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Outcomes and Prognostic Factors in COVID-19 (COVIP)

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ClinicalTrials.gov Identifier: NCT04321265
Recruitment Status : Completed
First Posted : March 25, 2020
Last Update Posted : September 27, 2021
Sponsor:
Information provided by (Responsible Party):
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 (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. Each center aims to recruit 20 patients, but more patients per center are possible.

The COVIP Study has two diferent recruitment periods. Period 1 (march to May 2020) has finished representing the first wave of the pandemic in most countries. The second recruitment period has been definded beinng from Septmeber 1st to December 31st 2020 representing the second wave in most countries.

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Study Type : Observational
Actual Enrollment : 3957 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
Actual Primary Completion Date : June 15, 2021
Actual Study Completion Date : September 15, 2021



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

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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


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


Locations
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Denmark
Department of Intensive Care, Aarhus University Hospital
Aarhus, Denmark
France
Hôpitaux de Paris, Hôpital Saint-Antoine, service de réanimation médicale
Paris, France
INSERM, UMR_S 1136, Institut Pierre Louis d'Epidémiologie et de Santé Publique
Paris, France
Sorbonne Universités, UPMC Univ Paris 06, UMR_S 1136, Institut Pierre Louis d'Epidémiologie et de Santé Publique
Paris, France
Germany
Division of Cardiology, Pulmonary Disease and Vascular Medicine
Duesseldorf, Germany, 40225
Norway
Department of Anaestesia and Intensive Care, Haukeland University Hospital
Bergen, Norway
Department of Clinical Medecine,University of Bergen
Bergen, Norway
Sponsors and Collaborators
Heinrich-Heine University, Duesseldorf
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: September 27, 2021
Last Verified: September 2021

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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