Outcomes and Prognostic Factors in COVID-19 (COVIP)

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

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.

Study Overview

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

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 Type: Observational
• Enrollment (Anticipated): 1500

Contacts and Locations

• Study Contact: Name: Christian Jung, MD; Phone Number: +2118118800; Email: contact@vipstudy.org
• Study Contact Backup: Name: Raphael Bruno, MD; Phone Number: +2118118800; Email: covip@med.uni-duesseldorf.de

Study Locations

• Denmark
  • Aarhus, Denmark
    • Recruiting
    • Department of Intensive Care, Aarhus University Hospital
    • Contact: Jesper Fjølner, MD; Email: jespfjoe@rm.dk
• France
  • Paris, France
    • Recruiting
    • Hôpitaux de Paris, Hôpital Saint-Antoine, service de réanimation médicale
  • Paris, France
    • Recruiting
    • INSERM, UMR_S 1136, Institut Pierre Louis d'Epidémiologie et de Santé Publique
    • Contact: Bertrand Guidet, MD
  • Paris, France
    • Recruiting
    • Sorbonne Universités, UPMC Univ Paris 06, UMR_S 1136, Institut Pierre Louis d'Epidémiologie et de Santé Publique
    • Contact: Bertrand Guidet, MD
• Germany
  • Duesseldorf, Germany, 40225
    • Recruiting
    • Division of Cardiology, Pulmonary Disease and Vascular Medicine
    • Contact: Christian Jung, MD, PhD; Email: contact@vipstudy.org
    • Contact: Lisa Dannenberg, MD; Email: ctu@med.uni-duesseldorf.de
• Norway
  • Bergen, Norway
    • Recruiting
    • Department of Anaestesia and Intensive Care, Haukeland University Hospital
    • Contact: Hans Flaatten, MD PhD.; Email: hans.flaatten@uib.no
  • Bergen, Norway
    • Recruiting
    • Department of Clinical Medecine,University of Bergen
    • Contact: Hans Flaatten, MD PhD.; Email: hans.flaatten@uib.no

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 70 years and older (OLDER_ADULT)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patient with Infection with SARS-CoV-2

Description

Inclusion Criteria:

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

Exclusion Criteria:

1. Age <70 years

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Survival	up to 30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Heinrich-Heine University, Duesseldorf

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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. Erratum In: Intensive Care Med. 2022 Mar 31;:
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 19, 2020
• Primary Completion (ANTICIPATED): December 31, 2022
• Study Completion (ANTICIPATED): March 31, 2023

Study Registration Dates

• First Submitted: March 19, 2020
• First Submitted That Met QC Criteria: March 23, 2020
• First Posted (ACTUAL): March 25, 2020

Study Record Updates

• Last Update Posted (ACTUAL): November 7, 2022
• Last Update Submitted That Met QC Criteria: November 4, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: COVID-19; Elderly patients
• Additional Relevant MeSH Terms: Pathologic Processes; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; Disease Attributes; COVID-19; Critical Illness
• Other Study ID Numbers: 20-004

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No