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. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04321265|
Recruitment Status : Completed
First Posted : March 25, 2020
Last Update Posted : September 27, 2021
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|
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.
|Study Type :||Observational|
|Actual Enrollment :||3957 participants|
|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|
- Survival [ Time Frame: up to 30 days ]
- 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)
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
|Department of Intensive Care, Aarhus University Hospital|
|Hôpitaux de Paris, Hôpital Saint-Antoine, service de réanimation médicale|
|INSERM, UMR_S 1136, Institut Pierre Louis d'Epidémiologie et de Santé Publique|
|Sorbonne Universités, UPMC Univ Paris 06, UMR_S 1136, Institut Pierre Louis d'Epidémiologie et de Santé Publique|
|Division of Cardiology, Pulmonary Disease and Vascular Medicine|
|Duesseldorf, Germany, 40225|
|Department of Anaestesia and Intensive Care, Haukeland University Hospital|
|Department of Clinical Medecine,University of Bergen|