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

Pneumonia, Viral Clinical Trial

— SARI-PREP  

Official title:

Severe Acute Respiratory Infection - Preparedness

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04786301
• Other study ID #: STUDY00011343
• Status: Recruiting
• Start date: April 30, 2020
• Est. completion date: March 2022

Study information

• Verified date: March 2021
• Source: University of Washington
• Contact: Nikki Dodd
• Phone: 206-221-0523
• Email: doddn[@]uw.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1200
• Est. completion date: March 2022
• Est. primary completion date: January 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pneumonia
• Pneumonia, Viral
• Respiratory Tract Infections

Locations

Country	Name	City	State
United States	Bellevue Hospital Center	New York	New York
United States	NYU Langone Medical Center	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
University of Washington	Centers for Disease Control and Prevention

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ventilator-free days (VFD)	Number of days alive and free of mechanical ventilation	30 days
Secondary	Mortality		28-day and 90-day
Secondary	Organ failure free days		30 days
Secondary	World Health Organization respiratory failure ordinal score		30 days