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

July 20, 2020 updated by: EicOsis Human Health Inc.

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

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 Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with laboratory-confirmed SARS-CoV-2 infection requiring hospitalization for COVID-19

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes on eicosanoid lipid mediators
Time Frame: 10 days
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
Time Frame: 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.
10 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Severe clinical outcome
Time Frame: 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
Through study completion, an average of 10 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

EicOsis Human Health Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

July 1, 2020

Primary Completion (Anticipated)

September 1, 2020

Study Completion (Anticipated)

April 1, 2021

Study Registration Dates

First Submitted

June 27, 2020

First Submitted That Met QC Criteria

June 29, 2020

First Posted (Actual)

July 1, 2020

Study Record Updates

Last Update Posted (Actual)

July 21, 2020

Last Update Submitted That Met QC Criteria

July 20, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EC1153-2-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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