- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05926076
COVID-19 Infection
June 27, 2023 updated by: Yingxin FU.MD, Tianjin First Central Hospital
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.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
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 Type
Observational
Enrollment (Estimated)
610
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Yingxin Fu, MD
- Email: fuyingxin@vip.163.com
Study Contact Backup
- Name: Jianyong pan, MD
- Phone Number: 075561222333
- Email: panjianyong98@163.com
Study Locations
-
-
Guangdong
-
Shenzhen, Guangdong, China, 518000
- yingxin Fu
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Sampling Method
Non-Probability Sample
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.
Description
Inclusion Criteria:
Confirmed novel coronavirus infection between December 2022 to February 2023,
Exclusion Criteria:
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Kidney Transplant Recipients Group (KTR)
|
Patients with different diagnoses will get different treatment options
|
Non-Kidney Transplant Recipients Group(NKTR)
|
Patients with different diagnoses will get different treatment options
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
ICU admission or death
Time Frame: through study completion, an average of 1 month
|
patients have ICU admission or death
|
through study completion, an average of 1 month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
July 25, 2023
Primary Completion (Estimated)
July 30, 2023
Study Completion (Estimated)
July 30, 2023
Study Registration Dates
First Submitted
June 24, 2023
First Submitted That Met QC Criteria
June 27, 2023
First Posted (Actual)
July 3, 2023
Study Record Updates
Last Update Posted (Actual)
July 3, 2023
Last Update Submitted That Met QC Criteria
June 27, 2023
Last Verified
June 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2023-036-02
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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