COVID-19 Pandemic and Worldwide Organ Procurement

NCT ID: NCT04416256

Last Updated: 2020-06-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

230000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-02-01

Study Completion Date

2022-02-28

Brief Summary

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End-stage organ failure is estimated to affect more than 4 to 6 million persons worldwide. In 2018, transplant systems across the globe enabled around 150,000 patients to benefit from a kidney, heart, lung, liver, or other solid organ, a number that was far less than the demand. According to data from the World Health Organization, more than 1,500,000 persons live with a transplanted organ worldwide. In the US, approximately 40,000 patients receive an organ transplant every year, but 120,000 still remain waitlisted for transplantation today, with 7,600 dying annually while waiting for an organ transplant. A similar lack of organs and high death rates on the waiting list affect patients in Europe and many other countries.

As nations adjust to new realities driven by the coronavirus (COVID-19) outbreak, many health care providers, institutions and patients are concerned about the potential impact that COVID-19 will have on organ donation and transplantation. One concern is that transplant recipients may have a greater susceptibility to infection and greater viral burden. A second concern is that hospitals will lack the resources in terms of staff and equipment to care for recipients after transplantation, who often require intensive care and multispecialty management.

Because of the overwhelming healthcare system burden, a dramatic negative effect on worldwide organ donation and transplantation is anticipated, but has not been measured. Our objective was to quantify the worldwide impact of COVID-19 pandemic on organ donation and transplantation and consequences for waitlisted patients.

Detailed Description

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Conditions

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COVID-19

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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France

All organs procured for transplantation and transplanted during the observation period. These include kidney, lung, liver, heart, and combined transplantations.

No interventions assigned to this group

Spain

All organs procured for transplantation and transplanted during the observation period. These include kidney, lung, liver, heart, and combined transplantations.

No interventions assigned to this group

Portugal

All organs procured for transplantation and transplanted during the observation period. These include kidney, lung, liver, heart, and combined transplantations.

No interventions assigned to this group

Croatia

All organs procured for transplantation and transplanted during the observation period. These include kidney, lung, liver, heart, and combined transplantations.

No interventions assigned to this group

Germany

All organs procured for transplantation and transplanted during the observation period. These include kidney, lung, liver, heart, and combined transplantations.

No interventions assigned to this group

Italy

All organs procured for transplantation and transplanted during the observation period. These include kidney, lung, liver, heart, and combined transplantations.

No interventions assigned to this group

Netherlands

All organs procured for transplantation and transplanted during the observation period. These include kidney, lung, liver, heart, and combined transplantations.

No interventions assigned to this group

Austria

All organs procured for transplantation and transplanted during the observation period. These include kidney, lung, liver, heart, and combined transplantations.

No interventions assigned to this group

US

All organs procured for transplantation and transplanted during the observation period. These include kidney, lung, liver, heart, and combined transplantations.

No interventions assigned to this group

Canada

All organs procured for transplantation and transplanted during the observation period. These include kidney, lung, liver, heart, and combined transplantations.

No interventions assigned to this group

Mexico

All organs procured for transplantation and transplanted during the observation period. These include kidney, lung, liver, heart, and combined transplantations.

No interventions assigned to this group

Brazil

All organs procured for transplantation and transplanted during the observation period. These include kidney, lung, liver, heart, and combined transplantations.

No interventions assigned to this group

Uruguay

All organs procured for transplantation and transplanted during the observation period. These include kidney, lung, liver, heart, and combined transplantations.

No interventions assigned to this group

Argentina

All organs procured for transplantation and transplanted during the observation period. These include kidney, lung, liver, heart, and combined transplantations.

No interventions assigned to this group

Chile

All organs procured for transplantation and transplanted during the observation period. These include kidney, lung, liver, heart, and combined transplantations.

No interventions assigned to this group

Australia

All organs procured for transplantation and transplanted during the observation period. These include kidney, lung, liver, heart, and combined transplantations.

No interventions assigned to this group

Belgium

All organs procured for transplantation and transplanted during the observation period. These include kidney, lung, liver, heart, and combined transplantations.

No interventions assigned to this group

Finland

All organs procured for transplantation and transplanted during the observation period. These include kidney, lung, liver, heart, and combined transplantations.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* All organs procured for transplantation and transplanted during the observation period. These include kidney, lung, liver, heart, and combined transplantations.

