> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/evaluate-the-efficacy-and-safety-of-azvudine-in-preventing-901801dc-7ffe-469c-a69e-87fb40f66fc2 > Record changed: 2026-10-13 # Evaluate the Efficacy and Safety of Azvudine in Preventing SARS-Cov-2 Infection in Household Contacts of Covid-19 NCT05633433 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05633433) Phase Phase 2/Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05633433) Recruitment status Unknown Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05633433) Participants 1,550 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05633433) Lead sponsor Shanghai Henlius Biotech Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05633433) Start date 2022-12-29 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05633433) Number of sites 10 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05633433) ## Title and summary **Summary** A Phase II/III 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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05633433) **Short title** Evaluate the Efficacy and Safety of Azvudine in Preventing SARS-Cov-2 Infection in Household Contacts of Covid-19 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05633433) **Official title** A Phase II/III 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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05633433) ## Status and phase **Control arm** Placebo Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05633433) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05633433) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05633433) **Recruitment status** Unknown Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05633433) **Phase** Phase 2/Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05633433) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05633433) ## Dates **Completion date** 2024-07-15 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05633433) **First posted** 2022-12-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05633433) **Registry last updated** 2023-01-09 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05633433) **Primary completion date** 2024-06-15 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05633433) **Start date** 2022-12-29 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05633433) ## Size and sites **Participants** 1,550 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05633433) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05633433) **Planned participants** 1,550 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05633433) **Protocol amendments** 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05633433) **Number of sites** 10 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05633433) ## Sponsor and oversight **Data monitoring committee** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05633433) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05633433) **Lead sponsor** Shanghai Henlius Biotech Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05633433) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05633433) ## Identifiers **Registry ID** NCT05633433 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05633433) **ClinicalTrials.gov ID** NCT05633433 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05633433) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05633433) ## 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/NCT05633433) ## Outcomes ### Primary outcomes 1. Efficacy-Incidence of SARS-CoV-2 infection in 7 days Timeframe: Day 2 to Day 7 The incidence of SARS-CoV-2 infection (RT-PCR positive) up to 7 days from 2 days after administration of Azvudine for prevention of SARS-CoV-2 infection. ### Secondary outcomes 1. Incidence of asymptomatic SARS-CoV-2 infection in 7 days Timeframe: Day 2 to Day 7 The incidence of asymptomatic SARS-CoV-2 infection (RT-PCR positive) up to 7 days from 2 days after administration of Azvudine for prevention of SARS-CoV-2 infection. 2. Incidence of symptomatic SARS-CoV-2 infection in 7 days Timeframe: Day 2 to Day 7 The incidence of symptomatic SARS-CoV-2 infection (RT-PCR positive) up to 7 days from 2 days after administration of Azvudine for prevention of SARS-CoV-2 infection. 3. Incidence of SARS-CoV-2 infection in 14 days Timeframe: Day 2 to Day 14 The incidence of SARS-CoV-2 infection (RT-PCR positive) up to 14 days from 2 days after administration of Azvudine for prevention of SARS-CoV-2 infection. 4. Incidence of asymptomatic SARS-CoV-2 infection in 14 days Timeframe: Day 2 to Day 14 The incidence of asymptomatic SARS-CoV-2 infection (RT-PCR positive) up to 14 days from 2 days after administration of Azvudine for prevention of SARS-CoV-2 infection. 