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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Methylprednisolone(<40mg/d) | Experimental |
| |
| Methylprednisolone(40~80mg/d) | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Methylprednisolone | Drug | Patients in the Group I will receive basic symptomatic supportive treatment,plus methylprednisolone(<40mg/d intravenous drip for 7 days). |
|
| 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 |
| 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 |
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Inclusion Criteria:
1.Meet the definition of severe pneumonia(Comply with any of the followings):
2.2019-nCoV nucleic acid test was positive.
3.CT of the lung conformed to the manifestation of viral pneumonia.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Qing Ning, Professor | Contact | +8613971521450 | qning@vip.sina.com | |
| Meifang Han, Professor | Contact | +8613986093605 | mfhan@foxmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department and Institute of Infectious Disease | Recruiting | Wuhan | Hubei | 430030 | China |
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| ID | Term |
|---|---|
| D008775 | Methylprednisolone |
| ID | Term |
|---|---|
| D011239 | Prednisolone |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
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| Methylprednisolone | Drug | Patients in the Group II will receive basic symptomatic supportive treatment,plus methylprednisolone(40~80mg/d intravenous drip for 7 days). |
|
| 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 |
| D013256 |
| Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |