Overview

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

Status:
Completed
Trial end date:
2020-04-13
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 2/Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Peking Union Medical College Hospital
Collaborators:
Renmin Hospital of Wuhan University
Zhongda Hospital
Zhongnan Hospital
Treatments:
Glucocorticoids
Methylprednisolone
Methylprednisolone Acetate
Methylprednisolone Hemisuccinate
Prednisolone
Prednisolone acetate
Prednisolone hemisuccinate
Prednisolone phosphate
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