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A Study to Evaluate the Efficacy and Safety of Ivermectin in COVID-19 Prevention | Clinical Trials | Clareo Health

COMPLETEDPHASE2

A Study to Evaluate the Efficacy and Safety of Ivermectin in COVID-19 Prevention

A Multicentre Randomised, Double-Blind, Placebo-controlled, Study to Evaluate the efficAcy and Safety of Oral IVErmectin Tablets in the Prevention of COVID-19

NCT05305560•MedinCell S.A

View on ClinicalTrials.gov

Summary

A multicenter, randomized, double-blind, placebo-controlled, study to evaluate the efficacy and safety of oral ivermectin tablets versus placebo for COVID-19 prophylaxis

Detailed Description

This trial comprises a total observation period of up to 56 days (an on-treatment period of up to 28 days and a safety follow-up of up to 28 days).

Eligibility

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Age between 18 and 65 years, inclusive.
•2. Body weight \>45 kg.
•3. Body Mass Index \>18.5.
•4. Close contact with a person who has a PCR-confirmed SARS-CoV-2 infection within 5 days before screening.
•5. Only one member in the same household will be enrolled.
•6. Participants must be able to give informed consent and comply with the study's scheduled events/visits and study assessments.
•7. SARS-CoV-2 positive index case must be able to give consent to enable collection of the documented positive PCR test.
•8. Female participants of childbearing potential must use a highly effective method of contraception for the duration of the trial.

Exclusion Criteria

•1. Pregnant or breast-feeding.
•2. Participants who have been administered COVID-19 vaccine prior to the inclusion or have a planned vaccination during the duration of the study.
•3. A positive COVID-19 result (PCR or antigen test) within 8 days of screening.
•4. Presence of typical COVID-19 symptoms (fever \>38°C, SpO2 below 93%, dyspnoea, difficulty breathing, chills, repeated shaking with chills, ageusia, anosmia, cough, myalgia, headache) in the past 48 hours prior to screening.
•5. Hypersensitivity to any component of ivermectin.
•6. Participants who have been administered ivermectin within 30 days prior to screening.
•7. Participation in another interventional trial within the last 30 days or 5 half-lives of the IMP of the other trial, whichever comes first.
•8. Participants with gastrointestinal erosions and ulcers (e.g. erosive esophagitis, stomach ulcers, ulcerative colitis etc.).
•9. History of neurotoxicity with ivermectin or other para-glycoprotein (p-gp) substrates or inhibitors.
•10. Current use of monoclonal antibodies for the treatment of COVID-19.

Locations (1)

Medical Center Medic Ltd.

Sofia, Bulgaria

Key Dates

Start Date

March 25, 2022

Primary Completion Date

September 15, 2022

Completion Date

October 13, 2022

Last Updated

December 31, 2024

Enrollment

400

ACTUAL participants

Conditions

COVID-19

Interventions

Ivermectin Tablets

DRUG

Matching placebo tablets

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 31, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Study to Evaluate the Efficacy and Safety of Ivermectin in COVID-19 Prevention

Inclusion Criteria

Exclusion Criteria

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