Evaluate the Efficacy and Safety of Azvudine in Preventing SARS-Cov-2 Infection in Household Contacts of Covid-19
- 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
- Short title
- Evaluate the Efficacy and Safety of Azvudine in Preventing SARS-Cov-2 Infection in Household Contacts of Covid-19
- 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
- Control arm
- Placebo
- Registry reports results
- Listing at source
- Listed
- Recruitment status
- Unknown
- Phase
- Phase 2/Phase 3
- Study type
- Interventional
- Completion date
- 2024-07-15
- First posted
- 2022-12-01
- Registry last updated
- 2023-01-09
- Primary completion date
- 2024-06-15
- Start date
- 2022-12-29
- Participants
- 1,550
- Participant count basis
- Estimated
- Planned participants
- 1,550
- Protocol amendments
- Number of sites
- Data monitoring committee
- Registry sponsor category
- Industry
- Lead sponsor
- Shanghai Henlius Biotech
- Source registry
- ClinicalTrials.gov
- Registry ID
- NCT05633433
- ClinicalTrials.gov ID
- NCT05633433
- 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 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.
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.
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.
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.
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.
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.
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.
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.
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.
Duration of symptoms
Timeframe: Day 1 to Day 28
Duration of symptoms in participants with COVID-19.
Adverse events
Timeframe: Day 1 to Day 28
Number of participants with adverse events after administration of Azvudine will be evaluated.
Maximum serum concentration (Cmax)
Timeframe: Day 1 to Day 28
The Cmax of Azvudine after administration in participants will be evaluated.
Time to reach maximum serum concentration (Tmax)
Timeframe: Day 1 to Day 28
The Tmax of Azvudine after administration in participants will be evaluated.
Terminal half-life (T1/2)
Timeframe: Day 1 to Day 28
The T1/2 of Azvudine after administration in participants will be evaluated.
Apparent total clearance (CL/F)
Timeframe: Day 1 to Day 28
The CL/F of Azvudine after administration in participants will be evaluated.
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.
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.
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.
- Sex
- All
- Age groups
- Adults, Older adults
- Minimum age
- 18 Years
- Healthy volunteers
- Yes
- ≥18 years old at the signing of informed consent.
- 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.
- 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.
- Subject expects to be living in the same household with the symptomatic COVID-19 cases during the whole study period.
- Willing and able to comply with study visits and study-related procedures/assessments.
- Provide informed consent signed by study subject or legally acceptable representative.
- Subject with a history of SARS-CoV-2 vaccinations within 6 months before randomization.
- Subject with a history of SARS-CoV-2 infection within 6 months before randomization.
- Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >3×Upper Limit of Normal (ULN) ,or total bilirubin (TBIL) >2×ULN.
- Creatinine clearance (Ccr, calculated by Cockcroft-Gault equation)<60 ml/min or Creatinine >1.2×ULN.
- 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.
- Previous administration of any antiretroviral drugs (e.g., antiretroviral drugs for HIV, HBV, or HCV) within 7 days before randomization.
- 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.
- 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
Related records
Drugs (1)
Collaborators (2)
- Henan Genuine Biotech Co., Ltd.
- Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd.