Viral PneumoniaCOVID19IFNCT04394026
Imaging Feature of SARS-CoV2 Infection
An observational study of Viral Pneumonia and COVID, run by Francesco De Cobelli at 1 site in Italy.
Trial summary
The novel coronavirus SARS-CoV2 clinically presents with pneumonia, characterised by fever, cough, dyspnea. The severity of the disease varies widely with evidence of mild disease in the majority of confirmed cases, severe pneumonia-dyspnea, hypoxia or lung involvement at imaging within 24-48 hours- and critical… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Viral Pneumonia, COVID
- How many people
- 200 participants
- Where
- 1 siteItaly
- Study dates
- 16 Apr 2020to 30 Dec 2021
- 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
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with proven COVID-19
Who may be able to join
- CoViD-19 positive patients (rRT-PCR naso-pharyngeal swab)
- Suspicion of SARS-CoV2 on chest X-ray and/or chest CT presentation of disease
- Patients of all ages
- Subjects at risk (minors, patients in emergency situations, pregnant women, potentially incapable of giving their consent )
- Having signed the Informed Consent
Who cannot join
- Not fulfilling any of the above
Trial locations and contacts
1 site in 1 country.
About this study
Official title: COVID-19 Imaging Features
The novel coronavirus SARS-CoV2 clinically presents with pneumonia, characterised by fever, cough, dyspnea. The severity of the disease varies widely with evidence of mild disease in the majority of confirmed cases, severe pneumonia-dyspnea, hypoxia or lung involvement at imaging within 24-48 hours- and critical disease with respiratory failure, shock or multi-organ failure in particular patient cohorts. Imaging plays a key role is diagnosis and progression of this disease.
Read the detailed description
In March 2020, the third highest number of positive cases in the world was recorded in Italy, mainly due to 2 outbreaks of 2 different clusters in Lombardy and Veneto.
Fever is the most common symptom, followed by fatigue and dry cough; worsening of dyspnea and acute respiratory distress syndrome are found in severe cases. Previous reports have highlighted the key role of chest computed tomography (CT) and chest X-ray (CXR) in the diagnosis and follow-up of CoViD-19.
The most frequent clinical manifestation seems to be viral pneumonia, characterised by fever, cough, dyspnea. The severity of the disease varies widely: with evidence of mild disease in the majority of confirmed cases, severe pneumonia on a part of these, defined as dyspnea, hypoxia or lung involvement > 40% at imaging within 24-48 hours, and critical disease defined as respiratory failure, shock or multi-organ failure in particular patient cohorts.The mortality rate between cases ranges from approximately 4% in early reports to 14%, depending on the intensity of transmission and time of infection, and most fatal cases occurred in older patients or in patients with pre-existing medical co-morbidities.
Imaging plays an essential role in the diagnosis and follow-up of this infection.Several studies have been published describing the results of imaging, mainly using chest CT (computed tomography) with a limited number of articles describing disease in European patients or the possible different clinical/radiological presentation of the disease in European patients.
Pulmonary pathological findings appear to be similar to those previously described in SARS and MERS, with a prevalence of frosted glass densities and occasional consolidation.According to the literature, the 3 main features for the diagnosis of CoVid-19 pneumonia are: alveolar disease, represented by ground glass densities, bilateral distribution and prevalent peripheral involvement. This triad is more common in intermediate stages of the disease. In the early stages of the disease, a significant proportion of patients may present with negative or dubious X-rays and CT scans.There is an important overlap with imaging findings of other viral pneumonia, in particular with other members of the coronaviridae family: consolidation, however, seems to be less common in the early stages of CoViD-19 and bilateral distribution is less frequent in SARS and MERS pneumonia. Very little data have been published on the radiological evolution and modification of radiological aspects during infection: as the disease progresses, parenchymal consolidations begin to resorb and assume a frosted glass appearance. Another possible evolution is the progression towards the radiological aspect of the "white lung". This study aims to describe imaging aspects of CoViD-19 infection in Italian patients and the data on the radiological evolution.
- Conditions
- Viral Pneumonia, COVID
- Keywords
- diagnosis, disease progression, imaging features, SARS-CoV2, COVID
- Medical subject headings
- Pneumonia, Viral, Disease, Disease Progression
What is being measured
The primary outcome is the main question the study is designed to answer.
Describe qualitative and quantitative variables
Evaluate RX imaging aspects at the time of diagnosis and until discharge.
Measured: Through study completion, an average of 5 months
Describe qualitative and quantitative variables
Evaluate CT imaging aspects at the time of diagnosis and until discharge.
