COVID-19 OUTBREAK AND SOLID ORGAN TRANSPLANTATIONNCT04367896
COVID-19 OUTBREAK AND SOLID ORGAN TRANSPLANTATION (SOT) : AN INTERNATIONAL WEB-BASED SURVEY
An observational study of COVID-19 OUTBREAK AND SOLID ORGAN TRANSPLANTATION, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
Trial summary
Background COVID-19 has brought into questioning the equitable distribution of resources. Solid Organ Transplants (SOT) are life-saving procedures. Rapid changes in the management of patients are occurring, with potential for inequity. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- COVID-19 OUTBREAK AND SOLID ORGAN TRANSPLANTATION
- What is being tested?
- Survey Group
- How many people
- 1,819 participants
- Where
- 1 siteItaly
- Study dates
- 24 Mar 2020to 17 Apr 2020
- 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
- Child, Adult, Older adult
Study population: Country macro regions, subspecilaties and organ of interest
Who may be able to join
- transplant surgeons, referring doctors, transplant physicians, transplant coordinators, transplant ICU doctors, COVID-19 ICU, Infectious Disease Doctors, Pulmonologists, Internist, and Ethicists
Who cannot join
- not applicable
Trial locations and contacts
1 site in 1 country.
About this study
Background COVID-19 has brought into questioning the equitable distribution of resources. Solid Organ Transplants (SOT) are life-saving procedures. Rapid changes in the management of patients are occurring, with potential for inequity. Drawing on professionals across transplant specialities, we investigated resource distribution specifically for SOT to guide healthcare policies.
A multidisciplinary team developed a survey. The survey included demographic questions to contextualise respondents, questions on resource allocation for SOT. Multiple strategies were used to distribute the survey internationally. Descriptive, uni-multivariate ordinal regressions analysis were performed. Open comments were analysed using qualitative methods.
- Being tested
- Survey Group
- Keywords
- COVID-19, Solid Organ Transplantation
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Survey GroupOther
The survey sought to elucidate equity principles that are influencing transplant decision making. The group of respondents included solid organ transplant doctors (surgeons, referring doctors, transplant physicians, transplant coordinators, ICU transplant doctors), COVID-doctors (ICU doctors, Infectious Disease Doctors, Pulmonologists, Internists), and Ethicists with experience of transplant related issues.
Respondent identification:
- The e-mail addresses of corresponding authors from Scopus January 1, 2017 and march 20, 2020:
All ("surgery") AND subj ("medi") and key ("transplantation"), All ("critical care") AND subj ("medi") and key ("transplantation"), All ("ethics") AND subj ("medi") and key ("transplantation"). B. Emailing through the mailing list of scientific societies. C. The link to the survey published online. D. The link to the survey circulated through personal contacts and via social media sites.
What is being measured
The primary outcome is the main question the study is designed to answer.
Management of Solid Organ Transplant during COVID-19 pandemic
Question 1"Given the COVID-19 outbreak, should liver transplant activities be stopped?" with three possible answers (Completely, Selectively and Not at All)
Measured: 20/04/2020
Equity of resource distribution
Question 2"I feel that the current policy to allocate most resources to COVID-19 meets the equity of access in healthcare for different diseases" with four possible alternative answers (strongly agree, partially agree, partially disagree and strongly disagree).
Measured: 20/04/2020
Secondary outcomes (1)
Equity rank of resource distribution
Scale (10 strongly agree- 0 strongly disagree).
Measured: 20/04/2020
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2020
- Study start24 Mar 2020
- Primary completion17 Apr 2020
- Study completion17 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for COVID-19 OUTBREAK AND SOLID ORGAN TRANSPLANTATIONStudies of the same condition, open and under way.
- More trials run by Fondazione Policlinico Universitario Agostino Gemelli IRCCSThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Other
- Time perspective
- Prospective
- Enrolment
- 1,819 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04367896
- Sponsor's protocol ID
- Covid-19_V1
- Status last verified
- Apr 2020
- First submitted
- 27 Apr 2020
- Last updated
- 29 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ritschl PV, Nevermann N, Wiering L, Wu HH, Moroder P, Brandl A, Hillebrandt K, Tacke F, Friedersdorff F, Schlomm T, Schoning W, Ollinger R, Schmelzle M, Pratschke J. Solid organ transplantation programs facing lack of empiric evidence in the COVID-19 pandemic: A By-proxy Society Recommendation Consensus approach. Am J Transplant. 2020 Jul;20(7):1826-1836. doi: 10.1111/ajt.15933. Epub 2020 May 10.
PubMed 32323460The Lancet. India under COVID-19 lockdown. Lancet. 2020 Apr 25;395(10233):1315. doi: 10.1016/S0140-6736(20)30938-7. No abstract available.
PubMed 32334687Redelmeier DA, Shafir E. Pitfalls of judgment during the COVID-19 pandemic. Lancet Public Health. 2020 Jun;5(6):e306-e308. doi: 10.1016/S2468-2667(20)30096-7. Epub 2020 Apr 23. No abstract available.
