COVID-19NCT04452942
Cytokine and Eicosanoid Mediators in Coronavirus Disease 2019 (COVID-19)
An observational study of COVID-19, run by EicOsis Human Health Inc. at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2020to Apr 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with laboratory-confirmed SARS-CoV-2 infection requiring hospitalization for COVID-19
Who may be able to join
- Admitted to a hospital with symptoms suggestive of COVID-19.
- 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.
- Subject (or legally authorized representative) provides written informed consent prior to initiation of any study procedures.
- Understands and agrees to comply with planned study procedures.
- Agrees to the collection of whole blood samples.
Who cannot join
- Inability to obtain informed consent.
- Anticipated transfer to another hospital which is not a study site within 48 hours.
- Inability to obtain sequential blood samples due to patient's characteristics (i.e. difficult vascular access).
- Obstetric patients.
- Prisoners.
Trial locations and contacts
1 site in 1 country.
United States1 site
Stony Brook University Hospital
New York, New York, 11794
Ana Mavarez-Martinez, MD, ana.mavarezmartinez@stonybrookmedicine.edu
Sergio Bergese, MD
About this study
Official title: 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.
- Conditions
- COVID-19
- Keywords
- Coronavirus Disease 2019, SARS-CoV-2, Eicosanoids, Eicosanoid storm, Cytokine storm
- Medical subject headings
- COVID-19, Cytokine Release Syndrome
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 10 days
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.
Measured: 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
Measured: Through study completion, an average of 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2020
- Study startJul 2020 (estimated)
- Primary completionSep 2020 (estimated)
- Study completionApr 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- EicOsis Human Health Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04452942
- Sponsor's protocol ID
- EC1153-2-01
- Status last verified
- Jul 2020
- First submitted
- 27 Jun 2020
- Last updated
- 21 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dynamic Changes in Cytokine and Eicosanoid Mediators Among Hospitalized Patients With Coronavirus Infectious Disease 2019 (COVID-19)
- ClinicalTrials.gov ID
- NCT04452942
- Acronym / sponsor ID
- EC1153-2-01
- Conditions
- COVID-19
- Keywords
- Coronavirus Disease 2019, SARS-CoV-2, Eicosanoids, Eicosanoid storm, Cytokine storm
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- EicOsis Human Health Inc.Industry (pharma, biotech, devices)
- Study start
- Jul 2020 (estimated)
- Primary completion
- Sep 2020 (estimated)
- Study completion
- Apr 2021 (estimated)
- First posted
- 1 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with laboratory-confirmed SARS-CoV-2 infection requiring hospitalization for COVID-19
Key inclusion criteria (5 listed)
- Admitted to a hospital with symptoms suggestive of COVID-19.
- 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.
- Subject (or legally authorized representative) provides written informed consent prior to initiation of any study procedures.
- Understands and agrees to comply with planned study procedures.
- Agrees to the collection of whole blood samples.
Key exclusion criteria (5 listed)
- Inability to obtain informed consent.
- Anticipated transfer to another hospital which is not a study site within 48 hours.
- Inability to obtain sequential blood samples due to patient's characteristics (i.e. difficult vascular access).
- Obstetric patients.
- Prisoners.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
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.
1 secondary outcome
Severe clinical outcome
Time frame: Through study completion, an average of 10 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2020.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19, run by EicOsis Human Health Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Irene Cortes-Puch, MD (3018215857, icortespuch@eicosis.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes on eicosanoid lipid mediators (time frame: 10 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2020.