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

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ClinicalTrials.gov Identifier: NCT04244591

Recruitment Status : Completed

First Posted : January 28, 2020

Last Update Posted : June 16, 2020

View this study on Beta.ClinicalTrials.gov

Sponsor:

Collaborators:

Zhongda Hospital

Zhongnan Hospital

Renmin Hospital of Wuhan University

Information provided by (Responsible Party):

Peking Union Medical College Hospital

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.

Condition or disease	Intervention/treatment	Phase
COVID-19 Infections	Drug: methylprednisolone therapy Other: Standard care	Phase 2 Phase 3

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 Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	80 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	Glucocorticoid Therapy for Critically Ill Patients With Severe Acute Respiratory Infections Caused by COVID-19: a Prospective, Randomized Controlled Trial
Actual Study Start Date :	January 26, 2020
Actual Primary Completion Date :	April 13, 2020
Actual Study Completion Date :	April 13, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: COVID-19 (Coronavirus Disease 2019) Steroids

Drug Information available for: Prednisolone Prednisolone acetate Methylprednisolone acetate Methylprednisolone Prednisolone sodium phosphate Prednisolone phosphate Prednisolone sodium succinate Methylprednisolone sodium succinate

Genetic and Rare Diseases Information Center resources: Acute Graft Versus Host Disease

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Placebo Comparator: standard care standard care	Other: Standard care Standard care
Experimental: standard care + methylprednisolone therapy Methylprednisolone 40 mg q12h for 5 days	Drug: methylprednisolone therapy Methylprednisolone 40 mg q12h for 5 days Other Name: Steroids

Outcome Measures

Primary Outcome Measures :

Lower Murray lung injury score [ Time Frame: 7 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.
Lower Murray lung injury score [ Time Frame: 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 :

The difference of PaO2/FiO2 between two groups [ Time Frame: 7 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.
Lower Sequential Organ Failure Assessment (SOFA) score [ Time Frame: 7 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.
Mechanical ventilation support [ Time Frame: 7 days after randomization ]
Percentage of patients requiring Mechanical ventilation support
The difference of PaO2/FiO2 between two groups [ Time Frame: 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.
Lower Sequential Organ Failure Assessment (SOFA) score [ Time Frame: 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.
Mechanical ventilation support [ Time Frame: 14 days after randomization ]
Percentage of patients requiring Mechanical ventilation support
Clearance of noval coronavirus [ Time Frame: 14 days after randomization ]
Clearance of noval coronavirus in upper respiratory tract or lower respiratory tract
All-cause mortality [ Time Frame: 30 days after randomization ]
All-cause mortality

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04244591

Locations

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China, Beijing
Medical ICU,Peking Union Medical College Hospital
Beijing, Beijing, China, 010

Sponsors and Collaborators

Peking Union Medical College Hospital

Zhongda Hospital

Zhongnan Hospital

Renmin Hospital of Wuhan University

More Information

Publications:

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.

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.

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.

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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

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Responsible Party:	Peking Union Medical College Hospital
ClinicalTrials.gov Identifier:	NCT04244591
Other Study ID Numbers:	Glucocorticoid COVID-19
First Posted:	January 28, 2020 Key Record Dates
Last Update Posted:	June 16, 2020
Last Verified:	February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	No

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Studies a U.S. FDA-regulated Drug Product:	No
Studies a U.S. FDA-regulated Device Product:	No

Additional relevant MeSH terms:

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Infections COVID-19 Pneumonia, Viral Pneumonia Respiratory Tract Infections Virus Diseases Coronavirus Infections Coronaviridae Infections Nidovirales Infections RNA Virus Infections Lung Diseases Respiratory Tract Diseases Methylprednisolone Methylprednisolone Acetate Methylprednisolone Hemisuccinate	Prednisolone Prednisolone acetate Prednisolone hemisuccinate Prednisolone phosphate Anti-Inflammatory Agents Antiemetics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Gastrointestinal Agents Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Neuroprotective Agents Protective Agents

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