COVID-19NCT06006611
Risk Factors for Severe Disease in Hospitalized Patients With COVID-19 and the Effect of Azvudine Treatment: a Retrospective Cohort Study
An observational study of COVID-19, run by Fifth Affiliated Hospital, Sun Yat-Sen University at 1 site in China.
Trial summary
The purpose of this study is to explore the factors that can affect the development of severe cases in hospitalized patients with COVID-19, including basic diseases, laboratory parameters, and clinical manifestations; In addition,to explore whether Azvudine can reduce the mortality of hospitalized patients with… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19
- What is being tested?
- Azvudine
- How many people
- 4,201 participants
- Where
- 1 siteChina
- Study dates
- 5 Aug 2023to 30 Oct 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The COVID-19 positive patients
Who may be able to join
- The COVID-19 positive patients
Who cannot join
- patients treated with both azvudine and monotamivir;
- patients receiving other antiviral drugs such as nematavir/ritonavir;
- age \< 18 years old
Trial locations and contacts
1 site in 1 country.
China1 site
The Fifth Affiliated Hospital of Sun Yat-sen University
Zhuhai, Guangdong, 519000
About this study
Official title: Risk Factors for Severe Disease in Hospitalized Patients With COVID-19 and the Effect
The purpose of this study is to explore the factors that can affect the development of severe cases in hospitalized patients with COVID-19, including basic diseases, laboratory parameters, and clinical manifestations; In addition,to explore whether Azvudine can reduce the mortality of hospitalized patients with COVID-19.
Read the detailed description
4201 COVID-19 patients discharged from our hospital were enrolled. Binary logistic regression analysis and ROC curve were used to investigate the role of comorbidities, laboratory parameters and clinical manifestation on progression of COVID-19 patients. We used propensity-score models conditional on baseline characteristics and Univariate Cox regression model to examine whether Azvudine can reduce the mortality of COVID-19 patients.
- Conditions
- COVID-19
- Being tested
- Azvudine
- Keywords
- COVID-19, Azvudine, severity
- 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
Received antiviral treatment with azvudine
| Study group | Role | What they receive |
|---|---|---|
| Azvudine group | Azvudine group included COVID-19 patients treated with azvudine antiviral therapy; Receives: Drug: Azvudine | |
| No antiviral group | No antiviral group included COVID-19 patients treated with no antiviral therapy; | |
| Monotamivir | Monotamivir group included COVID-19 patients treated with monotamivir antiviral therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
All-cause mortality of COVID-19 patients
All-cause mortality of COVID-19 patients
Measured: Time from onset to death
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2023
- Study start5 Aug 2023
- Primary completion25 Oct 2023 (estimated)
- Study completion30 Oct 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.
- 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 4,201 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fifth Affiliated Hospital, Sun Yat-Sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06006611
- Sponsor's protocol ID
- ZDWY.BAS.001
- Status last verified
- Aug 2023
- First submitted
- 21 Aug 2023
- Last updated
- 21 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Publication of academic papers
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk Factors for Severe Disease in Hospitalized Patients With COVID-19 and the Effect
- ClinicalTrials.gov ID
- NCT06006611
- Acronym / sponsor ID
- ZDWY.BAS.001
- Conditions
- COVID-19
- Keywords
- COVID-19, Azvudine, severity
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 4,201 participants (estimated)
- Lead sponsor
- Fifth Affiliated Hospital, Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- 5 Aug 2023 (actual)
- Primary completion
- 25 Oct 2023 (estimated)
- Study completion
- 30 Oct 2023 (estimated)
- First posted
- 23 Aug 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.
The purpose of this study is to explore the factors that can affect the development of severe cases in hospitalized patients with COVID-19, including basic diseases, laboratory parameters, and clinical manifestations; In addition,to explore whether Azvudine can reduce the mortality of hospitalized patients with COVID-19.
Detailed description
4201 COVID-19 patients discharged from our hospital were enrolled. Binary logistic regression analysis and ROC curve were used to investigate the role of comorbidities, laboratory parameters and clinical manifestation on progression of COVID-19 patients. We used propensity-score models conditional on baseline characteristics and Univariate Cox regression model to examine whether Azvudine can reduce the mortality of COVID-19 patients.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Azvudine group | – | Drug: AzvudineAzvudine group included COVID-19 patients treated with azvudine antiviral therapy; |
| No antiviral group | – | –No antiviral group included COVID-19 patients treated with no antiviral therapy; |
| Monotamivir | – | –Monotamivir group included COVID-19 patients treated with monotamivir antiviral therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The COVID-19 positive patients
Key inclusion criteria (1 listed)
- The COVID-19 positive patients
Key exclusion criteria (3 listed)
- patients treated with both azvudine and monotamivir;
- patients receiving other antiviral drugs such as nematavir/ritonavir;
- age \< 18 years old
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 |
|---|---|---|
| AzvudineReceived antiviral treatment with azvudine | Drug | Azvudine group |
Primary outcome
All-cause mortality of COVID-19 patients
Time frame: Time from onset to death
All-cause mortality of COVID-19 patients
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2023.
- Individual participant dataSharing planned: No. Publication of academic papers
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19, run by Fifth Affiliated Hospital, Sun Yat-Sen University at 1 site in China.
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 1 inclusion and 3 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 21 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
All-cause mortality of COVID-19 patients (time frame: Time from onset to death). 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 21 Sep 2023.