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

COVID-19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04429711
• Other study ID #: SHEBA-20-7156-ES-CTIL
• Status: Recruiting
• Phase: N/A
• Start date: May 12, 2020
• Est. completion date: October 31, 2020

Study information

• Verified date: June 2020
• Source: Sheba Medical Center
• Contact: Eli Schwartz, Prof.
• Phone: 972 3 5308456
• Email: Eli.schwartz[@]sheba.health.gov.il
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: October 31, 2020
• Est. primary completion date: September 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19

Intervention

Drug:
• Ivermectin Oral Product
3mg Capsules, 12-15mg/ day for 3 days

Locations

Country	Name	City	State
Israel	Sheba Medical Center	Ramat-Gan

Sponsors (1)

Lead Sponsor	Collaborator
Sheba Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Symptoms clearance time	Time between drug treatment and symptoms resolution	Outcome will be determined till 14 days post intervention