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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04429711

Enrollment

100

Registered

2020-06-12

Start date

2020-05-12

Completion date

2020-10-31

Last updated

2020-06-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COVID-19

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.

Interventions

DRUGIvermectin Oral Product

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Intervention model description

Double blind randomized

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Countries

Israel

Contacts

Primary ContactEli Schwartz, Prof.

Eli.schwartz@sheba.health.gov.il972 3 5308456

Backup ContactAsaf Biber, Dr.

Asaf.Biber@sheba.health.gov.il972 50 7339184

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026