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

NCT ID: NCT04452942

Last Updated: 2020-07-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-07-31

Study Completion Date

2021-04-30

Brief Summary

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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

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Conditions

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COVID-19

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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EicOsis Human Health Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Stony Brook University Hospital

New York, New York, United States

Site Status

Countries

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United States

Central Contacts

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Irene Cortes-Puch, MD

Role: CONTACT

3018215857

Facility Contacts

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Ana Mavarez-Martinez, MD

Role: primary

Related Links

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Other Identifiers

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EC1153-2-01

Identifier Type: -

Identifier Source: org_study_id

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