COVID-19 Infections
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DRUGmethylprednisolone therapy
Methylprednisolone 40 mg q12h for 5 days
OTHERStandard care
Standard care
Sponsors
Zhongda Hospital
Zhongnan Hospital
Renmin Hospital of Wuhan University
Peking Union Medical College Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult * PCR confirmed COVID-19 infection * Symptoms developed more than 7 days * PaO2/FiO2 \< 200 mmHg * Positive pressure ventilation (non-invasive or invasive) or high flow nasal cannula (HFNC) higher than 45 L/min for less than 48 hours * Requiring ICU admission
Exclusion criteria
* pregnancy; * patients currently taking corticosteroids (cumulative 400 mg prednisone or equivalent); * Severe underlying disease, i.e. end stage of malignancy disease or end stage of pulmonary disease; * Severe adverse events before ICU admission, i.e. cardiac arrest; * Underlying disease requiring corticosteroids; * Contraindication for corticosteroids; * Recruited in other clinical intervention trial
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Lower Murray lung injury score | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The difference of PaO2/FiO2 between two groups | 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. |
| Lower Sequential Organ Failure Assessment (SOFA) score | 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. |
| Mechanical ventilation support | 7 days after randomization | Percentage of patients requiring Mechanical ventilation support |
| Clearance of noval coronavirus | 14 days after randomization | Clearance of noval coronavirus in upper respiratory tract or lower respiratory tract |
| All-cause mortality | 30 days after randomization | All-cause mortality |
Countries
China
Outcome results
None listed