Cytokine and Eicosanoid Mediators in Coronavirus Disease 2019 (COVID-19)
Dynamic Changes in Cytokine and Eicosanoid Mediators Among Hospitalized Patients With Coronavirus Infectious Disease 2019 (COVID-19)
1 other identifier
observational
30
1 country
1
Brief Summary
This study is a prospective, single center, observational, cohort study of patients to (1) describe the kinetics and temporal relationship of changes in eicosanoid and cytokine mediators in patients with severe COVID-19 admitted to the hospital; and (2) correlate the dynamic changes in eicosanoid mediators with available patient clinical status, including measures of severity of illness, routine laboratory tests, and outcomes.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Jul 2020
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 27, 2020
CompletedFirst Posted
Study publicly available on registry
July 1, 2020
CompletedStudy Start
First participant enrolled
July 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2021
CompletedJuly 21, 2020
July 1, 2020
2 months
June 27, 2020
July 20, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Changes on eicosanoid lipid mediators
Temporal changes on eicosanoid lipid mediators over a course of 10 days (or until discharge) in COVID-19 patients requiring hospitalization
10 days
Changes on plasma levels of a panel of 40 human cytokines and chemokines
Temporal changes on the levels of 40 human cytokines, chemokines and growth factors included in a commercially available panel (Bio-Rad, Human Chemokine Panel, 40-Plex #171AK99MR2) over a course of 10 days (or until discharge) in COVID-19 patients requiring hospitalization.
10 days
Secondary Outcomes (1)
Severe clinical outcome
Through study completion, an average of 10 days
Eligibility Criteria
Patients with laboratory-confirmed SARS-CoV-2 infection requiring hospitalization for COVID-19
You may qualify if:
- Admitted to a hospital with symptoms suggestive of COVID-19.
- Confirmed infection with SARS-CoV-2 as determined by polymerase chain reaction (PCR) or other commercial or public health assay in the 72 hours prior to hospital admission or any time during hospital admission.
- Subject (or legally authorized representative) provides written informed consent prior to initiation of any study procedures.
- Understands and agrees to comply with planned study procedures.
- Agrees to the collection of whole blood samples.
You may not qualify if:
- Inability to obtain informed consent.
- Anticipated transfer to another hospital which is not a study site within 48 hours.
- Inability to obtain sequential blood samples due to patient's characteristics (i.e. difficult vascular access).
- Obstetric patients.
- Prisoners.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Stony Brook University Hospital
New York, New York, 11794, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 27, 2020
First Posted
July 1, 2020
Study Start
July 1, 2020
Primary Completion
September 1, 2020
Study Completion
April 1, 2021
Last Updated
July 21, 2020
Record last verified: 2020-07
Data Sharing
- IPD Sharing
- Will not share