Real-world Study Evaluating the Efficacy and Safety of Azvudine in Nursing Home Patients

A Non-interventional Real-world Study Evaluating the Efficacy and Safety of Azvudine in Nursing Home Patients With Mild/Normal COVID-19

NCT05675748•Shanghai Henlius Biotech

View on ClinicalTrials.gov

Summary

This study was a multicenter, non-intervention, real world study. To evaluate the efficacy and safety of azvudine in nursing homes with mild/common COVID-19 patients. The primary outcome measure was the proportion of patients with severe/critical illness within 28 days.

Eligibility

Age

All ages

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Living in a nursing home who has taken or intends to take azvudine tablets depending on their condition;
•2. Mild/normal subjects who are SARS-CoV-2 RT-RCR positive or antigen-positive;
•3. Subjects have at least one or more of the following clinical symptoms of COVID-19 in the 24 hours prior to initial administration, including but not limited to: fever, cough, sore throat, stuffy or runny nose, headache, muscle pain, nausea, vomiting, diarrhea, shortness of breath or difficulty breathing, chills or chills;
•4. Volunteer to participate in the experiment and sign the informed consent in person or complete the informed consent over the phone.

Exclusion Criteria

•1. Subjects have received antiviral therapy, such as Paxlovid and SARS-CoV-2 monoclonal antibody therapy (except previous treatment for COVID-19 infection) before entering the study;
•2. Shortness of breath, RR≥30 times/min or resting state, oxygen saturation of finger when sucking air ≤93%;
•3. Mechanical ventilation is required or expected to be urgently required;
•4. Severe infections requiring systemic treatment within 14 days prior to initial medication;
•5. Use of other antiviral drugs (such as anti-HIV, hepatitis B, and hepatitis C drugs) within 14 days prior to the first medication.

Key Dates

Start Date

January 15, 2023

Primary Completion Date

March 15, 2023

Completion Date

April 15, 2023

Last Updated

January 13, 2023

Enrollment

400

ESTIMATED participants

Conditions

COVID-19

Interventions

Azvudine

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 13, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Real-world Study Evaluating the Efficacy and Safety of Azvudine in Nursing Home Patients

Inclusion Criteria

Exclusion Criteria

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