COVID-19NCT04492865
MSCT Chest in Suspected COVID-19 Patients
An observational study of COVID-19, run by Assiut University at 1 site in Egypt.
Trial summary
The present study aimed to evaluate the accuracy of MSCT chest in the detection of COVID-19 cases and to correlate its diagnostic performance with that of the clinical presentation and CBC indices; using RT-PCR assays as a gold standard. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19
- What is being tested?
- MSCT
- Type of treatment
- Medical device
- How many people
- 150 participants
- Where
- 1 siteEgypt
- Study dates
- 30 Jul 2020to 30 Oct 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: A prospective single-center cohort study includes all patients ≥18 years of both sex attended to the emergency unit of Assiut University Hospital with a clinical suspicion of COVID-19 infection.
Who may be able to join
- patients presented by fever, myalgia or respiratory symptoms
- Close contact with a confirmed COVID-19 patient
Who cannot join
- pediatric patients
- patients refuse any of the following: MSCT chest, taking of nasopharyngeal swabs or blood sample
- chest MSCT -Angiography was done for suspected vascular complications (e.g., pulmonary embolism)
- severely dyspneic patients with motion artifact on MSCT images.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: MSCT Chest in Suspected COVID-19 Patients in Correlation With Symptomology and Laboratory Findings
The present study aimed to evaluate the accuracy of MSCT chest in the detection of COVID-19 cases and to correlate its diagnostic performance with that of the clinical presentation and CBC indices; using RT-PCR assays as a gold standard.
Read the detailed description
Coronaviruses are non-segmented positive-stranded RNA viruses with a roughly 30 kb genome surrounded by a protein envelope . Two serious coronavirus disease outbreaks have happened in the past two decades: severe acute respiratory syndrome (SARS) in 2003, and Middle East respiratory syndrome (MERS) in 2012 .
Since December 2019, severe acute respiratory syndrome of coronavirus 2 (SARS-CoV-2) has been recognized as the causal factor in a series of severe cases of pneumonia originating in Wuhan, Hubei Province, China . The disease is highly infectious, spreads rapidly worldwide and has been named coronavirus disease 2019 by the World Health Organization that declared the ongoing outbreak as a global pandemic on March 11, 2020.
COVID-19 infection is usually transmitted from human-to-human by close contact. During close contact, people catch the disease by droplet transmission either directly after breathing of contaminated respiratory droplets that were exhaled by an infected person during coughing, sneezing or talking or indirectly by dealing with surfaces and objects used by the infected person. Some aerosol generating medical procedures (i.e., endotracheal intubation, bronchoscopy or disconnecting a patient from the ventilator), may result in easier transmission of such small droplets for greater distances and longer periods of time, in what is known as airborne transmission .
The virus is most contagious during the first three days after onset of symptoms, although the infection may occur up to two days before appearance of symptoms (presymptomatic transmission) and in later stages of the disease. Some people have been infected and recovered without showing symptoms, but uncertainties remain in terms of asymptomatic transmission .
The lungs are the organs most commonly affected by COVID 19 because the virus accesses host cells via the enzyme angiotensin-converting enzyme 2 (ACE2), which is most abundant in type II alveolar cells of the lungs. The density of ACE2 in each tissue correlates with the severity of the disease in that tissue and some have suggested that decreasing ACE2 activity might be protective .The virus uses a special surface glycoprotein called a "spike" (peplomer) to connect to ACE2 and enter the host cell . Though, autopsies of people who died of COVID 19 have found diffuse alveolar damage , and lymphocyte-containing inflammatory infiltrates within the lung .
The clinical presentation is fundamental to identify and isolate suspected COVID-19 cases. Studies have shown that COVID-19 could induce fever, dry cough, dyspnea, and fatigue in infected patients. In more severe cases, the infection can cause viral pneumonia, severe acute respiratory distress syndrome (ARDS) and even death.
Real-time reverse-transcriptase polymerase chain reaction (RT-PCR) is considered the standard diagnostic method of COVID-19 by detection of the viral nucleic acid in the respiratory secretions collected by nasal or oropharyngeal swab. However, high-false-negative rates (FNRs) have been reported with RT-PCR due to multiple intrinsic limitations that includes collection and transportation of samples and diagnostic kit performance. Also, results from quantitative RT-PCR could be affected by variations in viral RNA sequences or in viral loads in the different anatomic sites during the disease natural history . By estimate, the sensitivity of RT-PCR ranges between 60% and 71% . Considering 1014 COVID-19 cases, a recent report found that only 59% of real COVID-19 patients had positive swabs at initial presentation, while chest CT had higher sensitivity in the diagnosis of COVID-19. Chest CT can be helpful in early detection of typical pulmonary abnormalities in case of high suspicion for COVID-19 infection even with initially negative RT-PCR results . Furthermore, CT may be useful in patients follow up and consequently in evaluation of therapeutic efficacy of treatment .
