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

• Status: Unknown
• Conditions: COVID-19
• Intervention / Treatment: Drug: Ivermectin Oral Product

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Israel
  • 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: 14 years to 76 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: IVERMECTIN	Drug: Ivermectin Oral Product; 3mg Capsules, 12-15mg/ day for 3 days
Active Comparator: PLACEBO	Drug: Ivermectin Oral Product; 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	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

Collaborators and Investigators

• Sponsor: Sheba Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): May 12, 2020
• Primary Completion (Anticipated): September 30, 2020
• Study Completion (Anticipated): October 31, 2020

Study Registration Dates

• First Submitted: May 24, 2020
• First Submitted That Met QC Criteria: June 11, 2020
• First Posted (Actual): June 12, 2020

Study Record Updates

• Last Update Posted (Actual): June 16, 2020
• Last Update Submitted That Met QC Criteria: June 14, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19; Anti-Infective Agents; Antiparasitic Agents; Ivermectin
• Other Study ID Numbers: SHEBA-20-7156-ES-CTIL

Drug and device information, study documents

• 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