- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04485364
Place of Circulating Biomarkers and Respiratory Eicosanoids in the Prognosis of Severe Forms of Covid-19 Pneumonia (BIOCOVID)
Place of Circulating Biomarkers and Respiratory Eicosanoids in the Prognosis of Severe Forms of Covid-19 Pneumonia: BioCovid Study
Study Overview
Status
Conditions
Detailed Description
The reason for the involvement of overweight in the severity of viral respiratory pathologies, particularly during influenza and coronavirus infections, has been the subject of numerous studies which have made it possible to objectify the importance of viral load (at least in mice), particularly in the lower airways and in the alveolar sacs, leading to tissue alteration and alveolar haemorrhage. The mechanisms responsible for alveolar damage during viral pathologies, particularly Coronavirus, are very similar to those observed during acute respiratory distress syndromes in adults. In many situations, endotoxin (or lipopolysaccharide, LPS) plays a major role in the pathophysiology and even the severity of respiratory damage, in particular due to the existence of circulating endotoxin from the causative pathogen (Gram-negative bacteria), but also due to translocation of digestive origin in the context of sepsis (systemic inflammatory response) which is associated with (if not responsible for) respiratory aggression. The importance of this mechanism during pulmonary aggression of viral origin is however unknown. This respiratory attack is associated with a major systemic inflammatory response, reported during the course of Covid-19 infection as corresponding to a "cytokine storm". However, the course of the inflammation is poorly understood and its prognostic nature in the occurrence of a secondarily severe form is not yet better illustrated.
The inflammatory reaction (cytokines, eicosanoids, etc.) is an essential process for the elimination of pathogens by the host, but it must be limited in intensity and duration, otherwise it becomes deleterious for the infected organ. In the case of the lungs, it can induce an acute respiratory distress syndrome (ARDS), which can be severe as in Covid-19 patients with complications. It can be hypothesized that in the early stages of infection, these mediators may play a protective role against Covid-19. Inhibition of these mediators may therefore be deleterious as has been observed in subjects who have taken non-steroidal anti-inflammatory drugs (NSAIDs) that inhibit the production of eicosanoids.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Contact
- Name: François PHILLIPART, DR
- Phone Number: +33 01 44 12 70 21
- Email: fphillipart@ghpsj.fr
Study Locations
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Paris, France, 75014
- Groupe Hospitalier Paris Saint-Joseph
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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).
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Inflammatory response in the evolution of respiratory diseases
Time Frame: 6 months = the study duration
|
The importance of the inflammatory response in the evolution of respiratory disease during the the patients' hospital care based on criteria such as:
|
6 months = the study duration
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Impact of the respiratory disease during mechanical ventilation
Time Frame: 6 months = the study duration
|
Evolution of respiratory pathology during mechanical ventilation.
|
6 months = the study duration
|
Collaborators and Investigators
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- BIOCOVID
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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