Bilateral multiple peripherally located ground glass opacities (GGO) that commonly involve the posterior segments of the lower lobes with or without sub-segmental patchy consolidations are considered the typical chest CT findings in COVID-19 pneumonia . However, with the growing researches on COVID-19 cases, various other chest CT features was reported including reticular, nodular or crazy paving patterns, air way abnormalities, pleural effusion etc.
Complete blood count (CBC) is one of the laboratory examinations that was recommended by many Chinese reports for early and efficient screening of large number of people for COVID-19 viral infection . Several studies , concluded that during the early stage of infection, the peripheral blood samples revealed normal or slightly reduced lymphocyte, leukocyte and platelet counts. But, with progression of the disease and the appearance of clinical symptoms, most patients were presented with lymphopenia and less commonly thrombocytopenia and leukopenia. Other studies with consistent results, considered lymphopenia, increased neutrophil count and high neutrophil-to-lymphocyte ratio (NLR) as bad prognostic factors that were associated with more frequent development of critical clinical illness, acute respiratory distress syndrome (ARDS) and death.
In absence of treatment or vaccines for COVID-9 it is important to control this rapidly widespread outbreak; hence there is a need for rapid and accurate methods of detection and identification of suspected cases that can be used in the local hospitals and clinics responsible for the diagnosis and management of COVID-19 patients.
- Conditions
- COVID-19
- Being tested
- MSCT
- Keywords
- MSCT, RT-PCR
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MSCTDevice
Also called RT-PCR
-Laboratory tests: All routine indicators of CBC are evaluated
- Nasopharyngeal and oropharyngeal swabs are obtained from each patient to confirm the positivity to Covid-19 by performing RT-PCR to detect the viral RNA.
- MSCT Chest images of all patients are evaluated by three radiologists with variable experiences in CT chest interpretation. The readers are blinded of the RT-PCR results and the CBC indices of the patients and they have access only to the epidemiological history, clinical symptoms, and signs. By consensus, the radiologists score the chest CT as positive or negative for COVID-19 viral pneumonia. When the chest CT is classified as positive, the main CT features are recorded as present or absent (ground-glass opacity, crazy paving, consolidation, nodules, air bronchogram, air trapping, halo sign, reversed halo sign, bronchial wall abnormalities, vascular enlargement, pleural effusion, and lymphadenopathy.
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of non contrast MSCT chest in COVID-19
Correlation of its diagnostic performance with clinical presentation and CBC indices; using RT-PCR assays as a gold standard.
Measured: baseline
Secondary outcomes (1)
MSCT chest can be used as an alternative diagnostic tool for COVID-19 cases.
Rapid diagnostic tool in identification COVID-19 cases.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2020
- Study start30 Jul 2020 (estimated)
- Primary completion30 Aug 2020 (estimated)
- Study completion30 Oct 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for COVID-19Studies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gehan S. Seifeldein, Assiut University
- Investigators
- Abeer Ali, M D, Principal investigator, Assiut UniversitySara Hassanin, MD, Principal investigator, Assiut UniversityMarwa Khairallah, M D, Principal investigator, Assiut UniversityDalia Kamal, M D, Principal investigator, Assiut UniversityWalaa Ali, M D, Principal investigator, Assiut UniversitySalwa Seif Eldein, PhD, Principal investigator, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04492865
- Sponsor's protocol ID
- CTCOV
- Status last verified
- Jul 2020
- First submitted
- 25 Jul 2020
- Last updated
- 30 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
1. Masters PS. Coronavirus genomic RNA packaging. Virology. 2019;537:198-207. doi:10.1016/j.virol.2019.08.031 2. Shi Z, Hu Z. A review of studies on animal reservoirs of the SARS coronavirus. Virus Res. 2008;133(1):74-87. doi:10.1016/j.virusres.2007.03.012 3. Donnelly CA, Ghani AC, Leung GM, et al. Epidemiological determinants of spread of causal agent of severe acute respiratory syndrome in Hong Kong [published correction appears in Lancet. 2003 May 24;361(9371):1832]. Lancet. 2003;361(9371):1761-1766. doi:10.1016/S0140-6736(03)13410-1 4. Cauchemez S, Fraser C, Van Kerkhove MD, et al. Middle East respiratory syndrome coronavirus: quantification of the extent of the epidemic, surveillance biases, and transmissibility. Lancet Infect Dis. 2014;14(1):50-56. doi:10.1016/S1473-3099(13)70304-9
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MSCT Chest in Suspected COVID-19 Patients in Correlation With Symptomology and Laboratory Findings
- ClinicalTrials.gov ID
- NCT04492865
- Acronym / sponsor ID
- CTCOV
- Conditions
- COVID-19
- Keywords
- MSCT, RT-PCR
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 30 Jul 2020 (estimated)
- Primary completion
- 30 Aug 2020 (estimated)
- Study completion
- 30 Oct 2020 (estimated)
- First posted
- 30 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.
