NCT04775017

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,398

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2021

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

January 21, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 1, 2021

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 21, 2022

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2022

Completed
Last Updated

October 29, 2024

Status Verified

October 1, 2024

Enrollment Period

1.1 years

First QC Date

January 21, 2021

Last Update Submit

October 25, 2024

Conditions

Post Intensive Care Unit SyndromeIntensive Care Unit DeliriumCovid19

Outcome Measures

Primary Outcomes (1)

  • Incidence of delirium

    Delirium is measured by validated screening scores.

    01.01.2020 - 21.02.2022

Secondary Outcomes (24)

  • Risk factors for severe COVID-19

    01.01.2020 - 21.02.2022

  • Patient characteristics

    01.01.2020 - 21.02.2022

  • Blood gas analysis

    01.01.2020-31.07.2020

  • Enteral nutrition

    01.01.2020-31.07.2020

  • Parenteral nutrition

    01.01.2020 - 21.02.2022

  • +19 more secondary outcomes

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
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.

You may qualify if:

  • 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

You may not qualify if:

  • NONE

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Anesthesiology and Operative Intensive Care Medicine Campus Virchow-Klinikum

Berlin, 13353, Germany

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Claudia Spies, MD, Prof.

    Charité - Universitäsmedizin Berlin

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of the Department of Anesthesiology and Operative Intensive Care Medicine (CCM/CVK)

Study Record Dates

First Submitted

January 21, 2021

First Posted

March 1, 2021

Study Start

January 1, 2021

Primary Completion

February 21, 2022

Study Completion

August 31, 2022

Last Updated

October 29, 2024

Record last verified: 2024-10

Locations

DE(1)