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

NCT04786301 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 1200

Last updated 2021-03-12

No results posted yet for this study

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

Sponsors & Collaborators

Principal Investigators

  • Laura Evans, MD, MSc · University of Washington

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-04-30
Primary Completion
2022-01-31
Completion
2022-03-31

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04786301 on ClinicalTrials.gov