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

COVID-19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05682599
• Other study ID #: FNC-Covid201
• Status: Recruiting
• Phase: Phase 2
• Start date: January 6, 2023
• Est. completion date: May 15, 2023

Study information

• Verified date: January 2023
• Source: Shanghai Henlius Biotech
• Contact: chen mingquan
• Phone: 52889999
• Email: hsmqchen[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: May 15, 2023
• Est. primary completion date: April 15, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19

Intervention

Drug:
• Azvudine
Azvudine is a novel nucleoside reverse transcriptase inhibitor.
• Placebo
Placebo

Locations

Country	Name	City	State
China	Huashan Hospital	Shanghai	Shanghai

Sponsors (4)

Lead Sponsor	Collaborator
Shanghai Henlius Biotech	HeNan Sincere Biotech Co., Ltd, Huashan Hospital, Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy-Incidence of SARS-CoV-2 infection in 8 days	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.	Day 2 to Day 7