Evaluate the Efficacy and Safety of Azvudine in Preventing SARS-Cov-2 Infection in Household Contacts of Covid-19
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
1 other identifier
interventional
1,550
2 countries
10
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Dec 2022
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 30, 2022
CompletedFirst Posted
Study publicly available on registry
December 1, 2022
CompletedStudy Start
First participant enrolled
December 29, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 15, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
July 15, 2024
CompletedJanuary 9, 2023
January 1, 2023
1.5 years
November 30, 2022
January 5, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Efficacy-Incidence of SARS-CoV-2 infection in 7 days
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.
Day 2 to Day 7
Secondary Outcomes (17)
Incidence of asymptomatic SARS-CoV-2 infection in 7 days
Day 2 to Day 7
Incidence of symptomatic SARS-CoV-2 infection in 7 days
Day 2 to Day 7
Incidence of SARS-CoV-2 infection in 14 days
Day 2 to Day 14
Incidence of asymptomatic SARS-CoV-2 infection in 14 days
Day 2 to Day 14
Incidence of symptomatic SARS-CoV-2 infection in 14 days
Day 2 to Day 14
- +12 more secondary outcomes
Study Arms (5)
cohort A （Phase II）
EXPERIMENTALAzvudine 5 mg, QD PO, D1-D7
cohort B （Phase II）
EXPERIMENTALAzvudine 3 mg + placebo 2 mg, QD PO, D1-D7
cohort C （Phase II）
PLACEBO COMPARATORplacebo 5 mg, QD PO, D1-D7
Arm 1 (Phase III)
EXPERIMENTALAzvudine, dose to be determined according to phase II, QD PO, D1-D7
Arm 2 (Phase III)
PLACEBO COMPARATORPlacebo, dose to be the same as Arm1, QD PO, D1-D7
Interventions
Eligibility Criteria
You may qualify if:
- ≥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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (10)
University of Malaya Medical Centre
Kuala Lumpur, Malaysia
International Islamic University Malaysia
Kuantan, Malaysia
ALPS Medical Center
Shah Alam, Malaysia
Klinik Kesihatan Cheras
Shah Alam, Malaysia
Klinik Kesihatan Greentown
Shah Alam, Malaysia
Klinik Kesihatan Kuala Kedah
Shah Alam, Malaysia
Klinik Kesihatan Mahmoodiah
Shah Alam, Malaysia
Cebu Doctors' University Hospitol
Cebu City, Philippines
Perpetual Succour Hospital
Cebu City, Philippines
University of the East Ramon Magsaysay Memorial Medical Center
Quezon City, Philippines
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Gerard S. Garcia, M.D.
Cebu Doctor's University Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 30, 2022
First Posted
December 1, 2022
Study Start
December 29, 2022
Primary Completion
June 15, 2024
Study Completion
July 15, 2024
Last Updated
January 9, 2023
Record last verified: 2023-01
Data Sharing
- IPD Sharing
- Will not share