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

Study Overview
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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

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.

Official Title
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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

Conditions
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COVID-19

Intervention / Treatment
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* Drug: Azvudine
* Drug: Placebo


Participation Criteria
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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: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |