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NCT05675748
Real-world Study Evaluating the Efficacy and Safety of Azvudine in Nursing Home Patients
Conditions: COVID-19
Sex: All
Enrollment: 400
Sponsor: Shanghai Henlius Biotech
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.
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.
Source: ClinicalTrials.gov (NCT05675748). StuddyBuddy aggregates publicly available trial information.