Evaluate Azvudine in Preventing SARS-Cov-2 Infection in Household Contacts of Covid-19 in China
- 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
- Short title
- Evaluate Azvudine in Preventing SARS-Cov-2 Infection in Household Contacts of Covid-19 in China
- 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
- Control arm
- Placebo
- Registry reports results
- Listing at source
- Listed
- Recruitment status
- Unknown
- Phase
- Phase 2
- Study type
- Interventional
- Completion date
- 2023-05-15
- First posted
- 2023-01-12
- Registry last updated
- 2023-01-31
- Primary completion date
- 2023-04-15
- Start date
- 2023-01-06
- Participants
- Participant count basis
- Estimated
- Planned participants
- Protocol amendments
- Number of sites
- Data monitoring committee
- Registry sponsor category
- Industry
- Lead sponsor
- Shanghai Henlius Biotech
- Source registry
- ClinicalTrials.gov
- Registry ID
- NCT05682599
- ClinicalTrials.gov ID
- NCT05682599
- Registry record
- Open registry record
- Allocation
- Randomised
- Model
- Parallel groups
- Purpose
- Prevention
- Masking
- Quadruple masking
- Masked roles
- Participants, Care providers, Investigators, Outcome assessors
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.
- Sex
- All
- Age groups
- Adults, Older adults
- Minimum age
- 18 Years
- Maximum age
- 65 Years
- Healthy volunteers
- Yes
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.
- 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.
- Huashan HospitalShanghai, ChinaRecruiting
Related records
Drugs (1)
Collaborators (3)
- Henan Genuine Biotech Co., Ltd.
- Huashan Hospital
- Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd.
Lead sponsors (1)
Conditions (1)
- COVID-19 Primary condition