UnknownNot Applicable

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

400 participantsStarted 2023-01-15

Plain-language 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.

Who can participate

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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;

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

The proportion of patients with severe/critical illness within 28 days

Timeframe: up to 28 days from the first dose of Azvudine for treatment SARS-CoV-2 infection

Trial details

NCT IDNCT05675748

SponsorShanghai Henlius Biotech

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2023-03-15

View on ClinicalTrials.gov More COVID-19 trials

Who can participate

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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;