Outcomes and Prognostic Factors in COVID-19

Recruiting

• Conditions: COVID-19; Survival; Old Age; Elderly Patients; Critical Illness

• Registration Number: NCT04321265
• Lead Sponsor: 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 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.

Study Timeline

• Study Start: 2020-03-19
• Study First Submitted: 2020-03-19
• Study First Submitted QC: 2020-03-23
• Study First Posted: 2020-03-25
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-04
• Last Update Posted: 2022-11-07
• Primary Completion: 2022-12-31
• Study Completion: 2023-03-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1500

Inclusion Criteria

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

Exclusion Criteria

1. Age <70 years

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Survival	up to 30 days

Secondary Outcome Measures

Name	Time	Method
Frailty	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)

Trial Locations

Locations (7)

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

Department of Anaestesia and Intensive Care, Haukeland University Hospital; 🇳🇴 Bergen, Norway

Sorbonne Universités, UPMC Univ Paris 06, UMR_S 1136, Institut Pierre Louis d'Epidémiologie et de Santé Publique; 🇫🇷 Paris, France

Division of Cardiology, Pulmonary Disease and Vascular Medicine; 🇩🇪 Duesseldorf, Germany

Department of Clinical Medecine,University of Bergen; 🇳🇴 Bergen, Norway

Department of Intensive Care, Aarhus University Hospital; 🇩🇰 Aarhus, Denmark