Outcomes and Prognostic Factors in COVID-19

NCT ID: NCT04321265

Last Updated: 2022-11-07

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 1500 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-03-19
• Study Completion Date: 2023-03-31

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.

Conditions

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

1. Age > 70 years

2. ICU-Admission

3. Infection with SARS-CoV-2

Exclusion Criteria

1. Age <70 years

• Minimum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Heinrich-Heine University, Duesseldorf

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Department of Intensive Care, Aarhus University Hospital

Aarhus, , Denmark

Site Status: RECRUITING

Hôpitaux de Paris, Hôpital Saint-Antoine, service de réanimation médicale

Paris, , France

Site Status: RECRUITING

INSERM, UMR_S 1136, Institut Pierre Louis d'Epidémiologie et de Santé Publique

Paris, , France

Site Status: RECRUITING

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

Paris, , France

Site Status: RECRUITING

Division of Cardiology, Pulmonary Disease and Vascular Medicine

Düsseldorf, , Germany

Site Status: RECRUITING

Department of Anaestesia and Intensive Care, Haukeland University Hospital

Bergen, , Norway

Site Status: RECRUITING

Department of Clinical Medecine,University of Bergen

Bergen, , Norway

Site Status: RECRUITING

Countries

Denmark; France; Germany; Norway

Central Contacts

Christian Jung, MD

Role: CONTACT

contact@vipstudy.org

+2118118800

Raphael Bruno, MD

Role: CONTACT

covip@med.uni-duesseldorf.de

+2118118800

Facility Contacts

Jesper Fjølner, MD

Role: primary

jespfjoe@rm.dk

Bertrand Guidet, MD

Role: primary

bertrand.guidet@aphp.fr

Bertrand Guidet, MD

Role: primary

Bertrand Guidet, MD

Role: primary

Christian Jung, MD, PhD

Role: primary

contact@vipstudy.org

Lisa Dannenberg, MD

Role: backup

ctu@med.uni-duesseldorf.de

Hans Flaatten, MD PhD.

Role: primary

hans.flaatten@uib.no

Hans Flaatten, MD PhD.

Role: primary

hans.flaatten@uib.no

References

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.

Reference Type: BACKGROUND

PMID: 32105632 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 28238055 (View on PubMed)

Flaatten H, De Lange DW, Morandi A, Andersen FH, Artigas A, Bertolini G, Boumendil A, Cecconi M, Christensen S, Faraldi L, Fjolner J, Jung C, Marsh B, Moreno R, Oeyen S, Ohman 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.

Reference Type: BACKGROUND

PMID: 28936626 (View on PubMed)

Rockwood K, Stadnyk K, MacKnight C, McDowell I, Hebert R, Hogan DB. A brief clinical instrument to classify frailty in elderly people. Lancet. 1999 Jan 16;353(9148):205-6. doi: 10.1016/S0140-6736(98)04402-X. No abstract available.

Reference Type: BACKGROUND

PMID: 9923878 (View on PubMed)

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, Fjolner 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.

Reference Type: BACKGROUND

PMID: 31784798 (View on PubMed)

Katz S, Downs TD, Cash HR, Grotz RC. Progress in development of the index of ADL. Gerontologist. 1970 Spring;10(1):20-30. doi: 10.1093/geront/10.1_part_1.20. No abstract available.

Reference Type: BACKGROUND

PMID: 5420677 (View on PubMed)

Jung C, Wernly B, Muessig JM, Kelm M, Boumendil A, Morandi A, Andersen FH, Artigas A, Bertolini G, Cecconi M, Christensen S, Faraldi L, Fjolner J, Lichtenauer M, Bruno RR, Marsh B, Moreno R, Oeyen S, Ohman 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.