Exclusion Criteria

* None
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Agence de La Biomédecine

OTHER_GOV

Sponsor Role collaborator

Eurotransplant

UNKNOWN

Sponsor Role collaborator

United Network for Organ Sharing

UNKNOWN

Sponsor Role collaborator

Deutsche Stiftung Organtransplantation

UNKNOWN

Sponsor Role collaborator

Centro Nazionale Trapianti

UNKNOWN

Sponsor Role collaborator

Brazilian Organ Transplant Association

UNKNOWN

Sponsor Role collaborator

The Canadian Association of Transplantation

UNKNOWN

Sponsor Role collaborator

Scandiatransplant

UNKNOWN

Sponsor Role collaborator

Nederlandse Transplantatie Vereniging

UNKNOWN

Sponsor Role collaborator

Austrotransplant

UNKNOWN

Sponsor Role collaborator

Centro Nacional de Trasplantes

UNKNOWN

Sponsor Role collaborator

Instituto Nacional de Donación y Trasplante de Células, Tejidos y Órganos

UNKNOWN

Sponsor Role collaborator

Donor Network of Croatia

UNKNOWN

Sponsor Role collaborator

Instituto Nacional Central Único Coordinador de Ablación e Implante

OTHER_GOV

Sponsor Role collaborator

Corporación Nacional de Trasplantes de Chile

UNKNOWN

Sponsor Role collaborator

Australian Organ and Tissue Donation and Transplantation Authority

UNKNOWN

Sponsor Role collaborator

Organización Nacional de Trasplantes

UNKNOWN

Sponsor Role collaborator

Autoridade Para Services de Sangue e Transplantacáo

UNKNOWN

Sponsor Role collaborator

Paris Translational Research Center for Organ Transplantation

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Alexandre Loupy

Role: PRINCIPAL_INVESTIGATOR

Paris Translational Research Center for Organ Transplantation

Locations

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Paris Transplant Group

Paris, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Alexandre Loupy

Role: CONTACT

+33 1 53 98 80 00

Facility Contacts

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Alexandre Loupy

Role: primary

+33 1 53 98 80 00

References

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Xu B, Kraemer MUG; Open COVID-19 Data Curation Group. Open access epidemiological data from the COVID-19 outbreak. Lancet Infect Dis. 2020 May;20(5):534. doi: 10.1016/S1473-3099(20)30119-5. Epub 2020 Feb 19. No abstract available.

Reference Type BACKGROUND
PMID: 32087115 (View on PubMed)

Anderson RM, Heesterbeek H, Klinkenberg D, Hollingsworth TD. How will country-based mitigation measures influence the course of the COVID-19 epidemic? Lancet. 2020 Mar 21;395(10228):931-934. doi: 10.1016/S0140-6736(20)30567-5. Epub 2020 Mar 9. No abstract available.

Reference Type BACKGROUND
PMID: 32164834 (View on PubMed)

Ahn C, Amer H, Anglicheau D, Ascher NL, Baan CC, Battsetset G, Bat-Ireedui B, Berney T, Betjes MGH, Bichu S, Birn H, Brennan D, Bromberg J, Caillard S, Cannon RM, Cantarovich M, Chan A, Chen ZS, Chapman JR, Cole EH, Cross N, Durand F, Egawa H, Emond JC, Farrero M, Friend PJ, Geissler EK, Ha J, Haberal MA, Henderson ML, Hesselink DA, Humar A, Jassem W, Jeong JC, Kaplan B, Kee T, Kim SJ, Kumar D, Legendre CM, Man K, Moulin B, Muller E, Munkhbat R, Od-Erdene L, Perrin P, Rela M, Tanabe K, Tedesco Silva H, Tinckam KT, Tullius SG, Wong G. Global Transplantation COVID Report March 2020. Transplantation. 2020 Oct;104(10):1974-1983. doi: 10.1097/TP.0000000000003258. No abstract available.

Reference Type BACKGROUND
PMID: 32243281 (View on PubMed)

Zhang X. Epidemiology of Covid-19. N Engl J Med. 2020 May 7;382(19):1869. doi: 10.1056/NEJMc2005157. Epub 2020 Mar 27. No abstract available.

