MedDataX Logo

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

NCT ID: NCT05305560

Last Updated: 2024-12-31

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-25

Study Completion Date

2022-10-13

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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).

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

COVID-19

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Prophylaxis RT-PCR test

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Active IMP

Group Type EXPERIMENTAL

Ivermectin Tablets

Intervention Type DRUG

Daily ivermectin tablets intake for 28 days ; 200 mcg/kg on D1 then 100 mcg/kg daily from D2 to D28.

Placebo

Group Type PLACEBO_COMPARATOR

Matching placebo tablets

Intervention Type DRUG

Daily placebo tablets intake for 28 days

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Ivermectin Tablets

Daily ivermectin tablets intake for 28 days ; 200 mcg/kg on D1 then 100 mcg/kg daily from D2 to D28.

Intervention Type DRUG

Matching placebo tablets

Daily placebo tablets intake for 28 days

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Violaine Desort-Hénin, DVM

UNKNOWN

Sponsor Role collaborator

MedinCell S.A

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Anna Kostova, MD

Role: PRINCIPAL_INVESTIGATOR

Medical Center Medic Ltd.

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Medical Center Medic Ltd.

Sofia, , Bulgaria

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Bulgaria

Provided Documents

Download supplemental materials such as informed consent forms, study protocols, or participant manuals.

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2021-001938-19

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

mdc-TTG-CT-002

Identifier Type: -

Identifier Source: org_study_id