Cytokine and Eicosanoid Mediators in Coronavirus Disease 2019 (COVID-19)

EicOsis Human Health Inc.30 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

COVID-19

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Admitted to a hospital with symptoms suggestive of COVID-19. 2. 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. 3. Subject (or legally authorized representative) provides written informed consent prior to initiation of any study procedures. 4. Understands and agrees to comply with planned study procedures. 5. Agrees to the collection of whole blood samples. Exclusion Criteria: 1. Inability to obtain informed consent. 2. Anticipated transfer to another hospital which is not a study site within 48 hours. 3. Inability to obtain sequential blood samples due to patient's characteristics (i.e. difficult vascular access). 4. Obstetric patients. 5. Prisoners.

Locations (1)

Stony Brook University Hospital

New York, New York, United States

Outcomes

Primary Outcomes

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

Time frame: 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.

Time frame: 10 days

Secondary Outcomes

Severe clinical outcome

Severe clinical outcome defined as need for ICU admission and/or need for mechanical ventilation and/or multi-organ failure and/or death during hospitalization

Time frame: Through study completion, an average of 10 days

Central Contacts

Irene Cortes-Puch, MD

CONTACT

3018215857 icortespuch@eicosis.com

Data from ClinicalTrials.gov

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