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

Sponsor
University of Washington (Other)
Overall Status
Recruiting
CT.gov ID
NCT04786301
Collaborator
Centers for Disease Control and Prevention (U.S. Fed)
1,200
2
22
600
27.3

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    1200 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Severe Acute Respiratory Infection - Preparedness
    Actual Study Start Date :
    Apr 30, 2020
    Anticipated Primary Completion Date :
    Jan 1, 2022
    Anticipated Study Completion Date :
    Mar 1, 2022

    Outcome Measures

    Primary Outcome Measures

    1. Ventilator-free days (VFD) [30 days]

      Number of days alive and free of mechanical ventilation

    Secondary Outcome Measures

    1. Mortality [28-day and 90-day]

    2. Organ failure free days [30 days]

    3. World Health Organization respiratory failure ordinal score [30 days]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Bellevue Hospital Center New York New York United States 10016
    2 NYU Langone Medical Center New York New York United States 10016

    Sponsors and Collaborators

    • University of Washington
    • Centers for Disease Control and Prevention

    Investigators

    • Principal Investigator: Laura Evans, MD, MSc, University of Washington

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Laura Evans, Associate Professor, Pulmonary, Critical Care and Sleep Medicine, University of Washington
    ClinicalTrials.gov Identifier:
    NCT04786301
    Other Study ID Numbers:
    • STUDY00011343
    First Posted:
    Mar 8, 2021
    Last Update Posted:
    Mar 12, 2021
    Last Verified:
    Mar 1, 2021
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Mar 12, 2021