Clinical trial NCT05305560: A Study to Evaluate the Efficacy and Safety of Ivermectin in COVID-19 Prevention
Official title: A Multicentre Randomised, Double-Blind, Placebo-controlled, Study to Evaluate the efficAcy and Safety of Oral IVErmectin Tablets in the Prevention of COVID-19
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: COVID-19
Keywords: Prophylaxis
RT-PCR test
Lead sponsor: MedinCell S.A
Sponsor class: INDUSTRY
Collaborators: name: Violaine Desort-Hénin, DVM
First posted: 2022-03-31
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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 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.

Primary outcomes:
measure: COVID-19 Prophylaxis
timeFrame: From Day 1 to Day 28
Secondary outcomes:
measure: COVID-19 Symptoms Development
timeFrame: From Day 1 to Day 28
measure: COVID-19 Prophylaxis Timeframe
timeFrame: From Day 1 to Day 28
measure: COVID-19 Hospitalisations
timeFrame: From Day 1 to Day 56
measure: COVID-19 Mortality
timeFrame: From Day 1 to Day 56
measure: To Assess the Safety and Tolerability of IVM Given for a Period of 28 Days
timeFrame: 56 days
Other outcomes:
Locations:
city: Sofia
country: Bulgaria
facility: Medical Center Medic Ltd.
Study officials:
affiliation: Medical Center Medic Ltd.
name: Anna Kostova, MD
role: PRINCIPAL_INVESTIGATOR
References: