Official Title
Glucocorticoid Therapy for Critically Ill Patients With Severe Acute Respiratory Infections Caused by COVID-19: a Prospective, Randomized Controlled Trial
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.

Completed
COVID-19 Infections

Drug: methylprednisolone therapy

Methylprednisolone 40 mg q12h for 5 days
Other Name: Steroids

Other: Standard care

Standard care

Eligibility Criteria

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

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: N/A
Countries
China
Locations

Medical ICU,Peking Union Medical College Hospital
Beijing, Beijing, China

Peking Union Medical College Hospital
NCT Number
MeSH Terms
Infections
COVID-19
Methylprednisolone
Methylprednisolone Acetate
Methylprednisolone Hemisuccinate
Prednisolone
Prednisolone acetate
Prednisolone hemisuccinate
Prednisolone phosphate