The Efficacy of Different Hormone Doses in 2019-nCoV Severe Pneumonia

Study Overview
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Brief Summary
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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.

Official Title
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An Open, Prospective/Retrospective, Randomized Controlled Cohort Study to Compare the Efficacy of Different Hormone Doses in the Treatment of 2019-nCoV Severe Pneumonia

Conditions
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2019-nCoV Severe Pneumonia

Intervention / Treatment
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* Drug: Methylprednisolone
* Drug: Methylprednisolone


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Methylprednisolone(<40mg/d)<br> | Drug: Methylprednisolone<br>* Patients in the Group I will receive basic symptomatic supportive treatment,plus methylprednisolone(<40mg/d intravenous drip for 7 days).<br>|
| Experimental: Methylprednisolone(40 80mg/d)<br> | Drug: Methylprednisolone<br>* Patients in the Group II will receive basic symptomatic supportive treatment,plus methylprednisolone(40 80mg/d intravenous drip for 7 days).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | day 7 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of normal tempreture | Rate of patients without fever at day 7 | day 7 | 
| Rate of respiratory symptom remission | Rate of patients with respiratory symptom remission at day 7 | day 7 | 
| Rate of lung imaging recovery | Rate of patients with lung imaging recovery at day 7 | day 7 | 
| Rate of laboratory indicator recovery | Rate of patients with laboratory indicator recovery at day 7 | day 7 | 
| Rate of undetectable viral RNA | Rate of patients withundetectable viral RNA at day 7 | day 7 |