A Phase II 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 in China
Overview
- Phase
- Phase 2
- Intervention
- Azvudine
- Conditions
- COVID-19
- Sponsor
- Shanghai Henlius Biotech
- Enrollment
- 300
- Locations
- 1
- Primary Endpoint
- Efficacy-Incidence of SARS-CoV-2 infection in 8 days
- Status
- Recruiting
- Last Updated
- 3 years ago
Overview
Brief Summary
A Phase II 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 in China
Detailed Description
A multicentre, randomized, double-blind, placebo-controlled phase II clinical study to evaluate the efficacy and safety of Azvudine versus placebo in preventing SARS-CoV-2 infection in household contacts with SARS-CoV-2 infection individuals.Approximately 300 adults with household contact exposure to individuals with a confirmed SARS-CoV-2 infection will be enrolled.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1、18-65 years old at the signing of informed consent. 2、Household contacts of individual with symptomatic COVID-
- •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 24 hours before randomization, 2) have at least one symptom attributable to COVID-
- •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.
Exclusion Criteria
- •Subject with a history of SARS-CoV-2 vaccinations within 1 months before randomization.
- •Subject with a history of SARS-CoV-2 infection within 6 months before randomization.
- •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.
- •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.
Arms & Interventions
A：Azvudine 5 mg
Azvudine 5 mg, QD PO, D1-D7
Intervention: Azvudine
B：Azvudine 3 mg
Azvudine 3 mg + placebo 2 mg, QD PO, D1-D7
Intervention: Azvudine
B：Azvudine 3 mg
Azvudine 3 mg + placebo 2 mg, QD PO, D1-D7
Intervention: Placebo
C：placebo
placebo 5 mg, QD PO, D1-D7
Intervention: Placebo
Outcomes
Primary Outcomes
Efficacy-Incidence of SARS-CoV-2 infection in 8 days
Time Frame: Day 2 to Day 7
The incidence of SARS-CoV-2 infection (RT-PCR positive) up to 8 days from 2 days after administration of Azvudine for prevention of SARS-CoV-2 infection.