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COVID-19COVIDNCT04416256

COVID-19 Pandemic and Worldwide Organ Procurement

An observational study of COVID-19, run by Paris Translational Research Center for Organ Transplantation at 1 site in France.

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 The sponsor has not verified this record for over two years, so it may be out of date.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

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. Read more about this study

Who is it for?
Any age
Conditions the study is for
COVID-19
How many people
230,000 participants
Where
1 siteFrance
Study dates
1 Feb 2020to Feb 2022
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 Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

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)

Who may be able to join

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

Who cannot join

  • None

Trial locations and contacts

1 site in 1 country.

France1 site, 1 recruiting
  • Paris Transplant Group

    Paris, 75015

    Alexandre Loupy, +33 1 53 98 80 00, alexandre.loupy@inserm.fr

    Alexandre Loupy, MD

    Recruiting

Other trials in France

About this study

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

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.

Conditions
COVID-19
Keywords
organ, procurement, transplantation, pandemic
Medical subject headings
COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT04416256
Study groupRoleWhat they receive
FranceAll organs procured for transplantation and transplanted during the observation period. These include kidney, lung, liver, heart, and combined transplantations.
SpainAll organs procured for transplantation and transplanted during the observation period. These include kidney, lung, liver, heart, and combined transplantations.
PortugalAll organs procured for transplantation and transplanted during the observation period. These include kidney, lung, liver, heart, and combined transplantations.
CroatiaAll organs procured for transplantation and transplanted during the observation period. These include kidney, lung, liver, heart, and combined transplantations.
GermanyAll organs procured for transplantation and transplanted during the observation period. These include kidney, lung, liver, heart, and combined transplantations.
ItalyAll organs procured for transplantation and transplanted during the observation period. These include kidney, lung, liver, heart, and combined transplantations.
NetherlandsAll organs procured for transplantation and transplanted during the observation period. These include kidney, lung, liver, heart, and combined transplantations.
AustriaAll organs procured for transplantation and transplanted during the observation period. These include kidney, lung, liver, heart, and combined transplantations.
USAll organs procured for transplantation and transplanted during the observation period. These include kidney, lung, liver, heart, and combined transplantations.
CanadaAll organs procured for transplantation and transplanted during the observation period. These include kidney, lung, liver, heart, and combined transplantations.
MexicoAll organs procured for transplantation and transplanted during the observation period. These include kidney, lung, liver, heart, and combined transplantations.
BrazilAll organs procured for transplantation and transplanted during the observation period. These include kidney, lung, liver, heart, and combined transplantations.
UruguayAll organs procured for transplantation and transplanted during the observation period. These include kidney, lung, liver, heart, and combined transplantations.
ArgentinaAll organs procured for transplantation and transplanted during the observation period. These include kidney, lung, liver, heart, and combined transplantations.
ChileAll organs procured for transplantation and transplanted during the observation period. These include kidney, lung, liver, heart, and combined transplantations.
AustraliaAll organs procured for transplantation and transplanted during the observation period. These include kidney, lung, liver, heart, and combined transplantations.
BelgiumAll organs procured for transplantation and transplanted during the observation period. These include kidney, lung, liver, heart, and combined transplantations.
FinlandAll organs procured for transplantation and transplanted during the observation period. These include kidney, lung, liver, heart, and combined transplantations.

What is being measured

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

  1. 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.

    Measured: Two years since COVID-19 outbreak.

Secondary outcomes (1)
  1. 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.

    Measured: Two years since COVID-19 outbreak.

Timeline

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

  1. First posted4 Jun 2020
  2. Study start1 Feb 2020
  3. Primary completionFeb 2022 (estimated)
  4. Study completionFeb 2022 (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
230,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04416256
Sponsor's protocol ID
COVID/W.W.
Acronym
COVID
Status last verified
Jun 2020
First submitted
29 May 2020
Last updated
4 Jun 2020
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 32087115
  • 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.

    PubMed 32164834
  • 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.

    PubMed 32243281
  • 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.

    PubMed 32220200
  • 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.

    PubMed 32305079
  • 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.

    PubMed 32329975
  • 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.

    PubMed 32354635
  • 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.

    PubMed 32181795
  • 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.

    PubMed 32250388
  • 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.

    PubMed 32087114
  • 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.

    PubMed 28434650
  • 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.

    PubMed 34474014

Questions about this trial

What is this clinical trial studying?

An observational study of COVID-19, run by Paris Translational Research Center for Organ Transplantation at 1 site in France.

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 1 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 4 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. 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 Alexandre Loupy (+33 1 53 98 80 00, alexandre.loupy@inserm.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Organ transplantation activity during COVID-19 pandemic (time frame: Two years since COVID-19 outbreak.). 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 NCT04416256, which also lists 12 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 4 Jun 2020; AzTrials last refreshed its copy on 6 Nov 2026.

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