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COVID-19COVIPNCT04321265

Outcomes and Prognostic Factors in COVID-19

An observational study of COVID-19 and Elderly Patients, run by Heinrich-Heine University, Duesseldorf at 7 sites in 4 countries.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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… Read more about this study

Who is it for?
Ages 70 years and older
Conditions the study is for
COVID-19, Elderly Patients, Critical Illness
How many people
1,500 participants
Where
7 sitesin 4 countries
Study dates
19 Mar 2020to 31 Mar 2023
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 70 years and older
  • All sexes
  • Older adult

Study population: Patient with Infection with SARS-CoV-2

Who may be able to join

  • Age > 70 years
  • ICU-Admission
  • Infection with SARS-CoV-2

Who cannot join

  • 1. Age <70 years

Trial locations and contacts

7 sites in 4 countries.

Christian Jung, MD contact

+2118118800

contact@vipstudy.org

Raphael Bruno, MD contact

+2118118800

covip@med.uni-duesseldorf.de

7 sites in 4 countries

France3 sites, 3 recruiting

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

    Paris

    Bertrand Guidet, MD, bertrand.guidet@aphp.fr

    Recruiting

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

    Paris

    Bertrand Guidet, MD

    Recruiting

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

    Paris

    Bertrand Guidet, MD

    Recruiting

Other trials in France

Norway2 sites, 2 recruiting

  • Department of Anaestesia and Intensive Care, Haukeland University Hospital

    Bergen

    Hans Flaatten, MD PhD., hans.flaatten@uib.no

    Recruiting

  • Department of Clinical Medecine,University of Bergen

    Bergen

    Hans Flaatten, MD PhD., hans.flaatten@uib.no

    Recruiting

Other trials in Norway

Denmark1 site, 1 recruiting

  • Department of Intensive Care, Aarhus University Hospital

    Aarhus

    Jesper Fjølner, MD, jespfjoe@rm.dk

    Recruiting

Other trials in Denmark

Germany1 site, 1 recruiting

  • Division of Cardiology, Pulmonary Disease and Vascular Medicine

    Düsseldorf, 40225

    Christian Jung, MD, PhD, contact@vipstudy.org

    Lisa Dannenberg, MD, ctu@med.uni-duesseldorf.de

    Recruiting

Other trials in Germany

About this study

Official title: 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.

Read the 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.

Keywords
COVID-19, Elderly patients
Medical subject headings
COVID-19, Critical Illness

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Survival

    Measured: up to 30 days

Secondary outcomes (1)

  1. 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)

    Measured: pre-admission

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Mar 2020
  2. Study start19 Mar 2020
  3. Primary completion31 Dec 2022 (estimated)
  4. Study completion31 Mar 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
1,500 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04321265
Sponsor's protocol ID
20-004
Acronym
COVIP
Status last verified
Nov 2022
First submitted
19 Mar 2020
Last updated
7 Nov 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

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.

    PubMed 32105632

  • 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.

    PubMed 28238055

  • 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.

    PubMed 28936626

  • 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.

    PubMed 9923878

  • 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.

    PubMed 31784798

  • 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.

    PubMed 5420677

  • 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.

    PubMed 31055187

  • 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.

    PubMed 39631193

  • 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.

    PubMed 36854893

  • 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.

    PubMed 36812571

  • 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.

    PubMed 36575394

  • 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.

    PubMed 35945477

  • 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.

    PubMed 35869557

  • 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.

    PubMed 35303201

  • 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.

    PubMed 35274490

Questions about this trial

What is this clinical trial studying?

An observational study of COVID-19 and Elderly Patients, run by Heinrich-Heine University, Duesseldorf at 7 sites in 4 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 7 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in France, Norway, Denmark, Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Christian Jung, MD (+2118118800, contact@vipstudy.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Survival (time frame: up to 30 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04321265, which also lists 23 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2022.

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