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

• Conditions: COVID-19

• Registration Number: NCT04452942
• Lead Sponsor: EicOsis Human Health Inc.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-06-27
• Study First Submitted QC: 2020-06-29
• Status Verified: 2020-07
• Study Start: 2020-07
• Study First Posted: 2020-07-01
• Last Update Submitted: 2020-07-20
• Last Update Posted: 2020-07-21
• Primary Completion: 2020-09
• Study Completion: 2021-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Stony Brook University Hospital; 🇺🇸 New York, New York, United States