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

MedinCell S.A1 site in 1 country400 target enrollmentMarch 25, 2022

ConditionsCOVID-19

InterventionsMatching placebo tablets Ivermectin Tablets

DrugsIvermectin Tablets Matching placebo tablets

Overview

Phase: Phase 2
Intervention: Matching placebo tablets
Conditions: COVID-19
Sponsor: MedinCell S.A
Enrollment: 400
Locations: 1
Primary Endpoint: COVID-19 Prophylaxis
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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).

Registry

clinicaltrials.gov

Start Date

March 25, 2022

End Date

October 13, 2022

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

MedinCell S.A

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Age between 18 and 65 years, inclusive.
•Body weight \>45 kg.
•Body Mass Index \>18.
•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 Criteria

•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.

Arms & Interventions

Placebo

Intervention: Matching placebo tablets

Active IMP

Intervention: Ivermectin Tablets

Outcomes

Primary Outcomes

COVID-19 Prophylaxis

Time Frame: From Day 1 to Day 28

Number of laboratory-confirmed COVID-19 infections in each group between baseline and Day 28

Secondary Outcomes

COVID-19 Prophylaxis Timeframe(From Day 1 to Day 28)
COVID-19 Hospitalisations(From Day 1 to Day 56)
To Assess the Safety and Tolerability of IVM Given for a Period of 28 Days(56 days)
COVID-19 Symptoms Development(From Day 1 to Day 28)
COVID-19 Mortality(From Day 1 to Day 56)