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.

Trial Health

At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date

Enrollment

230,000

participants targeted

Target at P75+ for all trials

Timeline

Completed

Started Feb 2020

Geographic Reach

1 country

1 active site

Status

unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

2 years study duration

Study Start

First participant enrolled

February 1, 2020

Completed

4 months until next milestone

First Submitted

Initial submission to the registry

May 29, 2020

Completed

6 days until next milestone

First Posted

Study publicly available on registry

June 4, 2020

Completed

1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2022

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2022

Completed

Last Updated

June 4, 2020

Status Verified

June 1, 2020

Enrollment Period

2 years

First QC Date

May 29, 2020

Last Update Submit

June 3, 2020

Conditions

COVID-19

Keywords

organprocurementtransplantationpandemic

Outcome Measures

Primary Outcomes (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.
Two years since COVID-19 outbreak.