Evaluate the Efficacy and Safety of Azvudine in Preventing SARS-Cov-2 Infection in Household Contacts of Covid-19

Last updated: January 5, 2023
Sponsor: Shanghai Henlius Biotech
Overall Status: Active - Recruiting

Phase

2/3

Condition

Corona Virus

Covid-19

Treatment

N/A

Clinical Study ID

NCT05633433
FNC-Covid304
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

Study 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

Eligibility Criteria

Inclusion

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 antigentest 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 beforerandomization, 2) have at least one symptom attributable to COVID-19.
  3. RT-PCR test negative (with nasopharyngeal [NP] swab samples) OR rapid antigen testnegative 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 casesduring 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

Exclusion Criteria:

  1. Subject with a history of SARS-CoV-2 vaccinations within 6 months beforerandomization.
  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 ofNormal (ULN) ,or total bilirubin (TBIL) >2×ULN.
  4. Creatinine clearance (Ccr, calculated by Cockcroft-Gault equation)<60 ml/min orCreatinine >1.2×ULN.
  5. With any serious infection requiring systemic anti-infective therapy within 14 daysbefore 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 forHIV, HBV, or HCV) within 7 days before randomization.
  9. Women of childbearing potential who are unwilling to practice highly effectivecontraception during the study, and for at least 6 months after the study; Sexuallyactive men who are unwilling to use medically acceptable birth control during thestudy period.
  10. Have other conditions not suitable for inclusion as judged by the investigator.

Study Design

Total Participants: 1550
Study Start date:
December 29, 2022
Estimated Completion Date:
July 15, 2024

Study Description

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.

Connect with a study center

  • University of Malaya Medical Centre

    Kuala Lumpur,
    Malaysia

    Site Not Available

  • International Islamic University Malaysia

    Kuantan,
    Malaysia

    Site Not Available

  • Klinik Kesihatan Cheras

    Shah Alam,
    Malaysia

    Site Not Available

  • Klinik Kesihatan Greentown

    Shah Alam,
    Malaysia

    Site Not Available

  • Klinik Kesihatan Kuala Kedah

    Shah Alam,
    Malaysia

    Site Not Available

  • Klinik Kesihatan Mahmoodiah

    Shah Alam,
    Malaysia

    Site Not Available

  • ALPS Medical Center

    Shah Alam,,
    Malaysia

    Site Not Available

  • Cebu Doctors' University Hospitol

    Cebu City,
    Philippines

    Active - Recruiting

  • Perpetual Succour Hospital

    Cebu City,
    Philippines

    Site Not Available

  • University of the East Ramon Magsaysay Memorial Medical Center

    Quezon City,
    Philippines

    Site Not Available

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