IVERMECTIN	Ivermectin Oral Product	-
PLACEBO	Ivermectin Oral Product	-

Primary Outcome Measures

Name	Time	Method
Viral clearance at day 6	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	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	Outcome will be determined till 14 days post intervention	Time between drug treatment and symptoms resolution

Trial Locations

Locations (1)

Sheba Medical Center; 🇮🇱 Ramat-Gan, Israel