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

NCT ID: NCT04244591

Last Updated: 2020-06-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-01-26
• Study Completion Date: 2020-04-13

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.

Conditions

COVID-19 Infections

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

standard care

standard care

Group Type: PLACEBO_COMPARATOR

Standard care

Intervention Type: OTHER

Standard care

standard care + methylprednisolone therapy

Methylprednisolone 40 mg q12h for 5 days

Group Type: EXPERIMENTAL

methylprednisolone therapy

Intervention Type: DRUG

Methylprednisolone 40 mg q12h for 5 days

Interventions

methylprednisolone therapy

Methylprednisolone 40 mg q12h for 5 days

Intervention Type: DRUG

Standard care

Standard care

Intervention Type: OTHER

Other Intervention Names

Steroids

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zhongda Hospital

OTHER

Sponsor Role: collaborator

Zhongnan Hospital

OTHER

Sponsor Role: collaborator

Renmin Hospital of Wuhan University

OTHER

Sponsor Role: collaborator

Peking Union Medical College Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Medical ICU,Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

Countries

China

References

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.

Reference Type: BACKGROUND

PMID: 29161116 (View on PubMed)

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

PMID: 21742209 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 9824069 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 33240091 (View on PubMed)

Other Identifiers

Glucocorticoid COVID-19

Identifier Type: -

Identifier Source: org_study_id