Glucocorticoid Therapy for COVID-19 Critically Ill Patients With Severe Acute Respiratory Failure
Primary Purpose
COVID-19 Infections
Status
Completed
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
methylprednisolone therapy
Standard care
Sponsored by
About this trial
This is an interventional treatment trial for COVID-19 Infections
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
Sites / Locations
- Medical ICU,Peking Union Medical College Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
standard care
standard care + methylprednisolone therapy
Arm Description
standard care
Methylprednisolone 40 mg q12h for 5 days
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
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.
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.
Mechanical ventilation support
Percentage of patients requiring Mechanical ventilation support
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.
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.
Mechanical ventilation support
Percentage of patients requiring Mechanical ventilation support
Clearance of noval coronavirus
Clearance of noval coronavirus in upper respiratory tract or lower respiratory tract
All-cause mortality
All-cause mortality
Full Information
NCT ID
NCT04244591
First Posted
January 23, 2020
Last Updated
June 13, 2020
Sponsor
Peking Union Medical College Hospital
Collaborators
Zhongda Hospital, Zhongnan Hospital, Renmin Hospital of Wuhan University
1. Study Identification
Unique Protocol Identification Number
NCT04244591
Brief Title
Glucocorticoid Therapy for COVID-19 Critically Ill Patients With Severe Acute Respiratory Failure
Official Title
Glucocorticoid Therapy for Critically Ill Patients With Severe Acute Respiratory Infections Caused by COVID-19: a Prospective, Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
January 26, 2020 (Actual)
Primary Completion Date
April 13, 2020 (Actual)
Study Completion Date
April 13, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Peking Union Medical College Hospital
Collaborators
Zhongda Hospital, Zhongnan Hospital, Renmin Hospital of Wuhan University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19 Infections
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
standard care
Arm Type
Placebo Comparator
Arm Description
standard care
Arm Title
standard care + methylprednisolone therapy
Arm Type
Experimental
Arm Description
Methylprednisolone 40 mg q12h for 5 days
Intervention Type
Drug
Intervention Name(s)
methylprednisolone therapy
Other Intervention Name(s)
Steroids
Intervention Description
Methylprednisolone 40 mg q12h for 5 days
Intervention Type
Other
Intervention Name(s)
Standard care
Intervention Description
Standard care
Primary Outcome Measure Information:
Title
Lower Murray lung injury score
Description
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
Title
Lower Murray lung injury score
Description
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 Outcome Measure Information:
Title
The difference of PaO2/FiO2 between two groups
Description
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
Title
Lower Sequential Organ Failure Assessment (SOFA) score
Description
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
Title
Mechanical ventilation support
Description
Percentage of patients requiring Mechanical ventilation support
Time Frame
7 days after randomization
Title
The difference of PaO2/FiO2 between two groups
Description
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
Title
Lower Sequential Organ Failure Assessment (SOFA) score
Description
Lower SOFA score means better outcome. The SOFA score system range from 0 to 24 according to the severity of the condition.
Time Frame
14 days after randomization
Title
Mechanical ventilation support
Description
Percentage of patients requiring Mechanical ventilation support
Time Frame
14 days after randomization
Title
Clearance of noval coronavirus
Description
Clearance of noval coronavirus in upper respiratory tract or lower respiratory tract
Time Frame
14 days after randomization
Title
All-cause mortality
Description
All-cause mortality
Time Frame
30 days after randomization
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Medical ICU,Peking Union Medical College Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
010
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
29161116
Citation
Arabi YM, Mandourah Y, Al-Hameed F, Sindi AA, Almekhlafi GA, Hussein MA, Jose J, Pinto R, Al-Omari A, Kharaba A, Almotairi A, Al Khatib K, Alraddadi B, Shalhoub S, Abdulmomen A, Qushmaq I, Mady A, Solaiman O, Al-Aithan AM, Al-Raddadi R, Ragab A, Balkhy HH, Al Harthy A, Deeb AM, Al Mutairi H, Al-Dawood A, Merson L, Hayden FG, Fowler RA; Saudi Critical Care Trial Group. Corticosteroid Therapy for Critically Ill Patients with Middle East Respiratory Syndrome. Am J Respir Crit Care Med. 2018 Mar 15;197(6):757-767. doi: 10.1164/rccm.201706-1172OC.
Results Reference
background
PubMed Identifier
16038758
Citation
Auyeung TW, Lee JS, Lai WK, Choi CH, Lee HK, Lee JS, Li PC, Lok KH, Ng YY, Wong WM, Yeung YM. The use of corticosteroid as treatment in SARS was associated with adverse outcomes: a retrospective cohort study. J Infect. 2005 Aug;51(2):98-102. doi: 10.1016/j.jinf.2004.09.008.
Results Reference
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PubMed Identifier
21742209
Citation
Raghavendran K, Napolitano LM. Definition of ALI/ARDS. Crit Care Clin. 2011 Jul;27(3):429-37. doi: 10.1016/j.ccc.2011.05.006.
Results Reference
background
PubMed Identifier
9824069
Citation
Vincent JL, de Mendonca A, Cantraine F, Moreno R, Takala J, Suter PM, Sprung CL, Colardyn F, Blecher S. Use of the SOFA score to assess the incidence of organ dysfunction/failure in intensive care units: results of a multicenter, prospective study. Working group on "sepsis-related problems" of the European Society of Intensive Care Medicine. Crit Care Med. 1998 Nov;26(11):1793-800. doi: 10.1097/00003246-199811000-00016.
Results Reference
background
PubMed Identifier
33240091
Citation
Sultana J, Crisafulli S, Gabbay F, Lynn E, Shakir S, Trifiro G. Challenges for Drug Repurposing in the COVID-19 Pandemic Era. Front Pharmacol. 2020 Nov 6;11:588654. doi: 10.3389/fphar.2020.588654. eCollection 2020.
Results Reference
derived
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Glucocorticoid Therapy for COVID-19 Critically Ill Patients With Severe Acute Respiratory Failure
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