Acute Respiratory Distress SyndromePR-Covid-19NCT04385004
Clinical, Biological and Histological Pulmonary and Renal Damage Associated With the SARS-CoV-2 Syndrome in Patients Admitted in ICU
An observational study of Acute Respiratory Distress Syndrome, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
Renal damage in patients hospitalized for ARDS in the ICU can also be related to multiple causes including, but not limited to, the consequences of hemodynamic fluctuations in these patients or the use of nephrotoxic drugs responsible for acute post-ischemic or toxic tubular necrosis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Respiratory Distress Syndrome
- How many people
- 320 participants
- Where
- 1 siteFrance
- Study dates
- 27 Apr 2020to Jul 2020
- 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
- Adult, Older adult
Study population: Adult patients diagnosed Covid-19 by RT PCR
Who may be able to join
- Patients over 18 years of age
- Diagnosed Covid-19 by RT PCR
- Hospitalized in intensive care for management of complications related to Covid-19 from March 1, 2020 to April 20, 2020
- Patient not having expressed his or her opposition, after information, to the re-use of his or her data for the purposes of this research.
Who cannot join
- Subject who expressed opposition to participating in the study
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Service Reanimation Medicale
Strasbourg, 67091
Ferhat MEZIANI, MD, PhD, 33 3 69 55 10 24, ferhat.meziani@chru-strasbourg.fr
Ferhat MEZIANI, MD, PhD
About this study
Official title: Characterization of the Clinical, Biological and Histological Pulmonary and Renal Damage Associated With the SARS-CoV-2 Syndrome in Patients Admitted in the Intensive Care Unit
Renal damage in patients hospitalized for ARDS in the ICU can also be related to multiple causes including, but not limited to, the consequences of hemodynamic fluctuations in these patients or the use of nephrotoxic drugs responsible for acute post-ischemic or toxic tubular necrosis. Frequently observed abnormalities of cioagumation may also have a potential impact on renal structures, particularly glomerular capillaries.
The researchers wish to characterize and phenotype the renal impairment of patients hospitalized in intensive care with tables of severe Covid19 infections in ARDS: clinical, biological and histological (by performing post-mortem biopsies).
Translated with www.DeepL.com/Translator (free version)
- Conditions
- Acute Respiratory Distress Syndrome
- Keywords
- ARDS, Covid-19, SARS-CoV-2, Inflammatory cytokine, Sepsis, ICU, Tbular necrosis, Ischemia, Pulmonary damage, Renal damage, Kidney damage
- Medical subject headings
- Respiratory Distress Syndrome, COVID-19, Sepsis, Ischemia
What is being measured
The primary outcome is the main question the study is designed to answer.
Analysis of Clinical, Biological and Histological Pulmonary and Renal Impairment Related to SARS-CoV-2
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2020
- Study start27 Apr 2020
- Primary completionJul 2020 (estimated)
- Study completionJul 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Respiratory Distress SyndromeStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe sponsor's other registered studies.
- 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
- Case only
- Time perspective
- Other
- Enrolment
- 320 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04385004
- Sponsor's protocol ID
- 7815
- Acronym
- PR-Covid-19
- Status last verified
- May 2020
- First submitted
- 8 May 2020
- Last updated
- 28 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Beloncle F, Studer A, Seegers V, Richard JC, Desprez C, Fage N, Merdji H, Pavlovsky B, Helms J, Cunat S, Mortaza S, Demiselle J, Brochard L, Mercat A, Meziani F. Longitudinal changes in compliance, oxygenation and ventilatory ratio in COVID-19 versus non-COVID-19 pulmonary acute respiratory distress syndrome. Crit Care. 2021 Jul 15;25(1):248. doi: 10.1186/s13054-021-03665-8.
PubMed 34266454
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterization of the Clinical, Biological and Histological Pulmonary and Renal Damage Associated With the SARS-CoV-2 Syndrome in Patients Admitted in the Intensive Care Unit
- ClinicalTrials.gov ID
- NCT04385004
- Acronym / sponsor ID
- PR-Covid-19 / 7815
- Conditions
- Acute Respiratory Distress Syndrome
- Keywords
- ARDS, Covid-19, SARS-CoV-2, Inflammatory cytokine, Sepsis, ICU, Tbular necrosis, Ischemia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 320 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 27 Apr 2020 (actual)
- Primary completion
- Jul 2020 (estimated)
- Study completion
- Jul 2020 (estimated)
- First posted
- 12 May 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.
Renal damage in patients hospitalized for ARDS in the ICU can also be related to multiple causes including, but not limited to, the consequences of hemodynamic fluctuations in these patients or the use of nephrotoxic drugs responsible for acute post-ischemic or toxic tubular necrosis. Frequently observed abnormalities of cioagumation may also have a potential impact on renal structures, particularly glomerular capillaries.
The researchers wish to characterize and phenotype the renal impairment of patients hospitalized in intensive care with tables of severe Covid19 infections in ARDS: clinical, biological and histological (by performing post-mortem biopsies).
Translated with www.DeepL.com/Translator (free version)
Study design
- Observational model
- Case only
- Time perspective
- Other
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Adult patients diagnosed Covid-19 by RT PCR
Key inclusion criteria (4 listed)
- Patients over 18 years of age
- Diagnosed Covid-19 by RT PCR
- Hospitalized in intensive care for management of complications related to Covid-19 from March 1, 2020 to April 20, 2020
- Patient not having expressed his or her opposition, after information, to the re-use of his or her data for the purposes of this research.
Key exclusion criteria (1 listed)
- Subject who expressed opposition to participating in the study
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
Analysis of Clinical, Biological and Histological Pulmonary and Renal Impairment Related to SARS-CoV-2
Time frame: 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2020.
- Derived from this study: PubMed 34266454Beloncle F, Studer A, Seegers V, Richard JC, Desprez C, Fage N, Merdji H, Pavlovsky B, Helms J, Cunat S, Mortaza S, Demiselle J, Brochard L, Mercat A, Meziani F. Longitudinal changes in compliance, oxygenation and ventilatory ratio in COVID-19 versus non-COVID-19 pulmonary acute respiratory distress syndrome. Crit Care. 2021 Jul 15;25(1):248. doi: 10.1186/s13054-021-03665-8.
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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 Acute Respiratory Distress Syndrome, run by University Hospital, Strasbourg, France 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 4 inclusion and 1 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 28 May 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ferhat MEZIANI, MD, PhD (33 3 69 55 10 24, ferhat.meziani@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Analysis of Clinical, Biological and Histological Pulmonary and Renal Impairment Related to SARS-CoV-2 (time frame: 1 month). 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 NCT04385004, which also lists 1 linked publication.
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 28 May 2020.