COVID-19NCT05675748
Real-world Study Evaluating the Efficacy and Safety of Azvudine in Nursing Home Patients
An observational study of COVID-19, run by Shanghai Henlius Biotech.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- COVID-19
- What is being tested?
- Azvudine
- Type of treatment
- Pill or oral medicine
- How many people
- 400 participants
- Where
- No sites listed yet
- Study dates
- 15 Jan 2023to 15 Apr 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: nursing homes patients with mild/common COVID-19 symptom
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
Official title: 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.
- Conditions
- COVID-19
- Being tested
- Azvudine
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AzvudineDrug
Azvudine tablets are taken orally 5mg daily for a maximum of 14 days
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of patients with severe/critical illness within 28 days
Measured: 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
Measured: 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
Measured: up to 28 days from the first dose of Azvudine for treatment SARS-CoV-2 infection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2023
- Study start15 Jan 2023 (estimated)
- Primary completion15 Mar 2023 (estimated)
- Study completion15 Apr 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- More trials run by Shanghai Henlius BiotechThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Henlius Biotech
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05675748
- Sponsor's protocol ID
- FNC-Covid202
- Status last verified
- Jan 2023
- First submitted
- 6 Jan 2023
- Last updated
- 13 Jan 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Non-interventional Real-world Study Evaluating the Efficacy and Safety of Azvudine in Nursing Home Patients With Mild/Normal COVID-19
- ClinicalTrials.gov ID
- NCT05675748
- Acronym / sponsor ID
- FNC-Covid202
- Conditions
- COVID-19
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Shanghai Henlius BiotechIndustry (pharma, biotech, devices)
- Collaborators
- Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd., Huashan Hospital
- Study start
- 15 Jan 2023 (estimated)
- Primary completion
- 15 Mar 2023 (estimated)
- Study completion
- 15 Apr 2023 (estimated)
- First posted
- 9 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- nursing homes patients with mild/common COVID-19 symptom
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AzvudineAzvudine tablets are taken orally 5mg daily for a maximum of 14 days | Drug | – |
Primary outcome
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
2 secondary outcomes
all-cause mortality within 28 days
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19, run by Shanghai Henlius Biotech.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2023.