Real-world Study Evaluating the Efficacy and Safety of Azvudine in Nursing Home Patients
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
Study Design
Outcome Measures
Primary Outcome Measures
- 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
- 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]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Living in a nursing home who has taken or intends to take azvudine tablets depending on their condition;
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Mild/normal subjects who are SARS-CoV-2 RT-RCR positive or antigen-positive;
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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;
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Volunteer to participate in the experiment and sign the informed consent in person or complete the informed consent over the phone.
Exclusion Criteria:
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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;
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Shortness of breath, RR≥30 times/min or resting state, oxygen saturation of finger when sucking air ≤93%;
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Mechanical ventilation is required or expected to be urgently required;
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Severe infections requiring systemic treatment within 14 days prior to initial medication;
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Use of other antiviral drugs (such as anti-HIV, hepatitis B, and hepatitis C drugs) within 14 days prior to the first medication.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Shanghai Henlius Biotech
- Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd.
- Huashan Hospital
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- FNC-Covid202