CoV2 SARS PneumoniaPREDISCANNCT04483752
Predicting the Progression to Chronic Fibrosis of Lung Lesions Related to Covid-19 Infection From Chest CT Images
A study testing CHEST CT SCAN in people with CoV2 SARS Pneumonia, run by Centre Chirurgical Marie Lannelongue at 3 sites in France.
Trial summary
The main differences observed between SARSCoV-2 pneumonia and other epidemic viral pneumopathies (e.g., seasonal influenza) are the greater infectivity of SARSCoV-2, the clinical severity of the disease, particularly in young patients without co-morbidities, and the observation of radiological images related to… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- CoV2 SARS Pneumonia
- What is being tested?
- CHEST CT SCAN
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 3 sitesFrance
- Study dates
- 8 Jun 2020to 24 Dec 2022
- Phase
- Interventional
- 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
Who may be able to join
- Patient hospitalized for SARS CoV-2 infection proved by RT-PCR and/or by a typical SARS CoV-2 pneumonia clinic and imaging that required hospitalization Scan performed when the patient is no longer oxygenating, i.e. at least 48 hours prior to hospital discharge (discharge criterion) up to a maximum of 1 month after hospitalisation.
- Patient ≥ 18 years old
- Patient who has given free, informed and written consent
Who cannot join
- Patient ≤ 18 years old
- CT Contraindication
- Pregnant or breastfeeding woman
Trial locations and contacts
3 sites in 1 country.
France3 sites, 3 recruiting
- Recruiting
Hôpital Marie Lannelongue
Le Plessis-Robinson, 92350
CAROLINE CARAMELLA, MD
- Not yet recruiting
Hôpital Saint Joseph
Paris, 75014
Marie De Torcy
- Not yet recruiting
Institut Gustave Roussy (IGR)
Villejuif
Corinne Institut Gustave Roussy (IGR), MD
About this study
The main differences observed between SARSCoV-2 pneumonia and other epidemic viral pneumopathies (e.g., seasonal influenza) are the greater infectivity of SARSCoV-2, the clinical severity of the disease, particularly in young patients without co-morbidities, and the observation of radiological images related to significant parenchymal aggression in a large number of patients.
The lesions in the acute phase correspond essentially to bilateral ground glass opacity more or less associated with condensations which would be markers of more severe infections.
Read more
The major scope of the lesions in the acute phase raises the question of whether or not the scanning anomalies are completely resolved over time, and the possible impact on lung function. This risk of sequelae is very important to study given the large number of patients affected by SARSCoV-2, especially since these are often young patients who appear to be "healthy".
In the current context of the CoV-2 SARS pandemic, the improved quality and availability of diagnostic scanners provides a wealth of information on the semiology and progression of lung disease with minimal exposure to ionizing radiation. A majority of hospitalized patients with SARSCoV-2 received a CT scan in the early phase of the disease. Indeed, the French Society of Radiology has recommended the performance of a CT scan without injection in thin sections in case of suspicion or for confirmation of the diagnosis in patients presenting initial or secondary clinical signs of severity and justifying hospital management due to the initial lack of reagents for performing biological tests (RT-PCR) and the high sensitivity of the CT scan and its specificity in epidemic periods.
The present study aims to study the kinetics of lung involvement in SARS CoV 2, to study the predictive character of the chest CT scan performed at the patient's discharge on the existence of radiological sequelae at 3 months but also at 1 year in order not to misunderstand the constitution of late fibrosis after partial resolution of the CT images. The investigatos will study the correlation between possible radiological abnormalities and the clinical presentation (patient symptoms and lung function). The rigorous follow-up of these patients will allow us to set up, if necessary, early treatment of the detected abnormalities (inhaled corticoids in case of bronchial or bronchiolar damage, study of the place of an anti-fibrosis treatment in case of fibrosis,...).
- Conditions
- CoV2 SARS Pneumonia
- Being tested
- CHEST CT SCAN
- Keywords
- SARS CoV2, COVID-19, fibrosis
- Medical subject headings
- COVID-19, Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CHEST CT SCANOther
Chest CTscan at 3 and 12 months
| Study group | Role | What they receive |
|---|---|---|
| Patients hospitalised for SARS CoV-2 infection. | Other | Not described Receives: Other: CHEST CT SCAN |
What is being measured
The primary outcome is the main question the study is designed to answer.
