Early Short Course Corticosteroids in COVID-19

NCT04374071 | Completed FDA Drug

• 1 other identifier: HFH IRB # 13739
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators intend to study the role of early use of methylprednisolone in the hospitalized patients with a diagnosis of COVID-19 pneumonia.

Conditions

COVID; Pneumonia, Viral

Keywords

methyprednisolone

Outcome Measures

Primary Outcomes (3)

• Transfer to Intensive care unit (ICU)

  Number of patients transferred to ICU is each of the groups

  14 days followup for every patient in each group

• Need for Mechanical Ventilation

  Number of patients that needed mechanical ventilation in each of the groups

  14 days followup for every patient in each group

• Mortality

  Number of patients who died in each of the groups

  14 days followup for every patient in each group

Secondary Outcomes (2)

• Development and Severity of ARDS

  14 days followup for every patient in each group

• Length of hospital stay (LOS).

  14 days followup for every patient in each group

Study Arms (2)

Pre-Corticosteroid protocol

Patients with moderate or severe disease who presented to HFHS within the first week of the COVID epidemic in Detroit were initially treated with supportive care with or without a combination of lopinavir-ritonavir and ribavirin or hydroxychloroquine according an institutional guideline developed by Infectious Diseases Physicians and Pharmacists. The institutional guidelines were developed by consensus, and based on the available literature, experience from Wuhan, China and other centers around the world affected by COVID-19 before Michigan. Intravenous (IV) remdesivir compassionate use was requested for eligible mechanically ventilated patients. On March 17, 2020 lopinavir-ritonavir with ribavirin was removed from the COVID-19 institutional protocol.

Corticosteroid Protocol

As a result of observed poor outcomes, clinical rationale based upon immunology, clinical course of COVID-19, and more recently best available evidence, the HFHS corticosteroid protocol was developed. We hypothesized that early corticosteroids would combat the inflammatory cascade leading to respiratory failure, ICU escalation of care, and mechanical ventilation. The corticosteroid protocol became the institutional standard on March 20, 2020. Patients with confirmed influenza infection were not recommended to receive corticosteroids. Patients with moderate COVID-19 who required 4 liters or more of oxygen per minute on admission, or who had escalating oxygen requirements from baseline, were recommended to receive IV methylprednisolone 0.5 to 1 mg/kg/day in 2 divided doses for 3 days. Patients who required ICU admission were recommended to receive the above regimen of hydroxychloroquine and IV methylprednisolone 0.5 to 1 mg/kg/day in 2 divided doses for 3 to 7 days.

Drug: Methylprednisolone

Interventions

Methylprednisolone DRUG

IV methylprednisolone 0.5 to 1 mg/kg/day in 2 divided doses for 3 days

Also known as: Corticosteorids

Corticosteroid Protocol

Eligibility Criteria

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

Study Population

Consecutive patients hospitalized with confirmed COVID-19 between March 12, 2020 through March 27, 2020 were eligible for inclusion. Risk stratification by severity of symptoms on presentation: Patients without hypoxia or exertional dyspnea were considered to have mild COVID-19 and not admitted to the hospital. Patients who presented with infiltrates on chest radiography and required supplemental oxygen by nasal cannula or HFNC were classified as having moderate COVID-19. Patients who had respiratory failure requiring mechanical ventilation were classified as having severe COVID-19.

You may qualify if:

• years of age or older
• Confirmed COVID-19 infection
• Radiographic evidence of bilateral pulmonary infiltrates
• Oxygen requirement by nasal cannula, high-flow nasal cannula (HFNC), or mechanical ventilation

You may not qualify if:

• Transfer from an out-of-system hospital
• Death within 24 hours of presentation to the ED
• Admitted for less than 24 hours

Sponsors & Collaborators

• Henry Ford Health System: lead

Study Sites (1)

Henry Ford Hospital

Detroit, Michigan, 48202, United States

Location

Related Publications (1)

• Fadel R, Morrison AR, Vahia A, Smith ZR, Chaudhry Z, Bhargava P, Miller J, Kenney RM, Alangaden G, Ramesh MS; Henry Ford COVID-19 Management Task Force. Early Short-Course Corticosteroids in Hospitalized Patients With COVID-19. Clin Infect Dis. 2020 Nov 19;71(16):2114-2120. doi: 10.1093/cid/ciaa601.

  PMID: 32427279 DERIVED

MeSH Terms

Conditions

Pneumonia, Viral

Interventions

Methylprednisolone

Condition Hierarchy (Ancestors)

Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Prednisolone; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Mayur Ramesh

  Henry Ford Health System

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Staff Physician, Infectious Diseases

Study Record Dates

• First Submitted: April 30, 2020
• First Posted: May 5, 2020
• Study Start: March 12, 2020
• Primary Completion: March 27, 2020
• Study Completion: April 30, 2020
• Last Updated: May 5, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR, ANALYTIC CODE
• Time Frame: One year from publication
• Access Criteria: All requests for IPD should be referred to the PI by email.

Locations

US (1)