Pneumonia, ViralSARI-PREPNCT04786301
Severe Acute Respiratory Infection - Preparedness (COVID-19 and Influenza)
An observational study of Pneumonia, Viral, run by University of Washington at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pneumonia, Viral
- How many people
- 1,200 participants
- Where
- 2 sitesUnited States
- Study dates
- 30 Apr 2020to Mar 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Adults admitted to the hospital with a diagnosis of severe acute respiratory infection.
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites, 2 recruiting
- Recruiting
Bellevue Hospital Center
New York, New York, 10016
Radu Postelnicu, MD
- Recruiting
NYU Langone Medical Center
New York, New York, 10016
Leo Segal, MD
About this study
Official title: Severe Acute Respiratory Infection - Preparedness
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
- Medical subject headings
- Pneumonia, Viral
What is being measured
The primary outcome is the main question the study is designed to answer.
Ventilator-free days (VFD)
Number of days alive and free of mechanical ventilation
Measured: 30 days
Secondary outcomes (3)
Mortality
Measured: 28-day and 90-day
Organ failure free days
Measured: 30 days
World Health Organization respiratory failure ordinal score
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2021
- Study start30 Apr 2020
- Primary completionJan 2022 (estimated)
- Study completionMar 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pneumonia, ViralStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- Centers for Disease Control and Prevention
- Responsible party
- Principal investigator, Laura Evans, University of Washington
- Investigators
- Laura Evans, MD, MSc, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04786301
- Sponsor's protocol ID
- STUDY00011343
- Acronym
- SARI-PREP
- Status last verified
- Mar 2021
- First submitted
- 3 Mar 2021
- Last updated
- 12 Mar 2021
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Severe Acute Respiratory Infection - Preparedness
- ClinicalTrials.gov ID
- NCT04786301
- Acronym / sponsor ID
- SARI-PREP / STUDY00011343
- Conditions
- Pneumonia, Viral
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,200 participants (estimated)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- Centers for Disease Control and Prevention
- Study start
- 30 Apr 2020 (actual)
- Primary completion
- Jan 2022 (estimated)
- Study completion
- Mar 2022 (estimated)
- First posted
- 8 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults admitted to the hospital with a diagnosis of severe acute respiratory infection.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Ventilator-free days (VFD)
Time frame: 30 days
Number of days alive and free of mechanical ventilation
3 secondary outcomes
Mortality
Time frame: 28-day and 90-day
Organ failure free days
Time frame: 30 days
World Health Organization respiratory failure ordinal score
Time frame: 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Laura Evans, MD, MSc principal investigator
University of Washington
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pneumonia, Viral, run by University of Washington at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nikki Dodd (206-221-0523, doddn@uw.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ventilator-free days (VFD) (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2021.