COVID-19 Respiratory InfectionNCT05621993
An Observational, Ambispective Cohort Study of Azvudine in the Treatment of Patients With COVID-19 Pneumonia
An observational study of COVID-19 Respiratory Infection, run by Qianfoshan Hospital at 1 site in China.
Trial summary
This is a multicenter, ambispective observational cohort study. The patients with corona virus disease 2019 (COVID-19) will be included in the study. The patients will be divided into 4 groups according to the treatment mode (Azvudine treatment group within 48 hours after the first positive for nucleic acid, Azvudine… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- COVID-19 Respiratory Infection
- What is being tested?
- Azvudine
- How many people
- 500 participants
- Where
- 1 siteChina
- Study dates
- 22 Nov 2022to 31 Dec 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All the patients who were diagnosed as COVID-19 pneumonia will be included in the study.
Who may be able to join
- Patients with confirmed diagnosis of COVID-19 pneumonia
- Patients with the ability to take medication orally
Who cannot join
- Severe vomiting and difficulty in taking oral medication or ingestion of drugs after oral administration
- Suspected or confirmed active systemic infection other than COVID-19 pneumonia
- Pregnant or lactating women
- Patients with mental disorders
- Patients with severe liver damage
- Patients who are treated with small molecule drugs such as Nirmatrelvir Tablets/Ritonavir Tablets(co-packaged)
- Patients who are treated with RNA-dependent RNA polymerase (RDRP) inhibitors (Junshipharma VV116, Ascletis Pharma Inc. Asc10, Kexing biopharm Shen26, and Molnupiravir).
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of Respiratory, The First Affiliated Hospital of Shandong First Medical University & Shandong Provincial Qianfoshan Hospital, #16766, Jingshi Road, Jinan City, Shandong Province, China
Jinan, Shandong
Qian Qi, Dr., +86 13706380314, qiqianqlh@163.com
About this study
Official title: Efficacy and Safety of Azvudine in the Treatment of Patients With Corona Virus Disease (COVID-19) Pneumonia in China: an Multi-center Observational, Ambispective Cohort, Real-world Study
This is a multicenter, ambispective observational cohort study. The patients with corona virus disease 2019 (COVID-19) will be included in the study. The patients will be divided into 4 groups according to the treatment mode (Azvudine treatment group within 48 hours after the first positive for nucleic acid, Azvudine treatment group after 48 hours after the first positive for nucleic acid, short course of Azvudine treatment without nucleic acid turning negative, and the control group) . This study aims to analyze the efficacy and safety of Azvudine in the treatment of patients with COVID-19.
- Conditions
- COVID-19 Respiratory Infection
- Being tested
- Azvudine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AzvudineDrug
Azvudine is a small molecular antiviral drug. On August 9, 2022, Azvudine was included in the Diagnostic and therapeutic protocol for COVID-9 in China.
| Study group | Role | What they receive |
|---|---|---|
| Combination therapy group | Patients who are treated with the combination therapy of Azvudine and Chinese herbal medicine will be included in this group. The combination therapy is Azvudine treatment (5 mg once a day) within 48 hours of first positive nucleic acid testing for COVID-19, combined with Chinese herbal medicine treatment. Receives: Drug: Azvudine | |
| Sequential therapy group | Patients who are treated with the sequential therapy of Azvudine and Chinese herbal medicine will be included in this group. The sequential therapy is Azvudine treatment (5 mg once a day) after 48 hours of first positive nucleic acid testing for COVID-19, combined with Chinese herbal medicine treatment. Receives: Drug: Azvudine | |
| Non-standard therapy group | Patients are treated with Azvudine combined with Chinese herbal medicine treatment. But Azvudine treatment is discontinued before the nucleic acid turns negative. Receives: Drug: Azvudine | |
| The control group | Patients are treated with Chinese herbal medicine without Azvudine. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time from positive nucleic acid to negative
The time from the day when patients are first positive nucleic acid to the day when the Ct value of nucleic acid test is ≥35 or the result of nucleic acid test is negative.
