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)

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04452942

Enrollment

Registered

2020-07-01

Start date

2020-07-31

Completion date

2021-04-30

Last updated

2020-07-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COVID-19

Keywords

Coronavirus Disease 2019, SARS-CoV-2, Eicosanoids, Eicosanoid storm, Cytokine storm

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Changes on eicosanoid lipid mediators	10 days	Temporal changes on eicosanoid lipid mediators over a course of 10 days (or until discharge) in COVID-19 patients requiring hospitalization
Changes on plasma levels of a panel of 40 human cytokines and chemokines	10 days	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.

Secondary

Measure	Time frame	Description
Severe clinical outcome	Through study completion, an average of 10 days	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

Countries

United States

Contacts

Primary ContactIrene Cortes-Puch, MD

icortespuch@eicosis.com3018215857

Outcome results