Evaluate Azvudine in Preventing SARS-Cov-2 Infection in Household Contacts of Covid-19 in China

Phase 2

Recruiting

• Conditions: COVID-19
• Interventions: Drug: Azvudine; Drug: Placebo

• Registration Number: NCT05682599
• Lead Sponsor: Shanghai Henlius Biotech

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.

Study Timeline

• Status Verified: 2023-01
• Study Start: 2023-01-06
• Study First Submitted: 2023-01-10
• Study First Submitted QC: 2023-01-10
• Study First Posted: 2023-01-12
• Last Update Submitted: 2023-01-28
• Last Update Posted: 2023-01-31
• Primary Completion: 2023-04-15
• Study Completion: 2023-05-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

1、18-65 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 24 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.

Exclusion Criteria

1. Subject with a history of SARS-CoV-2 vaccinations within 1 months before randomization.
2. Subject with a history of SARS-CoV-2 infection within 6 months before randomization.
3. With any serious infection requiring systemic anti-infective therapy within 14 days before randomization.
4. Allergic to the investigational agent or any components of the formulation. Pregnant or breast-feeding women.
5. 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.
6. Have other conditions not suitable for inclusion as judged by the investigator.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A：Azvudine 5 mg	Azvudine	Azvudine 5 mg, QD PO, D1-D7
C：placebo	Placebo	placebo 5 mg, QD PO, D1-D7
B：Azvudine 3 mg	Placebo	Azvudine 3 mg + placebo 2 mg, QD PO, D1-D7
B：Azvudine 3 mg	Azvudine	Azvudine 3 mg + placebo 2 mg, QD PO, D1-D7

Primary Outcome Measures

Name	Time	Method
Efficacy-Incidence of SARS-CoV-2 infection in 8 days	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.

Trial Locations

Locations (1)

Huashan Hospital; 🇨🇳 Shanghai, Shanghai, China