Medical ICU,Peking Union Medical College Hospital
Beijing, Beijing Municipality, 010, China
NCT Number: NCT04244591
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.
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Notify Me18 year and older
All sexes
Interventional
Phase 2 / Phase 3
Beijing, Beijing Municipality, 010, China
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Methylprednisolone 40 mg q12h for 5 days
Other names: Steroids
Standard care
Time frame: 7 days after randomization
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.
Time frame: 14 days after randomization
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.
Time frame: 7 days after randomization
PaO2/FiO2 denotes ratio of arterial partial pressure of O2 and the fraction of inspired oxygen, with a higher PaO2/FiO2 means favorable outcome.
Time frame: 7 days after randomization
Lower SOFA score means better outcome. The SOFA score system range from 0 to 24 according to the severity of the condition.
Time frame: 7 days after randomization
Percentage of patients requiring Mechanical ventilation support
Time frame: 14 days after randomization
PaO2/FiO2 denotes ratio of arterial partial pressure of O2 and the fraction of inspired oxygen, with a higher PaO2/FiO2 means favorable outcome.
Time frame: 14 days after randomization
Lower SOFA score means better outcome. The SOFA score system range from 0 to 24 according to the severity of the condition.
Time frame: 14 days after randomization
Percentage of patients requiring Mechanical ventilation support
Time frame: 14 days after randomization
Clearance of noval coronavirus in upper respiratory tract or lower respiratory tract
Time frame: 30 days after randomization
All-cause mortality
Peking Union Medical College Hospital
Other
Glucocorticoid Therapy for Critically Ill Patients With Severe Acute Respiratory Infections Caused by COVID-19: a Prospective, Randomized Controlled Trial
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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