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Outcomes and Prognostic Factors in COVID-19 (COVIP)

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ClinicalTrials.gov Identifier: NCT04321265
Recruitment Status : Recruiting
First Posted : March 25, 2020
Last Update Posted : November 7, 2022
Sponsor:
Information provided by (Responsible Party):
Heinrich-Heine University, Duesseldorf

Study Description
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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 scale in this cohort, and in particular if this is an instrument that can be used for outcome prediction in this group. In addition, various other parameters of potential relevance for older critically ill patients will be studied.

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

Detailed Description:

The study started in March 2020 and included until summer 2021 nearly 4000 patients. Several comprehensive analyses were conducted and published. Subsequently, in December 2021 the protocol was slightly changed and recruitment continues in 2022.

Data are collected regarding: Pre-Admission life conditions with Frailty (Clinical Frailty Scale, CFSF.R.A.I.L Score); vaccination status; ICU-Admission (e.g. SOFA), ICU-Treatment, Survival (30 day and 3 months).

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 up to 400 ICUs that will continuously collect data. The COVIP Study had two different previous recruitment periods. Period 1 (march to May 2020) finished representing the first wave of the pandemic in most countries. The second recruitment period has been defined being from September 1st to December 31st 2020 representing the second wave in most countries. Recruitment in 2021 also continued until the summer without allocating a specific recruitment period. However, the third recruitment period opened January 1st 2022 and is still ongoing.

Study Design
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Study Type : Observational
Estimated Enrollment : 1500 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 : December 31, 2022
Estimated Study Completion Date : March 31, 2023

Resource links provided by the National Library of Medicine


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

Secondary Outcome Measures :
  1. Frailty [ Time Frame: pre-admission ]
    Frailty 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)


Eligibility Criteria
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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 with SARS-CoV-2
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

1. Age <70 years

Contacts and Locations
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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
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Contact: Christian Jung, MD +2118118800 contact@vipstudy.org
Contact: Raphael Bruno, MD +2118118800 covip@med.uni-duesseldorf.de

Locations
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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: Lisa Dannenberg, MD       ctu@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
More Information
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Additional Information:

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: 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: November 7, 2022
Last Verified: November 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Heinrich-Heine University, Duesseldorf:
COVID-19
Elderly patients
Additional relevant MeSH terms:
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COVID-19
Critical Illness
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
 Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Disease Attributes
Pathologic Processes