Severe Acute Respiratory Infection - Preparedness (COVID-19 and Influenza)

NCT04786301 | Unknown

• 1 other identifier: STUDY00011343
• Study Type: observational
• Target: 1,200
• Locations: 1 country
• Sites: 2

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.

Conditions

Pneumonia, Viral

Outcome Measures

Primary Outcomes (1)

• Ventilator-free days (VFD)

  Number of days alive and free of mechanical ventilation

  30 days

Secondary Outcomes (3)

• Mortality

  28-day and 90-day

• Organ failure free days

  30 days

• World Health Organization respiratory failure ordinal score

  30 days

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults admitted to the hospital with a diagnosis of severe acute respiratory infection.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Washington: lead
• Centers for Disease Control and Prevention: collaborator

Study Sites (2)

Bellevue Hospital Center

New York, New York, 10016, United States

RECRUITING

NYU Langone Medical Center

New York, New York, 10016, United States

RECRUITING

MeSH Terms

Conditions

Pneumonia, Viral

Condition Hierarchy (Ancestors)

Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Laura Evans, MD, MSc

  University of Washington

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nikki Dodd

CONTACT

206-221-0523; doddn@uw.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Pulmonary, Critical Care and Sleep Medicine

Study Record Dates

• First Submitted: March 3, 2021
• First Posted: March 8, 2021
• Study Start: April 30, 2020
• Primary Completion: January 1, 2022
• Study Completion: March 1, 2022
• Last Updated: March 12, 2021

Record last verified: 2021-03

Locations

US (2)