Clinical trial NCT04786301: Severe Acute Respiratory Infection - Preparedness (COVID-19 and Influenza)
Official title: Severe Acute Respiratory Infection - Preparedness
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pneumonia, Viral
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: Centers for Disease Control and Prevention
First posted: 2021-03-08
Enrollment: 1200
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults admitted to the hospital with a diagnosis of severe acute respiratory infection.

Brief summary: Severe Acute Respiratory Infection (SARI) is defined by the World Health Organization (WHO) as acute respiratory infection with a history of fever ≥38°C and cough for less than 10 days duration that requires hospital admission. SARI-PREP is a multi-center consortium funded by the CDC Foundation 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. A current example of a form of SARI to be targeted by SARI-PREP is COVID-19 the acute respiratory infectious disease caused by SARS-CoV-2 infection. COVID-19 has a broad set of manifestations and severity with a subset of affected patients developing severe disease leading to respiratory failure and other forms of organ dysfunction. As with many outbreaks of novel viral pathogens causing SARI there was no efficacious therapeutic intervention at the beginning of the COVID-19 pandemic. Furthermore, while there is emerging knowledge of clinical risks for severe COVID-19, there remains a paucity of information about the viral dynamics and host responses that might indicate a patient is at high risk for poor outcomes.

The COVID-19 pandemic will be the initial target of the SARI-PREP consortium with the overall goal of developing a multi-institutional collaborative network of Acute Care Hospitals that will rapidly enroll, sample, and follow patients admitted with severe COVID-19 and to develop research protocols to rapidly determine demographic, clinical, host molecular, virologic, and institutional correlates of outcome. Overall, the information gained from this effort will help to rapidly inform and improve clinical management of epidemic/pandemic SARI patients.


Eligibility criteria: Inclusion Criteria:

* Admission to an acute care or intensive care unit with a clinical syndrome of lower respiratory tract infection suspicious for viral SARI:
* fever
* cough
* AND (radiographic infiltrates by imaging (chest x-ray, CT scan, etc.) OR SpO2 ≤ 94% on room air OR requiring new supplemental oxygen (above baseline if preexisting) OR requiring invasive or non-invasive mechanical ventilation).
* confirmed viral cause for SARI by respiratory viral RT-PCR testing.

Exclusion Criteria:

* Prisoners or wards of the state
* Inability to consent or lack of availability of legal surrogate
* Do not attempt resuscitation/do not intubate status on admission

Primary outcomes:
measure: Ventilator-free days (VFD)
timeFrame: 30 days
Secondary outcomes:
measure: Mortality
timeFrame: 28-day and 90-day
measure: Organ failure free days
timeFrame: 30 days
measure: World Health Organization respiratory failure ordinal score
timeFrame: 30 days
Other outcomes:
Locations:
city: New York
country: United States
facility: Bellevue Hospital Center
state: New York
city: New York
country: United States
facility: NYU Langone Medical Center
state: New York
Study officials:
affiliation: University of Washington
name: Laura Evans, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References: