Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT04484597 |
| Other study ID # |
Prof. Refat Sadeq |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
March 15, 2020 |
| Est. completion date |
September 15, 2020 |
Study information
| Verified date |
July 2020 |
| Source |
Port Said University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
Clinical Picture: Symptomatic COVID-19 presents with a recognizable clinical syndrome that is
predictable prior to testing. Clinical judgement remains important, particularly when
interpreting negative test results; 2. Biomarkers Associated with COVID-19 Patients: The most
common laboratory features reported in patients with COVID-19
Description:
The COVID-19 pandemic put tremendous pressures on the public health system and the health
workers in almost every country around the world. Egypt was no exception, one of the main
challenges faced is the limited number of CPR centers, equipment and kits which consequently
affecting the number of tests that could be performed.
Although testing is critical, clinical judgement is the first mean to evaluate patients for
COVID-19. Ancillary Diagnostic Tests and Chest imaging are also important tools before
proceeding to the PCR testing. However, important gaps remain in screening asymptomatic
persons in the incubation phase, as well as in the accurate determination of live viral
shedding during convalescence to inform decisions to end isolation. The main objectives of
the study: To set an evidence-based protocol with some criteria and procedures to reach - as
accurate as possible - diagnosis without compromising the limited available resources. Such
protocol shall make full use of the three main traditional pillars: Clinical picture,
Ancillary Diagnostic Tests and Chest imaging before proceeding to the PCR testing:
1. Clinical Picture: Symptomatic COVID-19 presents with a recognizable clinical syndrome
that is predictable prior to testing. Clinical judgement remains important, particularly
when interpreting negative test results;
2. Biomarkers Associated with COVID-19 Patients: The most common laboratory features
reported in patients with COVID-19 include: • Decreased albumin; • Elevated C-reactive
protein ; • Elevated lactate dehydrogenase levels ; and • Lymphopenia .
3. Other biomarkers that have been reported include increased erythrocyte sedimentation
rates; elevated aspartate aminotransferase, alanine aminotransferase, and creatine
kinase levels, leukopenia, leukocytosis, increased bilirubin and creatinine levels. No
biomarker or combination of biomarkers currently exists that is sensitive or specific
enough to establish a diagnosis of COVID-19, or to pragmatically predict its clinical
course.
4. Radiographic Tests: Many centers have evaluated the utility of chest imaging for
diagnosis: • On chest radiography, bilateral pneumonia is the most frequently reported
feature (range,11.8% to 100%) and is more common than a unilateral focus; • Computed
tomography is regarded as more sensitive than radiography, with several cohort studies
reporting that most patients (77.8% to 100%) had ground glass opacities. Other features
commonly reported with COVID-19 on chest computed tomography include a peripheral
distribution, fine reticular opacities, and vascular thickening. Compared with serial
nasopharyngeal sampling, chest computed tomography may be more sensitive than an RT-PCR
test at a single time point for the diagnosis of COVID-19. In addition, artificial
intelligence may help distinguish COVID-19 from other etiologic agents of
community-acquired pneumonia. However, these findings are not completely specific to
COVID-19 and do not exclude a co-infection or an alternative diagnosis.
CPR: Who Should Be Tested? The current situation exemplifies the challenge of how to best
utilize testing during outbreaks of novel pathogens. The initial testing criteria were too
narrow to monitor and control the spread of the disease, but the sudden pivot to a far
broader testing approach, even as capacity remains limited, may be an overcorrection. As of
March 4, CDC discontinued specific guidance and recommends that "clinicians should use their
judgment to determine if a patient has signs and symptoms compatible with COVID-19 and
whether the patient should be tested," advising that "decisions on which patients receive
testing should be based on the local epidemiology of COVID-19, as well as the clinical course
of illness." High priorities for testing include patients with serious, unexplained
respiratory illness and contacts of known cases, Methods: It is a comparative study between
tests to diagnose COVID-19. In developed countries (in which Egypt is one of them) PCR is
high cost. Though much of cases escape Diagnosis and clinician depend on clinical picture
only. This study would allow to find what degree of dependence on other tests. In this study,
100 cases positive COVID-19 by PCR will be analyzed and tested for other ancillary tests and
CT chest to compare them and find out which is the most sensitive in both moderate and severe
clinical condition.
