COVID-19NCT04295551
Multicenter Clinical Study on the Efficacy and Safety of Xiyanping Injection in the Treatment of New Coronavirus Infection Pneumonia (General and Severe)
A study testing Lopinavir / ritonavir tablets combined with Xiyanping injection and Lopinavir/ritonavir treatment in people with COVID-19, run by Jiangxi Qingfeng Pharmaceutical Co. Ltd..
Trial summary
In December 2019, Wuhan, in Hubei province, China, became the center of an outbreak of pneumonia of unknown cause. In a short time, Chinese scientists had shared the genome information of a novel coronavirus (2019-nCoV) from these pneumonia patients and developed a real-time reverse transcription PCR (real time… Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- COVID-19
- What is being tested?
- Lopinavir / ritonavir tablets combined with Xiyanping injection and Lopinavir/ritonavir treatment
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 14 Mar 2020to 14 Apr 2021
- Phase
- Interventional
- 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 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged >=18 years;
- Novel coronavirus pneumonia patients diagnosed by pathogenic testing;
- The patient himself participated in the study voluntarily, agreed and signed the informed consent.
Who cannot join
- Meet the diagnostic criteria for severe new-type coronavirus infection pneumonia;
- Severe primary diseases that affect survival, including: uncontrolled malignant tumors, hematological diseases, and HIV that have not been metastasized in multiple places;
- Obstructive pneumonia, pulmonary interstitial fibrosis, alveolar proteinosis, and allergic alveolitis caused by lung tumors;
- Women who are breastfeeding or pregnant;
- Those who are known to be allergic to the ingredients contained in the research medication, or patients with allergies;
- Those who have continued to use immunosuppressive agents or organ transplants in the past 6 months;
- Patients who have participated in other drug clinical trials within 3 months before the screening test;
- The investigator judges that he or she cannot complete or should not participate in the study (expected death within 48 hours, and the patient refuses active treatment)
About this study
In December 2019, Wuhan, in Hubei province, China, became the center of an outbreak of pneumonia of unknown cause. In a short time, Chinese scientists had shared the genome information of a novel coronavirus (2019-nCoV) from these pneumonia patients and developed a real-time reverse transcription PCR (real time RT-PCR) diagnostic assay.
In view of the fact that there is currently no effective antiviral therapy, the prevention or treatment of lung injury caused by COVID-19 can be an alternative target for current treatment. Xiyanping injection has anti-inflammatory and immune regulation effects. This study is a Randomized, Parallel Controlled Clinical Study to treat patients with COVID-19 infection.
Read the detailed description
The new coronavirus (COVID-19) [1] belongs to the new beta coronavirus. Current research shows that it has 85% homology with bat SARS-like coronavirus (bat-SL-CoVZC45), but its genetic characteristics are similar to SARSr-CoV. There is a clear difference from MERSr-COV. Since December 2019, Wuhan City, Hubei Province has successively found multiple cases of patients with pneumonia infected by a new type of coronavirus. With the spread of the epidemic, as of 12:00 on February 12, 2020, a total of 44726 confirmed cases nationwide (Hubei Province) 33,366 cases, accounting for 74.6%), with 1,114 deaths (1068 cases in Hubei Province), and a mortality rate of 2.49% (3.20% in Hubei Province).
In view of the fact that there is currently no effective antiviral therapy, the prevention or treatment of lung injury caused by COVID-19 can be an alternative target for current treatment. Xiyanping injection has anti-inflammatory and immune regulation effects. In the early clinical practice of treating severe H1N1, it was clinically concerned, and combined with conventional treatment, and achieved good results.
- Conditions
- COVID-19
- Being tested
- Lopinavir / ritonavir tablets combined with Xiyanping injection, Lopinavir/ritonavir treatment
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lopinavir / ritonavir tablets combined with Xiyanping injectionDrug
Xiyanping injection, 10-20ml daily, Qd, the maximum daily does not exceed 500mg (20mL) + Lopinavir tablet or Ritonavir tablet+Alpha-interferon nebulization, for 7-14 days,
Lopinavir/ritonavir treatmentDrug
Lopinavir / ritonavir tablets, 2 times a day, 2 tablets at a time; alpha-interferon nebulization
| Study group | Role | What they receive |
|---|---|---|
| Experimental group of ordinary COVID-19 | Experimental | Lopinavir / ritonavir tablets combined with Xiyanping injection Receives: Drug: Lopinavir / ritonavir tablets combined with Xiyanping injection |
| Control group of ordinary COVID-19 | Active comparator | ritonavir/ritonavir treatment Receives: Drug: Lopinavir/ritonavir treatment |
| Experimental group of severe COVID-19 | Experimental | Lopinavir / ritonavir tablets combined with Xiyanping injection Receives: Drug: Lopinavir / ritonavir tablets combined with Xiyanping injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical recovery time
The time from study drug use to complete fever reduction and cough recovery is measured in hours.
