Evaluate the Efficacy and Safety of Azvudine in Preventing SARS-Cov-2 Infection in Household Contacts of Covid-19
SARS-CoV-2 Infection
About this trial
This is an interventional prevention trial for SARS-CoV-2 Infection
Eligibility Criteria
Inclusion Criteria: ≥18 years old at the signing of informed consent. 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. 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. Subject expects to be living in the same household with the symptomatic COVID-19 cases during the whole study period. Willing and able to comply with study visits and study-related procedures/assessments. Provide informed consent signed by study subject or legally acceptable representative. Exclusion Criteria: Subject with a history of SARS-CoV-2 vaccinations within 6 months before randomization. Subject with a history of SARS-CoV-2 infection within 6 months before randomization. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >3×Upper Limit of Normal (ULN) ,or total bilirubin (TBIL) >2×ULN. Creatinine clearance (Ccr, calculated by Cockcroft-Gault equation)<60 ml/min or Creatinine >1.2×ULN. With any serious infection requiring systemic anti-infective therapy within 14 days before randomization. Allergic to the investigational agent or any components of the formulation. Pregnant or breast-feeding women. Previous administration of any antiretroviral drugs (e.g., antiretroviral drugs for HIV, HBV, or HCV) within 7 days before randomization. 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. Have other conditions not suitable for inclusion as judged by the investigator.
Sites / Locations
- University of Malaya Medical Centre
- International Islamic University Malaysia
- ALPS Medical Center
- Klinik Kesihatan Cheras
- Klinik Kesihatan Greentown
- Klinik Kesihatan Kuala Kedah
- Klinik Kesihatan Mahmoodiah
- Cebu Doctors' University HospitolRecruiting
- Perpetual Succour Hospital
- University of the East Ramon Magsaysay Memorial Medical Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Experimental
Experimental
Placebo Comparator
Experimental
Placebo Comparator
cohort A (Phase II)
cohort B (Phase II)
cohort C (Phase II)
Arm 1 (Phase III)
Arm 2 (Phase III)
Azvudine 5 mg, QD PO, D1-D7
Azvudine 3 mg + placebo 2 mg, QD PO, D1-D7
placebo 5 mg, QD PO, D1-D7
Azvudine, dose to be determined according to phase II, QD PO, D1-D7
Placebo, dose to be the same as Arm1, QD PO, D1-D7