Community-acquired PneumoniaLPSARS2NCT04505605
Study of a Possible Respiratory Degradation Prognosis Caused by Biomarkers in Severe Forms of COVID-19 Pneumonia
An observational study of Community-acquired Pneumonia and Covid19, run by Fondation Hôpital Saint-Joseph at 2 sites in France.
Trial summary
Respiratory infection with the SARS-CoV2 virus is associated with a major risk of viral pneumonia that can lead to respiratory distress requiring resuscitation. In the most severe forms, it may require a mechanical ventilation or even lead to an acute respiratory distress syndrome with a particularly poor prognosis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Community-acquired Pneumonia, Covid19
- What is being tested?
- Blood samples
- How many people
- 20 participants
- Where
- 2 sitesFrance
- Study dates
- 14 May 2020to 18 Oct 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: Patient aged from 18 years, infected by the COVID-19 and suffers from a severe form of COVID 19 acquired pneumonia that requires an hospitalization.
Who may be able to join
- Patient aged from 18 years old
- French-speaking patient
- Patient whose COVID-19 respiratory infection was confirmed by laboratory tests (either by a PCR and any other commercial or public health tests) or a scanner, that requires a hospitalization in a healthcare institution.
Who cannot join
- Patient/ relative or proxy person opposed to the study participation
- Patient under guardianship or curators
- Patient deprived of liberty
- Patient under the safeguard of justice.
- Dying / Moribund patient
- Pregnant or breastfeeding woman
Trial locations and contacts
2 sites in 1 country.
France2 sites
Centre Hospitalier Victor Dupouy
Argenteuil, 95107
Groupe Hospitalier Paris Saint-Joseph
Paris, Île-de-France Region, 75014
About this study
Official title: Study of a Possible Respiratory Degradation Prognosis Caused by Biomarkers in Severe Forms of COVID-19 Pneumonia: the LPSARS2 Study
Respiratory infection with the SARS-CoV2 virus is associated with a major risk of viral pneumonia that can lead to respiratory distress requiring resuscitation. In the most severe forms, it may require a mechanical ventilation or even lead to an acute respiratory distress syndrome with a particularly poor prognosis. The SARS-CoV2 is a single-stranded RNA virus of positive polarity and belongs to the beta genus of Coronaviruses. SARS-CoV2 is responsible for the third epidemic in less than twenty years secondary to a Coronavirus (SARS-CoV then MERS-CoV) and if the mortality associated with it is lower than that of previous strains, particularly MERS-CoV (Middle East Respiratory Syndrome), its spread is considerably bigger. As a result, the number of patients developing respiratory distress that require an invasive mechanical ventilation is high, with prolonged ventilation duration in these situations.
Read the detailed description
The mechanisms responsible for alveolar damage during viral pathologies, particularly Coronavirus, are very similar to those observed during acute respiratory distress syndromes in adults. Macrophages present in the pulmonary parenchyma appear to play a central role in the severity of the inflammatory response and the production of proinflammatory mediators, notably chemokines leading to secondary leukocyte infiltration. The recent monocytic origin could explain the particular severity of this inflammatory response whose usual control is no longer assured. The alteration of infectious control by alveolar macrophages during ageing also tends to confirm the central role of these cells in the pattern of respiratory distress observed during COVID-19 infection, which is particularly severe in the elderly.
In many situations, the 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 pathogenic agent responsible (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. Such an alteration of the mucous membrane is particularly noticeable in cases of obesity. The importance of this mechanism during pulmonary aggression of viral origin is, on the other hand, unknown.
Few data are available on the prediction of early onset of respiratory distress syndrome in low respiratory infection in the absence of mechanical ventilation.