Reference Type: BACKGROUND

PMID: 31055187 (View on PubMed)

Bruno RR, Wernly B, Artigas A, Fuest K, Schaller SJ, Dannenberg L, Kindgen-Milles D, Kelm M, Beil M, Sviri S, Elhadi M, Joannidis M, Oeyen S, Kondili E, Moreno R, Leaver S, Guidet B, De Lange DW, Flaatten H, Szczeklik W, Jung C; COVIP study group and collaborators on behalf of the COVIP study group. Electronic address: covip@med.uni-duesseldorf.de. Contemporary assessment of short- and functional 90-days outcome in old intensive care patients suffering from COVID-19. J Crit Care. 2025 Apr;86:154984. doi: 10.1016/j.jcrc.2024.154984. Epub 2024 Dec 3.

Reference Type: DERIVED

PMID: 39631193 (View on PubMed)

Mayerhofer T, Klein S, Wernly B, Flaatten H, Guidet B, De Lange DW, Fjolner J, Leaver S, Beil M, Sviri S, Bruno RR, Artigas A, van Heerden PV, Pinto BB, Schefold JC, Moreno R, Cecconi M, Szczeklik W, Jung C, Joannidis M; COVIP study group. Diabetes mellitus is associated with 90-day mortality in old critically ill COVID-19 patients: a multicenter prospective observational cohort study. Infection. 2023 Oct;51(5):1407-1415. doi: 10.1007/s15010-023-02001-2. Epub 2023 Mar 1.

Reference Type: DERIVED

PMID: 36854893 (View on PubMed)

Mamandipoor B, Bruno RR, Wernly B, Wolff G, Fjolner J, Artigas A, Pinto BB, Schefold JC, Kelm M, Beil M, Sigal S, Leaver S, De Lange DW, Guidet B, Flaatten H, Szczeklik W, Jung C, Osmani V. COVID-19 machine learning model predicts outcomes in older patients from various European countries, between pandemic waves, and in a cohort of Asian, African, and American patients. PLOS Digit Health. 2022 Nov 8;1(11):e0000136. doi: 10.1371/journal.pdig.0000136. eCollection 2022 Nov.

Reference Type: DERIVED

PMID: 36812571 (View on PubMed)

Baldia PH, Wernly B, Flaatten H, Fjolner J, Artigas A, Pinto BB, Schefold JC, Kelm M, Beil M, Bruno RR, Binnebossel S, Wolff G, Erkens R, Sigal S, van Heerden PV, Szczeklik W, Elhadi M, Joannidis M, Oeyen S, Marsh B, Andersen FH, Moreno R, Leaver S, De Lange DW, Guidet B, Jung C; COVIP study group. The association of prior paracetamol intake with outcome of very old intensive care patients with COVID-19: results from an international prospective multicentre trial. BMC Geriatr. 2022 Dec 27;22(1):1000. doi: 10.1186/s12877-022-03709-w.

Reference Type: DERIVED

PMID: 36575394 (View on PubMed)

Wolff G, Wernly B, Flaatten H, Fjolner J, Bruno RR, Artigas A, Pinto BB, Schefold JC, Kelm M, Binneboessel S, Baldia P, Beil M, Sivri S, van Heerden PV, Szczeklik W, Elhadi M, Joannidis M, Oeyen S, Flamm M, Zafeiridis T, Marsh B, Andersen FH, Moreno R, Boumendil A, De Lange DW, Guidet B, Leaver S, Jung C; COVIP Study Group. Sex-specific treatment characteristics and 30-day mortality outcomes of critically ill COVID-19 patients over 70 years of age-results from the prospective COVIP study. Can J Anaesth. 2022 Nov;69(11):1390-1398. doi: 10.1007/s12630-022-02304-2. Epub 2022 Aug 9.