5. Incidence of symptomatic SARS-CoV-2 infection in 14 days Timeframe: Day 2 to Day 14 The incidence of SARS-CoV-2 infection (RT-PCR positive) up to 14 days from 2 days after administration of Azvudine for prevention of SARS-CoV-2 infection. 6. Incidence of severe COVID-19 Timeframe: Day 1 to Day 28 To describe the incidence of severe COVID-19 up to 28 days after administration of Azvudine for prevention of SARS-CoV-2 infection. 7. Incidence of all-cause mortality Timeframe: Day 1 to Day 28 To describe the incidence of all-cause mortality during the 28 days after administration of Azvudine for prevention of SAR-CoV-2 infection. 8. Time to SARS-CoV-2 infection Timeframe: Day 1 to Day 28 The time to SARS-CoV-2 infection after the the first dose of Azvudine will be evaluated in the RT-PCR positive participants. 9. Duration of symptoms Timeframe: Day 1 to Day 28 Duration of symptoms in participants with COVID-19. 10. Adverse events Timeframe: Day 1 to Day 28 Number of participants with adverse events after administration of Azvudine will be evaluated. 11. Maximum serum concentration (Cmax) Timeframe: Day 1 to Day 28 The Cmax of Azvudine after administration in participants will be evaluated. 12. Time to reach maximum serum concentration (Tmax) Timeframe: Day 1 to Day 28 The Tmax of Azvudine after administration in participants will be evaluated. 13. Terminal half-life (T1/2) Timeframe: Day 1 to Day 28 The T1/2 of Azvudine after administration in participants will be evaluated. 14. Apparent total clearance (CL/F) Timeframe: Day 1 to Day 28 The CL/F of Azvudine after administration in participants will be evaluated. 15. Apparent volume of distribution based on terminal phase (Vz/F) Timeframe: Day 1 to Day 28 The Vz/F of Azvudine after administration in participants will be evaluated. 16. Area under the concentration-time curve from time 0 to the last concentration-measurable time point (AUC0-t) Timeframe: Day 1 to Day 28 The AUC0-t of Azvudine after administration in participants will be evaluated. 17. Area under the concentration-time curve from time 0 to infinity (AUC0-∞) Timeframe: Day 1 to Day 28 The AUC0-∞ of Azvudine after administration in participants will be evaluated. Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05633433) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Healthy volunteers** Yes ### Inclusion criteria 1. ≥18 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 48 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. 5. Willing and able to comply with study visits and study-related procedures/assessments. 6. Provide informed consent signed by study subject or legally acceptable representative. ### Exclusion criteria 1. Subject with a history of SARS-CoV-2 vaccinations within 6 months before randomization. 2. Subject with a history of SARS-CoV-2 infection within 6 months before randomization. 3. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >3×Upper Limit of Normal (ULN) ,or total bilirubin (TBIL) >2×ULN. 4. Creatinine clearance (Ccr, calculated by Cockcroft-Gault equation)<60 ml/min or Creatinine >1.2×ULN. 5. With any serious infection requiring systemic anti-infective therapy within 14 days before randomization. 6. Allergic to the investigational agent or any components of the formulation. 7. Pregnant or breast-feeding women. 8. Previous administration of any antiretroviral drugs (e.g., antiretroviral drugs for HIV, HBV, or HCV) within 7 days before randomization. 9. 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. 10. Have other conditions not suitable for inclusion as judged by the investigator. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05633433) ## Sites - University of Malaya Medical CentreKuala Lumpur, MalaysiaNot yet recruiting - International Islamic University MalaysiaKuantan, MalaysiaNot yet recruiting - ALPS Medical CenterShah Alam, MalaysiaNot yet recruiting - Klinik Kesihatan CherasShah Alam, MalaysiaNot yet recruiting - Klinik Kesihatan GreentownShah Alam, MalaysiaNot yet recruiting - Klinik Kesihatan Kuala KedahShah Alam, MalaysiaNot yet recruiting - Klinik Kesihatan MahmoodiahShah Alam, MalaysiaNot yet recruiting - Cebu Doctors' University HospitolCebu City, PhilippinesRecruiting - Perpetual Succour HospitalCebu City, PhilippinesNot yet recruiting - University of the East Ramon Magsaysay Memorial Medical CenterQuezon City, PhilippinesNot yet recruiting Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05633433) ## Related records ### Drugs (1) - [RO-0622](https://trialight.com/data/asset/ro-0622-1855dd7f-0857-4056-8d15-a6ea7b8391aa.md) ### Collaborators (2) - Henan Genuine Biotech Co., Ltd. - 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) --- ## 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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