Glucocorticoid Therapy for Critically Ill Patients With Severe Acute Respiratory Infections Caused by COVID-19: a Prospective, Randomized Controlled Trial
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- Lower Murray lung injury score
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
Arms & Interventions
standard care
standard care
Intervention: Standard care (Other)
standard care + methylprednisolone therapy
Methylprednisolone 40 mg q12h for 5 days
Intervention: methylprednisolone therapy (Drug)
Outcomes
Primary Outcomes
Lower Murray lung injury score
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.
Secondary Outcomes
- The difference of PaO2/FiO2 between two groups(14 days after randomization)
- Mechanical ventilation support(14 days after randomization)
- Lower Sequential Organ Failure Assessment (SOFA) score(14 days after randomization)
- Clearance of noval coronavirus(14 days after randomization)
- All-cause mortality(30 days after randomization)