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:
2025-12-25 @ 2:42 AM
Ignite Modification Date:
2025-12-25 @ 2:42 AM
NCT ID:
NCT05633433
Eligibility Criteria:
Inclusion Criteria:
1. ≥18 years old at the signing of informed consent.
2. Household contacts of individual with symptomatic COVID-19. Symptomatic COVID-19 cases (index case) to be identified as those symptomatic and recently tested (rapid antigen test or RT-PCR) positive for SARS-CoV-2 and must fulfill the following criteria 1) collection of the first positive SARS-CoV-2 test sample less than 48 hours before randomization, 2) have at least one symptom attributable to COVID-19.
3. RT-PCR test negative (with nasopharyngeal \[NP\] swab samples) OR rapid antigen test negative at the time of screening and without any suspicious COVID-19 symptoms within 2 weeks before randomization.
4. Subject expects to be living in the same household with the symptomatic COVID-19 cases during the whole study period.
5. Willing and able to comply with study visits and study-related procedures/assessments.
6. Provide informed consent signed by study subject or legally acceptable representative.
Exclusion Criteria:
1. Subject with a history of SARS-CoV-2 vaccinations within 6 months before randomization.
2. Subject with a history of SARS-CoV-2 infection within 6 months before randomization.
3. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \>3×Upper Limit of Normal (ULN) ,or total bilirubin (TBIL) \>2×ULN.
4. Creatinine clearance (Ccr, calculated by Cockcroft-Gault equation)\<60 ml/min or Creatinine \>1.2×ULN.
5. With any serious infection requiring systemic anti-infective therapy within 14 days before randomization.
6. Allergic to the investigational agent or any components of the formulation.
7. Pregnant or breast-feeding women.
8. Previous administration of any antiretroviral drugs (e.g., antiretroviral drugs for HIV, HBV, or HCV) within 7 days before randomization.
9. Women of childbearing potential who are unwilling to practice highly effective contraception during the study, and for at least 6 months after the study; Sexually active men who are unwilling to use medically acceptable birth control during the study period.
10. Have other conditions not suitable for inclusion as judged by the investigator.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05633433
Study Brief:
Protocol Section:
NCT05633433