Outcomes and Prognostic Factors in COVID-19

COVID-19 Clinical Trial

— COVIP  

Official title:

Outcomes and Prognostic Factors in Coronavirus Disease (COVID-19) in Very Old Intensive Care Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04321265
• Other study ID #: 20-004
• Status: Recruiting
• Start date: March 19, 2020
• Est. completion date: March 31, 2023

Study information

• Verified date: November 2022
• Source: Heinrich-Heine University, Duesseldorf
• Contact: Christian Jung, MD
• Phone: +2118118800
• Email: contact[@]vipstudy.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1500
• Est. completion date: March 31, 2023
• Est. primary completion date: December 31, 2022
• Gender: All
• Age group: 70 Years and older

Eligibility

Inclusion Criteria:

1. Age > 70 years

2. ICU-Admission

3. Infection with SARS-CoV-2

Exclusion Criteria:

1. Age <70 years

Related Conditions & MeSH terms

• COVID-19
• Critical Illness
• Elderly Patients
• Old Age
• Survival

Locations

Country	Name	City	State
Denmark	Department of Intensive Care, Aarhus University Hospital	Aarhus
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
Germany	Division of Cardiology, Pulmonary Disease and Vascular Medicine	Duesseldorf
Norway	Department of Anaestesia and Intensive Care, Haukeland University Hospital	Bergen
Norway	Department of Clinical Medecine,University of Bergen	Bergen

Sponsors (1)

Lead Sponsor	Collaborator
Heinrich-Heine University, Duesseldorf

Countries where clinical trial is conducted

Denmark,  France,  Germany,  Norway, 

References & Publications (7)

Flaatten H, de Lange DW, Artigas A, Bin D, Moreno R, Christensen S, Joynt GM, Bagshaw SM, Sprung CL, Benoit D, Soares M, Guidet B. The status of intensive care medicine research and a future agenda for very old patients in the ICU. Intensive Care Med. 2017 Sep;43(9):1319-1328. doi: 10.1007/s00134-017-4718-z. Epub 2017 Feb 25. Review. — View Citation

Flaatten H, De Lange DW, Morandi A, Andersen FH, Artigas A, Bertolini G, Boumendil A, Cecconi M, Christensen S, Faraldi L, Fjølner J, Jung C, Marsh B, Moreno R, Oeyen S, Öhman CA, Pinto BB, Soliman IW, Szczeklik W, Valentin A, Watson X, Zaferidis T, Guidet B; VIP1 study group. The impact of frailty on ICU and 30-day mortality and the level of care in very elderly patients (= 80 years). Intensive Care Med. 2017 Dec;43(12):1820-1828. doi: 10.1007/s00134-017-4940-8. Epub 2017 Sep 21. — View Citation

Guidet B, de Lange DW, Boumendil A, Leaver S, Watson X, Boulanger C, Szczeklik W, Artigas A, Morandi A, Andersen F, Zafeiridis T, Jung C, Moreno R, Walther S, Oeyen S, Schefold JC, Cecconi M, Marsh B, Joannidis M, Nalapko Y, Elhadi M, Fjølner J, Flaatten H; VIP2 study group. The contribution of frailty, cognition, activity of daily life and comorbidities on outcome in acutely admitted patients over 80 years in European ICUs: the VIP2 study. Intensive Care Med. 2020 Jan;46(1):57-69. doi: 10.1007/s00134-019-05853-1. Epub 2019 Nov 29. — View Citation

Jung C, Wernly B, Muessig JM, Kelm M, Boumendil A, Morandi A, Andersen FH, Artigas A, Bertolini G, Cecconi M, Christensen S, Faraldi L, Fjølner J, Lichtenauer M, Bruno RR, Marsh B, Moreno R, Oeyen S, Öhman CA, Pinto BB, Soliman IW, Szczeklik W, Valentin A, Watson X, Zafeiridis T, De Lange DW, Guidet B, Flaatten H; VIP1 study group. Electronic address: hans.flaatten@uib.no. A comparison of very old patients admitted to intensive care unit after acute versus elective surgery or intervention. J Crit Care. 2019 Aug;52:141-148. doi: 10.1016/j.jcrc.2019.04.020. Epub 2019 May 2. — View Citation

Katz S, Downs TD, Cash HR, Grotz RC. Progress in development of the index of ADL. Gerontologist. 1970 Spring;10(1):20-30. — View Citation

Rockwood K, Stadnyk K, MacKnight C, McDowell I, Hébert R, Hogan DB. A brief clinical instrument to classify frailty in elderly people. Lancet. 1999 Jan 16;353(9148):205-6. — View Citation

Yang X, Yu Y, Xu J, Shu H, Xia J, Liu H, Wu Y, Zhang L, Yu Z, Fang M, Yu T, Wang Y, Pan S, Zou X, Yuan S, Shang Y. Clinical course and outcomes of critically ill patients with SARS-CoV-2 pneumonia in Wuhan, China: a single-centered, retrospective, observational study. Lancet Respir Med. 2020 May;8(5):475-481. doi: 10.1016/S2213-2600(20)30079-5. Epub 2020 Feb 24. Erratum in: Lancet Respir Med. 2020 Apr;8(4):e26. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Survival		up to 30 days
Secondary	Frailty	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)	pre-admission

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