Severe InfluenzaNCT03947411
Evaluate the Safety and Efficacy of Xiyanping in Pediatric Participants With Severe Influenza-Like Symptoms
A study testing Oseltamivir Phosphate and Xiyanping injection+Oseltamivir Phosphate in people with Severe Influenza, run by Jiangxi Qingfeng Pharmaceutical Co. Ltd. at 1 site in China.
Trial summary
This is a multicenter, randomized, open Label, add-on study. Read more about this study
- Who is it for?
- Ages 3 to 6 years
- Conditions the study is for
- Severe Influenza
- What is being tested?
- Oseltamivir Phosphate and Xiyanping injection+Oseltamivir Phosphate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteChina
- Study dates
- 4 Mar 2019to 31 Mar 2020
- 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 3 to 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age between 3 and 6 years old;
- Clinical diagnosis of Severe Influenza with hospital treatment needed;
- Patients did not accept oseltamivir phosphate treatment or symptoms persisted for more than 3 days treatment;
- （1)Fever ≥ 39°C (tympanic temperature) for at least 3 days with Severe cough,sputum, blood stasis, or chest pain; （2）Combined pneumonia;
- The rapid viral antigen test of throat swab and nose swab results were positive;
- Guardians understood and assigned the informed consent;
Who cannot join
- Participants allergenic to XiYanPing injection, Andrographolide or Oseltamivir Phosphate;
- Creatinine clearance <80ml/min or received continuous renal replacement therapy (CRRT) test;
- Need extracorporeal membrane oxygenation (ECMO) at baseline;
- Glasgow Coma Rating Scale (GCS) score ≤ 9 points when dyspnea, altered consciousness, severe vomiting, or coma appeared at baseline;
- Crisis influenza Symptoms, such as respiratory failure, acute necrotizing encephalopathy, septic shock, multiple organ dysfunction and other serious clinical conditions requiring monitoring;
- Use of systemic steroids or other immunosuppressants;
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- Participants with the following underlying diseases, including: heart disease (such as New York Heart Function Classification II-IV) or clinically significant arrhythmia (such as QTc ≥ 480ms), malignant tumor or other malignant diseases, autoimmune diseases; liver and kidney diseases ( ALT and AST ≥ 1.5 × ULN; Cr and BUN > 1.2 × ULN), blood diseases, nervous system diseases, immune system diseases and endocrine diseases, consciousness, speech, behavioral abnormalities caused by encephalitis / encephalopathy or limb paralysis, severe malnutrition, etc.
- Participants used Influenza virus vaccine within 3 months;
- Participants with drug dependence or with mental disorders within 1 year;
- Participants participated in other clinical research in the last 30 days;
- Any condition which would make the subject, in the opinion of the investigator or designee, not suitable for the study for any reason.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The First Affliated Hospital of Tianjin University of Traditional Chinese Medicine
Tianjin
Xilian Zhang, 022-27432299, yfyiec@163.com
About this study
Official title: A Multicenter, Randomized, Open Label, Add-on Study to Assess Efficacy and Safety of Xiyanping Injection in Pediatric Participants With Severe Influenza-Like Symptoms
This is a multicenter, randomized, open Label, add-on study.
Read the detailed description
This is an add-on study of efficacy and safety of intravenous injection of Xiyanping injection in pediatric subjects with severe Influenza-Like Symptoms.
The purpose to determine the efficacy and safety of Oseltamivir Phosphate combined with or without Xiyanping injection in the treatment of severe Influenza-Like Symptoms. The study will enroll 72 Pediatric severe Influenza-Like Symptoms volunteers, who will be randomized into 2 groups (1:1 ratio): volunteers from the first group will receive Oseltamivir Phosphate and Xiyanping injection for severe Influenza; volunteers from the second group will receive Oseltamivir Phosphate for severe Influenza. Xiyanping injection will be administration as intravenous injection of 0.4mL/kg/day once daily for 7-10 days concomitantly with Oseltamivir Phosphate for severe Influenza-Like Symptoms.
