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

Sheba Medical Center

Status: Unknown

Conditions: COVID-19

Treatments: Drug: Ivermectin Oral Product

Study type: Interventional

Funder types: Other

Identifiers

NCT04429711

SHEBA-20-7156-ES-CTIL

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

100 participants in 2 patient groups, including a placebo group

IVERMECTIN

Placebo Comparator group

Treatment:

Drug: Ivermectin Oral Product

PLACEBO

Active Comparator group

Treatment:

Drug: Ivermectin Oral Product