COVID-19STOICNCT04355507
Computed Tomography for COVID-19 Diagnosis
An observational study of COVID-19, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
The purpose of this study is to build a large dataset of Computed Tomography (CT) images for identification of accurate CT criteria and development of deep learning-based solutions for diagnosis, quantification and prognostic estimation. 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?
- Chest computed tomography (CT) and Reverse-transcription polymerase chain reaction (RT-PCR)
- How many people
- 10,735 participants
- Where
- 1 siteFrance
- Study dates
- 1 Mar 2020to 16 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: Patients with suspicions of COVID-19 pneumonia
Who may be able to join
- Age>18 years
- CT examination performed for suspicion or follow-up of COVID-19
- Non opposition for use of data
Who cannot join
- Unavailability of RT-PCR results for SARS-Cov-2
- Failure of CT image anonymized export
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Computed Tomography for Coronavirus Disease 19 Diagnosis
The purpose of this study is to build a large dataset of Computed Tomography (CT) images for identification of accurate CT criteria and development of deep learning-based solutions for diagnosis, quantification and prognostic estimation.
Read the detailed description
The outbreak of the novel coronavirus SARS-CoV-2, initially epicentred in China and responsible for COVID-19 pneumonia has now spread to France, with 7730 confirmed cases and 175 deaths as on March 17th. Diagnosis relies on the identification of viral RNA by reverse-transcription polymerase chain reaction (RT-PCR), but its positivity can be delayed. A series based on 1014 chinese patients reported higher sensitivity for CT, with a mean interval time between the initial negative to positive RT-PCR results of 5.1 ± 1.5 days (PMID: 32101510). Moreover, obtaining RT-PCR results requires several hours, which is problematic for patients triage.
Chest CT can allow early depiction of COVID-19, especially when performed more than 3 days after symptoms onset. It is important to distinguish between COVID-19 and bacterial causes of pulmonary infection, which requires expertise in thoracic imaging. Thus, it is important to identify reliable CT diagnostic criteria based on visual assessment, and also develop deep-learning based solutions for early positive diagnosis which could be used by less experienced readers, in a context of large epidemic.
Several risk factors for poor outcome are already identified, such as older age, comorbidities, or an elevated d-dimer level at presentation (PMID: 32171076). Extensive CT abnormalities are linked to poor outcome, but some patients secondarily worsen despite non extensive abnormalities at first assessment, highlighting the need for worsening prediction based on initial imaging findings. Lastly, there is currently no drug with a proven efficacy for patients with acute respiratory distress syndrome, who for management relies on mechanical ventilation and supportive care. Some hypothesized that Remdesivir, an antiviral therapy could be effective (PMID: 32147516), with ongoing randomized trials conducted in China and the US. Automated tools allowing quantifying the disease extent on CT would be desirable in order to evaluate the efficacy of new treatments.
Building a large dataset of CT images is needed for identification of accurate CT criteria and development of deep learning-based solutions for diagnosis, quantification and prognostic estimation.
The aim of this project is three fold: (i) create a multi-centric open database repository on CT scans relative to COVID-19, (ii) create a multi-expert annotation protocol with different level of annotations depicting the severity of the disease, (iii) allow the development of non-proprietary computer aided solutions (academia \& industry) for automatic quantification of the diseases and prognosis through the use of the latest advances in the field of artificial intelligence.
For patients, the validation of reliable diagnostic criteria will allow early detection of the disease, and better distinction with other potential cause of acute respiratory symptoms, requiring a specific treatment, such as bacterial bronchopneumonia. It will contribute to a standardization of care as well as an equal access to diagnosis and treatment for the ensemble of the population.
Public health benefit will be an access to CT diagnosis of COVID-19 independently from the availability of local expertise in thoracic imaging. The possibility to anticipate the need for ventilation, based on the developed CT severity scores, will also positively impact the management of patients in particular in the context of a massive flow of patients as expected at the epidemic peak. This project will allow evaluating the proportion of patients likely to present respiratory sequelae, based on the severity and extent of lung abnormalities at the acute phase of the disease.
The availability of automated quantification tools will help evaluating treatment efficacy if new therapeutic approaches are developed.
Lastly, the developed tools for early diagnosis, evaluation of severity and prediction of outcomes could prove useful if other viral pandemic occurs in the future. Indeed SARS-Cov2 outbreak has been preceded by SARS and MERS outbreaks due to other coronavirus.
