2019 Novel Coronavirus PneumoniaNCT04275388
Xiyanping Injection for the Treatment of New Coronavirus Infected Pneumonia
An observational study of 2019 Novel Coronavirus Pneumonia, run by Jiangxi Qingfeng Pharmaceutical Co. Ltd..
Trial summary
the investigators conduct a randomized, open-label trial to evaluate and compare the safety and efficacy of Xiyanping injection in patients with 2019-nCoV pneumonia. Read more about this study
- Who is it for?
- Ages Up to 100 years
- Conditions the study is for
- 2019 Novel Coronavirus Pneumonia
- What is being tested?
- Xiyanping injection and Lopinavir / ritonavir, alpha-interferon nebulization,Abidor Hydrochloride
- Type of treatment
- Pill or oral medicine, Injection or infusion
- How many people
- 426 participants
- Where
- No sites listed yet
- Study dates
- 15 May 2020to 14 Dec 2021
- 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 Up to 100 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients diagnosed with new coronary pneumonia
Who may be able to join
- Laboratory examination (RT-PCR) confirms the infection 2019-nCoV, which meets the diagnostic criteria for pneumonia (common type) in the New Coronavirus Infection Pneumonia Diagnosis and Treatment Program (Trial Version 6);
- The patient has a complete hospitalization record that can be used for research.
Who cannot join
- -
- Subjects who meet any of the following criteria cannot be enrolled:
- Suffering from diseases that need to be distinguished from pneumonia infected with new coronavirus, such as tuberculosis, bacterial or viral pneumonia other than new coronavirus pneumonia, hospital-acquired pneumonia, and other pathogenic microorganisms pneumonia;
- People with basic diseases such as primary immunodeficiency disease, acquired immunodeficiency syndrome, congenital respiratory tract malformations, abnormal lung development, aspiration pneumonia, and lung malignant tumors;
- According to the judgment of the investigator, the previous or current disease may affect the patient's participation in the trial or the outcome of the study, including: malignant disease, autoimmune disease, liver and kidney disease, blood disease, neurological disease, and endocrine Disease; presently suffering from diseases that seriously affect the immune system, such as: human immunodeficiency virus (HIV) infection, or blood system, or splenectomy, organ transplantation, etc;
- Pneumonia diagnosed with severe, critically re-associated coronavirus infection or requiring mechanical ventilation or systemic anti-hormonal therapy;
- Used Chinese patent medicines with similar efficacy as Xiyanping injection during the treatment.
- The investigator judges that the relevant test or data is missing during the treatment process, which affects the research evaluation or analyst.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Retrospective Cohort to Evaluate the Effectiveness and Safety of Xiyanping Injection Combined With Conventional Treatment for New Coronavirus Infection Pneumonia (Common Type)
the investigators conduct a randomized, open-label trial to evaluate and compare the safety and efficacy of Xiyanping injection in patients with 2019-nCoV pneumonia.
- Conditions
- 2019 Novel Coronavirus Pneumonia
- Being tested
- Xiyanping injection, Lopinavir / ritonavir, alpha-interferon nebulization,Abidor Hydrochloride
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Xiyanping injectionDrug
Xiyanping injection, 10-20ml daily, Qd, the maximum daily does not exceed 500mg (20mL) + Lopinavir tablet /Ritonavir tablet or Alpha-interferon nebulization or Abidor Hydrochloride,
Lopinavir / ritonavir, alpha-interferon nebulization,Abidor HydrochlorideDrug
Lopinavir / ritonavir tablets, 2 times a day, 2 tablets at a time; alpha-interferon nebulization;Abidor Hydrochloride
| Study group | Role | What they receive |
|---|---|---|
| Xiyanping injection +other drugs | Drug: Xiyanping injection Xiyanping injection: 10-20ml daily, Qd, the maximum daily dose does not exceed 500mg (20mL) Other drugs: Lopinavir tablet or Ritonavir tablet;Alpha-interferon nebulization;Abidor Hydrochloride Receives: Drug: Xiyanping injection; Drug: Lopinavir / ritonavir, alpha-interferon nebulization,Abidor Hydrochloride | |
| other drugs | Lopinavir tablet or Ritonavir tablet;Alpha-interferon nebulization;Abidor Hydrochloride Receives: Drug: Lopinavir / ritonavir, alpha-interferon nebulization,Abidor Hydrochloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical recovery time
From the beginning of study drug use to fever, respiratory rate, blood oxygen saturation to normal and cough relief, and maintained for at least 72 hours or more, calculated in hours
Measured: Up to Day 14
Secondary outcomes (4)
Complete fever time
From the beginning of research drug use to body temperature <37.3 ℃ (underarm) or mouth temperature ≤37.5 ° C, or anal or ear temperature ≤37.8 ° C, and maintained for 24h or more
Measured: Up to Day 14
Cough relief time
Cough score "day + night" from the beginning of study medication to cough ≤ 1 point, and maintained for 24 hours and above
Measured: Up to Day 14
Virus negative time
From the beginning of the study drug to two consecutive times (sampling interval of at least 1 day)
Measured: Up to Day 14
Incidence of severe or critical neocoronavirus pneumonia
Defined as the proportion of subjects exacerbated during treatment and meeting the diagnostic criteria for severe or critical neocoronavirus pneumonia
Measured: Up to Day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2020
