Evaluate the Efficacy and Safety of Azvudine in Preventing SARS-Cov-2 Infection in Ousehold in China

January 10, 2023 updated by: Shanghai Henlius Biotech

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

300

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: A：Azvudine 5 mg
Azvudine 5 mg, QD PO, D1-D7
Drug: Azvudine
Azvudine is a novel nucleoside reverse transcriptase inhibitor.
Other Names:
  • FNC
Experimental: B：Azvudine 3 mg
Azvudine 3 mg + placebo 2 mg, QD PO, D1-D7
Drug: Placebo
Placebo
Drug: Azvudine
Azvudine is a novel nucleoside reverse transcriptase inhibitor.
Other Names:
  • FNC
Placebo Comparator: C：placebo
placebo 5 mg, QD PO, D1-D7
Drug: Placebo
Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Day 2 to Day 7

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Henlius Biotech

Collaborators

Huashan Hospital
Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd.
HeNan Sincere Biotech Co., Ltd

Investigators

  • Principal Investigator: chen mingquan, Huashan Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 6, 2023

Primary Completion (Anticipated)

April 15, 2023

Study Completion (Anticipated)

May 15, 2023

Study Registration Dates

First Submitted

January 10, 2023

First Submitted That Met QC Criteria

January 10, 2023

First Posted (Actual)

January 12, 2023

Study Record Updates

Last Update Posted (Actual)

January 12, 2023

Last Update Submitted That Met QC Criteria

January 10, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FNC-Covid201

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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