2019-nCoV Severe Pneumonia
Conditions
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.
Interventions
DRUGMethylprednisolone
Patients in the Group I will receive basic symptomatic supportive treatment,plus methylprednisolone(\<40mg/d intravenous drip for 7 days).
Sponsors
Tongji Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1.Meet the definition of severe pneumonia(Comply with any of the followings): 1. Shortness of breath,RR≥30 bpm; 2. In a resting state:SPO2≤93%; 3. 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
1. dying state (i.e. survival time is less than 24 hours); 2. progressive malignant tumor with life expectancy less than 6 months; 3. immunosuppressive status(patients using immunosuppressants or chemotherapeutic drugs) 4. underlying diseases requiring long-term glucocorticoid treatment in the past 6 months or short-term glucocorticoid therapy in the past 4 weeks; 5. pregnancy 6. patients with glucocorticoid taboos
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of disease remission | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of lung imaging recovery | day 7 | Rate of patients with lung imaging recovery at day 7 |
| Rate of normal tempreture | day 7 | Rate of patients without fever at day 7 |
| Rate of undetectable viral RNA | day 7 | Rate of patients withundetectable viral RNA at day 7 |
| Rate of laboratory indicator recovery | day 7 | Rate of patients with laboratory indicator recovery at day 7 |
| Rate of respiratory symptom remission | day 7 | Rate of patients with respiratory symptom remission at day 7 |
Countries
China
Contacts
Primary ContactQing Ning, Professor
Backup ContactMeifang Han, Professor
Outcome results
None listed