COVID-19NCT05926076
COVID-19 Infection
An observational study of COVID-19 and Renal Transplant Infection, run by Tianjin First Central Hospital at 1 site in China.
Trial summary
Post-transplant patients with COVID-19 infection who attended Shenzhen No. 3 Hospital from December 2022 to February 2023, and enrolled the general population with COVID-19 infection who were hospitalized during the same period, matched by age and gender. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- COVID-19, Renal Transplant Infection
- What is being tested?
- Treatment plan
- How many people
- 610 participants
- Where
- 1 siteChina
- Study dates
- 25 Jul 2023to 30 Jul 2023
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: post-transplant patients with COVID-19 infection who attended Shenzhen No. 3 Hospital from December 2022 to February 2023, and enrolled the general population with COVID-19 infection who were hospitalized during the same period, matched by age and gender.
Who may be able to join
- Confirmed novel coronavirus infection between December 2022 to February 2023,
Who cannot join
- Age less than 18; failure of the transplanted kidney before the new coronavirus infection; exclusion of oral immunosuppressed and other types of organ transplant recipients from the non-renal transplant population
Trial locations and contacts
1 site in 1 country.
Yingxin Fu, MD contact
About this study
Official title: Comparative Study of COVID-19 Infection in Renal Transplant Recipients and Non Transplant Recipients
Post-transplant patients with COVID-19 infection who attended Shenzhen No. 3 Hospital from December 2022 to February 2023, and enrolled the general population with COVID-19 infection who were hospitalized during the same period, matched by age and gender.
Read the detailed description
Data collection：Age, BMI, underlying comorbidities and other basic information were collected retrospectively from the two groups. The medical records were used to collect information about the patients' new coronavirus infection, such as the time of onset of symptoms, time of diagnosis, time of conversion and common symptoms such as fever, cough, nasal congestion and runny nose, muscle aches and pains.To compare the differences of the diagnosis and treatment of KTRs and the general population infected with Omicron
- Conditions
- COVID-19, Renal Transplant Infection
- Being tested
- Treatment plan
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treatment planOther
Patients with different diagnoses will get different treatment options
| Study group | Role | What they receive |
|---|---|---|
| Kidney Transplant Recipients Group (KTR) | Not described Receives: Other: Treatment plan | |
| Non-Kidney Transplant Recipients Group（NKTR） | Not described Receives: Other: Treatment plan |
What is being measured
The primary outcome is the main question the study is designed to answer.
ICU admission or death
patients have ICU admission or death
Measured: through study completion, an average of 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2023
- Study start25 Jul 2023 (estimated)
- Primary completion30 Jul 2023 (estimated)
- Study completion30 Jul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- 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-control
- Time perspective
- Retrospective
- Enrolment
- 610 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tianjin First Central Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Shenzhen Third People's Hospital
- Responsible party
- Principal investigator, Yingxin FU.MD, Tianjin First Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05926076
- Sponsor's protocol ID
- 2023-036-02
- Status last verified
- Jun 2023
- First submitted
- 24 Jun 2023
- Last updated
- 3 Jul 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study of COVID-19 Infection in Renal Transplant Recipients and Non Transplant Recipients
- ClinicalTrials.gov ID
- NCT05926076
- Acronym / sponsor ID
- 2023-036-02
- Conditions
- COVID-19, Renal Transplant Infection
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 610 participants (estimated)
- Lead sponsor
- Tianjin First Central HospitalUniversity, hospital or other
- Collaborators
- Shenzhen Third People's Hospital
- Study start
- 25 Jul 2023 (estimated)
- Primary completion
- 30 Jul 2023 (estimated)
- Study completion
- 30 Jul 2023 (estimated)
- First posted
- 3 Jul 2023 (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.
Post-transplant patients with COVID-19 infection who attended Shenzhen No. 3 Hospital from December 2022 to February 2023, and enrolled the general population with COVID-19 infection who were hospitalized during the same period, matched by age and gender.
Detailed description
Data collection：Age, BMI, underlying comorbidities and other basic information were collected retrospectively from the two groups. The medical records were used to collect information about the patients' new coronavirus infection, such as the time of onset of symptoms, time of diagnosis, time of conversion and common symptoms such as fever, cough, nasal congestion and runny nose, muscle aches and pains.To compare the differences of the diagnosis and treatment of KTRs and the general population infected with Omicron
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Kidney Transplant Recipients Group (KTR) | – | Other: Treatment plan |
| Non-Kidney Transplant Recipients Group（NKTR） | – | Other: Treatment plan |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- post-transplant patients with COVID-19 infection who attended Shenzhen No. 3 Hospital from December 2022 to February 2023, and enrolled the general population with COVID-19 infection who were hospitalized during the same period, matched by age and gender.
Key inclusion criteria (1 listed)
- Confirmed novel coronavirus infection between December 2022 to February 2023,
Key exclusion criteria (1 listed)
- Age less than 18; failure of the transplanted kidney before the new coronavirus infection; exclusion of oral immunosuppressed and other types of organ transplant recipients from the non-renal transplant population
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 |
|---|---|---|
| Treatment planPatients with different diagnoses will get different treatment options | Other | Kidney Transplant Recipients Group (KTR), Non-Kidney Transplant Recipients Group（NKTR） |
Primary outcome
ICU admission or death
Time frame: through study completion, an average of 1 month
patients have ICU admission or death
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2023.
- Individual participant dataSharing planned: No
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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.
Yingxin Fu, MD contact
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 and Renal Transplant Infection, run by Tianjin First Central Hospital at 1 site in China.
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 3 Jul 2023. 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 China. 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 Yingxin Fu, MD (fuyingxin@vip.163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ICU admission or death (time frame: through study completion, an average of 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Jul 2023.