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

COVID-19 Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04244591
• Other study ID #: Glucocorticoid COVID-19
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: January 26, 2020
• Est. completion date: April 13, 2020

Study information

• Verified date: February 2020
• Source: Peking Union Medical College Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: April 13, 2020
• Est. primary completion date: April 13, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19 Infections
• Infection

Intervention

Drug:
• methylprednisolone therapy
Methylprednisolone 40 mg q12h for 5 days

Other:
• Standard care
Standard care

Locations

Country	Name	City	State
China	Medical ICU,Peking Union Medical College Hospital	Beijing	Beijing

Sponsors (4)

Lead Sponsor	Collaborator
Peking Union Medical College Hospital	Renmin Hospital of Wuhan University, Zhongda Hospital, Zhongnan Hospital

Country where clinical trial is conducted

China, 

References & Publications (4)

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. — View 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. — View 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. — View Citation

Vincent JL, de Mendonça 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	7 days after randomization
Primary	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.	14 days after randomization
Secondary	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.	7 days after randomization
Secondary	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.	7 days after randomization
Secondary	Mechanical ventilation support	Percentage of patients requiring Mechanical ventilation support	7 days after randomization
Secondary	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.	14 days after randomization
Secondary	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.	14 days after randomization
Secondary	Mechanical ventilation support	Percentage of patients requiring Mechanical ventilation support	14 days after randomization
Secondary	Clearance of noval coronavirus	Clearance of noval coronavirus in upper respiratory tract or lower respiratory tract	14 days after randomization
Secondary	All-cause mortality	All-cause mortality	30 days after randomization