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

NCT ID: NCT04786301

Last Updated: 2021-03-12

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 1200 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-04-30
• Study Completion Date: 2022-03-31

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Centers for Disease Control and Prevention

FED

Sponsor Role: collaborator

University of Washington

OTHER

Sponsor Role: lead

Responsible Party

Laura Evans

Associate Professor, Pulmonary, Critical Care and Sleep Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Laura Evans, MD, MSc

Role: PRINCIPAL_INVESTIGATOR

University of Washington

Locations

Bellevue Hospital Center

New York, New York, United States

Site Status: RECRUITING

NYU Langone Medical Center

New York, New York, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Nikki Dodd

Role: CONTACT

doddn@uw.edu

206-221-0523

Facility Contacts

Radu Postelnicu, MD

Role: primary

Leo Segal, MD

Role: primary

Other Identifiers

STUDY00011343

Identifier Type: -

Identifier Source: org_study_id