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COVID-19 Pandemic and Worldwide Organ Procurement (COVID)

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ClinicalTrials.gov Identifier: NCT04416256
Recruitment Status : Recruiting
First Posted : June 4, 2020
Last Update Posted : June 4, 2020
Sponsor:
Collaborators:
Agence de La Biomédecine
Eurotransplant
United Network for Organ Sharing
Deutsche Stiftung Organtransplantation
Centro Nazionale Trapianti
Brazilian Organ Transplant Association
The Canadian Association of Transplantation
Scandiatransplant
Nederlandse Transplantatie Vereniging
Austrotransplant
Centro Nacional de Trasplantes
Instituto Nacional de Donación y Trasplante de Células, Tejidos y Órganos
Donor Network of Croatia
Instituto Nacional Central Único Coordinador de Ablación e Implante
Corporación Nacional de Trasplantes de Chile
Australian Organ and Tissue Donation and Transplantation Authority
Organización Nacional de Trasplantes
Autoridade Para Services de Sangue e Transplantacáo
Information provided by (Responsible Party):
Paris Translational Research Center for Organ Transplantation

Brief Summary:

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.


Condition or disease
COVID-19

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Study Type : Observational
Estimated Enrollment : 230000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Consequences of the COVID-19 Pandemic on Worldwide Organ Procurement and Transplantation
Actual Study Start Date : February 1, 2020
Estimated Primary Completion Date : February 2022
Estimated Study Completion Date : February 2022

Group/Cohort
France
All organs procured for transplantation and transplanted during the observation period. These include kidney, lung, liver, heart, and combined transplantations.
Spain
All organs procured for transplantation and transplanted during the observation period. These include kidney, lung, liver, heart, and combined transplantations.
Portugal
All organs procured for transplantation and transplanted during the observation period. These include kidney, lung, liver, heart, and combined transplantations.
Croatia
All organs procured for transplantation and transplanted during the observation period. These include kidney, lung, liver, heart, and combined transplantations.
Germany
All organs procured for transplantation and transplanted during the observation period. These include kidney, lung, liver, heart, and combined transplantations.
Italy
All organs procured for transplantation and transplanted during the observation period. These include kidney, lung, liver, heart, and combined transplantations.
Netherlands
All organs procured for transplantation and transplanted during the observation period. These include kidney, lung, liver, heart, and combined transplantations.
Austria
All organs procured for transplantation and transplanted during the observation period. These include kidney, lung, liver, heart, and combined transplantations.
US
All organs procured for transplantation and transplanted during the observation period. These include kidney, lung, liver, heart, and combined transplantations.
Canada
All organs procured for transplantation and transplanted during the observation period. These include kidney, lung, liver, heart, and combined transplantations.
Mexico
All organs procured for transplantation and transplanted during the observation period. These include kidney, lung, liver, heart, and combined transplantations.
Brazil
All organs procured for transplantation and transplanted during the observation period. These include kidney, lung, liver, heart, and combined transplantations.
Uruguay
All organs procured for transplantation and transplanted during the observation period. These include kidney, lung, liver, heart, and combined transplantations.
Argentina
All organs procured for transplantation and transplanted during the observation period. These include kidney, lung, liver, heart, and combined transplantations.
Chile
All organs procured for transplantation and transplanted during the observation period. These include kidney, lung, liver, heart, and combined transplantations.
Australia
All organs procured for transplantation and transplanted during the observation period. These include kidney, lung, liver, heart, and combined transplantations.
Belgium
All organs procured for transplantation and transplanted during the observation period. These include kidney, lung, liver, heart, and combined transplantations.
Finland
All organs procured for transplantation and transplanted during the observation period. These include kidney, lung, liver, heart, and combined transplantations.



Primary Outcome Measures :
  1. Organ transplantation activity during COVID-19 pandemic [ Time Frame: Two years since COVID-19 outbreak. ]
    Overall deceased donor transplantation performed during the COVID-19 pandemic. Stratified analysis by deceased donor type (Kidney, lung, Liver, heart), and combined transplantations during the COVID-19 pandemic.


Secondary Outcome Measures :
  1. Further analysis on organ transplantation with stratification [ Time Frame: Two years since COVID-19 outbreak. ]
    Geographic disparities related to organ transplantation rates and association with COVID-19 clusters Living donor transplantation performed during the COVID-19 pandemic. Quality of transplanted organs (kidney) before and after the COVID-19 pandemic. Change in relationship between living donors and their recipients before and after the COVID-19 pandemic.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Solid organ transplants performed during the study period (kidney, lung, heart, liver and combined organs in Europe (France, Spain, Portugal, Germany, Italy, Croatia, Belgium, Netherlands, Austria), North America (US and Canada), Central and South America (Mexico, Brazil, Uruguay, Argentina and Chile) and Oceania (Australia)
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04416256


Contacts
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Contact: Alexandre Loupy +33 1 53 98 80 00 alexandre.loupy@inserm.fr

Locations
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France
Paris Transplant Group Recruiting
Paris, France, 75015
Contact: Alexandre Loupy    +33 1 53 98 80 00    alexandre.loupy@inserm.fr   
Principal Investigator: Alexandre Loupy, MD         
Principal Investigator: Carmen Lefaucheur, MD         
Principal Investigator: Olivier Aubert, MD         
Sponsors and Collaborators
Paris Translational Research Center for Organ Transplantation
Agence de La Biomédecine
Eurotransplant
United Network for Organ Sharing
Deutsche Stiftung Organtransplantation
Centro Nazionale Trapianti
Brazilian Organ Transplant Association
The Canadian Association of Transplantation
Scandiatransplant
Nederlandse Transplantatie Vereniging
Austrotransplant
Centro Nacional de Trasplantes
Instituto Nacional de Donación y Trasplante de Células, Tejidos y Órganos
Donor Network of Croatia
Instituto Nacional Central Único Coordinador de Ablación e Implante
Corporación Nacional de Trasplantes de Chile
Australian Organ and Tissue Donation and Transplantation Authority
Organización Nacional de Trasplantes
Autoridade Para Services de Sangue e Transplantacáo
Investigators
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Principal Investigator: Alexandre Loupy Paris Translational Research Center for Organ Transplantation
Publications of Results:
Other Publications:

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Responsible Party: Paris Translational Research Center for Organ Transplantation
ClinicalTrials.gov Identifier: NCT04416256    
Other Study ID Numbers: COVID/W.W.
First Posted: June 4, 2020    Key Record Dates
Last Update Posted: June 4, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Paris Translational Research Center for Organ Transplantation:
organ
procurement
transplantation
pandemic