Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:38 PM
Ignite Modification Date:
2025-12-24 @ 7:38 PM
NCT ID:
NCT05231603
Eligibility Criteria:
Inclusion Criteria:
1. Asymptomatic individuals exposed to a confirmed positive COVID-19 case within 5 days from the study recruitment day (include household, workplace and social close contact)
2. Aged ≥18 years; male or female
3. No fever with temperature less than 37.5ºC
4. RTK Ag for COVID-19 is negative on the recruitment day.
5. For subject who had received COVID-19 vaccination:
* Any primary series vaccine (eg: Pfizer, Sinovac, AstraZeneca etc) : past 90 days after the second dose
* Any booster vaccine: past 90 days after the booster dose
6. In women of childbearing potential (18-55 years old), negative pregnancy test and agree to use any contraceptive method up to 7 days after the second dose of IP administration
7. Have access to video and phone call
8. Willing to take 2 doses of study medication (2 days apart between Dose 1 and Dose 2)
9. Willing to comply with all study procedures
10. Able to provide written informed consent
Exclusion Criteria:
1. Unable to take drugs by mouth
2. History of positive confirmed COVID-19 infection within past 3 months
3. Involved in any COVID-19 vaccine clinical trial
4. Patients with suspected concomitant bacterial, fungal infections, concurrent congestive heart failure prior to initiation of study drug
5. Known case of liver disease (any severity)
6. Alcohol intake more than recommended (2 drinks or more in a day for men and 1 drink or more in a day for women)
7. Mal-absorption syndrome or other clinically significant gastrointestinal disease that may affect absorption of the study drug (non-correctable vomiting, diarrhea, ulcerative colitis, and others).
8. Pregnant or nursing/breastfeeding women or women planning for pregnancy.
9. Female patients who cannot consent to contraceptive use (any method) from the start of IP administration to 7 days after the second dose of IP administration
10. Male patients whose partner cannot agree to use the contraception method as in 9)
11. Patients with a history of gout or on treatment for gout or hyperuricemia
12. Patients receiving immunosuppressant
13. Patients who have previously received Ivermectin.
14. Patients who are not able to provide written consent.
15. Other patients judged ineligible by the principal investigator or sub-investigator
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05231603
Study Brief:
Protocol Section:
NCT05231603