CoronavirusBIOCOVIDNCT04485364
Place of Circulating Biomarkers and Respiratory Eicosanoids in the Prognosis of Severe Forms of Covid-19 Pneumonia
An observational study of Coronavirus and Covid19, run by Fondation Hôpital Saint-Joseph at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronavirus, Covid19
- How many people
- 97 participants
- Where
- 1 siteFrance
- Study dates
- 14 Apr 2020to 6 Jun 2022
- 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: 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.
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Place of Circulating Biomarkers and Respiratory Eicosanoids in the Prognosis of Severe Forms of Covid-19 Pneumonia: BioCovid Study
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.
Read the 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.
- Conditions
- Coronavirus, Covid19
- Keywords
- eicosanoids, biomarkers, covid19
- Medical subject headings
- Coronavirus Infections, COVID-19
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months = the study duration
Secondary outcomes (1)
Impact of the respiratory disease during mechanical ventilation
Evolution of respiratory pathology during mechanical ventilation.
Measured: 6 months = the study duration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2020
- Study start14 Apr 2020
- Primary completion31 May 2022
- Study completion6 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for CoronavirusStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 97 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondation Hôpital Saint-Joseph
- Sponsor type
- University, hospital or other
- Collaborators
- Versailles Hospital, Centre Hospitalier Victor Dupouy
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04485364
- Sponsor's protocol ID
- BIOCOVID
- Acronym
- BIOCOVID
- Status last verified
- Mar 2023
- First submitted
- 23 Jul 2020
- Last updated
- 7 Mar 2023
- Results posted
- No
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.
PubMed 31054790Yin 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.
PubMed 29052924Vijayanand 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.
PubMed 15139736Fehr 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.
PubMed 27576010
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Place of Circulating Biomarkers and Respiratory Eicosanoids in the Prognosis of Severe Forms of Covid-19 Pneumonia: BioCovid Study
- ClinicalTrials.gov ID
- NCT04485364
- Acronym / sponsor ID
- BIOCOVID / BIOCOVID
- Conditions
- Coronavirus, Covid19
- Keywords
- eicosanoids, biomarkers, covid19
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 97 participants (actual)
- Lead sponsor
- Fondation Hôpital Saint-JosephUniversity, hospital or other
- Collaborators
- Versailles Hospital, Centre Hospitalier Victor Dupouy
- Study start
- 14 Apr 2020 (actual)
- Primary completion
- 31 May 2022 (actual)
- Study completion
- 6 Jun 2022 (actual)
- First posted
- 24 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.
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.
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 design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
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
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: * 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.
1 secondary outcome
Impact of the respiratory disease during mechanical ventilation
Time frame: 6 months = the study duration
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2023.
- Results publication: PubMed 31054790Bradley 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.
- Results publication: PubMed 29052924Yin 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.
- Results publication: PubMed 15139736Vijayanand 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.
- Results publication: PubMed 27576010Fehr 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.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Coronavirus and Covid19, run by Fondation Hôpital Saint-Joseph at 1 site in France.
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 6 inclusion and 4 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: finished, as of the sponsor's last update on 7 Mar 2023. 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 France. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Inflammatory response in the evolution of respiratory diseases (time frame: 6 months = the study duration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04485364, which also lists 4 linked publications.
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 7 Mar 2023.