The present study aimed to evaluate the accuracy of MSCT chest in the detection of COVID-19 cases and to correlate its diagnostic performance with that of the clinical presentation and CBC indices; using RT-PCR assays as a gold standard.
Detailed description
Coronaviruses are non-segmented positive-stranded RNA viruses with a roughly 30 kb genome surrounded by a protein envelope . Two serious coronavirus disease outbreaks have happened in the past two decades: severe acute respiratory syndrome (SARS) in 2003, and Middle East respiratory syndrome (MERS) in 2012 .
Since December 2019, severe acute respiratory syndrome of coronavirus 2 (SARS-CoV-2) has been recognized as the causal factor in a series of severe cases of pneumonia originating in Wuhan, Hubei Province, China . The disease is highly infectious, spreads rapidly worldwide and has been named coronavirus disease 2019 by the World Health Organization that declared the ongoing outbreak as a global pandemic on March 11, 2020.
COVID-19 infection is usually transmitted from human-to-human by close contact. During close contact, people catch the disease by droplet transmission either directly after breathing of contaminated respiratory droplets that were exhaled by an infected person during coughing, sneezing or talking or indirectly by dealing with surfaces and objects used by the infected person. Some aerosol generating medical procedures (i.e., endotracheal intubation, bronchoscopy or disconnecting a patient from the ventilator), may result in easier transmission of such small droplets for greater distances and longer periods of time, in what is known as airborne transmission .
The virus is most contagious during the first three days after onset of symptoms, although the infection may occur up to two days before appearance of symptoms (presymptomatic transmission) and in later stages of the disease. Some people have been infected and recovered without showing symptoms, but uncertainties remain in terms of asymptomatic transmission .
The lungs are the organs most commonly affected by COVID 19 because the virus accesses host cells via the enzyme angiotensin-converting enzyme 2 (ACE2), which is most abundant in type II alveolar cells of the lungs. The density of ACE2 in each tissue correlates with the severity of the disease in that tissue and some have suggested that decreasing ACE2 activity might be protective .The virus uses a special surface glycoprotein called a "spike" (peplomer) to connect to ACE2 and enter the host cell . Though, autopsies of people who died of COVID 19 have found diffuse alveolar damage , and lymphocyte-containing inflammatory infiltrates within the lung .
The clinical presentation is fundamental to identify and isolate suspected COVID-19 cases. Studies have shown that COVID-19 could induce fever, dry cough, dyspnea, and fatigue in infected patients. In more severe cases, the infection can cause viral pneumonia, severe acute respiratory distress syndrome (ARDS) and even death.
Real-time reverse-transcriptase polymerase chain reaction (RT-PCR) is considered the standard diagnostic method of COVID-19 by detection of the viral nucleic acid in the respiratory secretions collected by nasal or oropharyngeal swab. However, high-false-negative rates (FNRs) have been reported with RT-PCR due to multiple intrinsic limitations that includes collection and transportation of samples and diagnostic kit performance. Also, results from quantitative RT-PCR could be affected by variations in viral RNA sequences or in viral loads in the different anatomic sites during the disease natural history . By estimate, the sensitivity of RT-PCR ranges between 60% and 71% . Considering 1014 COVID-19 cases, a recent report found that only 59% of real COVID-19 patients had positive swabs at initial presentation, while chest CT had higher sensitivity in the diagnosis of COVID-19. Chest CT can be helpful in early detection of typical pulmonary abnormalities in case of high suspicion for COVID-19 infection even with initially negative RT-PCR results . Furthermore, CT may be useful in patients follow up and consequently in evaluation of therapeutic efficacy of treatment .
Bilateral multiple peripherally located ground glass opacities (GGO) that commonly involve the posterior segments of the lower lobes with or without sub-segmental patchy consolidations are considered the typical chest CT findings in COVID-19 pneumonia . However, with the growing researches on COVID-19 cases, various other chest CT features was reported including reticular, nodular or crazy paving patterns, air way abnormalities, pleural effusion etc.