- Conditions
- COVID-19
- Being tested
- Chest computed tomography (CT), Reverse-transcription polymerase chain reaction (RT-PCR)
- Keywords
- Computed Tomography (CT), COVID-19, Artificial intelligence, Deep Learning
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chest computed tomography (CT)Diagnostic test
Chest computed tomography (CT) examination
Reverse-transcription polymerase chain reaction (RT-PCR)Diagnostic test
Identification of viral RNA by reverse-transcription polymerase chain reaction
| Study group | Role | What they receive |
|---|---|---|
| Patients with suspicions of COVID-19 pneumonia | Patients with suspicions of COVID-19 pneumonia Receives: Diagnostic Test: Chest computed tomography (CT); Diagnostic Test: Reverse-transcription polymerase chain reaction (RT-PCR) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Predictive values of CT criteria
Sensibility specificity positive and negative predictive values of CT criteria with RT-PCR results as standard of reference.
Measured: 1 month
Secondary outcomes (4)
Accuracy of CT composite severity score
Accuracy (ROC curve analysis) of CT visual composite score to predict ventilation requirement and 1-month mortality
Measured: 1 month
Accuracy of deep-learning based score
Accuracy (ROC curve analysis) of deep-learning based score to predict ventilation requirement and 1-month mortality
Measured: 1 month
Predictive values of deep-learning based diagnostic algorithms
Sensibility specificity Positive and Negative predictive values of deep-learning based diagnostic algorithms
Measured: 1 month
Dice similarity coefficient between manual and automated segmentation of lung disease abnormalities
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2020
- Study start1 Mar 2020
- Primary completion16 Oct 2020
- Study completion16 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)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 Assistance Publique - Hôpitaux de ParisThe 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
- Retrospective
- Enrolment
- 10,735 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- Institut National de la Santé Et de la Recherche Médicale, France, GE Healthcare, Orange healthcare, TheraPanacea, URC-CIC Paris Descartes Necker Cochin
- Responsible party
- Sponsor
- Investigators
- Marie-Pierre REVEL, MD,PhD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04355507
- Sponsor's protocol ID
- APHP200434
- Acronym
- STOIC
- Status last verified
- Jan 2026
- First submitted
- 17 Apr 2020
- Last updated
- 21 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ai T, Yang Z, Hou H, Zhan C, Chen C, Lv W, Tao Q, Sun Z, Xia L. Correlation of Chest CT and RT-PCR Testing for Coronavirus Disease 2019 (COVID-19) in China: A Report of 1014 Cases. Radiology. 2020 Aug;296(2):E32-E40. doi: 10.1148/radiol.2020200642. Epub 2020 Feb 26.
PubMed 32101510Zhou F, Yu T, Du R, Fan G, Liu Y, Liu Z, Xiang J, Wang Y, Song B, Gu X, Guan L, Wei Y, Li H, Wu X, Xu J, Tu S, Zhang Y, Chen H, Cao B. Clinical course and risk factors for mortality of adult inpatients with COVID-19 in Wuhan, China: a retrospective cohort study. Lancet. 2020 Mar 28;395(10229):1054-1062. doi: 10.1016/S0140-6736(20)30566-3. Epub 2020 Mar 11.
PubMed 32171076Ko WC, Rolain JM, Lee NY, Chen PL, Huang CT, Lee PI, Hsueh PR. Arguments in favour of remdesivir for treating SARS-CoV-2 infections. Int J Antimicrob Agents. 2020 Apr;55(4):105933. doi: 10.1016/j.ijantimicag.2020.105933. Epub 2020 Mar 6. No abstract available.
PubMed 32147516Revel MP, Boussouar S, de Margerie-Mellon C, Saab I, Lapotre T, Mompoint D, Chassagnon G, Milon A, Lederlin M, Bennani S, Moliere S, Debray MP, Bompard F, Dangeard S, Hani C, Ohana M, Bommart S, Jalaber C, El Hajjam M, Petit I, Fournier L, Khalil A, Brillet PY, Bellin MF, Redheuil A, Rocher L, Bousson V, Rousset P, Gregory J, Deux JF, Dion E, Valeyre D, Porcher R, Jilet L, Abdoul H. Study of Thoracic CT in COVID-19: The STOIC Project. Radiology. 2021 Oct;301(1):E361-E370. doi: 10.1148/radiol.2021210384. Epub 2021 Jun 29.
PubMed 34184935
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Computed Tomography for Coronavirus Disease 19 Diagnosis
- ClinicalTrials.gov ID
- NCT04355507
- Acronym / sponsor ID
- STOIC / APHP200434
- Conditions
- COVID-19
- Keywords
- Computed Tomography (CT), COVID-19, Artificial intelligence, Deep Learning
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10,735 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- Institut National de la Santé Et de la Recherche Médicale, France, GE Healthcare, Orange healthcare, TheraPanacea, URC-CIC Paris Descartes Necker Cochin
- Study start
- 1 Mar 2020 (actual)
- Primary completion
- 16 Oct 2020 (actual)
- Study completion
- 16 Oct 2020 (actual)
- First posted
- 21 Apr 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 purpose of this study is to build a large dataset of Computed Tomography (CT) images for identification of accurate CT criteria and development of deep learning-based solutions for diagnosis, quantification and prognostic estimation.
