SARI-PREP

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

How will the institutional review board be addressed?

Central institutional review board (IRB) will be through the University of Nebraska. For additional IRB information, please contact SCCM staff.

What are the criteria?

Inclusion 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 (e.g., chest radiograph, CT) 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 criteria above plus confirmed viral cause for SARI by respiratory viral reverse transcription polymerase chain reaction testing.

Exclusion criteria:

• 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

• George L. Anesi, MD, MSCE, MBE, University of Pennsylvania
• Pavan Bhatraju, MD, MSc, University of Washington
• J. Perren Cobb, MD, FCCM, University of Southern California
• Chris Kratochvil, MD, University of Nebraska
• Douglas Landsittel, PhD, University of Pittsburgh
• Richard Lee, MD, University of California, Irvine
• Janice Lieber, MD, University of Southern California
• Karen Lutrick, PhD, University of Arizona

• David Brett-Major, MD, MPH, University of Nebraska
• Vikramjit Mukherjee, MD, NYU Langone
• Radu Postelnicu, MD, NYU Langone
• Leopoldo N. Segal, MD, NYU Langone
• Jonathan E. Sevransky, MD, FCCM, Emory University
• Timothy Uyeki, MD, Centers for Disease Control and Prevention
• Mark M. Wurfel, MD, PhD, University of Washington
• David Wyles, MD, Denver Health