COVID-19 Pandemic and Worldwide Organ Procurement

COVID-19 Clinical Trial

— COVID  

Official title:

Consequences of the COVID-19 Pandemic on Worldwide Organ Procurement and Transplantation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04416256
• Other study ID #: COVID/W.W.
• Status: Recruiting
• Start date: February 1, 2020
• Est. completion date: February 2022

Study information

• Verified date: June 2020
• Source: Paris Translational Research Center for Organ Transplantation
• Contact: Alexandre Loupy
• Phone: +33 1 53 98 80 00
• Email: alexandre.loupy[@]inserm.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 230000
• Est. completion date: February 2022
• Est. primary completion date: February 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19

Locations

Country	Name	City	State
France	Paris Transplant Group	Paris

Sponsors (19)

Lead Sponsor

Collaborator

Paris Translational Research Center for Organ Transplantation

Agence de La Biomédecine, Australian Organ and Tissue Donation and Transplantation Authority, Austrotransplant, Autoridade Para Services de Sangue e Transplantacáo, Brazilian Organ Transplant Association, Centro Nacional de Trasplantes, Centro Nazionale Trapianti, Corporación Nacional de Trasplantes de Chile, Deutsche Stiftung Organtransplantation, Donor Network of Croatia, Eurotransplant, Instituto Nacional Central Único Coordinador de Ablación e Implante, Instituto Nacional de Donación y Trasplante de Células, Tejidos y Órganos, Nederlandse Transplantatie Vereniging, Organización Nacional de Trasplantes, Scandiatransplant, The Canadian Association of Transplantation, United Network for Organ Sharing

Country where clinical trial is conducted

France, 

References & Publications (11)

Ahn C, Amer H, Anglicheau D, Ascher N, Baan C, Bat-Ireedui B, Berney T, Betjes MGH, Bichu S, Birn H, Brennan D, Bromberg J, Caillard S, Cannon R, Cantarovich M, Chan A, Chen Z, Chapman JR, Cole EH, Cross N, Durand F, Egawa H, Emond J, Farrero M, Friend F, Geissler EK, Ha J, Haberal M, Henderson M, Hesselink DA, Humar A, Jassem W, Jeong JC, Kaplan B, Kee T, Kim SJ, Kumar D, Legendre C, 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 Apr 1. doi: 10.1097/TP.0000000000003258. [Epub ahead of print] — View Citation

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 Apr 24. doi: 10.1056/NEJMc2011117. [Epub ahead of print] — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Levin A, Tonelli M, Bonventre J, Coresh J, Donner JA, Fogo AB, Fox CS, Gansevoort RT, Heerspink HJL, Jardine M, Kasiske B, Köttgen A, Kretzler M, Levey AS, Luyckx VA, Mehta R, Moe O, Obrador G, Pannu N, Parikh CR, Perkovic V, Pollock C, Stenvinkel P, Tutt — View Citation

Livingston E, Bucher K. Coronavirus Disease 2019 (COVID-19) in Italy. JAMA. 2020 Mar 17. doi: 10.1001/jama.2020.4344. [Epub ahead of print] — View Citation

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. — View Citation

Omer SB, Malani P, Del Rio C. The COVID-19 Pandemic in the US: A Clinical Update. JAMA. 2020 Apr 6. doi: 10.1001/jama.2020.5788. [Epub ahead of print] — View Citation

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. — View Citation

Zhang X. Epidemiology of Covid-19. N Engl J Med. 2020 May 7;382(19):1869. doi: 10.1056/NEJMc2005157. Epub 2020 Mar 27. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Organ transplantation activity during COVID-19 pandemic	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.	Two years since COVID-19 outbreak.
Secondary	Further analysis on organ transplantation with stratification	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.	Two years since COVID-19 outbreak.