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NCT05633433
Evaluate the Efficacy and Safety of Azvudine in Preventing SARS-Cov-2 Infection in Household Contacts of Covid-19
Conditions: SARS-CoV-2 Infection
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: 1
Phase: PHASE2, PHASE3
Enrollment: 1550
Sponsor: Shanghai Henlius Biotech
Location: Malaysia
Summary
A Phase II/III Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of Azvudine in Preventing SARS-Cov-2 Infection in Household Contacts of Individuals Infected with SARS-CoV-2
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.
Source: ClinicalTrials.gov (NCT05633433). StuddyBuddy aggregates publicly available trial information.