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Clinical, Biological and Histological Pulmonary and Renal Damage Associated With the SARS-CoV-2 Syndrome in Patients Admitted in ICU (PR-Covid-19)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04385004
Recruitment Status : Recruiting
First Posted : May 12, 2020
Last Update Posted : May 28, 2020
Sponsor:
Information provided by (Responsible Party):
University Hospital, Strasbourg, France

Brief 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. 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)


Condition or disease
Acute Respiratory Distress Syndrome

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Study Type : Observational
Estimated Enrollment : 320 participants
Observational Model: Case-Only
Time Perspective: Other
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
Actual Study Start Date : April 27, 2020
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : July 2020





Primary Outcome Measures :
  1. Analysis of Clinical, Biological and Histological Pulmonary and Renal Impairment Related to SARS-CoV-2 [ Time Frame: 1 month ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Adult patients diagnosed Covid-19 by RT PCR
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

- Subject who expressed opposition to participating in the study


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04385004


Contacts
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Contact: Ferhat MEZIANI, MD, PhD 33 3 69 55 10 24 ferhat.meziani@chru-strasbourg.fr
Contact: Saïd CHAYER, PhD, HDR 33 3 88 11 66 90 said.chayer@chru-strasbourg.fr

Locations
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France
Service Reanimation Medicale Recruiting
Strasbourg, France, 67091
Contact: Ferhat MEZIANI, MD, PhD    33 3 69 55 10 24    ferhat.meziani@chru-strasbourg.fr   
Principal Investigator: Ferhat MEZIANI, MD, PhD         
Sub-Investigator: Bruno MOULIN, MD, PhD         
Sub-Investigator: Sophie CAILLARD, MD, PhD         
Sub-Investigator: Francis SCHNEIDER, MD, PhD         
Sub-Investigator: Michel MERTES, MD, PhD         
Sub-Investigator: Patrick OHLMANN, MD, PhD         
Sub-Investigator: Julie HELMS, MD         
Sub-Investigator: Romain KESSLER, MD, PhD         
Sub-Investigator: Alexandra MONNIER, MD         
Sub-Investigator: Hamid MERDJI, MD         
Sub-Investigator: Margaux DELLA CHIESA, MD         
Sub-Investigator: François SEVERAC, MD         
Sponsors and Collaborators
University Hospital, Strasbourg, France
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Responsible Party: University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier: NCT04385004    
Other Study ID Numbers: 7815
First Posted: May 12, 2020    Key Record Dates
Last Update Posted: May 28, 2020
Last Verified: May 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Strasbourg, France:
ARDS
Covid-19
SARS-CoV-2
Inflammatory cytokine
Sepsis
ICU
Tbular necrosis
Ischemia
Pulmonary damage
Renal damage
Kidney damage
Additional relevant MeSH terms:
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Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Acute Lung Injury
Syndrome
Disease
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Lung Injury