Measured: every 3 days
Secondary outcomes (2)
Proportion of patients with relapsed positive nucleic acid test within 28 days after negative
Measured: up tp 28 days
Proportion of patients with adverse events
Measured: up tp 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2022
- Study start22 Nov 2022
- Primary completion16 Nov 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19 Respiratory InfectionStudies of the same condition, open and under way.
- More trials run by Qianfoshan HospitalThe 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
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qianfoshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Qian Qi, Qianfoshan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05621993
- Sponsor's protocol ID
- 2022-11-16-QFS
- Status last verified
- Sep 2023
- First submitted
- 16 Nov 2022
- Last updated
- 3 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Azvudine in the Treatment of Patients With Corona Virus Disease (COVID-19) Pneumonia in China: an Multi-center Observational, Ambispective Cohort, Real-world Study
- ClinicalTrials.gov ID
- NCT05621993
- Acronym / sponsor ID
- 2022-11-16-QFS
- Conditions
- COVID-19 Respiratory Infection
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Qianfoshan HospitalUniversity, hospital or other
- Study start
- 22 Nov 2022 (actual)
- Primary completion
- 16 Nov 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 18 Nov 2022 (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 is a multicenter, ambispective observational cohort study. The patients with corona virus disease 2019 (COVID-19) will be included in the study. The patients will be divided into 4 groups according to the treatment mode (Azvudine treatment group within 48 hours after the first positive for nucleic acid, Azvudine treatment group after 48 hours after the first positive for nucleic acid, short course of Azvudine treatment without nucleic acid turning negative, and the control group) . This study aims to analyze the efficacy and safety of Azvudine in the treatment of patients with COVID-19.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Combination therapy group | – | Drug: AzvudinePatients who are treated with the combination therapy of Azvudine and Chinese herbal medicine will be included in this group. The combination therapy is Azvudine treatment (5 mg once a day) within 48 hours of first positive nucleic acid testing for COVID-19, combined with Chinese herbal medicine treatment. |
| Sequential therapy group | – | Drug: AzvudinePatients who are treated with the sequential therapy of Azvudine and Chinese herbal medicine will be included in this group. The sequential therapy is Azvudine treatment (5 mg once a day) after 48 hours of first positive nucleic acid testing for COVID-19, combined with Chinese herbal medicine treatment. |
| Non-standard therapy group | – | Drug: AzvudinePatients are treated with Azvudine combined with Chinese herbal medicine treatment. But Azvudine treatment is discontinued before the nucleic acid turns negative. |
| The control group | – | –Patients are treated with Chinese herbal medicine without Azvudine. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All the patients who were diagnosed as COVID-19 pneumonia will be included in the study.
Key inclusion criteria (2 listed)
- Patients with confirmed diagnosis of COVID-19 pneumonia
- Patients with the ability to take medication orally
Key exclusion criteria (7 listed)
- Severe vomiting and difficulty in taking oral medication or ingestion of drugs after oral administration
- Suspected or confirmed active systemic infection other than COVID-19 pneumonia
- Pregnant or lactating women
- Patients with mental disorders
- Patients with severe liver damage
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 is a small molecular antiviral drug. On August 9, 2022, Azvudine was included in the Diagnostic and therapeutic protocol for COVID-9 in China. | Drug | Combination therapy group, Non-standard therapy group, Sequential therapy group |
Primary outcome
Time from positive nucleic acid to negative
Time frame: every 3 days
The time from the day when patients are first positive nucleic acid to the day when the Ct value of nucleic acid test is ≥35 or the result of nucleic acid test is negative.
2 secondary outcomes
Proportion of patients with relapsed positive nucleic acid test within 28 days after negative
Time frame: up tp 28 days
Proportion of patients with adverse events
Time frame: up tp 28 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2023.
- Individual participant dataSharing planned: No
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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.
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 Respiratory Infection, run by Qianfoshan Hospital 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 2 inclusion and 7 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 3 Oct 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?
Contact Qian Qi, Dr. (+86 13706380314, qiqianqlh@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time from positive nucleic acid to negative (time frame: every 3 days). 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 3 Oct 2023.