- Conditions
- Severe Influenza
- Being tested
- Oseltamivir Phosphate, Xiyanping injection+Oseltamivir Phosphate
- Keywords
- severe Influenza
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oseltamivir PhosphateDrug
Take the dosage of Oseltamivir Phosphate recommended according to the instructions.support treatment such as antiasthmatic, expectorant and antipyretic use only in need.
Xiyanping injection+Oseltamivir PhosphateDrug
Take the dosage of Oseltamivir Phosphate recommended according to the instructions.Xiyanping injection intravenous administration of 0.4mL/kg/day ,QD for 7-10 days.support treatment such as antiasthmatic, expectorant and antipyretic use only in need.
| Study group | Role | What they receive |
|---|---|---|
| Oseltamivir Phosphate+Xiyanping injection | Experimental | Oseltamivir Phosphate+Xiyanping injection treatment for 7-10 days Receives: Drug: Xiyanping injection+Oseltamivir Phosphate |
| Oseltamivir Phosphate treatment only | Active comparator | Oseltamivir Phosphate treatment for 7-10 days Receives: Drug: Oseltamivir Phosphate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Alleviation of Influenza Signs and Symptoms
Time to alleviation of influenza signs and symptoms is defined as the length of time taken from the start of treatment to the point at which all of the signs and symptoms are alleviation or recovery.
Measured: Up to Day 12
Duration of Fever
Length of time taken by participants to return to afebrile state
Measured: Up to Day 12
Secondary outcomes (6)
Signs and Symptoms Score from baseline
(1) recovery: symptom score reduction rate ≥ 95%; (2) markedly effective: symptom score reduction rate ≥ 70%; (3) progress: symptom score reduction rate ≥ 30%; (4) invalid: Symptom score reduction rate <30%.
Measured: Up to Day 12
Usage of antibiotic,hormone and incidence of critical cases
Measured: Up to Day 12
Time to Cessation of Viral Shedding by RT-PCR
Measured: Up to Day 12
Relief time of individual symptom such as:expectoration, cough
Measured: Up to Day 12
Disease efficacy criteria
(1) Healing: The body temperature is normal within 48 hours of treatment, the symptoms disappeared without repetition. (2) markedly effective: the body temperature is normal within 48 hours of treatment, and the symptom score is reduced by more than 2/3. (3) Effective: The body temperature is normal within 72 hours of treatment, and the remaining symptom scores are reduced by 2/3-1/3. (4) Invalid: The condition did not improve or worsened after 72 hours of treatment.
Measured: Up to Day 12
Imaging improvement rate: number of people with normal or baseline imaging
Measured: Up to Day 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2019
- Study start4 Mar 2019
- Primary completion31 Mar 2020 (estimated)
- Study completion31 Mar 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe InfluenzaStudies 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
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiangxi Qingfeng Pharmaceutical Co. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- The First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine, Affiliated Hospital of Liaoning University of Traditional Chinese Medicine, Beijing Luhe Hospital, Qingdao Municipal Hospital, Cangzhou People's Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03947411
- Sponsor's protocol ID
- JXQF- XYP-1801
- Status last verified
- May 2019
- First submitted
- 8 May 2019
- Last updated
- 15 May 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Open Label, Add-on Study to Assess Efficacy and Safety of Xiyanping Injection in Pediatric Participants With Severe Influenza-Like Symptoms
- ClinicalTrials.gov ID
- NCT03947411
- Acronym / sponsor ID
- JXQF- XYP-1801
- Conditions
- Severe Influenza
- Keywords
- severe Influenza
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Jiangxi Qingfeng Pharmaceutical Co. Ltd.Industry (pharma, biotech, devices)
- Collaborators
- The First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine, Affiliated Hospital of Liaoning University of Traditional Chinese Medicine, Beijing Luhe Hospital, Qingdao Municipal Hospital, Cangzhou People's Hospital
- Study start
- 4 Mar 2019 (actual)
- Primary completion
- 31 Mar 2020 (estimated)
- Study completion
- 31 Mar 2020 (estimated)
- First posted
- 13 May 2019 (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, randomized, open Label, add-on study.
Detailed description
This is an add-on study of efficacy and safety of intravenous injection of Xiyanping injection in pediatric subjects with severe Influenza-Like Symptoms.
