Clinical trial NCT04321265: Outcomes and Prognostic Factors in COVID-19
Official title: Outcomes and Prognostic Factors in Coronavirus Disease (COVID-19) in Very Old Intensive Care Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: COVID-19
Elderly Patients
Critical Illness
Survival
Old Age
Keywords: COVID-19
Elderly patients
Lead sponsor: Heinrich-Heine University, Duesseldorf
Sponsor class: OTHER
First posted: 2020-03-25
Enrollment: 1500
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient with Infection with SARS-CoV-2

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.

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

1. Age \<70 years

Primary outcomes:
measure: Survival
timeFrame: up to 30 days
Secondary outcomes:
measure: Frailty
timeFrame: pre-admission
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Department of Intensive Care, Aarhus University Hospital
city: Paris
country: France
facility: Hôpitaux de Paris, Hôpital Saint-Antoine, service de réanimation médicale
city: Paris
country: France
facility: INSERM, UMR_S 1136, Institut Pierre Louis d'Epidémiologie et de Santé Publique
city: Paris
country: France
facility: Sorbonne Universités, UPMC Univ Paris 06, UMR_S 1136, Institut Pierre Louis d'Epidémiologie et de Santé Publique
city: Duesseldorf
country: Germany
facility: Division of Cardiology, Pulmonary Disease and Vascular Medicine
city: Bergen
country: Norway
facility: Department of Anaestesia and Intensive Care, Haukeland University Hospital
city: Bergen
country: Norway
facility: Department of Clinical Medecine,University of Bergen
Study officials:
References:
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