Recruiting

Observational Study

Sponsor:

University of Washington

Code:

NCT04786301

Conditions

Pneumonia, Viral

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Study Details

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 ID

NCT04786301

Start date

Apr 30, 2020

Status verified date

Mar, 2021

Completion date

Mar, 2022

Anticipated

Primary completion date

Jan, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

1200 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

  • Ventilator-free days (VFD) [ Time Frame: 30 days ]

Central Contacts and Locations

Central contacts

Locations

Bellevue Hospital Center

Recruiting

New York, New York, United States, 10016

NYU Langone Medical Center

Recruiting

New York, New York, United States, 10016

More Information

Sponsor

University of Washington

Last update posted

Mar 12, 2021

Last verified

Mar, 2021

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Washington on 2021-03-12.