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AzTrials

Covid19OMC-KTRNCT04542954

Optimized Management of Covid-19 Positive Kidney Transplant Recipients: Single Center Experience From the Middle East

An observational study of Covid19 and Kidney Transplant Infection, run by Hamid Al-Essa Organ Transplant Center at 1 site in Kuwait.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Any age
What is being tested?
Optimized Management of Covid-19 Positive Kidney Transplant Recipients: Single Center Experience from the Middle East
How many people
104 participants
Where
1 siteKuwait
Study dates
1 Mar 2020to 31 Aug 2020
How long will I take part?
30 Days
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 Any age
  • Child, Adult, Older adult

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

Who may be able to join

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

Who cannot join

  • Pediatric patients

Trial locations and contacts

1 site in 1 country.

Kuwait1 site
  • OTC, MOH , Kuwait

    Kuwait City, Kuwait

Other trials in Kuwait

About this study

Official title: Renal Dysfunction Among Patients With Severe Acute Respiratory Syndrome Coronavirus 2 (Covid-19) Patients: Kuwait Experience

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.

Read the 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.

Being tested
Optimized Management of Covid-19 Positive Kidney Transplant Recipients: Single Center Experience from the Middle East
Medical subject headings
COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Optimized Management of Covid-19 Positive Kidney Transplant Recipients: Single Center Experience from the Middle EastOther

    Optimized Management of Covid-19 Positive Kidney Transplant Recipients: Single Center Experience from the Middle East

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. patient outcome

    living patients (1), dead patients(2) during the study period

    Measured: 30 days

  2. Kidney graft outcome

    functioning graft(1), failed graft(2) and impaired graft(3) at the end of the study

    Measured: 30 days

Secondary outcomes (1)
  1. risk factors for getting COVID19 infection

    Diabetes(=!), IHD(=1), Hypertension(=1),pulmonary diseases(=1)

    Measured: 30 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Sep 2020
  2. Study start1 Mar 2020
  3. Primary completion31 Aug 2020
  4. Study completion31 Aug 2020

Resources

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
Cohort
Time perspective
Other
Enrolment
104 participants (actual)
Target duration
30 Days
IDs, dates and publications
ClinicalTrials.gov ID
NCT04542954
Sponsor's protocol ID
2020/1481
Acronym
OMC-KTR
Status last verified
Sep 2020
First submitted
7 Sep 2020
Last updated
9 Sep 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Covid19 and Kidney Transplant Infection, run by Hamid Al-Essa Organ Transplant Center at 1 site in Kuwait.

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: finished, as of the sponsor's last update on 9 Sep 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 Kuwait. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

patient outcome (time frame: 30 days). The study lists 2 primary outcomes in all. 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 9 Sep 2020.

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