Clinical trial NCT04542954: Optimized Management of Covid-19 Positive Kidney Transplant Recipients: Single Center Experience From the Middle East
Official title: Renal Dysfunction Among Patients With Severe Acute Respiratory Syndrome Coronavirus 2 (Covid-19) Patients: Kuwait Experience
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Covid19
Kidney Transplant Infection
Risk Factor, Cardiovascular
Immunosuppression
Outcome, Fatal
Graft Failure
Lead sponsor: Hamid Al-Essa Organ Transplant Center
Sponsor class: OTHER_GOV
Collaborators: name: Ministry of Health, Kuwait
First posted: 2020-09-09
Enrollment: 104
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All Adult renal transplant patients infected with COVID-19 during the period of 6 months from 3.2020 till the end of 8.2020

Brief summary: Methods: Out of 2000 kidney transplant recipients in our center in Kuwait, collecting data was started for all COVID-19-positive kidney transplant recipients till August 2020. Clinical features, management details and both patient and graft outcomes were reported.

Detailed description: Before COVID-19 pandemic, nearly 2000 kidney transplant recipients were followed in our center in Kuwait. Data collection of such infected cases were started after diagnosing the 1st case during 1st week of March 2020. An ongoing study was performed that included 8 governmental acute care hospitals in Kuwait. All COVID-19-positive adult kidney transplant recipients with a functioning allograft who presented to the emergency department and were either discharged or hospitalized between March 1, 2020 and August 1, 2020 were included. Clinical features, management details and both patient and graft outcomes were reported. Data were collected from the electronic health record reporting database of both the mother transplant center and isolation hospitals.

Laboratory diagnosis:

COVID-19 positivity was defined as a positive result on real-time polymerase chain reaction (PCR) assay of nasopharyngeal swab specimens targeting the RNA-dependent RNA polymerase gene using amplification according to manufacturer's recommendation. Kidney transplant status was defined as an active International Statistical Classification of Diseases and Related Health Problems 10 code of T86.1, T86.10, T86.11, T86.12, T86.13, T86.19, or Z94.0. All electronic files were manually reviewed for demographics, history of recent exposure, immunosuppression changes, clinical signs and symptoms suggesting COVID-19, and laboratory findings with special stress on serum creatinine, liver function tests, D dimer, procalcitonin (PCT), C reactive protein and complete blood count. Acute kidney injury was graded according to Kidney Disease Improving Global Outcomes (KDIGO) criteria. AKI was staged for severity according to the following criteria: Stage 1 when creatinine was ranging between 1.5-\<2 folds of basal; stage 2 if the creatinine was ranging between 2-\<3folds and stage 3 if creatinine was more than 3 folds the basal. The study was approved by the ethical committee of ministry of health of Kuwait. Written informed consent was waived in light of the urgent need to collect data.

Radiological assessment:

The presence of a radiologic abnormality was determined on the basis of the documentation or description in medical charts of infected patients; if imaging scans were available, they were reviewed by attending physicians in respiratory medicine who extracted the data. If a major disagreement between two reviewers happened it was resolved by consultation with a third reviewer. The degree of severity of Covid-19 (severe vs. non-severe) at the time of admission will be defined using the American Thoracic Society guidelines for community-acquired pneumonia.7

Statistics:

Statistical analyses were conducted using SPSS version 20.0 (SPSS, Chicago, IL, USA). Qualitative data were presented as number and percent, and quantitative data were presented as means ± standard deviation and median. The t-test was used to compare means and standard deviations of the studied groups. Categorical data were compared using the chi-squared test. P values will be considered significant if \< 0.05.

Eligibility criteria: Inclusion Criteria:

* All renal transplant patients infected with COVID-19 during the period of 6 months from 3.2020 till the end of 8.2020

Exclusion Criteria:

* Pediatric patients

Primary outcomes:
measure: patient outcome
timeFrame: 30 days
measure: Kidney graft outcome
timeFrame: 30 days
Secondary outcomes:
measure: risk factors for getting COVID19 infection
timeFrame: 30 days
Other outcomes:
Locations:
city: Kuwait
country: Kuwait
facility: OTC, MOH , Kuwait
Study officials:
References: