2019-nCoV Severe PneumoniaPhase 4NCT04263402
The Efficacy of Different Hormone Doses in 2019-nCoV Severe Pneumonia
A Phase 4 study testing Methylprednisolone in people with 2019-nCoV Severe Pneumonia, run by Tongji Hospital at 1 site in China.
Trial summary
At present, there is no specific and effective antiviral therapy.In this study, an open, prospective/retrospective, randomized controlled cohort study was designed to compare the efficacy of different hormone doses in the treatment of 2019-nCoV severe Pneumonia.This study explores effective treatment programs for… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- 2019-nCoV Severe Pneumonia
- What is being tested?
- Methylprednisolone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2020to 1 Jul 2020
- Phase
- Phase 4
- 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
Who may be able to join
- 1.Meet the definition of severe pneumonia(Comply with any of the followings):
- Shortness of breath,RR≥30 bpm;
- In a resting state:SPO2≤93%;
- PaO2/FiO2≤300mmHg.
- 2.2019-nCoV nucleic acid test was positive.
- 3.CT of the lung conformed to the manifestation of viral pneumonia.
Who cannot join
- dying state (i.e. survival time is less than 24 hours);
- progressive malignant tumor with life expectancy less than 6 months;
- immunosuppressive status(patients using immunosuppressants or chemotherapeutic drugs)
- underlying diseases requiring long-term glucocorticoid treatment in the past 6 months or short-term glucocorticoid therapy in the past 4 weeks;
- pregnancy
- patients with glucocorticoid taboos
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department and Institute of Infectious Disease
Wuhan, Hubei, 430030
Qin Ning, professor, qning@vip.sina.com
Meifang Han, professor, mfhan@foxmail.com
About this study
Official title: An Open, Prospective/Retrospective, Randomized Controlled Cohort Study to Compare the Efficacy of Different Hormone Doses in the Treatment of 2019-nCoV Severe Pneumonia
At present, there is no specific and effective antiviral therapy.In this study, an open, prospective/retrospective, randomized controlled cohort study was designed to compare the efficacy of different hormone doses in the treatment of 2019-nCoV severe Pneumonia.This study explores effective treatment programs for 2019-nCoV severe pneumonia and provides a reliable evidence-based basis for the treatment.
- Conditions
- 2019-nCoV Severe Pneumonia
- Being tested
- Methylprednisolone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patients in the Group I will receive basic symptomatic supportive treatment,plus methylprednisolone(<40mg/d intravenous drip for 7 days).
Patients in the Group II will receive basic symptomatic supportive treatment,plus methylprednisolone(40~80mg/d intravenous drip for 7 days).
| Study group | Role | What they receive |
|---|---|---|
| Methylprednisolone(<40mg/d) | Experimental | Not described Receives: Drug: Methylprednisolone |
| Methylprednisolone(40~80mg/d) | Experimental | Not described Receives: Drug: Methylprednisolone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of disease remission
For mild patients: disease remission refers to relieved symptoms with improved lung CT; For severe patients: disease remission refers to relieved symptoms with improved lung CT; or SPO2>93% or PaO2/FiO2 >300mmHg.
Measured: day 7
Rate and time of entering the critical stage
the critical stage refers to respiratory failure that occurs and requires mechanical ventilation, shock, or having other organ failure that needs ICU monitoring and treatment.
Measured: day 7
Secondary outcomes (5)
Rate of normal tempreture
Rate of patients without fever at day 7
Measured: day 7
Rate of respiratory symptom remission
Rate of patients with respiratory symptom remission at day 7
Measured: day 7
Rate of lung imaging recovery
Rate of patients with lung imaging recovery at day 7
Measured: day 7
Rate of laboratory indicator recovery
Rate of patients with laboratory indicator recovery at day 7
Measured: day 7
Rate of undetectable viral RNA
Rate of patients withundetectable viral RNA at day 7
Measured: day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2020
- Study start1 Feb 2020
- Primary completion1 Jun 2020 (estimated)
- Study completion1 Jul 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 2019-nCoV Severe PneumoniaStudies of the same condition, open and under way.