Measured: Through study completion, an average of 5 months
Ability of imaging to predict disease progression
Correlate imaging findings to OS
Measured: Through study completion, an average of 5 months
Ability of imaging to predict disease evolution
Correlate imaging findings over time
Measured: Through study completion, an average of 5 months
Secondary outcomes (2)
Imaging findings and demographic data
Correlate imaging findings to age and sex
Measured: Through study completion, an average of 5 months
Imaging findings and laboratory exams
Correlate imaging findings to laboratory values
Measured: Through study completion, an average of 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2020
- Study start16 Apr 2020
- Primary completion30 Dec 2021
- Study completion30 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Viral PneumoniaStudies 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
- Cohort
- Time perspective
- Other
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Francesco De Cobelli
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Francesco De Cobelli, IRCCS San Raffaele
- Investigators
- Carlo Martinenghi, MD, Principal investigator, IRCCS Ospedale San Raffaele
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04394026
- Sponsor's protocol ID
- COVID-19 IF
- Acronym
- COVID19IF
- Status last verified
- Jan 2023
- First submitted
- 15 May 2020
- Last updated
- 26 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COVID-19 Imaging Features
- ClinicalTrials.gov ID
- NCT04394026
- Acronym / sponsor ID
- COVID19IF / COVID-19 IF
- Conditions
- Viral Pneumonia, COVID
- Keywords
- diagnosis, disease progression, imaging features, SARS-CoV2, COVID
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Francesco De CobelliUniversity, hospital or other
- Study start
- 16 Apr 2020 (actual)
- Primary completion
- 30 Dec 2021 (actual)
- Study completion
- 30 Dec 2021 (actual)
- First posted
- 19 May 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 novel coronavirus SARS-CoV2 clinically presents with pneumonia, characterised by fever, cough, dyspnea. The severity of the disease varies widely with evidence of mild disease in the majority of confirmed cases, severe pneumonia-dyspnea, hypoxia or lung involvement at imaging within 24-48 hours- and critical disease with respiratory failure, shock or multi-organ failure in particular patient cohorts. Imaging plays a key role is diagnosis and progression of this disease.
Detailed description
In March 2020, the third highest number of positive cases in the world was recorded in Italy, mainly due to 2 outbreaks of 2 different clusters in Lombardy and Veneto.
Fever is the most common symptom, followed by fatigue and dry cough; worsening of dyspnea and acute respiratory distress syndrome are found in severe cases. Previous reports have highlighted the key role of chest computed tomography (CT) and chest X-ray (CXR) in the diagnosis and follow-up of CoViD-19.
The most frequent clinical manifestation seems to be viral pneumonia, characterised by fever, cough, dyspnea. The severity of the disease varies widely: with evidence of mild disease in the majority of confirmed cases, severe pneumonia on a part of these, defined as dyspnea, hypoxia or lung involvement > 40% at imaging within 24-48 hours, and critical disease defined as respiratory failure, shock or multi-organ failure in particular patient cohorts.The mortality rate between cases ranges from approximately 4% in early reports to 14%, depending on the intensity of transmission and time of infection, and most fatal cases occurred in older patients or in patients with pre-existing medical co-morbidities.
Imaging plays an essential role in the diagnosis and follow-up of this infection.Several studies have been published describing the results of imaging, mainly using chest CT (computed tomography) with a limited number of articles describing disease in European patients or the possible different clinical/radiological presentation of the disease in European patients.
Pulmonary pathological findings appear to be similar to those previously described in SARS and MERS, with a prevalence of frosted glass densities and occasional consolidation.According to the literature, the 3 main features for the diagnosis of CoVid-19 pneumonia are: alveolar disease, represented by ground glass densities, bilateral distribution and prevalent peripheral involvement. This triad is more common in intermediate stages of the disease. In the early stages of the disease, a significant proportion of patients may present with negative or dubious X-rays and CT scans.There is an important overlap with imaging findings of other viral pneumonia, in particular with other members of the coronaviridae family: consolidation, however, seems to be less common in the early stages of CoViD-19 and bilateral distribution is less frequent in SARS and MERS pneumonia. Very little data have been published on the radiological evolution and modification of radiological aspects during infection: as the disease progresses, parenchymal consolidations begin to resorb and assume a frosted glass appearance. Another possible evolution is the progression towards the radiological aspect of the "white lung". This study aims to describe imaging aspects of CoViD-19 infection in Italian patients and the data on the radiological evolution.
Study design
- Observational model
- Cohort
- Time perspective
- Other
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with proven COVID-19
Key inclusion criteria (5 listed)
- CoViD-19 positive patients (rRT-PCR naso-pharyngeal swab)
- Suspicion of SARS-CoV2 on chest X-ray and/or chest CT presentation of disease
- Patients of all ages
- Subjects at risk (minors, patients in emergency situations, pregnant women, potentially incapable of giving their consent )
- Having signed the Informed Consent
Key exclusion criteria (1 listed)
- Not fulfilling any of the above
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Describe qualitative and quantitative variables
Time frame: Through study completion, an average of 5 months
Evaluate RX imaging aspects at the time of diagnosis and until discharge.
Describe qualitative and quantitative variables
Time frame: Through study completion, an average of 5 months
Evaluate CT imaging aspects at the time of diagnosis and until discharge.
Ability of imaging to predict disease progression
Time frame: Through study completion, an average of 5 months
Correlate imaging findings to OS
Ability of imaging to predict disease evolution
Time frame: Through study completion, an average of 5 months
Correlate imaging findings over time
2 secondary outcomes
Imaging findings and demographic data
Time frame: Through study completion, an average of 5 months
Imaging findings and laboratory exams
Time frame: Through study completion, an average of 5 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2023.
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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.
Carlo Martinenghi, MD principal investigator
IRCCS Ospedale San Raffaele
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 Viral Pneumonia and COVID, run by Francesco De Cobelli at 1 site in Italy.
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 5 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 26 Jan 2023. 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 Italy. 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?
Describe qualitative and quantitative variables (time frame: Through study completion, an average of 5 months). The study lists 4 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 26 Jan 2023.