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

COVID-19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05675748
• Other study ID #: FNC-Covid202
• Status: Not yet recruiting
• Start date: January 15, 2023
• Est. completion date: April 15, 2023

Study information

• Verified date: January 2023
• Source: Shanghai Henlius Biotech
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 400
• Est. completion date: April 15, 2023
• Est. primary completion date: March 15, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Shanghai Henlius Biotech	Huashan Hospital, Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	all-cause mortality within 28 days		up to 28 days from the first dose of Azvudine for treatment SARS-CoV-2 infection
Secondary	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