COVID Clinical Trial
Official title:
Early Short Course Corticosteroids in Hospitalized Patients With COVID-19
The investigators intend to study the role of early use of methylprednisolone in the hospitalized patients with a diagnosis of COVID-19 pneumonia.
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).
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