Clinical Features and Risk Factors Associated With Worse... | NCT04362345 | Trialant
NCT04362345
Sponsor
University Hospital, Strasbourg, France
Status
Unknown status
Last Update Posted
Dec 28, 2020Actual
Enrollment
100Estimated
Phase
Not provided
Conditions
Covid-19
Interventions
Not provided
Countries
France
Protocol Section
Identification Module
NCT ID
Results Section
No data available
No data is available for this block.
Annotation Section
No data available
No data is available for this block.
Document Section
No data available
No data is available for this block.
Derived Section
Miscellaneous Info Module
Version Holder
NCT04362345
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
7773
Secondary IDs
Not provided
Brief Title
Clinical Features and Risk Factors Associated With Worse Outcome in Patients Hospitalized for Covid-19 Pneumonia
Official Title
Clinical Features and Risk Factors Associated With Worse Outcome in Patients Hospitalized for Covid-19 Pneumonia in France
Acronym
Not provided
Organization
University Hospital, Strasbourg, FranceOTHER
Status Module
Record Verification Date
Apr 2020
Overall Recruitment Status or Expanded Access Status
Unknown status
Last Known Status
Recruiting
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Apr 9, 2020Actual
Primary Completion Date
Jan 9, 2021Estimated
Completion Date
Jan 9, 2021Estimated
First Submitted Date
Apr 20, 2020
First Submission Date that Met QC Criteria
Apr 23, 2020
First Posted Date
Apr 24, 2020Actual
Results Waived
Not provided
Results First Submitted Date
Not provided
Results First Submitted that Met QC Criteria
Not provided
Results First Posted Date
Not provided
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Dec 24, 2020
Last Update Posted Date
Dec 28, 2020Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
University Hospital, Strasbourg, FranceOTHER
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
No
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
The aim of the research is to improve patient management by rapidly identifying, based on the terrain and clinical and biological characteristics, those patients likely to present a severe form of ARDS at risk of leading to intensive care
Detailed Description
Not provided
Conditions Module
Conditions
Covid-19
Keywords
Covid_19
SARS-CoV-2
ARDS
risk factors
infection
Design Module
Study Type
Observational
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
No
Target Follow-Up Duration
Not provided
Phases
Not provided
Interventional Study Design
Allocation
Not provided
Intervention Model
Biospecimen
No data available
No data is available for this block.
Enrollment
100Estimated
Arms/Interventions Module
No data available
No data is available for this block.
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Identification of risk factors for severity (death or transfer to resuscitation) of Covid-19 infection
Files analysed retrospectively from March 1st, 2020 to April 15, 2020 will be examined]
Secondary Outcomes
Not provided
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Major patient (≥18 years of age)
Admitted in March 2020 for confirmed Covid-19 lung disease (nasopharyngeal smear or sputum with SARS-CoV-2 positive PCR).
Exclusion Criteria:
Patient who has expressed opposition to participation in the study.
Mild forms of infection that do not require hospitalization,