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

Primary Purpose

COVID-19

Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Azvudine
Placebo
Sponsored by
Shanghai Henlius Biotech
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for COVID-19

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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: 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.

Sites / Locations

  • Huashan HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

A:Azvudine 5 mg

B:Azvudine 3 mg

C:placebo

Arm Description

Azvudine 5 mg, QD PO, D1-D7

Azvudine 3 mg + placebo 2 mg, QD PO, D1-D7

placebo 5 mg, QD PO, D1-D7

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
January 10, 2023
Last Updated
January 28, 2023
Sponsor
Shanghai Henlius Biotech
Collaborators
Huashan Hospital, Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd., HeNan Sincere Biotech Co., Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT05682599
Brief Title
Evaluate Azvudine in Preventing SARS-Cov-2 Infection in Household Contacts of Covid-19 in China
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 6, 2023 (Actual)
Primary Completion Date
April 15, 2023 (Anticipated)
Study Completion Date
May 15, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shanghai Henlius Biotech
Collaborators
Huashan Hospital, Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd., HeNan Sincere Biotech Co., Ltd

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
A:Azvudine 5 mg
Arm Type
Experimental
Arm Description
Azvudine 5 mg, QD PO, D1-D7
Arm Title
B:Azvudine 3 mg
Arm Type
Experimental
Arm Description
Azvudine 3 mg + placebo 2 mg, QD PO, D1-D7
Arm Title
C:placebo
Arm Type
Placebo Comparator
Arm Description
placebo 5 mg, QD PO, D1-D7
Intervention Type
Drug
Intervention Name(s)
Azvudine
Other Intervention Name(s)
FNC
Intervention Description
Azvudine is a novel nucleoside reverse transcriptase inhibitor.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
Efficacy-Incidence of SARS-CoV-2 infection in 8 days
Description
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.
Time Frame
Day 2 to Day 7

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
chen mingquan
Phone
52889999
Email
hsmqchen@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
chen mingquan
Organizational Affiliation
Huashan Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Huashan Hospital
City
Shanghai
State/Province
Shanghai
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
zhang wenhong
Phone
52889999
Email
hsmqchen@gmail.com
First Name & Middle Initial & Last Name & Degree
chen mingquan
Phone
52889999
Email
hsmqchen@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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