Delirium in Covid-19: Germany-wide Covid-19 Intensive Reg... | NCT04775017

Studies
Delirium in Covid-19: Germany-wide Covid-19 Intensive Register

NCT04775017

Sponsor

Charite University, Berlin, Germany

Status

Completed

Last Update Posted

Oct 29, 2024Actual

Enrollment

2,398Actual

Phase

Not provided

Conditions

Intensive Care Unit Delirium
Covid19
Post Intensive Care Unit Syndrome

Interventions

Not provided

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

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

Status Module

Record Verification Date

Oct 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2021Actual

Primary Completion Date

Feb 21, 2022Actual

Completion Date

Aug 31, 2022Actual

First Submitted Date

Jan 21, 2021

First Submission Date that Met QC Criteria

Feb 26, 2021

First Posted Date

Mar 1, 2021Actual

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

Oct 25, 2024

Last Update Posted Date

Oct 29, 2024Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Claudia Spies, Head of the Department of Anesthesiology and Operative Intensive Care Medicine (CCM/CVK), Charite University, Berlin, GermanyPrincipal Investigator

Lead Sponsor

Charite University, Berlin, GermanyOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

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 global pandemic caused by the SARS-CoV-2 virus is confronting the German health system with a novel pathogen. This means that a timely evaluation of all available results is required. In the field of intensive care in particular, there are significant gaps in knowledge, particularly with regard to delirium. In this respect, this study also serves directly to investigate the pathways of delirium outcome in COVID-19 patients.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

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

2,398Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Incidence of delirium	Delirium is measured by validated screening scores.	01.01.2020 - 21.02.2022

Secondary Outcomes

Measure	Description	Time Frame
Risk factors for severe COVID-19	Risk factors are defined according to actual literature e.g. obesity, diabetes or hypertension.	01.01.2020 - 21.02.2022
Patient characteristics	Patient characteristics at hospital admission e.g. score level

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

All patients with SARS-CoV-2 positive Covid-19 disease

Age≥18 years
Proven by positive PCR tests from nasal/ throat swabs as well as samples from the deep respiratory tract.
Period 01.01.2020 to 21.02.2022

Exclusion Criteria:

NONE

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients who have COVID-19 and have been treated in an intensive care unit of Charité Universitätsmedizin and whose therapy has already been completed on 21.02.2022.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Claudia Spies, MD, Prof.	Charité - Universitäsmedizin Berlin	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Anesthesiology and Operative Intensive Care Medicine Campus Virchow-Klinikum		Berlin		13353	Germany

Condition Browse Module

MeSH Terms

ID	Term
D000086382	COVID-19

Ancestor Terms

ID	Term
D011024	Pneumonia, Viral
D011014	Pneumonia
D012141	Respiratory Tract Infections
D007239	Infections

Browse Leaves

Not provided

Browse Branches

Not provided