A Phase 2 interventional study of Azvudine and Placebo in COVID-19, sponsored by Shanghai Henlius Biotech. Status unknown at 1 site in China. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-01-31.
Sponsored by Shanghai Henlius Biotech · Phase 2, Interventional, and Prevention
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
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.
7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.
This study's planned enrollment of 300 is above the median of 100 across 4,099 interventional studies indexed under COVID-19.
Browse COVID-19 studies →Shanghai Henlius Biotech is the lead sponsor of 127 studies on the registry; 53 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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:
Azvudine 5 mg, QD PO, D1-D7
Drug: Azvudine
Azvudine 3 mg + placebo 2 mg, QD PO, D1-D7
Drug: Azvudine · Drug: Placebo
placebo 5 mg, QD PO, D1-D7
Drug: Placebo
Azvudine is a novel nucleoside reverse transcriptase inhibitor.
Also known as: FNC
Placebo
Efficacy-Incidence of SARS-CoV-2 infection in 8 days
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.
Time frame: Day 2 to Day 7
Plan to share: No
No publications or documents are linked to this record.
This study is status unknown, as verified in Jan 2023. You cannot join it, but the record below documents what was studied.
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Shanghai Henlius Biotech