SARS-CoV-2TX-COVIDNCT04360707
Solid Organ Transplant Recipients With SARS-CoV-2 French Registry
An observational study of SARS-CoV-2, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
Patients with comorbid condition are known to be at high risk of severe forms of Covid-19. It is highly probable that immunocompromised patients like solid organ transplant (SOT) recipients are also at risk of severe forms of Covid-19. Read more about this study
- Who is it for?
- Ages 1 year and older
- Conditions the study is for
- SARS-CoV-2
- How many people
- 300 participants
- Where
- 1 siteFrance
- Study dates
- 8 Apr 2020to 8 Apr 2021
- 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 1 year and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All Solid Organ Transplant recipients with a functioning graft and a high suspicion or a confirmed SARS-CoV-2 infection
Who may be able to join
- All Solid Organ Transplant recipients with a functioning graft and a high suspicion or a confirmed SARS-CoV-2 infection
- Adult and pediatric
Who cannot join
- There are no exclusion criteria, except for the patient's explicit refusal to participate
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Service de Néphrologie et Transplantation
Strasbourg, 67091
Sophie CAILLARD, MD, PhD, 33 3 69 55 13 20, sophie.caillard@chru-strasbourg.fr
Samira FAFI-KREMER, MD, PhD, 33 3 69 55 14 38, samira.fafi-kremer@chru-strasbourg.fr
About this study
Official title: Clinical Presentation and Incidence of SARS-CoV-2 Infection in Different Cohorts of Solid Organ Transplant Patients and Follow-up in France
Patients with comorbid condition are known to be at high risk of severe forms of Covid-19. It is highly probable that immunocompromised patients like solid organ transplant (SOT) recipients are also at risk of severe forms of Covid-19. For this purpose, The investigators conducted a nationwide multicentric and multiorgan Registry to collect data about all French SOT recipients who develop a SARS-CoV-2 infection. The aim is to describe the clinical, biological and virological characteristics of these patients and to give information about evolution and prognosis of these particular population
- Conditions
- SARS-CoV-2
- Keywords
- SARS-CoV-2, Covid-19, Solid Organ transplantation, Incidence, Prognosis, Cellular response, Humoral Response
- Medical subject headings
- COVID-19
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Presentation and Incidence of Covid-19 Infection in Different Cohorts of Solid Organ Transplant Patients
Measured: From 1st March 2020 to 1st March 2021
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2020
- Study start8 Apr 2020
- Primary completion8 Apr 2021 (estimated)
- Study completion8 Apr 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SARS-CoV-2Studies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sophie CAILLARD, MD, PhD, Study director, Service de Néphrologie et Transplantation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04360707
- Sponsor's protocol ID
- 7766
- Acronym
- TX-COVID
- Status last verified
- Apr 2020
- First submitted
- 22 Apr 2020
- Last updated
- 5 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Gerard AO, Barbosa S, Anglicheau D, Couzi L, Hazzan M, Thaunat O, Blancho G, Caillard S, Sicard A; French SOT COVID Registry. Association Between Maintenance Immunosuppressive Regimens and COVID-19 Mortality in Kidney Transplant Recipients. Transplantation. 2022 Oct 1;106(10):2063-2067. doi: 10.1097/TP.0000000000004254. Epub 2022 Jul 27.
PubMed 35883236
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Presentation and Incidence of SARS-CoV-2 Infection in Different Cohorts of Solid Organ Transplant Patients and Follow-up in France
- ClinicalTrials.gov ID
- NCT04360707
- Acronym / sponsor ID
- TX-COVID / 7766
- Conditions
- SARS-CoV-2
- Keywords
- SARS-CoV-2, Covid-19, Solid Organ transplantation, Incidence, Prognosis, Cellular response, Humoral Response
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 8 Apr 2020 (actual)
- Primary completion
- 8 Apr 2021 (estimated)
- Study completion
- 8 Apr 2021 (estimated)
- First posted
- 24 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.
Patients with comorbid condition are known to be at high risk of severe forms of Covid-19. It is highly probable that immunocompromised patients like solid organ transplant (SOT) recipients are also at risk of severe forms of Covid-19. For this purpose, The investigators conducted a nationwide multicentric and multiorgan Registry to collect data about all French SOT recipients who develop a SARS-CoV-2 infection. The aim is to describe the clinical, biological and virological characteristics of these patients and to give information about evolution and prognosis of these particular population
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 year and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All Solid Organ Transplant recipients with a functioning graft and a high suspicion or a confirmed SARS-CoV-2 infection
Key inclusion criteria (2 listed)
- All Solid Organ Transplant recipients with a functioning graft and a high suspicion or a confirmed SARS-CoV-2 infection
- Adult and pediatric
Key exclusion criteria (1 listed)
- There are no exclusion criteria, except for the patient's explicit refusal to participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Clinical Presentation and Incidence of Covid-19 Infection in Different Cohorts of Solid Organ Transplant Patients
Time frame: From 1st March 2020 to 1st March 2021
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2020.
- Derived from this study: PubMed 35883236Gerard AO, Barbosa S, Anglicheau D, Couzi L, Hazzan M, Thaunat O, Blancho G, Caillard S, Sicard A; French SOT COVID Registry. Association Between Maintenance Immunosuppressive Regimens and COVID-19 Mortality in Kidney Transplant Recipients. Transplantation. 2022 Oct 1;106(10):2063-2067. doi: 10.1097/TP.0000000000004254. Epub 2022 Jul 27.
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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.
Sophie CAILLARD, MD, PhD study director
Service de Néphrologie et Transplantation
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 SARS-CoV-2, run by University Hospital, Strasbourg, France 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 2 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 5 May 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 Sophie CAILLARD, MD, PhD (33 3 69 55 13 20, sophie.caillard@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Presentation and Incidence of Covid-19 Infection in Different Cohorts of Solid Organ Transplant Patients (time frame: From 1st March 2020 to 1st March 2021). 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 NCT04360707, which also lists 1 linked publication.
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 5 May 2020.