- Conditions
- Community-acquired Pneumonia, Covid19
- Being tested
- Blood samples
- Keywords
- covid19, pneumonia, community acquired pneumonia, biomarkers
- Medical subject headings
- Community-Acquired Pneumonia, COVID-19, Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood samplesOther
A blood sample will be collected on a dry tube with 5mL separating gel on each enrolled patients. Those will be made depending on the patients hospitalization.
| Study group | Role | What they receive |
|---|---|---|
| Patient hospitalized without being transferred in the ICU | A blood sample on a dry tube with 5 ml separating gel in addition to the blood test made on the basis of the usual medical care, will be taken on D1 (day of the enrollment = the day of hospitalization in the healthcare institution). The total volume of blood collected as part of the research is therefore 5 ml. Receives: Other: Blood samples | |
| Patient directly hospitalized in the ICU | A blood sample on a dry tube with a 5 ml separating gel in addition to the blood test made on the basis of the usual medical care, will be taken on D1 and D3 of the admission to intensive care. The total volume of blood collected for research is therefore 10 ml. Receives: Other: Blood samples | |
| Patient transferred from an other hospital service to the ICU | A blood sample on a dry tube with 5 ml separating gel in addition to the blood test that will be taken at D1 and D3 of the patient's admission to the intensive care unit, even if it has already been included in the study during the patient's admission to the unit (D1 hospitalization). The total volume of blood collected for the research is therefore 15 ml. Receives: Other: Blood samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of the dosage of biomarkers
The study aims at evaluating the interests of the biomarkers dosage: endotoxin (LPS) and circulating cytokines (HMGB1 or RAGE) in the prediction of respiratory degradation through a severe form of COVID-19 acquired pneumonia that requires a hospitalization.
Measured: 6 months = study duration
Secondary outcomes (1)
Link between the biomarkers
The study will be also focusing on the search for a correlation between the biomarkers by blood samples that will be taken on each hospitalized patients.
Measured: 6 months = study duration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2020
- Study start14 May 2020
- Primary completion18 Oct 2021
- Study completion18 Oct 2021
Why it stopped: The PI decided to stop the study due to the low number of inclusions.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Community-acquired PneumoniaStudies 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
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondation Hôpital Saint-Joseph
- Sponsor type
- University, hospital or other
- Collaborators
- Centre Hospitalier Victor Dupouy
- Responsible party
- Sponsor
- Investigators
- François PHILIPPART, MD, Principal investigator, Fondation Hôpital Saint-Joseph
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04505605
- Sponsor's protocol ID
- LPSARS2
- Acronym
- LPSARS2
- Status last verified
- Dec 2021
- First submitted
- 31 Jul 2020
- Last updated
- 18 Jan 2022
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of a Possible Respiratory Degradation Prognosis Caused by Biomarkers in Severe Forms of COVID-19 Pneumonia: the LPSARS2 Study
- ClinicalTrials.gov ID
- NCT04505605
- Acronym / sponsor ID
- LPSARS2 / LPSARS2
- Conditions
- Community-acquired Pneumonia, Covid19
- Keywords
- covid19, pneumonia, community acquired pneumonia, biomarkers
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: The PI decided to stop the study due to the low number of inclusions.
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Fondation Hôpital Saint-JosephUniversity, hospital or other
- Collaborators
- Centre Hospitalier Victor Dupouy
- Study start
- 14 May 2020 (actual)
- Primary completion
- 18 Oct 2021 (actual)
- Study completion
- 18 Oct 2021 (actual)
- First posted
- 10 Aug 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.
Respiratory infection with the SARS-CoV2 virus is associated with a major risk of viral pneumonia that can lead to respiratory distress requiring resuscitation. In the most severe forms, it may require a mechanical ventilation or even lead to an acute respiratory distress syndrome with a particularly poor prognosis. The SARS-CoV2 is a single-stranded RNA virus of positive polarity and belongs to the beta genus of Coronaviruses. SARS-CoV2 is responsible for the third epidemic in less than twenty years secondary to a Coronavirus (SARS-CoV then MERS-CoV) and if the mortality associated with it is lower than that of previous strains, particularly MERS-CoV (Middle East Respiratory Syndrome), its spread is considerably bigger. As a result, the number of patients developing respiratory distress that require an invasive mechanical ventilation is high, with prolonged ventilation duration in these situations.
