NCT05682599

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for phase_2 covid19

Timeline
Completed

Started Jan 2023

Shorter than P25 for phase_2 covid19

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

January 6, 2023

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

January 10, 2023

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 12, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 15, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 15, 2023

Completed
Last Updated

January 31, 2023

Status Verified

January 1, 2023

Enrollment Period

3 months

First QC Date

January 10, 2023

Last Update Submit

January 28, 2023

Conditions

COVID-19

Outcome Measures

Primary Outcomes (1)

  • 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.

    Day 2 to Day 7

Study Arms (3)

A：Azvudine 5 mg

EXPERIMENTAL

Azvudine 5 mg, QD PO, D1-D7

Drug: Azvudine

B：Azvudine 3 mg

EXPERIMENTAL

Azvudine 3 mg + placebo 2 mg, QD PO, D1-D7

Drug: AzvudineDrug: Placebo

C：placebo

PLACEBO COMPARATOR

placebo 5 mg, QD PO, D1-D7

Drug: Placebo

Interventions

AzvudineDRUG

Azvudine is a novel nucleoside reverse transcriptase inhibitor.

Also known as: FNC
A：Azvudine 5 mgB：Azvudine 3 mg
PlaceboDRUG

Placebo

B：Azvudine 3 mgC：placebo

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 、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.
  • 、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.

You may not qualify if:

  • Subject with a history of SARS-CoV-2 vaccinations within 1 months before randomization.
  • Subject with a history of SARS-CoV-2 infection within 6 months before randomization.
  • 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.
  • 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 (1)

Huashan Hospital

Shanghai, Shanghai Municipality, China

RECRUITING

MeSH Terms

Conditions

COVID-19

Interventions

azvudine

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • chen mingquan

    Huashan Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

chen mingquan

CONTACT

52889999hsmqchen@gmail.com

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

January 10, 2023

First Posted

January 12, 2023

Study Start

January 6, 2023

Primary Completion

April 15, 2023

Study Completion

May 15, 2023

Last Updated

January 31, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)