Complete blood count (CBC) is one of the laboratory examinations that was recommended by many Chinese reports for early and efficient screening of large number of people for COVID-19 viral infection . Several studies , concluded that during the early stage of infection, the peripheral blood samples revealed normal or slightly reduced lymphocyte, leukocyte and platelet counts. But, with progression of the disease and the appearance of clinical symptoms, most patients were presented with lymphopenia and less commonly thrombocytopenia and leukopenia. Other studies with consistent results, considered lymphopenia, increased neutrophil count and high neutrophil-to-lymphocyte ratio (NLR) as bad prognostic factors that were associated with more frequent development of critical clinical illness, acute respiratory distress syndrome (ARDS) and death.
In absence of treatment or vaccines for COVID-9 it is important to control this rapidly widespread outbreak; hence there is a need for rapid and accurate methods of detection and identification of suspected cases that can be used in the local hospitals and clinics responsible for the diagnosis and management of COVID-19 patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- A prospective single-center cohort study includes all patients ≥18 years of both sex attended to the emergency unit of Assiut University Hospital with a clinical suspicion of COVID-19 infection.
Key inclusion criteria (2 listed)
- patients presented by fever, myalgia or respiratory symptoms
- Close contact with a confirmed COVID-19 patient
Key exclusion criteria (4 listed)
- pediatric patients
- patients refuse any of the following: MSCT chest, taking of nasopharyngeal swabs or blood sample
- chest MSCT -Angiography was done for suspected vascular complications (e.g., pulmonary embolism)
- severely dyspneic patients with motion artifact on MSCT images.
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 |
|---|---|---|
| MSCTAlso: RT-PCR-Laboratory tests: All routine indicators of CBC are evaluated * Nasopharyngeal and oropharyngeal swabs are obtained from each patient to confirm the positivity to Covid-19 by performing RT-PCR to detect the viral RNA. * MSCT Chest images of all patients are evaluated by three radiologists with variable experiences in CT chest interpretation. The readers are blinded of the RT-PCR results and the CBC indices of the patients and they have access only to the epidemiological history, clinical symptoms, and signs. By consensus, the radiologists score the chest CT as positive or negative for COVID-19 viral pneumonia. When the chest CT is classified as positive, the main CT features are recorded as present or absent (ground-glass opacity, crazy paving, consolidation, nodules, air bronchogram, air trapping, halo sign, reversed halo sign, bronchial wall abnormalities, vascular enlargement, pleural effusion, and lymphadenopathy. | Device | – |
Primary outcome
Accuracy of non contrast MSCT chest in COVID-19
Time frame: baseline
Correlation of its diagnostic performance with clinical presentation and CBC indices; using RT-PCR assays as a gold standard.
1 secondary outcome
MSCT chest can be used as an alternative diagnostic tool for COVID-19 cases.
Time frame: baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2020.
- Background1. Masters PS. Coronavirus genomic RNA packaging. Virology. 2019;537:198-207. doi:10.1016/j.virol.2019.08.031 2. Shi Z, Hu Z. A review of studies on animal reservoirs of the SARS coronavirus. Virus Res. 2008;133(1):74-87. doi:10.1016/j.virusres.2007.03.012 3. Donnelly CA, Ghani AC, Leung GM, et al. Epidemiological determinants of spread of causal agent of severe acute respiratory syndrome in Hong Kong [published correction appears in Lancet. 2003 May 24;361(9371):1832]. Lancet. 2003;361(9371):1761-1766. doi:10.1016/S0140-6736(03)13410-1 4. Cauchemez S, Fraser C, Van Kerkhove MD, et al. Middle East respiratory syndrome coronavirus: quantification of the extent of the epidemic, surveillance biases, and transmissibility. Lancet Infect Dis. 2014;14(1):50-56. doi:10.1016/S1473-3099(13)70304-9
- Individual participant dataSharing planned: Undecided
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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.
Abeer Ali, M D principal investigator
Assiut University
Sara Hassanin, MD principal investigator
Assiut University
Marwa Khairallah, M D principal investigator
Assiut University
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 COVID-19, run by Assiut 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 2 inclusion and 4 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 30 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?
Contact Gehan S Seifeldein, M.D. (+201224417605, gehanseifeldein@aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy of non contrast MSCT chest in COVID-19 (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04492865, which also lists 1 linked publication.
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 30 Jul 2020.