Status:
COMPLETED
A Study to Evaluate the Efficacy and Safety of Ivermectin in COVID-19 Prevention
Lead Sponsor:
MedinCell S.A
Collaborating Sponsors:
Violaine Desort-Hénin, DVM
Conditions:
COVID-19
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief 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 Criteria
Inclusion
- Age between 18 and 65 years, inclusive.
- Body weight \>45 kg.
- Body Mass Index \>18.5.
- Close contact with a person who has a PCR-confirmed SARS-CoV-2 infection within 5 days before screening.
- Only one member in the same household will be enrolled.
- Participants must be able to give informed consent and comply with the study's scheduled events/visits and study assessments.
- SARS-CoV-2 positive index case must be able to give consent to enable collection of the documented positive PCR test.
- Female participants of childbearing potential must use a highly effective method of contraception for the duration of the trial.
Exclusion
- Pregnant or breast-feeding.
- Participants who have been administered COVID-19 vaccine prior to the inclusion or have a planned vaccination during the duration of the study.
- A positive COVID-19 result (PCR or antigen test) within 8 days of screening.
- 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.
- Hypersensitivity to any component of ivermectin.
- Participants who have been administered ivermectin within 30 days prior to screening.
- Participation in another interventional trial within the last 30 days or 5 half-lives of the IMP of the other trial, whichever comes first.
- Participants with gastrointestinal erosions and ulcers (e.g. erosive esophagitis, stomach ulcers, ulcerative colitis etc.).
- History of neurotoxicity with ivermectin or other para-glycoprotein (p-gp) substrates or inhibitors.
- Current use of monoclonal antibodies for the treatment of COVID-19.
Key Trial Info
Start Date :
March 25 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 13 2022
Estimated Enrollment :
400 Patients enrolled
Trial Details
Trial ID
NCT05305560
Start Date
March 25 2022
End Date
October 13 2022
Last Update
December 31 2024
Active Locations (1)
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1
Medical Center Medic Ltd.
Sofia, Bulgaria