COVID-19NCT06349655
The Real-world Clinical Study of Azvudine Tablets in the Treatment of COVID-19
An observational study of COVID-19 and Azvudine, run by The First Affiliated Hospital of Zhengzhou University at 1 site in China.
Trial summary
To establish a real-world clinical cohort and database of Azvudine in the treatment of SARS-CoV-2 infection, and to provide stable and reliable evidence for the clinical efficacy and safety evaluation of azvudine in the treatment of SARS-CoV-2 infection. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Azvudine and Paxlovid
- How many people
- 32,864 participants
- Where
- 1 siteChina
- Study dates
- 5 Dec 2023to 10 Mar 2024
- 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: People who have COVID-19 and have an indication for Azvudine or Paxlovid.
Who may be able to join
- Age above 18 years old (including the cut-off value), regardless of gender;
- Patients diagnosed with 2019-ncov infection according to the diagnostic criteria of the latest edition of the Diagnosis and Treatment Plan for 2019-ncov Pneumonia issued by the Health Commission of China;
- Informed consent has been signed.
Who cannot join
- Known or suspected allergic to the components of Azivudine tablets;
- Patients with severe liver, kidney, heart and other organ damage;
- Pregnant or lactating women who planned to give birth during or within 6 months after the trial;
- Had participated in other clinical trials or were using investigational drugs within 12 weeks before medication;
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450052
About this study
Official title: Real-World Effectiveness and Safety of Oral Azvudine in Hospitalized Patients With COVID-19: A Multicenter, Retrospective, Cohort Study
To establish a real-world clinical cohort and database of Azvudine in the treatment of SARS-CoV-2 infection, and to provide stable and reliable evidence for the clinical efficacy and safety evaluation of azvudine in the treatment of SARS-CoV-2 infection.
- Being tested
- Azvudine, Paxlovid
- 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
Antiviral drug
PaxlovidDrug
Also called Nirmatrelvir/Ritonavir
Antiviral drug
| Study group | Role | What they receive |
|---|---|---|
| Azvudine | COVID-19 patients with Azvudine treatment Receives: Drug: Azvudine | |
| Paxlovid | COVID-19 patients with Paxlovid treatment Receives: Drug: Paxlovid | |
| Control | COVID-19 Patients who have not been treated with Azvudine or Paxlovid |
What is being measured
The primary outcome is the main question the study is designed to answer.
All-cause death
All-cause death was ascertained by electronic medical records.
Measured: Up to 30 days (form the date of confirmed COVID-19)
Secondary outcomes (1)
Composite disease progression
Disease progression is defined as the occurrence of death, progression to severe or critical disease in mild or moderate patients, and the occurrence of death, progression to critical disease in severe patients. Severe disease is defined as respiratory rate ≥ 30 times/minute, or resting oxygen saturation ≤ 93%, or PaO2/FiO2 ≤ 300 mmHg, or lung lesions progressing >50% at 24-48 hours. Critical disease is defined as the need for mechanical ventilation, or shock, or ICU monitoring.
Measured: Up to 30 days (form the date of confirmed COVID-19)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2024
- Study start5 Dec 2023
- Primary completion15 Jan 2024
- Study completion10 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for COVID-19Studies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital of Zhengzhou UniversityThe 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 32,864 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Henan Provincial Chest Hospital, The Affiliated Infectious Disease Hospital of Zhengzhou University, The Fifth People's Hospital of Anyang, Shangqiu Municipal Hospital, Nanyang Central Hospital, Luoyang Central Hospital, Guangshan County People's Hospital, Fengqiu County People's Hospital
- Responsible party
- Principal investigator, Zhigang Ren, The First Affiliated Hospital of Zhengzhou University
- Investigators
- Zujiang Yu, Dr., Study director, The First Affiliated Hospital of Zhengzhou University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06349655
- Sponsor's protocol ID
- 2023-KY-0865-001
- Status last verified
- Apr 2024
- First submitted
- 2 Apr 2024
- Last updated
- 5 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Wang F, Jia B, Li G, Jin X, Yang M, Li G, Zhang S, Qian G, Luo H, Cheng M, Wang L, Zhang D, Li S, Liang H, Ren Z. Real-world effectiveness and safety of oral azvudine versus Paxlovid in patients with COVID-19 and pre-existing hypertension: a multicentre, retrospective, cohort study in Henan Province, China. BMJ Open. 2025 Jun 27;15(6):e090230. doi: 10.1136/bmjopen-2024-090230.
