Back to resultsThe Efficacy of Different Hormone Doses in 2019-nCoV Severe Pneumonia
Primary Purpose
2019-nCoV Severe Pneumonia
Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Methylprednisolone
Methylprednisolone
Sponsored by
About this trial
This is an interventional treatment trial for 2019-nCoV Severe Pneumonia
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
- 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
Sites / Locations
- Department and Institute of Infectious DiseaseRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Methylprednisolone(<40mg/d)
Methylprednisolone(40~80mg/d)
Arm Description
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
Rate of normal tempreture
Rate of patients without fever at day 7
Rate of respiratory symptom remission
Rate of patients with respiratory symptom remission at day 7
Rate of lung imaging recovery
Rate of patients with lung imaging recovery at day 7
Rate of laboratory indicator recovery
Rate of patients with laboratory indicator recovery at day 7
Rate of undetectable viral RNA
Rate of patients withundetectable viral RNA at day 7
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04263402
Brief Title
The Efficacy of Different Hormone Doses in 2019-nCoV Severe Pneumonia
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2020
Overall Recruitment Status
Unknown status
Study Start Date
February 1, 2020 (Actual)
Primary Completion Date
June 1, 2020 (Anticipated)
Study Completion Date
July 1, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tongji Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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 2019-nCoV severe pneumonia and provides a reliable evidence-based basis for the treatment.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
2019-nCoV Severe Pneumonia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Methylprednisolone(<40mg/d)
Arm Type
Experimental
Arm Title
Methylprednisolone(40~80mg/d)
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Methylprednisolone
Intervention Description
Patients in the Group I will receive basic symptomatic supportive treatment,plus methylprednisolone(<40mg/d intravenous drip for 7 days).
Intervention Type
Drug
Intervention Name(s)
Methylprednisolone
Intervention Description
Patients in the Group II will receive basic symptomatic supportive treatment,plus methylprednisolone(40~80mg/d intravenous drip for 7 days).
Primary Outcome Measure Information:
Title
Rate of disease remission
Description
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.
Time Frame
day 7
Title
Rate and time of entering the critical stage
Description
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.
Time Frame
day 7
Secondary Outcome Measure Information:
Title
Rate of normal tempreture
Description
Rate of patients without fever at day 7
Time Frame
day 7
Title
Rate of respiratory symptom remission
Description
Rate of patients with respiratory symptom remission at day 7
Time Frame
day 7
Title
Rate of lung imaging recovery
Description
Rate of patients with lung imaging recovery at day 7
Time Frame
day 7
Title
Rate of laboratory indicator recovery
Description
Rate of patients with laboratory indicator recovery at day 7
Time Frame
day 7
Title
Rate of undetectable viral RNA
Description
Rate of patients withundetectable viral RNA at day 7
Time Frame
day 7
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Qing Ning, Professor
Phone
+8613971521450
Email
qning@vip.sina.com
First Name & Middle Initial & Last Name or Official Title & Degree
Meifang Han, Professor
Phone
+8613986093605
Email
mfhan@foxmail.com
Facility Information:
Facility Name
Department and Institute of Infectious Disease
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430030
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Qin Ning, professor
Email
qning@vip.sina.com
First Name & Middle Initial & Last Name & Degree
Meifang Han, professor
Email
mfhan@foxmail.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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The Efficacy of Different Hormone Doses in 2019-nCoV Severe Pneumonia
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