Covid19 Clinical Trial
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.
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.
;
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT05047692 -
Safety and Immunogenicity Study of AdCLD-CoV19-1: A COVID-19 Preventive Vaccine in Healthy Volunteers
|
Phase 1 | |
Recruiting |
NCT04395768 -
International ALLIANCE Study of Therapies to Prevent Progression of COVID-19
|
Phase 2 | |
Completed |
NCT04506268 -
COVID-19 SAFE Enrollment
|
N/A | |
Terminated |
NCT04555096 -
A Trial of GC4419 in Patients With Critical Illness Due to COVID-19
|
Phase 2 | |
Completed |
NCT04508777 -
COVID SAFE: COVID-19 Screening Assessment for Exposure
|
||
Completed |
NCT04961541 -
Evaluation of the Safety and Immunogenicity of Influenza and COVID-19 Combination Vaccine
|
Phase 1/Phase 2 | |
Active, not recruiting |
NCT04546737 -
Study of Morphological, Spectral and Metabolic Manifestations of Neurological Complications in Covid-19 Patients
|
N/A | |
Completed |
NCT04494646 -
BARCONA: A Study of Effects of Bardoxolone Methyl in Participants With SARS-Corona Virus-2 (COVID-19)
|
Phase 2 | |
Not yet recruiting |
NCT04543006 -
Persistence of Neutralizing Antibodies 6 and 12 Months After a Covid-19
|
N/A | |
Terminated |
NCT04542993 -
Can SARS-CoV-2 Viral Load and COVID-19 Disease Severity be Reduced by Resveratrol-assisted Zinc Therapy
|
Phase 2 | |
Completed |
NCT04532294 -
Safety, Tolerability, Pharmacokinetics, and Immunogenicity of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2/COVID-19) Neutralizing Antibody in Healthy Participants
|
Phase 1 | |
Terminated |
NCT04581915 -
PHRU CoV01 A Trial of Triazavirin (TZV) for the Treatment of Mild-moderate COVID-19
|
Phase 2/Phase 3 | |
Completed |
NCT04537663 -
Prevention Of Respiratory Tract Infection And Covid-19 Through BCG Vaccination In Vulnerable Older Adults
|
Phase 4 | |
Not yet recruiting |
NCT04527211 -
Effectiveness and Safety of Ivermectin for the Prevention of Covid-19 Infection in Colombian Health Personnel
|
Phase 3 | |
Completed |
NCT04387292 -
Ocular Sequelae of Patients Hospitalized for Respiratory Failure During the COVID-19 Epidemic
|
N/A | |
Completed |
NCT04507867 -
Effect of a NSS to Reduce Complications in Patients With Covid-19 and Comorbidities in Stage III
|
N/A | |
Not yet recruiting |
NCT05038449 -
Study to Evaluate the Efficacy and Safety of Colchicine Tablets in Patients With COVID-19
|
N/A | |
Completed |
NCT04979858 -
Reducing Spread of COVID-19 in a University Community Setting: Role of a Low-Cost Reusable Form-Fitting Fabric Mask
|
N/A | |
Completed |
NCT04610502 -
Efficacy and Safety of Two Hyperimmune Equine Anti Sars-CoV-2 Serum in COVID-19 Patients
|
Phase 2 | |
Active, not recruiting |
NCT06042855 -
ACTIV-6: COVID-19 Study of Repurposed Medications - Arm G (Metformin)
|
Phase 3 |