Created at Source Raw Value Validated value
May 3, 2022, 4 p.m. eu

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.

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.