COVID-19 trials registries data warehouse

https://www.clinicaltrialsregister.eu/ctr-search/trial/2021-001938-19/BG

MedinCell S.A. - Head of Regulatory Affairs

christine.roussarie@medincell.com

2022-02-10

Completed

RCT

Randomized

Parallel

Blind label

multi-center

Prevention

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).

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.

2

MedinCell S.A.

18

65

France

Close contacts to covid patients

N/A

400

Proportion of laboratory-confirmed COVID-19 infections between baseline and Day 28.

Declared number of arm (3.0) differs from found arms (2.0)

Phase 2

[{"arm_notes": null, "treatment_id": 693, "treatment_name": "Ivermectin", "treatment_type": "Antiparasitics", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": null, "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]