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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

Tracking Information
First Submitted Date May 8, 2020
First Posted Date May 12, 2020
Last Update Posted Date May 28, 2020
Actual Study Start Date April 27, 2020
Estimated Primary Completion Date July 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 26, 2020)
Analysis of Clinical, Biological and Histological Pulmonary and Renal Impairment Related to SARS-CoV-2 [ Time Frame: 1 month ]
Original Primary Outcome Measures
 (submitted: May 8, 2020)
Characterisation of Clinical, Biological and Histological Pulmonary and Renal Impairment Related to SARS-CoV-2 [ Time Frame: 1 month ]
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Clinical, Biological and Histological Pulmonary and Renal Damage Associated With the SARS-CoV-2 Syndrome in Patients Admitted in ICU
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
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)

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Other
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Adult patients diagnosed Covid-19 by RT PCR
Condition Acute Respiratory Distress Syndrome
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: May 8, 2020)
320
Original Estimated Enrollment Same as current
Estimated Study Completion Date July 2020
Estimated Primary Completion Date July 2020   (Final data collection date for primary outcome measure)
Eligibility 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

Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Not Provided
Contacts
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
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT04385004
Other Study ID Numbers 7815
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party University Hospital, Strasbourg, France
Study Sponsor University Hospital, Strasbourg, France
Collaborators Not Provided
Investigators Not Provided
PRS Account University Hospital, Strasbourg, France
Verification Date May 2020