Positive COVID-19 by PCRPortsaiduniNCT04484597
Predictors of COVID-19 Infection and Disease Progression
An observational study of Positive COVID-19 by PCR, run by Port Said University at 1 site in Egypt.
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. Read more about this study
- Who is it for?
- Ages 4 days and olderHealthy volunteers can take part
- Conditions the study is for
- Positive COVID-19 by PCR
- What is being tested?
- Rt PCR
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Mar 2020to 15 Sep 2020
- 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 4 days and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: positive COVID-19 by PCR and tested for other ancillary tests and CT chest to compare them and analyse which is the most sensitive in both moderate and severe clinical condition
Who may be able to join
- All cases positive COVID 19 RT PCR
Who cannot join
- cases with chronic diseases ( cancers, diabetes Liver or Kidney )
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Prof. Refat Sadeq
Port Said, 22223
Refat A. Sadeq, Ph D, 01003737012, refat.sadek@med.psu.edu.eg
About this study
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
Read the detailed 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:
- 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;
- 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 .
- 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.
- 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.
- Conditions
- Positive COVID-19 by PCR
- Being tested
- Rt PCR
- Keywords
- COVID 19, Rt PCR, CT, Rapid tests
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rt PCRDiagnostic test
positive COVID-19 by PCR and tested for other ancillary tests and CT chest to compare them and analyse which is the most sensitive in both moderate and severe clinical condition
What is being measured
The primary outcome is the main question the study is designed to answer.
correlation of COVID-19 antibody to PCR
Finding the correlation between the results of COVID-19 RT PCR, antibody to PCR COVID-19 IgM \& IgG and the severity of the clinical picture
Measured: 1 year
Secondary outcomes (1)
correlation of ancillaey tests to PCR
Finding the correlation between the results of the ancillary tests (CRP, ESR, LFT, Ferritin, D dimer) and the severity of the clinical picture
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2020
- Study start15 Mar 2020
- Primary completion15 Aug 2020 (estimated)
- Study completion15 Sep 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Positive COVID-19 by PCRStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Port Said University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04484597
- Sponsor's protocol ID
- Prof. Refat Sadeq
- Acronym
- Portsaiduni
- Status last verified
- Jul 2020
- First submitted
- 14 Jul 2020
- Last updated
- 23 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictors of COVID-19 Infection and Disease Progression
- ClinicalTrials.gov ID
- NCT04484597
- Acronym / sponsor ID
- Portsaiduni / Prof. Refat Sadeq
- Conditions
- Positive COVID-19 by PCR
- Keywords
- COVID 19, Rt PCR, CT, Rapid tests
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Port Said UniversityUniversity, hospital or other
- Study start
- 15 Mar 2020 (actual)
- Primary completion
- 15 Aug 2020 (estimated)
- Study completion
- 15 Sep 2020 (estimated)
- First posted
- 23 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed 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:
- 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;
- 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 .
- 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.
- 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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 4 days and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- positive COVID-19 by PCR and tested for other ancillary tests and CT chest to compare them and analyse which is the most sensitive in both moderate and severe clinical condition
Key inclusion criteria (1 listed)
- All cases positive COVID 19 RT PCR
Key exclusion criteria (1 listed)
- cases with chronic diseases ( cancers, diabetes Liver or Kidney )
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rt PCRpositive COVID-19 by PCR and tested for other ancillary tests and CT chest to compare them and analyse which is the most sensitive in both moderate and severe clinical condition | Diagnostic test | – |
Primary outcome
correlation of COVID-19 antibody to PCR
Time frame: 1 year
Finding the correlation between the results of COVID-19 RT PCR, antibody to PCR COVID-19 IgM \& IgG and the severity of the clinical picture
1 secondary outcome
correlation of ancillaey tests to PCR
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2020.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Positive COVID-19 by PCR, run by Port Said University at 1 site in Egypt.
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: status not confirmed, as of the sponsor's last update on 23 Jul 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 Egypt. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
correlation of COVID-19 antibody to PCR (time frame: 1 year). 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 23 Jul 2020.