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

NCT ID: NCT04429711

Last Updated: 2020-06-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-05-12

Study Completion Date

2020-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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COVID-19

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Double blind randomized
Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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IVERMECTIN

Group Type PLACEBO_COMPARATOR

Ivermectin Oral Product

Intervention Type DRUG

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

PLACEBO

Group Type ACTIVE_COMPARATOR

Ivermectin Oral Product

Intervention Type DRUG

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

Interventions

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Ivermectin Oral Product

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

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sheba Medical Center

OTHER_GOV

Sponsor Role lead

Responsible Party

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Prof. Eli Schwartz MD, DTMH

Prinicipal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Sheba Medical Center

Ramat Gan, , Israel

Site Status RECRUITING

Countries

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Israel

Central Contacts

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Eli Schwartz, Prof.

Role: CONTACT

972 3 5308456

Asaf Biber, Dr.

Role: CONTACT

972 50 7339184

Facility Contacts

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Eli Schwartz, M.D

Role: primary

+972-35308456

Other Identifiers

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SHEBA-20-7156-ES-CTIL

Identifier Type: -

Identifier Source: org_study_id

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