Evaluate Azvudine in Preventing SARS-Cov-2 Infection in Household Contacts of Covid-19 in China
Study Details
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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
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 Design
Arms and Interventions
| 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:
|
| Experimental: B：Azvudine 3 mg Azvudine 3 mg + placebo 2 mg, QD PO, D1-D7 |
Drug: Azvudine
Azvudine is a novel nucleoside reverse transcriptase inhibitor.
Other Names:
Drug: Placebo
Placebo
|
| Placebo Comparator: C：placebo placebo 5 mg, QD PO, D1-D7 |
Drug: Placebo
Placebo
|
Outcome Measures
Primary Outcome Measures
- Efficacy-Incidence of SARS-CoV-2 infection in 8 days [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.
Eligibility Criteria
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.
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Subject with a history of SARS-CoV-2 infection within 6 months before randomization.
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With any serious infection requiring systemic anti-infective therapy within 14 days before randomization.
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Allergic to the investigational agent or any components of the formulation. Pregnant or breast-feeding women.
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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.
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Have other conditions not suitable for inclusion as judged by the investigator.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Huashan Hospital | Shanghai | Shanghai | China |
Sponsors and Collaborators
- Shanghai Henlius Biotech
- Huashan Hospital
- Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd.
- HeNan Sincere Biotech Co., Ltd
Investigators
- Principal Investigator: chen mingquan, Huashan Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- FNC-Covid201