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

NCT05675748 | Unknown

• 1 other identifier: FNC-Covid202
• Study Type: observational
• Target: 400
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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

Interventions

Azvudine DRUG

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

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

nursing homes patients with mild/common COVID-19 symptom

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Henlius Biotech: lead
• Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd.: collaborator
• Huashan Hospital: collaborator

MeSH Terms

Conditions

COVID-19

Interventions

azvudine

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 6, 2023
• First Posted: January 9, 2023
• Study Start: January 15, 2023
• Primary Completion: March 15, 2023
• Study Completion: April 15, 2023
• Last Updated: January 13, 2023

Record last verified: 2023-01