Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Neuroradiolological Analysis of COVID-19 Patients (COVID-19BRAIN)

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: NCT04368390
Recruitment Status : Recruiting
First Posted : April 29, 2020
Last Update Posted : April 29, 2020
Sponsor:
Information provided by (Responsible Party):
University Hospital, Strasbourg, France

Tracking Information
First Submitted Date April 28, 2020
First Posted Date April 29, 2020
Last Update Posted Date April 29, 2020
Actual Study Start Date April 3, 2020
Estimated Primary Completion Date April 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 28, 2020)
Neuroradiological analysis of patients brain MRI [ Time Frame: 1 year ]
Original Primary Outcome Measures Same as current
Change History No Changes Posted
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 Neuroradiolological Analysis of COVID-19 Patients
Official Title Imaging Analysis of COVID-19 + Patients With Abnormal Neurological Examination
Brief Summary To describe the radiological presentation of brain abnormalities in COVID-19 + patients
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 Patients COVID-19 with abnormal neurological examination
Condition Covid-19
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Kremer S, Lersy F, Anheim M, Merdji H, Schenck M, Oesterlé H, Bolognini F, Messie J, Khalil A, Gaudemer A, Carré S, Alleg M, Lecocq C, Schmitt E, Anxionnat R, Zhu F, Jager L, Nesser P, Mba YT, Hmeydia G, Benzakoun J, Oppenheim C, Ferré JC, Maamar A, Carsin-Nicol B, Comby PO, Ricolfi F, Thouant P, Boutet C, Fabre X, Forestier G, de Beaurepaire I, Bornet G, Desal H, Boulouis G, Berge J, Kazémi A, Pyatigorskaya N, Lecler A, Saleme S, Edjlali-Goujon M, Kerleroux B, Constans JM, Zorn PE, Mathieu M, Baloglu S, Ardellier FD, Willaume T, Brisset JC, Caillard S, Collange O, Mertes PM, Schneider F, Fafi-Kremer S, Ohana M, Meziani F, Meyer N, Helms J, Cotton F. Neurologic and neuroimaging findings in patients with COVID-19: A retrospective multicenter study. Neurology. 2020 Sep 29;95(13):e1868-e1882. doi: 10.1212/WNL.0000000000010112. Epub 2020 Jul 17.

*   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: April 28, 2020)
100
Original Estimated Enrollment Same as current
Estimated Study Completion Date April 2021
Estimated Primary Completion Date April 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Adults
  • COVID-19 +
  • Abnormal neurological examination
  • who underwent a brain MRI

Exclusion Criteria:

  • No participation agreement
  • Non COVID-19 patients
  • Patients COVID-19 + without neurological abnormality or without MRI examination
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Not Provided
Contacts
Contact: Stephane Kremer, MD, PhD 33 3 88 12 78 89 stephane.kremer@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 NCT04368390
Other Study ID Numbers 7759
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 April 2020