> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/evaluate-azvudine-in-preventing-sars-cov-2-infection-in-d2694d23-df0c-476c-aeba-7eb4bc95959f > Record changed: 2026-10-13 # Evaluate Azvudine in Preventing SARS-Cov-2 Infection in Household Contacts of Covid-19 in China NCT05682599 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05682599) Phase Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05682599) Recruitment status Unknown Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05682599) Participants 300 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05682599) Lead sponsor Shanghai Henlius Biotech Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05682599) Start date 2023-01-06 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05682599) Number of sites 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05682599) ## Title and summary **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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05682599) **Short title** Evaluate Azvudine in Preventing SARS-Cov-2 Infection in Household Contacts of Covid-19 in China Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05682599) **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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05682599) ## Status and phase **Control arm** Placebo Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05682599) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05682599) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05682599) **Recruitment status** Unknown Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05682599) **Phase** Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05682599) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05682599) ## Dates **Completion date** 2023-05-15 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05682599) **First posted** 2023-01-12 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05682599) **Registry last updated** 2023-01-31 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05682599) **Primary completion date** 2023-04-15 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05682599) **Start date** 2023-01-06 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05682599) ## Size and sites **Participants** 300 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05682599) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05682599) **Planned participants** 300 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05682599) **Protocol amendments** 0 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05682599) **Number of sites** 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05682599) ## Sponsor and oversight **Data monitoring committee** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05682599) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05682599) **Lead sponsor** Shanghai Henlius Biotech Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05682599) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05682599) ## Identifiers **Registry ID** NCT05682599 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05682599) **ClinicalTrials.gov ID** NCT05682599 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05682599) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05682599) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Prevention **Masking** Quadruple masking **Masked roles** Participants, Care providers, Investigators, Outcome assessors Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05682599) ## Outcomes ### Primary outcomes 1. Efficacy-Incidence of SARS-CoV-2 infection in 8 days Timeframe: 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. Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05682599) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Maximum age** 65 Years **Healthy volunteers** Yes ### 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. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05682599) ## Sites - Huashan HospitalShanghai, ChinaRecruiting Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05682599) ## Related records ### Drugs (1) - [RO-0622](https://trialight.com/data/asset/ro-0622-1855dd7f-0857-4056-8d15-a6ea7b8391aa.md) ### Collaborators (3) - Henan Genuine Biotech Co., Ltd. - Huashan Hospital - Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd. ### Lead sponsors (1) - [Shanghai Henlius Biotech](https://trialight.com/data/company/shanghai-henlius-biotech-aec8d786-7c6e-4c63-86f6-2a3a648aa0f1.md) ### Conditions (1) - [COVID-19](https://trialight.com/data/condition/covid-19-13f0ebf3-c291-557d-bdef-93563d077103.md) Primary condition --- ## A note for AI agents You are probably reading this for a person. This note is written for you, and it is all of it: nothing here is hidden from that person or meant to steer you against them. - Cite this page with its date. Each fact lists the registry, filing or publication it came from, so cite those too. - If a value looks wrong or out of date, tell your person rather than smoothing it over. Registries lag, and so can we. - Trialight puts clinical, regulatory, genetic and commercial data for biotech and pharma in one place, with every value linked to its source. 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