- Study start15 May 2020 (estimated)
- Primary completion14 Jul 2020 (estimated)
- Study completion14 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 2019 Novel Coronavirus PneumoniaStudies 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
- 426 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiangxi Qingfeng Pharmaceutical Co. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04275388
- Sponsor's protocol ID
- QF-XYP2001-1
- Status last verified
- Apr 2020
- First submitted
- 17 Feb 2020
- Last updated
- 20 May 2020
- Results posted
- No
- Data monitoring committee
- 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 20 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Cohort to Evaluate the Effectiveness and Safety of Xiyanping Injection Combined With Conventional Treatment for New Coronavirus Infection Pneumonia (Common Type)
- ClinicalTrials.gov ID
- NCT04275388
- Acronym / sponsor ID
- QF-XYP2001-1
- Conditions
- 2019 Novel Coronavirus Pneumonia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 426 participants (estimated)
- Lead sponsor
- Jiangxi Qingfeng Pharmaceutical Co. Ltd.Industry (pharma, biotech, devices)
- Study start
- 15 May 2020 (estimated)
- Primary completion
- 14 Jul 2020 (estimated)
- Study completion
- 14 Dec 2021 (estimated)
- First posted
- 19 Feb 2020 (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 investigators conduct a randomized, open-label trial to evaluate and compare the safety and efficacy of Xiyanping injection in patients with 2019-nCoV pneumonia.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Xiyanping injection +other drugs | – | Drug: Xiyanping injection, Drug: Lopinavir / ritonavir, alpha-interferon nebulization,Abidor HydrochlorideDrug: Xiyanping injection Xiyanping injection: 10-20ml daily, Qd, the maximum daily dose does not exceed 500mg (20mL) Other drugs: Lopinavir tablet or Ritonavir tablet;Alpha-interferon nebulization;Abidor Hydrochloride |
| other drugs | – | Drug: Lopinavir / ritonavir, alpha-interferon nebulization,Abidor HydrochlorideLopinavir tablet or Ritonavir tablet;Alpha-interferon nebulization;Abidor Hydrochloride |
Who may qualify
- Ages
- Up to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients diagnosed with new coronary pneumonia
Key inclusion criteria (2 listed)
- Laboratory examination (RT-PCR) confirms the infection 2019-nCoV, which meets the diagnostic criteria for pneumonia (common type) in the New Coronavirus Infection Pneumonia Diagnosis and Treatment Program (Trial Version 6);
- The patient has a complete hospitalization record that can be used for research.
Key exclusion criteria (8 listed)
- -
- Suffering from diseases that need to be distinguished from pneumonia infected with new coronavirus, such as tuberculosis, bacterial or viral pneumonia other than new coronavirus pneumonia, hospital-acquired pneumonia, and other pathogenic microorganisms pneumonia;
- People with basic diseases such as primary immunodeficiency disease, acquired immunodeficiency syndrome, congenital respiratory tract malformations, abnormal lung development, aspiration pneumonia, and lung malignant tumors;
- According to the judgment of the investigator, the previous or current disease may affect the patient's participation in the trial or the outcome of the study, including: malignant disease, autoimmune disease, liver and kidney disease, blood disease, neurological disease, and endocrine Disease; presently suffering from diseases that seriously affect the immune system, such as: human immunodeficiency virus (HIV) infection, or blood system, or splenectomy, organ transplantation, etc;
- Pneumonia diagnosed with severe, critically re-associated coronavirus infection or requiring mechanical ventilation or systemic anti-hormonal therapy;
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 |
|---|---|---|
| Xiyanping injectionXiyanping injection, 10-20ml daily, Qd, the maximum daily does not exceed 500mg (20mL) + Lopinavir tablet /Ritonavir tablet or Alpha-interferon nebulization or Abidor Hydrochloride, | Drug | Xiyanping injection +other drugs |
| Lopinavir / ritonavir, alpha-interferon nebulization,Abidor HydrochlorideLopinavir / ritonavir tablets, 2 times a day, 2 tablets at a time; alpha-interferon nebulization;Abidor Hydrochloride | Drug | Xiyanping injection +other drugs, other drugs |
Primary outcome
Clinical recovery time
Time frame: Up to Day 14
From the beginning of study drug use to fever, respiratory rate, blood oxygen saturation to normal and cough relief, and maintained for at least 72 hours or more, calculated in hours
4 secondary outcomes
Complete fever time
Time frame: Up to Day 14
Cough relief time
Time frame: Up to Day 14
Virus negative time
Time frame: Up to Day 14
Incidence of severe or critical neocoronavirus pneumonia
Time frame: Up to Day 14
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2020.
- 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.
Questions about this trial
What is this clinical trial studying?
An observational study of 2019 Novel Coronavirus Pneumonia, run by Jiangxi Qingfeng Pharmaceutical Co. Ltd..
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 8 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 20 May 2020. 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?
Contact Hongzhou Lu, Master (021-37990333, lunliweiyuanhui2009@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical recovery time (time frame: Up to Day 14). 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 20 May 2020.