NCT04485364

Brief Summary

The research is a prospective, multicentric (Groupe hospitalier Paris Saint-Joseph, Centre Hospitalier de Versailles André Mignot and Centre Hospitalier Victor Dupouy), non-interventional, prospective study. It aims at measuring eicosanoids at different stages of Covid-19 infection.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
97

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2020

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 14, 2020

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 23, 2020

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 24, 2020

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2022

Completed
6 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 6, 2022

Completed
Last Updated

March 7, 2023

Status Verified

March 1, 2023

Enrollment Period

2.1 years

First QC Date

July 23, 2020

Last Update Submit

March 6, 2023

Conditions

CoronavirusCovid19

Keywords

eicosanoidsbiomarkerscovid19

Outcome Measures

Primary Outcomes (1)

  • Inflammatory response in the evolution of respiratory diseases

    The importance of the inflammatory response in the evolution of respiratory disease during the the patients' hospital care based on criteria such as: * The search for systemic biomarkers: the previous work led by the Saint Joseph Hospital Group team has highlighted the potential interest of biomarkers of inflammation in the diagnosis of infectious pathology as well as in the eventual prognosis of these patients. * and the study of the production of eicosanoids and their presence in the systemic circulation and in the respiratory tree.

    6 months = the study duration

Secondary Outcomes (1)

  • Impact of the respiratory disease during mechanical ventilation

    6 months = the study duration

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patient aged over 18 years old who was positively tested to the Covid 19 infection and has been hospitalized in the Intensive care Unit and under invasive mechanical ventilation for less than 3 days.

You may qualify if:

  • Patient aged over 18 years
  • French-speaking
  • Patient whose Covid-19 respiratory infection was confirmed by laboratory tests, PCR and any other commercial or public health tests
  • Patient hospitalized in intensive care unit and under invasive mechanical ventilation for less than three days (early inflammatory phase)
  • Adult acute respiratory distress syndrome according to the Berlin definition
  • Patient on long-term statin therapy regardless of the rationale for treatment (or without treatment for the control group).

You may not qualify if:

  • Patient/family or "medical" proxy who refuses the patient's participation in the study
  • Patient under guardianship or curatorship
  • Patient deprived of liberty
  • Patient under the safeguard of justice.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Groupe Hospitalier Paris Saint-Joseph

Paris, 75014, France

Location

Related Publications (4)

  • Bradley BT, Bryan A. Emerging respiratory infections: The infectious disease pathology of SARS, MERS, pandemic influenza, and Legionella. Semin Diagn Pathol. 2019 May;36(3):152-159. doi: 10.1053/j.semdp.2019.04.006. Epub 2019 Apr 17.

    PMID: 31054790RESULT

  • Yin Y, Wunderink RG. MERS, SARS and other coronaviruses as causes of pneumonia. Respirology. 2018 Feb;23(2):130-137. doi: 10.1111/resp.13196. Epub 2017 Oct 20.

    PMID: 29052924RESULT

  • Vijayanand P, Wilkins E, Woodhead M. Severe acute respiratory syndrome (SARS): a review. Clin Med (Lond). 2004 Mar-Apr;4(2):152-60. doi: 10.7861/clinmedicine.4-2-152.

    PMID: 15139736RESULT

  • Fehr AR, Channappanavar R, Perlman S. Middle East Respiratory Syndrome: Emergence of a Pathogenic Human Coronavirus. Annu Rev Med. 2017 Jan 14;68:387-399. doi: 10.1146/annurev-med-051215-031152. Epub 2016 Aug 26.

    PMID: 27576010RESULT

Biospecimen

Retention: SAMPLES WITHOUT DNA

During the patient's hospitalization, a blood sample will be taken on a citrate tube in addition to the usual samples during the patient's hospital care. A tracheal aspiration will be systematically performed in order to limit patient congestion and the risk of atelectasis. These samples will be destroyed after the study.

MeSH Terms

Conditions

Coronavirus InfectionsCOVID-19

Condition Hierarchy (Ancestors)

Coronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsVirus DiseasesInfectionsPneumonia, ViralPneumoniaRespiratory Tract InfectionsLung DiseasesRespiratory Tract Diseases

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 23, 2020

First Posted

July 24, 2020

Study Start

April 14, 2020

Primary Completion

May 31, 2022

Study Completion

June 6, 2022

Last Updated

March 7, 2023

Record last verified: 2023-03

Locations

FR(1)