The purpose to determine the efficacy and safety of Oseltamivir Phosphate combined with or without Xiyanping injection in the treatment of severe Influenza-Like Symptoms. The study will enroll 72 Pediatric severe Influenza-Like Symptoms volunteers, who will be randomized into 2 groups (1:1 ratio): volunteers from the first group will receive Oseltamivir Phosphate and Xiyanping injection for severe Influenza; volunteers from the second group will receive Oseltamivir Phosphate for severe Influenza. Xiyanping injection will be administration as intravenous injection of 0.4mL/kg/day once daily for 7-10 days concomitantly with Oseltamivir Phosphate for severe Influenza-Like Symptoms.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oseltamivir Phosphate+Xiyanping injection | Experimental | Drug: Xiyanping injection+Oseltamivir PhosphateOseltamivir Phosphate+Xiyanping injection treatment for 7-10 days |
| Oseltamivir Phosphate treatment only | Active comparator | Drug: Oseltamivir PhosphateOseltamivir Phosphate treatment for 7-10 days |
Who may qualify
- Ages
- 3 to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Age between 3 and 6 years old;
- Clinical diagnosis of Severe Influenza with hospital treatment needed;
- Patients did not accept oseltamivir phosphate treatment or symptoms persisted for more than 3 days treatment;
- （1)Fever ≥ 39°C (tympanic temperature) for at least 3 days with Severe cough,sputum, blood stasis, or chest pain; （2）Combined pneumonia;
- The rapid viral antigen test of throat swab and nose swab results were positive;
Key exclusion criteria (11 listed)
- Participants allergenic to XiYanPing injection, Andrographolide or Oseltamivir Phosphate;
- Creatinine clearance <80ml/min or received continuous renal replacement therapy (CRRT) test;
- Need extracorporeal membrane oxygenation (ECMO) at baseline;
- Glasgow Coma Rating Scale (GCS) score ≤ 9 points when dyspnea, altered consciousness, severe vomiting, or coma appeared at baseline;
- Crisis influenza Symptoms, such as respiratory failure, acute necrotizing encephalopathy, septic shock, multiple organ dysfunction and other serious clinical conditions requiring monitoring;
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 |
|---|---|---|
| Oseltamivir PhosphateTake the dosage of Oseltamivir Phosphate recommended according to the instructions.support treatment such as antiasthmatic, expectorant and antipyretic use only in need. | Drug | Oseltamivir Phosphate treatment only |
| Xiyanping injection+Oseltamivir PhosphateTake the dosage of Oseltamivir Phosphate recommended according to the instructions.Xiyanping injection intravenous administration of 0.4mL/kg/day ,QD for 7-10 days.support treatment such as antiasthmatic, expectorant and antipyretic use only in need. | Drug | Oseltamivir Phosphate+Xiyanping injection |
Primary outcome
Time to Alleviation of Influenza Signs and Symptoms
Time frame: Up to Day 12
Time to alleviation of influenza signs and symptoms is defined as the length of time taken from the start of treatment to the point at which all of the signs and symptoms are alleviation or recovery.
Duration of Fever
Time frame: Up to Day 12
Length of time taken by participants to return to afebrile state
6 secondary outcomes
Signs and Symptoms Score from baseline
Time frame: Up to Day 12
Usage of antibiotic,hormone and incidence of critical cases
Time frame: Up to Day 12
Time to Cessation of Viral Shedding by RT-PCR
Time frame: Up to Day 12
Relief time of individual symptom such as:expectoration, cough
Time frame: Up to Day 12
Disease efficacy criteria
Time frame: Up to Day 12
Imaging improvement rate: number of people with normal or baseline imaging
Time frame: Up to Day 12
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2019.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oseltamivir Phosphate and Xiyanping injection+Oseltamivir Phosphate in people with Severe Influenza, run by Jiangxi Qingfeng Pharmaceutical Co. Ltd. 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 6 inclusion and 11 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 15 May 2019. 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 Xilian Zhang (022-27432299, yfyiec@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to Alleviation of Influenza Signs and Symptoms (time frame: Up to Day 12). The study lists 2 primary outcomes in all. 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 15 May 2019.