Detailed description
The mechanisms responsible for alveolar damage during viral pathologies, particularly Coronavirus, are very similar to those observed during acute respiratory distress syndromes in adults. Macrophages present in the pulmonary parenchyma appear to play a central role in the severity of the inflammatory response and the production of proinflammatory mediators, notably chemokines leading to secondary leukocyte infiltration. The recent monocytic origin could explain the particular severity of this inflammatory response whose usual control is no longer assured. The alteration of infectious control by alveolar macrophages during ageing also tends to confirm the central role of these cells in the pattern of respiratory distress observed during COVID-19 infection, which is particularly severe in the elderly.
In many situations, the 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 pathogenic agent responsible (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. Such an alteration of the mucous membrane is particularly noticeable in cases of obesity. The importance of this mechanism during pulmonary aggression of viral origin is, on the other hand, unknown.
Few data are available on the prediction of early onset of respiratory distress syndrome in low respiratory infection in the absence of mechanical ventilation.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Patient hospitalized without being transferred in the ICU | – | Other: Blood samplesA blood sample on a dry tube with 5 ml separating gel in addition to the blood test made on the basis of the usual medical care, will be taken on D1 (day of the enrollment = the day of hospitalization in the healthcare institution). The total volume of blood collected as part of the research is therefore 5 ml. |
| Patient directly hospitalized in the ICU | – | Other: Blood samplesA blood sample on a dry tube with a 5 ml separating gel in addition to the blood test made on the basis of the usual medical care, will be taken on D1 and D3 of the admission to intensive care. The total volume of blood collected for research is therefore 10 ml. |
| Patient transferred from an other hospital service to the ICU | – | Other: Blood samplesA blood sample on a dry tube with 5 ml separating gel in addition to the blood test that will be taken at D1 and D3 of the patient's admission to the intensive care unit, even if it has already been included in the study during the patient's admission to the unit (D1 hospitalization). The total volume of blood collected for the research is therefore 15 ml. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient aged from 18 years, infected by the COVID-19 and suffers from a severe form of COVID 19 acquired pneumonia that requires an hospitalization.
Key inclusion criteria (3 listed)
- Patient aged from 18 years old
- French-speaking patient
- Patient whose COVID-19 respiratory infection was confirmed by laboratory tests (either by a PCR and any other commercial or public health tests) or a scanner, that requires a hospitalization in a healthcare institution.
Key exclusion criteria (6 listed)
- Patient/ relative or proxy person opposed to the study participation
- Patient under guardianship or curators
- Patient deprived of liberty
- Patient under the safeguard of justice.
- Dying / Moribund patient
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood samplesA blood sample will be collected on a dry tube with 5mL separating gel on each enrolled patients. Those will be made depending on the patients hospitalization. | Other | Patient directly hospitalized in the ICU, Patient hospitalized without being transferred in the ICU, Patient transferred from an other hospital service to the ICU |
Primary outcome
Evaluation of the dosage of biomarkers
Time frame: 6 months = study duration
The study aims at evaluating the interests of the biomarkers dosage: endotoxin (LPS) and circulating cytokines (HMGB1 or RAGE) in the prediction of respiratory degradation through a severe form of COVID-19 acquired pneumonia that requires a hospitalization.
1 secondary outcome
Link between the biomarkers
Time frame: 6 months = study duration
Results and safety
The study was stopped early (reason given: The PI decided to stop the study due to the low number of inclusions.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2022.
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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.
François PHILIPPART, MD principal investigator
Fondation Hôpital Saint-Joseph
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Community-acquired Pneumonia and Covid19, run by Fondation Hôpital Saint-Joseph at 2 sites 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 3 inclusion and 6 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: stopped early, as of the sponsor's last update on 18 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 was stopped early (reason given: The PI decided to stop the study due to the low number of inclusions.). Results are not available in the source record.
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?
Evaluation of the dosage of biomarkers (time frame: 6 months = study duration). 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 18 Jan 2022.