NCT05675748Not yet recruitingNot Applicable
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 enrollmentStarted: January 15, 2023Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 400
- Primary Endpoint
- The proportion of patients with severe/critical illness within 28 days
Study 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.
Study Design
- Study Type
- Observational
- Observational Model
- Other
- Time Perspective
- Prospective
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
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)
Investigators
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