Measured: Up to Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2020
- Study start14 Mar 2020 (estimated)
- Primary completion14 Jul 2020 (estimated)
- Study completion14 Apr 2021 (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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 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
- NCT04295551
- Sponsor's protocol ID
- QF-XYP1990-1
- Status last verified
- Mar 2020
- First submitted
- 3 Mar 2020
- Last updated
- 4 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Clinical Study on the Efficacy and Safety of Xiyanping Injection in the Treatment of New Coronavirus Infection Pneumonia (General and Severe)
- ClinicalTrials.gov ID
- NCT04295551
- Acronym / sponsor ID
- QF-XYP1990-1
- Conditions
- COVID-19
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Jiangxi Qingfeng Pharmaceutical Co. Ltd.Industry (pharma, biotech, devices)
- Study start
- 14 Mar 2020 (estimated)
- Primary completion
- 14 Jul 2020 (estimated)
- Study completion
- 14 Apr 2021 (estimated)
- First posted
- 4 Mar 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.
In December 2019, Wuhan, in Hubei province, China, became the center of an outbreak of pneumonia of unknown cause. In a short time, Chinese scientists had shared the genome information of a novel coronavirus (2019-nCoV) from these pneumonia patients and developed a real-time reverse transcription PCR (real time RT-PCR) diagnostic assay.
In view of the fact that there is currently no effective antiviral therapy, the prevention or treatment of lung injury caused by COVID-19 can be an alternative target for current treatment. Xiyanping injection has anti-inflammatory and immune regulation effects. This study is a Randomized, Parallel Controlled Clinical Study to treat patients with COVID-19 infection.
Detailed description
The new coronavirus (COVID-19) [1] belongs to the new beta coronavirus. Current research shows that it has 85% homology with bat SARS-like coronavirus (bat-SL-CoVZC45), but its genetic characteristics are similar to SARSr-CoV. There is a clear difference from MERSr-COV. Since December 2019, Wuhan City, Hubei Province has successively found multiple cases of patients with pneumonia infected by a new type of coronavirus. With the spread of the epidemic, as of 12:00 on February 12, 2020, a total of 44726 confirmed cases nationwide (Hubei Province) 33,366 cases, accounting for 74.6%), with 1,114 deaths (1068 cases in Hubei Province), and a mortality rate of 2.49% (3.20% in Hubei Province).
In view of the fact that there is currently no effective antiviral therapy, the prevention or treatment of lung injury caused by COVID-19 can be an alternative target for current treatment. Xiyanping injection has anti-inflammatory and immune regulation effects. In the early clinical practice of treating severe H1N1, it was clinically concerned, and combined with conventional treatment, and achieved good results.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Experimental group of ordinary COVID-19 | Experimental | Drug: Lopinavir / ritonavir tablets combined with Xiyanping injectionLopinavir / ritonavir tablets combined with Xiyanping injection |
| Control group of ordinary COVID-19 | Active comparator | Drug: Lopinavir/ritonavir treatmentritonavir/ritonavir treatment |
| Experimental group of severe COVID-19 | Experimental | Drug: Lopinavir / ritonavir tablets combined with Xiyanping injectionLopinavir / ritonavir tablets combined with Xiyanping injection |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Aged >=18 years;
- Novel coronavirus pneumonia patients diagnosed by pathogenic testing;
- The patient himself participated in the study voluntarily, agreed and signed the informed consent.
Key exclusion criteria (8 listed)
- Meet the diagnostic criteria for severe new-type coronavirus infection pneumonia;
- Severe primary diseases that affect survival, including: uncontrolled malignant tumors, hematological diseases, and HIV that have not been metastasized in multiple places;
- Obstructive pneumonia, pulmonary interstitial fibrosis, alveolar proteinosis, and allergic alveolitis caused by lung tumors;
- Women who are breastfeeding or pregnant;
- Those who are known to be allergic to the ingredients contained in the research medication, or patients with allergies;
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 |
|---|---|---|
| Lopinavir / ritonavir tablets combined with Xiyanping injectionXiyanping injection, 10-20ml daily, Qd, the maximum daily does not exceed 500mg (20mL) + Lopinavir tablet or Ritonavir tablet+Alpha-interferon nebulization, for 7-14 days, | Drug | Experimental group of ordinary COVID-19, Experimental group of severe COVID-19 |
| Lopinavir/ritonavir treatmentLopinavir / ritonavir tablets, 2 times a day, 2 tablets at a time; alpha-interferon nebulization | Drug | Control group of ordinary COVID-19 |
Primary outcome
Clinical recovery time
Time frame: Up to Day 28
The time from study drug use to complete fever reduction and cough recovery is measured in hours.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2020.
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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?
A study testing Lopinavir / ritonavir tablets combined with Xiyanping injection and Lopinavir/ritonavir treatment in people with COVID-19, 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 3 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 4 Mar 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?
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?
Clinical recovery time (time frame: Up to Day 28). 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 4 Mar 2020.