Real-world Study Evaluating the Efficacy and Safety of Azvudine in Nursing Home Patients

NCT ID: NCT05675748

Last Updated: 2023-01-13

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 400 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-01-15
• Study Completion Date: 2023-04-15

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.

Conditions

COVID-19

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Interventions

Azvudine

Azvudine tablets are taken orally 5mg daily for a maximum of 14 days

Intervention Type: DRUG

Eligibility Criteria

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.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd.

INDUSTRY

Sponsor Role: collaborator

Huashan Hospital

OTHER

Sponsor Role: collaborator

Shanghai Henlius Biotech

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

FNC-Covid202

Identifier Type: -

Identifier Source: org_study_id