- More trials run by Tongji 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tongji Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Qin Ning, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04263402
- Sponsor's protocol ID
- TJ20200201
- Status last verified
- Mar 2020
- First submitted
- 2 Feb 2020
- Last updated
- 17 Mar 2020
- Results posted
- No
- Data monitoring committee
- 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 17 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open, Prospective/Retrospective, Randomized Controlled Cohort Study to Compare the Efficacy of Different Hormone Doses in the Treatment of 2019-nCoV Severe Pneumonia
- ClinicalTrials.gov ID
- NCT04263402
- Acronym / sponsor ID
- TJ20200201
- Conditions
- 2019-nCoV Severe Pneumonia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Tongji HospitalUniversity, hospital or other
- Study start
- 1 Feb 2020 (actual)
- Primary completion
- 1 Jun 2020 (estimated)
- Study completion
- 1 Jul 2020 (estimated)
- First posted
- 10 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.
At present, there is no specific and effective antiviral therapy.In this study, an open, prospective/retrospective, randomized controlled cohort study was designed to compare the efficacy of different hormone doses in the treatment of 2019-nCoV severe Pneumonia.This study explores effective treatment programs for 2019-nCoV severe pneumonia and provides a reliable evidence-based basis for the treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Methylprednisolone(<40mg/d) | Experimental | Drug: Methylprednisolone |
| Methylprednisolone(40~80mg/d) | Experimental | Drug: Methylprednisolone |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Shortness of breath,RR≥30 bpm;
- In a resting state:SPO2≤93%;
- PaO2/FiO2≤300mmHg.
- 2.2019-nCoV nucleic acid test was positive.
- 3.CT of the lung conformed to the manifestation of viral pneumonia.
Key exclusion criteria (6 listed)
- dying state (i.e. survival time is less than 24 hours);
- progressive malignant tumor with life expectancy less than 6 months;
- immunosuppressive status(patients using immunosuppressants or chemotherapeutic drugs)
- underlying diseases requiring long-term glucocorticoid treatment in the past 6 months or short-term glucocorticoid therapy in the past 4 weeks;
- pregnancy
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 |
|---|---|---|
| MethylprednisolonePatients in the Group I will receive basic symptomatic supportive treatment,plus methylprednisolone(<40mg/d intravenous drip for 7 days). | Drug | Methylprednisolone(<40mg/d) |
| MethylprednisolonePatients in the Group II will receive basic symptomatic supportive treatment,plus methylprednisolone(40~80mg/d intravenous drip for 7 days). | Drug | Methylprednisolone(40~80mg/d) |
Primary outcome
Rate of disease remission
Time frame: day 7
For mild patients: disease remission refers to relieved symptoms with improved lung CT; For severe patients: disease remission refers to relieved symptoms with improved lung CT; or SPO2>93% or PaO2/FiO2 >300mmHg.
Rate and time of entering the critical stage
Time frame: day 7
the critical stage refers to respiratory failure that occurs and requires mechanical ventilation, shock, or having other organ failure that needs ICU monitoring and treatment.
5 secondary outcomes
Rate of normal tempreture
Time frame: day 7
Rate of respiratory symptom remission
Time frame: day 7
Rate of lung imaging recovery
Time frame: day 7
Rate of laboratory indicator recovery
Time frame: day 7
Rate of undetectable viral RNA
Time frame: day 7
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2020.
- 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 Phase 4 study testing Methylprednisolone in people with 2019-nCoV Severe Pneumonia, run by Tongji 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 6 inclusion and 6 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 17 Mar 2020. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Qing Ning, Professor (+8613971521450, qning@vip.sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of disease remission (time frame: day 7). 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 17 Mar 2020.