PubMed 40578868Su G, Gao F, Yang M, Wang L, Liang L, Li S, Li G, Han N, Li G, Qian G, Zhang S, Luo H, Zhang D, Liang H, Ren Z. Effectiveness of azvudine versus nirmatrelvir/ritonavir for hospitalized patients with SARS-CoV-2 infection and pre-existing liver diseases. Virol J. 2025 May 19;22(1):147. doi: 10.1186/s12985-025-02771-1.
PubMed 40389963
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-World Effectiveness and Safety of Oral Azvudine in Hospitalized Patients With COVID-19: A Multicenter, Retrospective, Cohort Study
- ClinicalTrials.gov ID
- NCT06349655
- Acronym / sponsor ID
- 2023-KY-0865-001
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 32,864 participants (actual)
- Lead sponsor
- The First Affiliated Hospital of Zhengzhou UniversityUniversity, hospital or other
- Collaborators
- Henan Provincial Chest Hospital, The Affiliated Infectious Disease Hospital of Zhengzhou University, The Fifth People's Hospital of Anyang, Shangqiu Municipal Hospital, Nanyang Central Hospital, Luoyang Central Hospital, Guangshan County People's Hospital, Fengqiu County People's Hospital
- Study start
- 5 Dec 2023 (actual)
- Primary completion
- 15 Jan 2024 (actual)
- Study completion
- 10 Mar 2024 (actual)
- First posted
- 5 Apr 2024 (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.
To establish a real-world clinical cohort and database of Azvudine in the treatment of SARS-CoV-2 infection, and to provide stable and reliable evidence for the clinical efficacy and safety evaluation of azvudine in the treatment of SARS-CoV-2 infection.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Azvudine | – | Drug: AzvudineCOVID-19 patients with Azvudine treatment |
| Paxlovid | – | Drug: PaxlovidCOVID-19 patients with Paxlovid treatment |
| Control | – | –COVID-19 Patients who have not been treated with Azvudine or Paxlovid |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- People who have COVID-19 and have an indication for Azvudine or Paxlovid.
Key inclusion criteria (3 listed)
- Age above 18 years old (including the cut-off value), regardless of gender;
- Patients diagnosed with 2019-ncov infection according to the diagnostic criteria of the latest edition of the Diagnosis and Treatment Plan for 2019-ncov Pneumonia issued by the Health Commission of China;
- Informed consent has been signed.
Key exclusion criteria (4 listed)
- Known or suspected allergic to the components of Azivudine tablets;
- Patients with severe liver, kidney, heart and other organ damage;
- Pregnant or lactating women who planned to give birth during or within 6 months after the trial;
- Had participated in other clinical trials or were using investigational drugs within 12 weeks before 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 |
|---|---|---|
| AzvudineAntiviral drug | Drug | Azvudine |
| PaxlovidAlso: Nirmatrelvir/RitonavirAntiviral drug | Drug | Paxlovid |
Primary outcome
All-cause death
Time frame: Up to 30 days (form the date of confirmed COVID-19)
All-cause death was ascertained by electronic medical records.
1 secondary outcome
Composite disease progression
Time frame: Up to 30 days (form the date of confirmed COVID-19)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2024.
- Derived from this study: PubMed 40578868Wang F, Jia B, Li G, Jin X, Yang M, Li G, Zhang S, Qian G, Luo H, Cheng M, Wang L, Zhang D, Li S, Liang H, Ren Z. Real-world effectiveness and safety of oral azvudine versus Paxlovid in patients with COVID-19 and pre-existing hypertension: a multicentre, retrospective, cohort study in Henan Province, China. BMJ Open. 2025 Jun 27;15(6):e090230. doi: 10.1136/bmjopen-2024-090230.
- Derived from this study: PubMed 40389963Su G, Gao F, Yang M, Wang L, Liang L, Li S, Li G, Han N, Li G, Qian G, Zhang S, Luo H, Zhang D, Liang H, Ren Z. Effectiveness of azvudine versus nirmatrelvir/ritonavir for hospitalized patients with SARS-CoV-2 infection and pre-existing liver diseases. Virol J. 2025 May 19;22(1):147. doi: 10.1186/s12985-025-02771-1.
- Individual participant dataSharing planned: Undecided
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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.
Zujiang Yu, Dr. study director
The First Affiliated Hospital of Zhengzhou University
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 and Azvudine, run by The First Affiliated Hospital of Zhengzhou 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 3 inclusion and 4 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: finished, as of the sponsor's last update on 5 Apr 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 death (time frame: Up to 30 days (form the date of confirmed COVID-19)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06349655, which also lists 2 linked publications.
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 5 Apr 2024.