A Phase II Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacyand Safety of Azvudine in Preventing SARS-Cov-2 Infection in Household Contacts ofIndividuals Infected with SARS-CoV-2 in China
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.Approximately 300
adults with household contact exposure to individuals with a confirmed SARS-CoV-2
infection will be enrolled.
Drug: Azvudine
Azvudine is a novel nucleoside reverse transcriptase inhibitor.
Other Name: FNC
Drug: Placebo
Placebo
Inclusion Criteria:
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.
Exclusion Criteria:
1. Subject with a history of SARS-CoV-2 vaccinations within 1 months before
randomization.
2. Subject with a history of SARS-CoV-2 infection within 6 months before randomization.
3. With any serious infection requiring systemic anti-infective therapy within 14 days
before randomization.
4. Allergic to the investigational agent or any components of the formulation. Pregnant
or breast-feeding women.
5. 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.
6. Have other conditions not suitable for inclusion as judged by the investigator.
Huashan Hospital
Shanghai, Shanghai, China
Investigator: zhang wenhong
Contact: 52889999
hsmqchen@gmail.com
chen mingquan
52889999
hsmqchen@gmail.com
chen mingquan, Principal Investigator
Huashan Hospital