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

NCT04244591 | Completed Phase 2 DMC

• 1 other identifier: Glucocorticoid COVID-19
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

COVID-19 Infections

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (8)

• The difference of PaO2/FiO2 between two groups

  7 days after randomization

• Lower Sequential Organ Failure Assessment (SOFA) score

  7 days after randomization

• Mechanical ventilation support

  7 days after randomization

• The difference of PaO2/FiO2 between two groups

  14 days after randomization

• Lower Sequential Organ Failure Assessment (SOFA) score

  14 days after randomization

Study Arms (2)

standard care

PLACEBO COMPARATOR

standard care

Other: Standard care

standard care + methylprednisolone therapy

EXPERIMENTAL

Methylprednisolone 40 mg q12h for 5 days

Drug: methylprednisolone therapy

Interventions

methylprednisolone therapy DRUG

Methylprednisolone 40 mg q12h for 5 days

Also known as: Steroids

standard care + methylprednisolone therapy

Standard care OTHER

Standard care

standard care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead
• Zhongda Hospital: collaborator
• Zhongnan Hospital: collaborator
• Renmin Hospital of Wuhan University: collaborator

Study Sites (1)

Medical ICU,Peking Union Medical College Hospital

Beijing, Beijing Municipality, 010, China

Location

Related Publications (5)

• 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.

  PMID: 29161116 BACKGROUND

• 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.

  PMID: 16038758 BACKGROUND

• 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.

  PMID: 21742209 BACKGROUND

• 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.

  PMID: 9824069 BACKGROUND

• 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.

  PMID: 33240091 DERIVED

MeSH Terms

Interventions

Steroids; Standard of Care

Intervention Hierarchy (Ancestors)

Fused-Ring Compounds; Polycyclic Compounds; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 23, 2020
• First Posted: January 28, 2020
• Study Start: January 26, 2020
• Primary Completion: April 13, 2020
• Study Completion: April 13, 2020
• Last Updated: June 16, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)