Reference Type BACKGROUND
PMID: 32220200 (View on PubMed)

Martino F, Plebani M, Ronco C. Kidney transplant programmes during the COVID-19 pandemic. Lancet Respir Med. 2020 May;8(5):e39. doi: 10.1016/S2213-2600(20)30182-X. Epub 2020 Apr 16. No abstract available.

Reference Type BACKGROUND
PMID: 32305079 (View on PubMed)

Akalin E, Azzi Y, Bartash R, Seethamraju H, Parides M, Hemmige V, Ross M, Forest S, Goldstein YD, Ajaimy M, Liriano-Ward L, Pynadath C, Loarte-Campos P, Nandigam PB, Graham J, Le M, Rocca J, Kinkhabwala M. Covid-19 and Kidney Transplantation. N Engl J Med. 2020 Jun 18;382(25):2475-2477. doi: 10.1056/NEJMc2011117. Epub 2020 Apr 24. No abstract available.

Reference Type BACKGROUND
PMID: 32329975 (View on PubMed)

Coates PT, Wong G, Drueke T, Rovin B, Ronco P; Associate Editors, for the Entire Editorial Team. Early experience with COVID-19 in kidney transplantation. Kidney Int. 2020 Jun;97(6):1074-1075. doi: 10.1016/j.kint.2020.04.001. Epub 2020 Apr 9. No abstract available.

Reference Type BACKGROUND
PMID: 32354635 (View on PubMed)

Livingston E, Bucher K. Coronavirus Disease 2019 (COVID-19) in Italy. JAMA. 2020 Apr 14;323(14):1335. doi: 10.1001/jama.2020.4344. No abstract available.

Reference Type BACKGROUND
PMID: 32181795 (View on PubMed)

Omer SB, Malani P, Del Rio C. The COVID-19 Pandemic in the US: A Clinical Update. JAMA. 2020 May 12;323(18):1767-1768. doi: 10.1001/jama.2020.5788. No abstract available.

Reference Type BACKGROUND
PMID: 32250388 (View on PubMed)

Dong E, Du H, Gardner L. An interactive web-based dashboard to track COVID-19 in real time. Lancet Infect Dis. 2020 May;20(5):533-534. doi: 10.1016/S1473-3099(20)30120-1. Epub 2020 Feb 19. No abstract available.

Reference Type BACKGROUND
PMID: 32087114 (View on PubMed)

Levin A, Tonelli M, Bonventre J, Coresh J, Donner JA, Fogo AB, Fox CS, Gansevoort RT, Heerspink HJL, Jardine M, Kasiske B, Kottgen A, Kretzler M, Levey AS, Luyckx VA, Mehta R, Moe O, Obrador G, Pannu N, Parikh CR, Perkovic V, Pollock C, Stenvinkel P, Tuttle KR, Wheeler DC, Eckardt KU; ISN Global Kidney Health Summit participants. Global kidney health 2017 and beyond: a roadmap for closing gaps in care, research, and policy. Lancet. 2017 Oct 21;390(10105):1888-1917. doi: 10.1016/S0140-6736(17)30788-2. Epub 2017 Apr 20.

Reference Type RESULT
PMID: 28434650 (View on PubMed)

Aubert O, Yoo D, Zielinski D, Cozzi E, Cardillo M, Durr M, Dominguez-Gil B, Coll E, Da Silva MI, Sallinen V, Lemstrom K, Midtvedt K, Ulloa C, Immer F, Weissenbacher A, Vallant N, Basic-Jukic N, Tanabe K, Papatheodoridis G, Menoudakou G, Torres M, Soratti C, Hansen Krogh D, Lefaucheur C, Ferreira G, Silva HT Jr, Hartell D, Forsythe J, Mumford L, Reese PP, Kerbaul F, Jacquelinet C, Vogelaar S, Papalois V, Loupy A. COVID-19 pandemic and worldwide organ transplantation: a population-based study. Lancet Public Health. 2021 Oct;6(10):e709-e719. doi: 10.1016/S2468-2667(21)00200-0. Epub 2021 Aug 30.

Reference Type DERIVED
PMID: 34474014 (View on PubMed)

Other Identifiers

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COVID/W.W.

Identifier Type: -

Identifier Source: org_study_id

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