description of the different types of lesions
Measured: 3 months
Secondary outcomes (1)
quantification of circulating antibodies and correlation between the level of immunization against SARS CoV2, the severity of the initial disease and the existence or not of long-term pulmonary sequelae
Measured: 3 months
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 start8 Jun 2020
- Primary completion24 Dec 2021 (estimated)
- Study completion24 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CoV2 SARS 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Chirurgical Marie Lannelongue
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04483752
- Sponsor's protocol ID
- 2020-A01322-37
- Acronym
- PREDISCAN
- Status last verified
- Aug 2021
- First submitted
- 21 Jul 2020
- Last updated
- 9 Aug 2021
- 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 9 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predicting the Progression to Chronic Fibrosis of Lung Lesions Related to Covid-19 Infection From Chest CT Images
- ClinicalTrials.gov ID
- NCT04483752
- Acronym / sponsor ID
- PREDISCAN / 2020-A01322-37
- Conditions
- CoV2 SARS Pneumonia
- Keywords
- SARS CoV2, COVID-19, fibrosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Centre Chirurgical Marie LannelongueUniversity, hospital or other
- Study start
- 8 Jun 2020 (actual)
- Primary completion
- 24 Dec 2021 (estimated)
- Study completion
- 24 Dec 2022 (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.
The main differences observed between SARSCoV-2 pneumonia and other epidemic viral pneumopathies (e.g., seasonal influenza) are the greater infectivity of SARSCoV-2, the clinical severity of the disease, particularly in young patients without co-morbidities, and the observation of radiological images related to significant parenchymal aggression in a large number of patients.
The lesions in the acute phase correspond essentially to bilateral ground glass opacity more or less associated with condensations which would be markers of more severe infections.
The major scope of the lesions in the acute phase raises the question of whether or not the scanning anomalies are completely resolved over time, and the possible impact on lung function. This risk of sequelae is very important to study given the large number of patients affected by SARSCoV-2, especially since these are often young patients who appear to be "healthy".
In the current context of the CoV-2 SARS pandemic, the improved quality and availability of diagnostic scanners provides a wealth of information on the semiology and progression of lung disease with minimal exposure to ionizing radiation. A majority of hospitalized patients with SARSCoV-2 received a CT scan in the early phase of the disease. Indeed, the French Society of Radiology has recommended the performance of a CT scan without injection in thin sections in case of suspicion or for confirmation of the diagnosis in patients presenting initial or secondary clinical signs of severity and justifying hospital management due to the initial lack of reagents for performing biological tests (RT-PCR) and the high sensitivity of the CT scan and its specificity in epidemic periods.
The present study aims to study the kinetics of lung involvement in SARS CoV 2, to study the predictive character of the chest CT scan performed at the patient's discharge on the existence of radiological sequelae at 3 months but also at 1 year in order not to misunderstand the constitution of late fibrosis after partial resolution of the CT images. The investigatos will study the correlation between possible radiological abnormalities and the clinical presentation (patient symptoms and lung function). The rigorous follow-up of these patients will allow us to set up, if necessary, early treatment of the detected abnormalities (inhaled corticoids in case of bronchial or bronchiolar damage, study of the place of an anti-fibrosis treatment in case of fibrosis,...).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients hospitalised for SARS CoV-2 infection. | Other | Other: CHEST CT SCAN |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patient hospitalized for SARS CoV-2 infection proved by RT-PCR and/or by a typical SARS CoV-2 pneumonia clinic and imaging that required hospitalization Scan performed when the patient is no longer oxygenating, i.e. at least 48 hours prior to hospital discharge (discharge criterion) up to a maximum of 1 month after hospitalisation.
- Patient ≥ 18 years old
- Patient who has given free, informed and written consent
Key exclusion criteria (3 listed)
- Patient ≤ 18 years old
- CT Contraindication
- Pregnant or breastfeeding woman
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 |
|---|---|---|
| CHEST CT SCANChest CTscan at 3 and 12 months | Other | Patients hospitalised for SARS CoV-2 infection. |
Primary outcome
description of the different types of lesions
Time frame: 3 months
1 secondary outcome
quantification of circulating antibodies and correlation between the level of immunization against SARS CoV2, the severity of the initial disease and the existence or not of long-term pulmonary sequelae
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2021.
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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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CHEST CT SCAN in people with CoV2 SARS Pneumonia, run by Centre Chirurgical Marie Lannelongue at 3 sites in France.
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 3 inclusion and 3 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 9 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. 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 CAROLINE CARAMELLA, MD (01.40.94.85.71, a.caramella@hml.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
description of the different types of lesions (time frame: 3 months). 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 9 Aug 2021.