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

Phase 2

Completed

• Conditions: COVID-19
• Interventions: Drug: Ivermectin Tablets; Drug: Matching placebo tablets

• Registration Number: NCT05305560
• Lead Sponsor: MedinCell S.A

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).

Study Timeline

• Study Start: 2022-03-25
• Study First Submitted: 2022-03-28
• Study First Submitted QC: 2022-03-30
• Study First Posted: 2022-03-31
• Primary Completion: 2022-09-15
• Study Completion: 2022-10-13
• Results First Submitted: 2024-09-11
• Status Verified: 2024-12
• Results First Submitted QC: 2024-12-02
• Results First Posted: 2024-12-10
• Last Update Submitted: 2024-12-10
• Last Update Posted: 2024-12-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 400

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Active IMP	Ivermectin Tablets	-
Placebo	Matching placebo tablets	-

Primary Outcome Measures

Name	Time	Method
COVID-19 Prophylaxis	From Day 1 to Day 28	Number of laboratory-confirmed COVID-19 infections in each group between baseline and Day 28

Secondary Outcome Measures

Name	Time	Method
COVID-19 Prophylaxis Timeframe	From Day 1 to Day 28	Time to change from baseline in negative RT-PCR to positive RT-PCR
COVID-19 Hospitalisations	From Day 1 to Day 56	Proportion of COVID-19 related hospitalisations
To Assess the Safety and Tolerability of IVM Given for a Period of 28 Days	56 days	Descriptive comparison of AE rates and severity/seriousness between IVM and placebo
COVID-19 Symptoms Development	From Day 1 to Day 28	Number of symptomatic Participants according to the WHO COVID-18 scale
COVID-19 Mortality	From Day 1 to Day 56	Proportion of COVID-19 related mortality

Trial Locations

Locations (1)

Medical Center Medic Ltd.; 🇧🇬 Sofia, Bulgaria