A Phase II/III Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate theEfficacy and Safety of Azvudine in Preventing SARS-Cov-2 Infection in Household Contactsof Individuals Infected with SARS-CoV-2
The study has two parts:
Part 1 is a multicentre, randomized, double-blind, placebo-controlled phase II clinical
study to evaluate the efficacy and safety of Azvudine versus placebo in preventing
SARS-CoV-2 infection in household contacts with SARS-CoV-2 infection individuals. The
population of part 1 will consist of approximately 450 adults with household contact
exposure to individuals with a confirmed SARS-CoV-2 infection.A phase III study will be
further conducted if any of the treatment groups reduce SARS-CoV-2 infection rate
(Relative risk reduction) > 50% compared with the placebo group.
Part 2 is a multicentre, randomized, double-blind, placebo-controlled phase III clinical
study. The subject sample size will be calculated based on the results of the Phase II
trial.
Phase II and phase III studies have the same objectives and primary/secondary end points.
The primary endpoint is the proportion of subjects with positive SARS-CoV-2 RT-PCR assay
in 7 days. Nasopharyngeal swabs will be collected at D2, D4, D7, D10, and D14 by RT-PCR
to confirm SARS-CoV-2 infection.
Drug: Azvudine
Azvudine is a novel nucleoside reverse transcriptase inhibitor.
Other Name: FNC
Drug: Placebo
Placebo
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.
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
Gerard S. Garcia, M.D.
+63324169341
cduhrec@gmail.com
Gerard S. Garcia, M.D., Principal Investigator
Cebu Doctor's University Hospital