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

January 11, 2023 updated by: Shanghai Henlius Biotech

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

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.

Study Overview

Status

Not yet recruiting

Conditions

COVID-19

Intervention / Treatment

Drug: Azvudine

Study Type

Observational

Enrollment (Anticipated)

400

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

Child
Adult
Older Adult

Accepts Healthy Volunteers

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

nursing homes patients with mild/common COVID-19 symptom

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Observational Models: Other
Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The proportion of patients with severe/critical illness within 28 days Time Frame: up to 28 days from the first dose of Azvudine for treatment SARS-CoV-2 infection	up to 28 days from the first dose of Azvudine for treatment SARS-CoV-2 infection

Secondary Outcome Measures

Outcome Measure	Time Frame
all-cause mortality within 28 days Time Frame: up to 28 days from the first dose of Azvudine for treatment SARS-CoV-2 infection	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 Time Frame: up to 28 days from the first dose of Azvudine for treatment SARS-CoV-2 infection	up to 28 days from the first dose of Azvudine for treatment SARS-CoV-2 infection

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Henlius Biotech

Collaborators

Huashan Hospital

Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

January 15, 2023

Primary Completion (Anticipated)

March 15, 2023

Study Completion (Anticipated)

April 15, 2023

Study Registration Dates

First Submitted

January 6, 2023

First Submitted That Met QC Criteria