Early Short Course Corticosteroids in COVID-19

COVID Clinical Trial

Official title:

Early Short Course Corticosteroids in Hospitalized Patients With COVID-19

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04374071
• Other study ID #: HFH IRB # 13739
• Status: Completed
• Start date: March 12, 2020
• Est. completion date: April 30, 2020

Study information

• Verified date: May 2020
• Source: Henry Ford Health System
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Description:

Consecutive patients hospitalized between March 12, 2020 through March 27, 2020 are eligible for inclusion if they were 18 years of age or older, had confirmed COVID-19 infection, with radiographic evidence of bilateral pulmonary infiltrates, and required oxygen by nasal cannula, high-flow nasal cannula (HFNC), or mechanical ventilation. Patients are excluded if they were transferred from an out-of-system hospital, died within 24 hours of presentation to the ED, or were admitted for less than 24 hours. A confirmed case of COVID-19 was defined as a patient that had a positive reverse-transcriptase-polymerase- chain-reaction (RT-PCR) assay for SARS-CoV-2 in a nasopharyngeal sample.

Patients are risk stratified by severity of symptoms on presentation to the hospital as mild, moderate, or severe COVID-19. Patients without hypoxia or exertional dyspnea were considered to have mild COVID-19. Patients with mild COVID-19 were treated with symptom relief only 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.

This is a multi-center quasi-experimental study at HFHS, comprised of five hospitals in southeast and south-central Michigan. The study was approved by the institution's Investigational Review Board (#13739) with waiver of consent. Patients in the pre-corticosteroid protocol group from March 12, 2020 through March 19, 2020 were compared to a corticosteroid protocol group that included patients from March 20, 2020 through March 27, 2020.

Patients in both study groups received standard care, comprised of supplemental oxygen, HFNC, invasive ventilation, antibiotic agents, antiviral agents, vasopressor support, and renal-replacement therapy, as determined by the primary team. Patients who progressed to ARDS were managed with standard of care.

Data was ascertained from each institution's electronic medical record and recorded in a standardized electronic case report form. Demographic data, information on clinical symptoms or signs at presentation, and laboratory and radiologic results during admission. All laboratory tests and radiologic assessments, including plain chest radiography and computed tomography of the chest, were performed at the discretion of the treating physician.

Coexisting conditions were ascertained from electronic medical record and physician documentation. The National Early Warning Score (NEWS) was collected to evaluate baseline illness severity based on vital signs obtained in the Emergency Department. Additionally, the quick Sequential Organ Failure Assessment (qSOFA) was used to evaluate severity of illness of included patients based on ED vitals and examination. All patients were followed for at least 14 days after initial presentation. Patient data was censored on April 9, 2020.

Statistical Analysis: Continuous variables were reported as median and interquartile range (IQR) and compared using the Mann-Whitney test or t-test, as appropriate. Categorical data was reported as number and percentage (no., %) and compared using the chi-squared test or Fisher's exact test, as appropriate. No imputation was made for missing data points. The sample size was derived from all eligible consecutive hospitalized patients during the study period. A two-sided α < 0.05 was considered statistically significant. Bivariate and multivariable logistic regression analysis was planned a-priori to test the association between the composite endpoint and exposure to the corticosteroid protocol. Covariates in the bivariate analysis with a p-value <0.2 and clinical rationale were included in a multivariable regression model that was restricted to a subject-to-variable ratio of 10:1. Statistical analysis was performed using IBM SPSS version 25 (Chicago, IL) and SAS 9.4 (Cary, NC).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 250
• Est. completion date: April 30, 2020
• Est. primary completion date: March 27, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 18 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

Exclusion Criteria:

• Transfer from an out-of-system hospital

• Death within 24 hours of presentation to the ED

• Admitted for less than 24 hours

Related Conditions & MeSH terms

• COVID
• Pneumonia
• Pneumonia, Viral

Intervention

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

Locations

Country	Name	City	State
United States	Henry Ford Hospital	Detroit	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Henry Ford Health System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Mortality	Number of patients who died in each of the groups	14 days followup for every patient in each group
Secondary	Development and Severity of ARDS	Number of patients who developed ARDS of varying severity per Berlin classification in each of the groups	14 days followup for every patient in each group
Secondary	Length of hospital stay (LOS).	LOS in each of the groups	14 days followup for every patient in each group