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

Sheba Medical Center100 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

100

Conditions

COVID-19

Interventions

Ivermectin Oral ProductDRUG

3mg Capsules, 12-15mg/ day for 3 days

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Locations (1)

Sheba Medical Center

Ramat Gan, Israel

RECRUITING

Outcomes

Primary Outcomes

Viral clearance at day 6

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

Viral shedding duration

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

Symptoms clearance time

Time between drug treatment and symptoms resolution

Time frame: Outcome will be determined till 14 days post intervention

Central Contacts

Eli Schwartz, Prof.

CONTACT

972 3 5308456 Eli.schwartz@sheba.health.gov.il

Asaf Biber, Dr.

CONTACT

972 50 7339184 Asaf.Biber@sheba.health.gov.il

Data from ClinicalTrials.gov

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