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

Chinese Academy of Medical Sciences & Peking Union Medical College

Status and phase

Completed

Phase 3

Phase 2

Conditions

COVID-19 Infections

Treatments

Drug: methylprednisolone therapy

Other: Standard care

Study type

Interventional

Funder types

Other

Identifiers

NCT04244591

Glucocorticoid COVID-19

Details and patient eligibility

About

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.

Full 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.

Enrollment

80 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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