Reference Type: DERIVED

PMID: 35945477 (View on PubMed)

Polok K, Fronczek J, Artigas A, Flaatten H, Guidet B, De Lange DW, Fjolner J, Leaver S, Beil M, Sviri S, Bruno RR, Wernly B, Bollen Pinto B, Schefold JC, Studzinska D, Joannidis M, Oeyen S, Marsh B, Andersen FH, Moreno R, Cecconi M, Jung C, Szczeklik W; COVIP Study Group. Noninvasive ventilation in COVID-19 patients aged >/= 70 years-a prospective multicentre cohort study. Crit Care. 2022 Jul 22;26(1):224. doi: 10.1186/s13054-022-04082-1.

Reference Type: DERIVED

PMID: 35869557 (View on PubMed)

Bruno RR, Wernly B, Flaatten H, Fjolner J, Artigas A, Baldia PH, Binneboessel S, Bollen Pinto B, Schefold JC, Wolff G, Kelm M, Beil M, Sviri S, van Heerden PV, Szczeklik W, Elhadi M, Joannidis M, Oeyen S, Kondili E, Marsh B, Wollborn J, Andersen FH, Moreno R, Leaver S, Boumendil A, De Lange DW, Guidet B, Jung C; COVIP study group. The association of the Activities of Daily Living and the outcome of old intensive care patients suffering from COVID-19. Ann Intensive Care. 2022 Mar 18;12(1):26. doi: 10.1186/s13613-022-00996-9.

Reference Type: DERIVED

PMID: 35303201 (View on PubMed)

Bruno RR, Wernly B, Wolff G, Fjolner J, Artigas A, Bollen Pinto B, Schefold JC, Kindgen-Milles D, Baldia PH, Kelm M, Beil M, Sviri S, van Heerden PV, Szczeklik W, Topeli A, Elhadi M, Joannidis M, Oeyen S, Kondili E, Marsh B, Andersen FH, Moreno R, Leaver S, Boumendil A, De Lange DW, Guidet B, Flaatten H, Jung C; COVIP study group. Association of chronic heart failure with mortality in old intensive care patients suffering from Covid-19. ESC Heart Fail. 2022 Jun;9(3):1756-1765. doi: 10.1002/ehf2.13854. Epub 2022 Mar 10.

Reference Type: DERIVED

PMID: 35274490 (View on PubMed)

Guidet B, Jung C, Flaatten H, Fjolner J, Artigas A, Pinto BB, Schefold JC, Beil M, Sigal S, van Heerden PV, Szczeklik W, Joannidis M, Oeyen S, Kondili E, Marsh B, Andersen FH, Moreno R, Cecconi M, Leaver S, De Lange DW, Boumendil A; VIP2 and COVIP study groups. Increased 30-day mortality in very old ICU patients with COVID-19 compared to patients with respiratory failure without COVID-19. Intensive Care Med. 2022 Apr;48(4):435-447. doi: 10.1007/s00134-022-06642-z. Epub 2022 Feb 26.

Reference Type: DERIVED

PMID: 35218366 (View on PubMed)

Jung C, Mamandipoor B, Fjolner J, Bruno RR, Wernly B, Artigas A, Bollen Pinto B, Schefold JC, Wolff G, Kelm M, Beil M, Sviri S, van Heerden PV, Szczeklik W, Czuczwar M, Elhadi M, Joannidis M, Oeyen S, Zafeiridis T, Marsh B, Andersen FH, Moreno R, Cecconi M, Leaver S, De Lange DW, Guidet B, Flaatten H, Osmani V. Disease-Course Adapting Machine Learning Prognostication Models in Elderly Patients Critically Ill With COVID-19: Multicenter Cohort Study With External Validation. JMIR Med Inform. 2022 Mar 31;10(3):e32949. doi: 10.2196/32949.

Reference Type: DERIVED

PMID: 35099394 (View on PubMed)

Polok K, Fronczek J, van Heerden PV, Flaatten H, Guidet B, De Lange DW, Fjolner J, Leaver S, Beil M, Sviri S, Bruno RR, Wernly B, Artigas A, Pinto BB, Schefold JC, Studzinska D, Joannidis M, Oeyen S, Marsh B, Andersen FH, Moreno R, Cecconi M, Jung C, Szczeklik W; COVIP study group. Association between tracheostomy timing and outcomes for older critically ill COVID-19 patients: prospective observational study in European intensive care units. Br J Anaesth. 2022 Mar;128(3):482-490. doi: 10.1016/j.bja.2021.11.027. Epub 2021 Nov 29.