PubMed 32334647Leon DA, Shkolnikov VM, Smeeth L, Magnus P, Pechholdova M, Jarvis CI. COVID-19: a need for real-time monitoring of weekly excess deaths. Lancet. 2020 May 2;395(10234):e81. doi: 10.1016/S0140-6736(20)30933-8. Epub 2020 Apr 22. No abstract available.
PubMed 32333839
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COVID-19 OUTBREAK AND SOLID ORGAN TRANSPLANTATION (SOT) : AN INTERNATIONAL WEB-BASED SURVEY
- ClinicalTrials.gov ID
- NCT04367896
- Acronym / sponsor ID
- Covid-19_V1
- Keywords
- COVID-19, Solid Organ Transplantation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,819 participants (actual)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 24 Mar 2020 (actual)
- Primary completion
- 17 Apr 2020 (actual)
- Study completion
- 17 Apr 2020 (actual)
- First posted
- 29 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background COVID-19 has brought into questioning the equitable distribution of resources. Solid Organ Transplants (SOT) are life-saving procedures. Rapid changes in the management of patients are occurring, with potential for inequity. Drawing on professionals across transplant specialities, we investigated resource distribution specifically for SOT to guide healthcare policies.
A multidisciplinary team developed a survey. The survey included demographic questions to contextualise respondents, questions on resource allocation for SOT. Multiple strategies were used to distribute the survey internationally. Descriptive, uni-multivariate ordinal regressions analysis were performed. Open comments were analysed using qualitative methods.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Age groups
- Child, Adult, Older adult
- Study population
- Country macro regions, subspecilaties and organ of interest
Key inclusion criteria (1 listed)
- transplant surgeons, referring doctors, transplant physicians, transplant coordinators, transplant ICU doctors, COVID-19 ICU, Infectious Disease Doctors, Pulmonologists, Internist, and Ethicists
Key exclusion criteria (1 listed)
- not applicable
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Survey GroupThe survey sought to elucidate equity principles that are influencing transplant decision making. The group of respondents included solid organ transplant doctors (surgeons, referring doctors, transplant physicians, transplant coordinators, ICU transplant doctors), COVID-doctors (ICU doctors, Infectious Disease Doctors, Pulmonologists, Internists), and Ethicists with experience of transplant related issues. Respondent identification: A. The e-mail addresses of corresponding authors from Scopus January 1, 2017 and march 20, 2020: All ("surgery") AND subj ("medi") and key ("transplantation"), All ("critical care") AND subj ("medi") and key ("transplantation"), All ("ethics") AND subj ("medi") and key ("transplantation"). B. Emailing through the mailing list of scientific societies. C. The link to the survey published online. D. The link to the survey circulated through personal contacts and via social media sites. | Other | – |
Primary outcome
Management of Solid Organ Transplant during COVID-19 pandemic
Time frame: 20/04/2020
Question 1"Given the COVID-19 outbreak, should liver transplant activities be stopped?" with three possible answers (Completely, Selectively and Not at All)
Equity of resource distribution
Time frame: 20/04/2020
Question 2"I feel that the current policy to allocate most resources to COVID-19 meets the equity of access in healthcare for different diseases" with four possible alternative answers (strongly agree, partially agree, partially disagree and strongly disagree).
1 secondary outcome
Equity rank of resource distribution
Time frame: 20/04/2020
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2020.
- Results publication: PubMed 32323460Ritschl PV, Nevermann N, Wiering L, Wu HH, Moroder P, Brandl A, Hillebrandt K, Tacke F, Friedersdorff F, Schlomm T, Schoning W, Ollinger R, Schmelzle M, Pratschke J. Solid organ transplantation programs facing lack of empiric evidence in the COVID-19 pandemic: A By-proxy Society Recommendation Consensus approach. Am J Transplant. 2020 Jul;20(7):1826-1836. doi: 10.1111/ajt.15933. Epub 2020 May 10.
- Results publication: PubMed 32334687The Lancet. India under COVID-19 lockdown. Lancet. 2020 Apr 25;395(10233):1315. doi: 10.1016/S0140-6736(20)30938-7. No abstract available.
- Results publication: PubMed 32334647Redelmeier DA, Shafir E. Pitfalls of judgment during the COVID-19 pandemic. Lancet Public Health. 2020 Jun;5(6):e306-e308. doi: 10.1016/S2468-2667(20)30096-7. Epub 2020 Apr 23. No abstract available.
- Results publication: PubMed 32333839Leon DA, Shkolnikov VM, Smeeth L, Magnus P, Pechholdova M, Jarvis CI. COVID-19: a need for real-time monitoring of weekly excess deaths. Lancet. 2020 May 2;395(10234):e81. doi: 10.1016/S0140-6736(20)30933-8. Epub 2020 Apr 22. No abstract available.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19 OUTBREAK AND SOLID ORGAN TRANSPLANTATION, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
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: finished, as of the sponsor's last update on 29 Apr 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 Italy. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Management of Solid Organ Transplant during COVID-19 pandemic (time frame: 20/04/2020). The study lists 2 primary outcomes in all. 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 NCT04367896, which also lists 4 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 29 Apr 2020.