COVID-19 Infection

• Sponsor: Tianjin First Central Hospital (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05926076
• Collaborator: Shenzhen Third People's Hospital (Other)
• Enrollment: 610
• Location: 1
• Anticipated Duration (Days): 5
• Patients Per Site Per Month: 3713.4

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
COVID-19; Renal Transplant Infection	Other: Treatment plan

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

• Study Type: Observational
• Anticipated Enrollment: 610 participants
• Observational Model: Case-Control
• Time Perspective: Retrospective
• Official Title: Comparative Study of COVID-19 Infection in Renal Transplant Recipients and Non Transplant Recipients
• Anticipated Study Start Date: Jul 25, 2023
• Anticipated Primary Completion Date: Jul 30, 2023
• Anticipated Study Completion Date: Jul 30, 2023

Arms and Interventions

Arm	Intervention/Treatment
Kidney Transplant Recipients Group (KTR)	Other: Treatment plan; Patients with different diagnoses will get different treatment options
Non-Kidney Transplant Recipients Group（NKTR）	Other: Treatment plan; Patients with different diagnoses will get different treatment options

Outcome Measures

Primary Outcome Measures

1. ICU admission or death [through study completion, an average of 1 month]

   patients have ICU admission or death

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	yingxin Fu	Shenzhen	Guangdong	China	518000

Sponsors and Collaborators

• Tianjin First Central Hospital
• Shenzhen Third People's Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Yingxin FU.MD, Head of department, Tianjin First Central Hospital
• ClinicalTrials.gov Identifier: NCT05926076
• Other Study ID Numbers: 2023-036-02
• First Posted: Jul 3, 2023
• Last Update Posted: Jul 3, 2023
• Last Verified: Jun 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Infections; Communicable Diseases; COVID-19

Study Results

No Results Posted as of Jul 3, 2023