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

FNC-Covid202

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.

2023-01-15

2023-03-15

2023-04-15

Not yet recruiting

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.

{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'OTHER', 'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'count': 400, 'type': 'ESTIMATED'}}

2023-01-13