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

COVID-19 Clinical Trial

Official title:

Dynamic Changes in Cytokine and Eicosanoid Mediators Among Hospitalized Patients With Coronavirus Infectious Disease 2019 (COVID-19)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04452942
• Other study ID #: EC1153-2-01
• Status: Not yet recruiting
• Start date: July 2020
• Est. completion date: April 2021

Study information

• Verified date: July 2020
• Source: EicOsis Human Health Inc.
• Contact: Irene Cortes-Puch, MD
• Phone: 3018215857
• Email: icortespuch[@]eicosis.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: April 2021
• Est. primary completion date: September 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Coronavirus Infections
• COVID-19

Locations

Country	Name	City	State
United States	Stony Brook University Hospital	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
EicOsis Human Health Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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	Through study completion, an average of 10 days

External Links

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