Evaluate the Efficacy and Safety of Azvudine in Preventing SARS-Cov-2 Infection in Household Contacts of Covid-19

• Status: Not yet recruiting
• Trial end date: 2024-07-15
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Shanghai Henlius Biotech
• Collaborators: HeNan Sincere Biotech Co., Ltd; Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd.

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.