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

Phase 2

Completed

• Conditions: COVID-19 Infections
• Interventions: Other: Standard care; Drug: methylprednisolone therapy

• Registration Number: NCT04244591
• Lead Sponsor: Peking Union Medical College Hospital

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 Timeline

• Study First Submitted: 2020-01-23
• Study First Submitted QC: 2020-01-25
• Study Start: 2020-01-26
• Study First Posted: 2020-01-28
• Status Verified: 2020-02
• Primary Completion: 2020-04-13
• Study Completion: 2020-04-13
• Last Update Submitted: 2020-06-13
• Last Update Posted: 2020-06-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
standard care	Standard care	standard care
standard care + methylprednisolone therapy	methylprednisolone therapy	Methylprednisolone 40 mg q12h for 5 days

Primary Outcome Measures

Name	Time	Method
Lower Murray lung injury score	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 Outcome Measures

Name	Time	Method
The difference of PaO2/FiO2 between two groups	14 days after randomization	PaO2/FiO2 denotes ratio of arterial partial pressure of O2 and the fraction of inspired oxygen, with a higher PaO2/FiO2 means favorable outcome.
Mechanical ventilation support	14 days after randomization	Percentage of patients requiring Mechanical ventilation support
Lower Sequential Organ Failure Assessment (SOFA) score	14 days after randomization	Lower SOFA score means better outcome. The SOFA score system range from 0 to 24 according to the severity of the condition.
Clearance of noval coronavirus	14 days after randomization	Clearance of noval coronavirus in upper respiratory tract or lower respiratory tract
All-cause mortality	30 days after randomization	All-cause mortality

Trial Locations

Locations (1)

Medical ICU,Peking Union Medical College Hospital; 🇨🇳 Beijing, Beijing, China