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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-06

Study Completion Date

2023-05-15

Brief Summary

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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

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Detailed Description

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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.

Conditions

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COVID-19

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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A：Azvudine 5 mg

Azvudine 5 mg, QD PO, D1-D7

Group Type EXPERIMENTAL

Azvudine

Intervention Type DRUG

Azvudine is a novel nucleoside reverse transcriptase inhibitor.

B：Azvudine 3 mg

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

Group Type EXPERIMENTAL

Azvudine

Intervention Type DRUG

Azvudine is a novel nucleoside reverse transcriptase inhibitor.

Placebo

Intervention Type DRUG

Placebo

C：placebo

placebo 5 mg, QD PO, D1-D7

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo

Interventions

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Azvudine

Azvudine is a novel nucleoside reverse transcriptase inhibitor.

Intervention Type DRUG

Placebo

Intervention Type DRUG

Other Intervention Names

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FNC

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes