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

Shanghai Henlius Biotech0 sites400 target enrollmentJanuary 15, 2023

ConditionsCOVID-19

DrugsAzvudine

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: COVID-19
Sponsor: Shanghai Henlius Biotech
Enrollment: 400
Primary Endpoint: The proportion of patients with severe/critical illness within 28 days
Status: Not yet recruiting
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

January 15, 2023

End Date

April 15, 2023

Last Updated

3 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Shanghai Henlius Biotech

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Living in a nursing home who has taken or intends to take azvudine tablets depending on their condition;
•Mild/normal subjects who are SARS-CoV-2 RT-RCR positive or antigen-positive;
•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;
•Volunteer to participate in the experiment and sign the informed consent in person or complete the informed consent over the phone.

Exclusion Criteria

•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;
•Shortness of breath, RR≥30 times/min or resting state, oxygen saturation of finger when sucking air ≤93%;
•Mechanical ventilation is required or expected to be urgently required;
•Severe infections requiring systemic treatment within 14 days prior to initial medication;
•Use of other antiviral drugs (such as anti-HIV, hepatitis B, and hepatitis C drugs) within 14 days prior to the first medication.

Outcomes

Primary Outcomes

The proportion of patients with severe/critical illness within 28 days

Time Frame: up to 28 days from the first dose of Azvudine for treatment SARS-CoV-2 infection

Secondary Outcomes

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)