Glucocorticoid Therapy for COVID-19 Critically Ill Patients With Severe Acute Respiratory Failure

Peking Union Medical College Hospital80 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

COVID-19 Infections

Interventions

methylprednisolone therapyDRUG

Methylprednisolone 40 mg q12h for 5 days

Standard careOTHER

Standard care

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Medical ICU,Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 14 days after randomization

Secondary Outcomes

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.

Time frame: 7 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.

Time frame: 7 days after randomization

Mechanical ventilation support

Percentage of patients requiring Mechanical ventilation support

Time frame: 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.

Time frame: 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.

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.