Prophylaxis of COVID-19 infection MedDRA version: 23.0 Level: PT Classification code 10084268 Term: COVID-19 System Organ Class: 10021881 - Infections and infestations
Conditions
Interventions
Trade Name: Ivermectine Substipharm 3 mg, tablet
Product Name: Ivermectine Substipharm 3mg, tablet
Pharmaceutical Form: Tablet
INN or Proposed INN: IVERMECTIN
Other descriptive name: Ivermectin
Concen
Sponsors
MedinCell S.A.
Eligibility
Sex/Gender
All
Inclusion 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. Their male partners should also use a contraception method (i.e condom) unless vasectomized. (Refer to section 4.5 Contraception Requirements). 9. Male participants must use a contraception method (i.e condom) for the duration of the trial, unless vasectomized. Their female partners, if they are of childbearing potential, must use a highly effective method of contraception. (Refer to section 4.5 Contraception Requirements). Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 400 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
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. Presence of a known uncontrolled/unstable clinically significant medical condition, considered by the investigator as incompatible with study participation. 6. Known history of HIV, HBV and/or HCV. 7. Hypersensitivity to any component of ivermectin. 8. Participants who have been administered ivermectin within 30 days prior to screening. 9. Participation in another interventional trial within the last 30 days or 5 half-lives of the IMP of the other trial, whichever comes first. 10. Having undergone extensive bowel resection which may alter ivermectin absorption. 11. Participants with gastrointestinal erosions and ulcers (e.g. erosive esophagitis, stomach ulcers, ulcerative colitis etc.). 12. Known or clinically suspected disturbance of the blood-brain-barrier (e.g., ABCB-1 [=MDR1] mutation). 13. History of neurotoxicity with ivermectin or other para-glycoprotein (p-gp) substrates or inhibitors. 14. Current use of P-gp inhibitor drugs such as amiodarone, azithromycin, ketoconazole, cyclosporine. 15. Current use of monoclonal antibodies for the treatment of COVID-19. 16. Known drug or alcohol abuse. 17. Travel to endemic Loa loa regions within the past 3 months prior to screening (central and western Africa). 18. Participants under legal guardianship or trusteeship.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the efficacy of ivermectin compared to placebo in the prevention of laboratory-confirmed COVID-19 infection.;Secondary Objective: •To assess the efficacy of ivermectin on Time to RT-PCR positive testing. •To assess the efficacy of ivermectin on the occurence of severe COVID-19 symptoms. •To assess the efficacy of ivermectin on Time to first COVID-19 related clinical events. •To assess the efficacy of ivermectin on the rate of COVID-19 related hospitalisations. •To assess the efficacy of ivermectin on the rate of COVID-19 related mortality. •To assess the safety and tolerability of ivermectin given for a period of 28 days. ;Primary end point(s): Proportion of laboratory-confirmed COVID-19 infections between baseline and Day 28.;Timepoint(s) of evaluation of this end point: Day 28 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Time to change from baseline in negative RT-PCR to positive RT-PCR. • Change from baseline in the WHO-COVID 19 and NEWS-2 scores. • Time to change from baseline to first COVID-19 related clinical events. • Proportion of COVID-19 related hospitalisations. • Proportion of COVID-19 related mortality. • Safety and Tolerability of ivermectin based on treatment emergent adverse events (TEAE) and serious adverse events (SAE) according to Common Terminology Criteria for Adverse Events (CTCAE version 5.0).;Timepoint(s) of evaluation of this end point: Day 4, Day 7, Day 10, Day 28 and day 56 | — |
Countries
Bulgaria
Contacts
Public ContactHead of Regulatory Affairs
MedinCell S.A.
Outcome results
None listed