What is SARI-PREP?
SARI-PREP is a multicenter consortium funded by the Centers for Disease Control and Prevention (CDC) Foundation. It is being assembled with the goal of providing the infrastructure to rapidly collect prospective data on clinical risks and outcomes, hospital-level stress, and biologic specimens that will aid in the rapid development of diagnostic and treatment approaches.
Specific causes of severe acute respiratory infection (SARI) to be targeted by SARI-PREP include SARS-CoV-2, influenza A and B viruses, and other known or novel viral infections causing outbreaks, epidemics, and pandemics of SARI.
The information gained will help to rapidly inform and improve clinical management of epidemic/pandemic SARI patients. The completion date is October 2021.
What are the study objectives?
- Identify the clinical characteristics and treatments associated with risk for severity of disease and important clinical outcomes in hospitalized patients at high-risk for SARI due to respiratory viral illness caused by pathogens such as SARS-CoV-2 and influenza A and B viruses
- Identify clinical characteristics and treatments differentiating patients with SARI due to specific respiratory viruses such as SARS-CoV-2 and influenza A among hospitalized patients with suspected viral SARI
- Identify the molecular markers of risk for poor in-hospital and post-discharge clinical outcomes in hospitalized patients with viral SARI
- Evaluate which patient characteristics and treatments are associated with organ failure-free days and mortality in patients with viral SARI
- Report the natural history of a large cohort of patients with confirmed viral SARI
What are the inclusion and exclusion criteria?
- At-risk cohort requires admission to an acute care or intensive care unit with a clinical syndrome of lower respiratory tract infection suspicious for viral SARI. This will be defined by the presence of fever, cough, and radiographic infiltrates by imaging (chest radiograph, CT, etc.) or Spo2 ≤ 94% on room air or requiring new supplemental oxygen (above baseline if preexisting) or requiring invasive or noninvasive mechanical ventilation.
- Case cohort requires the above criteria plus confirmed viral cause for SARI by respiratory viral reverse transcription polymerase chain reaction testing.
- Prisoners or wards of the state
- Inability to consent or lack of availability of legal surrogate
- Status of do-not-attempt resuscitation or do-not-intubate on admission
University of Washington; University of Nebraska; Emory University; and Discovery, the Critical Care Research Network are leading the consortium study.
Laura E. Evans, MD (University of Washington)
Pavan Bhatraju, MD, MSc (University of Washington)
David Brett-Major, MD, MPH (University of Nebraska)
Chris Kratochvil, MD (University of Nebraska)
J. Perren Cobb, MD, FCCM (University of Southern California)
Janice Lieber, MD (University of Souther California)
Leopoldo N. Segal, MD (NYU Langone)
Jonathan E. Sevransky, MD, FCCM (Emory University)
Mark M. Wurfel, MD, PhD (University of Washington)
Radu Postelnicu, MD (NYU Langone)
Vikramjit Mukherjee, MD (NYU Langone)
Timothy Uyeki, MD
Institutional Review Board
Central institutional review board (IRB) will be through the University of Nebraska. For additional IRB information, please contact SCCM staff
Adair Andrews RN, MATD
(Society of Critical Care Medicine)
Vishakha Kumar, MD, MBA
(Society of Crticial Care Medicine)