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

Not yet recruiting

• Conditions: COVID-19

• Registration Number: NCT05675748
• Lead Sponsor: Shanghai Henlius Biotech

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-01
• Study First Submitted: 2023-01-06
• Study First Submitted QC: 2023-01-06
• Study First Posted: 2023-01-09
• Last Update Submitted: 2023-01-11
• Last Update Posted: 2023-01-13
• Study Start: 2023-01-15
• Primary Completion: 2023-03-15
• Study Completion: 2023-04-15

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 400

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The proportion of patients with severe/critical illness within 28 days	up to 28 days from the first dose of Azvudine for treatment SARS-CoV-2 infection

Secondary Outcome Measures

Name	Time	Method
all-cause mortality within 28 days	up to 28 days from the first dose of Azvudine for treatment SARS-CoV-2 infection
Proportion of hospitalization within 28 days and the duration of hospitalization	up to 28 days from the first dose of Azvudine for treatment SARS-CoV-2 infection