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

Outcomes and Prognostic Factors in COVID-19 (COVIP)

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: NCT04321265
Recruitment Status : Recruiting
First Posted : March 25, 2020
Last Update Posted : April 8, 2020
Sponsor:
Information provided by (Responsible Party):
Klinik für Kardiologie, Pneumologie und Angiologie, Heinrich-Heine University, Duesseldorf

Brief Summary:

The primary aim is to study the short-term outcome of elderly ICU patients (≥ 70 years) suffering from COVID-19 using a multicenter and multi-national approach The secondary aim is to investigate the properties of a simple frailty index in this cohort, and in particular if this is an instrument that can be used in resource and outcome prediction in this group To create hypothesis for further studies, in particular on various outcome prediction

To create hypothesis for further studies, in particular on various outcome prediction


Condition or disease
COVID-19 Elderly Patients Critical Illness Survival Old Age

Detailed Description:

Data are collected regarding: Pre-Admission life conditions with Frailty (CFS, optional: KATZ ADL); Comorbidities; ICU-Admission (e.g. SOFA), ICU-Treatment, Survival

Data are collected electronically through an e-CRF and with baseline documentation of the ICU. The database is located in Denmark, at the Department of Epidemiology, University of Aarhus. Each ICU will only have access through the database of their own patients, and patient ID is not registered (Names, birth-date or social security numbers) so it is in that sense anonymous.

The goal is to recruit at 200 ICUs that will give data until September. Each center aims to recruit 20 patients, but more patients per center are possible.

Layout table for study information
Study Type : Observational
Estimated Enrollment : 4000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Outcomes and Prognostic Factors in Coronavirus Disease (COVID-19) in Very Old Intensive Care Patients
Actual Study Start Date : March 19, 2020
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : December 2020



Primary Outcome Measures :
  1. Survival [ Time Frame: up to 30 days ]

Secondary Outcome Measures :
  1. Fragilty [ Time Frame: pre-admission ]
    Fragilty will be measured by using the Clinical frailty scale (CFS) a global clinical measure of fitness and frailty in elderly people (1=very fit to 9= terminally ill)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   70 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Patient with Infection or suspected infection with SARS-CoV-2
Criteria

Inclusion Criteria:

  1. Age > 70 years
  2. ICU-Admission
  3. Infection or suspected infection with SARS-CoV-2

Exclusion Criteria:

1. Age <70 years


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04321265


Contacts
Layout table for location contacts
Contact: Christian Jung, MD +2118118800 contact@vipstudy.org
Contact: Raphael Bruno, MD +2118118800 covip@med.uni-duesseldorf.de

Locations
Layout table for location information
Denmark
Department of Intensive Care, Aarhus University Hospital Recruiting
Aarhus, Denmark
Contact: Jesper Fjølner, MD       jespfjoe@rm.dk   
France
Hôpitaux de Paris, Hôpital Saint-Antoine, service de réanimation médicale Recruiting
Paris, France
Contact: Bertrand Guidet, MD       bertrand.guidet@aphp.fr   
INSERM, UMR_S 1136, Institut Pierre Louis d'Epidémiologie et de Santé Publique Recruiting
Paris, France
Contact: Bertrand Guidet, MD         
Sorbonne Universités, UPMC Univ Paris 06, UMR_S 1136, Institut Pierre Louis d'Epidémiologie et de Santé Publique Recruiting
Paris, France
Contact: Bertrand Guidet, MD         
Germany
Division of Cardiology, Pulmonary Disease and Vascular Medicine Recruiting
Duesseldorf, Germany, 40225
Contact: Christian Jung, MD, PhD       contact@vipstudy.org   
Contact: Rabea Wagstaff, MA       ctsu@med.uni-duesseldorf.de   
Principal Investigator: Christian Jung, MD, PhD         
Sub-Investigator: Raphael Bruno, MD         
Norway
Department of Anaestesia and Intensive Care, Haukeland University Hospital Recruiting
Bergen, Norway
Contact: Hans Flaatten, MD PhD.       hans.flaatten@uib.no   
Department of Clinical Medecine,University of Bergen Recruiting
Bergen, Norway
Contact: Hans Flaatten, MD PhD.       hans.flaatten@uib.no   
Sponsors and Collaborators
Heinrich-Heine University, Duesseldorf
Additional Information:
Publications:

Layout table for additonal information
Responsible Party: Klinik für Kardiologie, Pneumologie und Angiologie, Principle Investigator Prof. Dr. Dr. Christian Jung, Heinrich-Heine University, Duesseldorf
ClinicalTrials.gov Identifier: NCT04321265    
Other Study ID Numbers: 20-004
First Posted: March 25, 2020    Key Record Dates
Last Update Posted: April 8, 2020
Last Verified: April 2020

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Klinik für Kardiologie, Pneumologie und Angiologie, Heinrich-Heine University, Duesseldorf:
COVID-19
Elderly patients
Additional relevant MeSH terms:
Layout table for MeSH terms
Critical Illness
Disease Attributes
Pathologic Processes