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| Name | Class |
|---|---|
| Zhongda Hospital | OTHER |
| Zhongnan Hospital | OTHER |
| Renmin Hospital of Wuhan University | OTHER |
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In this multi-center, randomized, control study, the investigators will evaluate the efficacy and safety of glucocorticoid in combination with standard care for COVID-19 patents with Severe acute respiratory failure.
COVID-19 is a novel coronavirus that was initially outbreak in Wuhan, China. Severe acute respiratory infection with COVID-19 causes severe acute respiratory failure with substantial mortality. Currently, the standard care is supportive care, and no treatment is proven to be effective for this condition.
Glucocorticoid therapy is widely used among critically ill patients with other coronavirus infection such as SARS (severe acute respiratory syndrome) and MERS (Middle East respiratory syndrome). However, whether glucocorticoid improved the outcome of COVID-19 remains unknown. We hypothesized that glucocorticoid would improve the prognosis of patietns with COVID-19.
In this study, critically ill patients with COVID-19 were enrolled and randomized to receive ether standard care or standard care in combination with methylprednisolone therapy. The primary outcome is the difference of Murray lung injury score between two groups.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| standard care | Placebo Comparator | standard care |
|
| standard care + methylprednisolone therapy | Experimental | Methylprednisolone 40 mg q12h for 5 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| methylprednisolone therapy | Drug | Methylprednisolone 40 mg q12h for 5 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Lower Murray lung injury score | Murray lung injury score decreased more than one point means better outcome.The Murray scoring system range from 0 to 4 according to the severity of the condition. | 7 days after randomization |
| Lower Murray lung injury score | Murray lung injury score decreased more than one point means better outcome.The Murray scoring system range from 0 to 4 according to the severity of the condition. | 14 days after randomization |
| Measure | Description | Time Frame |
|---|---|---|
| The difference of PaO2/FiO2 between two groups | PaO2/FiO2 denotes ratio of arterial partial pressure of O2 and the fraction of inspired oxygen, with a higher PaO2/FiO2 means favorable outcome. | 7 days after randomization |
| Lower Sequential Organ Failure Assessment (SOFA) score |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical ICU,Peking Union Medical College Hospital | Beijing | Beijing Municipality | 010 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29161116 | Background | Arabi YM, Mandourah Y, Al-Hameed F, Sindi AA, Almekhlafi GA, Hussein MA, Jose J, Pinto R, Al-Omari A, Kharaba A, Almotairi A, Al Khatib K, Alraddadi B, Shalhoub S, Abdulmomen A, Qushmaq I, Mady A, Solaiman O, Al-Aithan AM, Al-Raddadi R, Ragab A, Balkhy HH, Al Harthy A, Deeb AM, Al Mutairi H, Al-Dawood A, Merson L, Hayden FG, Fowler RA; Saudi Critical Care Trial Group. Corticosteroid Therapy for Critically Ill Patients with Middle East Respiratory Syndrome. Am J Respir Crit Care Med. 2018 Mar 15;197(6):757-767. doi: 10.1164/rccm.201706-1172OC. | |
| 16038758 |
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| ID | Term |
|---|---|
| D013256 | Steroids |
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
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| Standard care | Other | Standard care |
|
Lower SOFA score means better outcome. The SOFA score system range from 0 to 24 according to the severity of the condition. |
| 7 days after randomization |
| Mechanical ventilation support | Percentage of patients requiring Mechanical ventilation support | 7 days after randomization |
| The difference of PaO2/FiO2 between two groups | PaO2/FiO2 denotes ratio of arterial partial pressure of O2 and the fraction of inspired oxygen, with a higher PaO2/FiO2 means favorable outcome. | 14 days after randomization |
| Lower Sequential Organ Failure Assessment (SOFA) score | Lower SOFA score means better outcome. The SOFA score system range from 0 to 24 according to the severity of the condition. | 14 days after randomization |
| Mechanical ventilation support | Percentage of patients requiring Mechanical ventilation support | 14 days after randomization |
| Clearance of noval coronavirus | Clearance of noval coronavirus in upper respiratory tract or lower respiratory tract | 14 days after randomization |
| All-cause mortality | All-cause mortality | 30 days after randomization |
| Background |
| Auyeung TW, Lee JS, Lai WK, Choi CH, Lee HK, Lee JS, Li PC, Lok KH, Ng YY, Wong WM, Yeung YM. The use of corticosteroid as treatment in SARS was associated with adverse outcomes: a retrospective cohort study. J Infect. 2005 Aug;51(2):98-102. doi: 10.1016/j.jinf.2004.09.008. |
| 21742209 | Background | Raghavendran K, Napolitano LM. Definition of ALI/ARDS. Crit Care Clin. 2011 Jul;27(3):429-37. doi: 10.1016/j.ccc.2011.05.006. |
| 9824069 | Background | Vincent JL, de Mendonca A, Cantraine F, Moreno R, Takala J, Suter PM, Sprung CL, Colardyn F, Blecher S. Use of the SOFA score to assess the incidence of organ dysfunction/failure in intensive care units: results of a multicenter, prospective study. Working group on "sepsis-related problems" of the European Society of Intensive Care Medicine. Crit Care Med. 1998 Nov;26(11):1793-800. doi: 10.1097/00003246-199811000-00016. |
| 33240091 | Derived | Sultana J, Crisafulli S, Gabbay F, Lynn E, Shakir S, Trifiro G. Challenges for Drug Repurposing in the COVID-19 Pandemic Era. Front Pharmacol. 2020 Nov 6;11:588654. doi: 10.3389/fphar.2020.588654. eCollection 2020. |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |