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Status unknownNCT04452942Updated Jul 21, 2020

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

An observational study in COVID-19, sponsored by EicOsis Human Health Inc.. Status unknown at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-07-21.

Sponsored by EicOsis Human Health Inc. · Observational

The sponsor has not verified this record recently (last verified Jul 2020), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
30
Ages
18 Years and older
Sex
All
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Study 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.

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Conditions studied

  • COVID-19

Keywords

  • Coronavirus Disease 2019
  • SARS-CoV-2
  • Eicosanoids
  • Eicosanoid storm
  • Cytokine storm
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In context

COVID-19

7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.

This study's planned enrollment of 30 is below the median of 260 across 3,135 observational studies indexed under COVID-19.

Browse COVID-19 studies →

Lead sponsor

EicOsis Human Health Inc. is the lead sponsor of 7 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

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

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.
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
30 participants (estimated)
Patient registry
No
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What researchers measure

Primary outcomes

  1. 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

  2. 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

  1. 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

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Study locations

1 site
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References and documents

Related links

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 21, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04452942
Lead sponsor
EicOsis Human Health Inc.
Responsible party
Sponsor
First posted
Jul 1, 2020
Start date
Jul 2020 (estimated)
Primary completion
Sep 2020 (estimated)
Completion
Apr 2021 (estimated)
Last update
Jul 21, 2020

Study contacts

Irene Cortes-Puch, MD
Contact
icortespuch@eicosis.com
3018215857

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jul 2020. You cannot join it, but the record below documents what was studied.

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