Reference Type: DERIVED

PMID: 34955167 (View on PubMed)

Jung C, Flaatten H, de Lange D, Beil M, Guidet B. The relationship between treatment limitations and pressure on intensive care units in elderly patients. Intensive Care Med. 2022 Jan;48(1):124-125. doi: 10.1007/s00134-021-06553-5. Epub 2021 Nov 5. No abstract available.

Reference Type: DERIVED

PMID: 34741189 (View on PubMed)

Jung C, Fjolner J, Bruno RR, Wernly B, Artigas A, Bollen Pinto B, Schefold JC, Wolff G, Kelm M, Beil M, Sviri S, van Heerden PV, Szczeklik W, Czuczwar M, Joannidis M, Oeyen S, Zafeiridis T, Andersen FH, Moreno R, Leaver S, Boumendil A, De Lange DW, Guidet B, Flaatten H; , COVIP Study Group. Differences in mortality in critically ill elderly patients during the second COVID-19 surge in Europe. Crit Care. 2021 Sep 23;25(1):344. doi: 10.1186/s13054-021-03739-7.

Reference Type: DERIVED

PMID: 34556171 (View on PubMed)

Bruno RR, Wernly B, Flaatten H, Fjolner J, Artigas A, Bollen Pinto B, Schefold JC, Binnebossel S, Baldia PH, Kelm M, Beil M, Sigal S, van Heerden PV, Szczeklik W, Elhadi M, Joannidis M, Oeyen S, Zafeiridis T, Wollborn J, Arche Banzo MJ, Fuest K, Marsh B, Andersen FH, Moreno R, Leaver S, Boumendil A, De Lange DW, Guidet B, Jung C; COVIP Study Group. Lactate is associated with mortality in very old intensive care patients suffering from COVID-19: results from an international observational study of 2860 patients. Ann Intensive Care. 2021 Aug 21;11(1):128. doi: 10.1186/s13613-021-00911-8.

Reference Type: DERIVED

PMID: 34417919 (View on PubMed)

Jung C, Flaatten H, Fjolner J, Bruno RR, Wernly B, Artigas A, Bollen Pinto B, Schefold JC, Wolff G, Kelm M, Beil M, Sviri S, van Heerden PV, Szczeklik W, Czuczwar M, Elhadi M, Joannidis M, Oeyen S, Zafeiridis T, Marsh B, Andersen FH, Moreno R, Cecconi M, Leaver S, Boumendil A, De Lange DW, Guidet B; COVIP study group. The impact of frailty on survival in elderly intensive care patients with COVID-19: the COVIP study. Crit Care. 2021 Apr 19;25(1):149. doi: 10.1186/s13054-021-03551-3.

Reference Type: DERIVED

PMID: 33874987 (View on PubMed)

Jung C, Bruno RR, Wernly B, Joannidis M, Oeyen S, Zafeiridis T, Marsh B, Andersen FH, Moreno R, Fernandes AM, Artigas A, Pinto BB, Schefold J, Wolff G, Kelm M, De Lange DW, Guidet B, Flaatten H, Fjolner J; COVIP study group. Inhibitors of the renin-angiotensin-aldosterone system and COVID-19 in critically ill elderly patients. Eur Heart J Cardiovasc Pharmacother. 2021 Jan 16;7(1):76-77. doi: 10.1093/ehjcvp/pvaa083. No abstract available.

Reference Type: DERIVED

PMID: 32645153 (View on PubMed)

Related Links

http://vipstudy.org/covip-study/

Related Info

Other Identifiers

20-004

Identifier Type: -

Identifier Source: org_study_id