Detailed description
The outbreak of the novel coronavirus SARS-CoV-2, initially epicentred in China and responsible for COVID-19 pneumonia has now spread to France, with 7730 confirmed cases and 175 deaths as on March 17th. Diagnosis relies on the identification of viral RNA by reverse-transcription polymerase chain reaction (RT-PCR), but its positivity can be delayed. A series based on 1014 chinese patients reported higher sensitivity for CT, with a mean interval time between the initial negative to positive RT-PCR results of 5.1 ± 1.5 days (PMID: 32101510). Moreover, obtaining RT-PCR results requires several hours, which is problematic for patients triage.
Chest CT can allow early depiction of COVID-19, especially when performed more than 3 days after symptoms onset. It is important to distinguish between COVID-19 and bacterial causes of pulmonary infection, which requires expertise in thoracic imaging. Thus, it is important to identify reliable CT diagnostic criteria based on visual assessment, and also develop deep-learning based solutions for early positive diagnosis which could be used by less experienced readers, in a context of large epidemic.
Several risk factors for poor outcome are already identified, such as older age, comorbidities, or an elevated d-dimer level at presentation (PMID: 32171076). Extensive CT abnormalities are linked to poor outcome, but some patients secondarily worsen despite non extensive abnormalities at first assessment, highlighting the need for worsening prediction based on initial imaging findings. Lastly, there is currently no drug with a proven efficacy for patients with acute respiratory distress syndrome, who for management relies on mechanical ventilation and supportive care. Some hypothesized that Remdesivir, an antiviral therapy could be effective (PMID: 32147516), with ongoing randomized trials conducted in China and the US. Automated tools allowing quantifying the disease extent on CT would be desirable in order to evaluate the efficacy of new treatments.
Building a large dataset of CT images is needed for identification of accurate CT criteria and development of deep learning-based solutions for diagnosis, quantification and prognostic estimation.
The aim of this project is three fold: (i) create a multi-centric open database repository on CT scans relative to COVID-19, (ii) create a multi-expert annotation protocol with different level of annotations depicting the severity of the disease, (iii) allow the development of non-proprietary computer aided solutions (academia \& industry) for automatic quantification of the diseases and prognosis through the use of the latest advances in the field of artificial intelligence.
For patients, the validation of reliable diagnostic criteria will allow early detection of the disease, and better distinction with other potential cause of acute respiratory symptoms, requiring a specific treatment, such as bacterial bronchopneumonia. It will contribute to a standardization of care as well as an equal access to diagnosis and treatment for the ensemble of the population.
Public health benefit will be an access to CT diagnosis of COVID-19 independently from the availability of local expertise in thoracic imaging. The possibility to anticipate the need for ventilation, based on the developed CT severity scores, will also positively impact the management of patients in particular in the context of a massive flow of patients as expected at the epidemic peak. This project will allow evaluating the proportion of patients likely to present respiratory sequelae, based on the severity and extent of lung abnormalities at the acute phase of the disease.
The availability of automated quantification tools will help evaluating treatment efficacy if new therapeutic approaches are developed.
Lastly, the developed tools for early diagnosis, evaluation of severity and prediction of outcomes could prove useful if other viral pandemic occurs in the future. Indeed SARS-Cov2 outbreak has been preceded by SARS and MERS outbreaks due to other coronavirus.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with suspicions of COVID-19 pneumonia | – | Diagnostic Test: Chest computed tomography (CT), Diagnostic Test: Reverse-transcription polymerase chain reaction (RT-PCR)Patients with suspicions of COVID-19 pneumonia |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with suspicions of COVID-19 pneumonia
Key inclusion criteria (3 listed)
- Age>18 years
- CT examination performed for suspicion or follow-up of COVID-19
- Non opposition for use of data
Key exclusion criteria (2 listed)
- Unavailability of RT-PCR results for SARS-Cov-2
- Failure of CT image anonymized export
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 computed tomography (CT)Chest computed tomography (CT) examination | Diagnostic test | Patients with suspicions of COVID-19 pneumonia |
| Reverse-transcription polymerase chain reaction (RT-PCR)Identification of viral RNA by reverse-transcription polymerase chain reaction | Diagnostic test | Patients with suspicions of COVID-19 pneumonia |
Primary outcome
Predictive values of CT criteria
Time frame: 1 month
Sensibility specificity positive and negative predictive values of CT criteria with RT-PCR results as standard of reference.
4 secondary outcomes
Accuracy of CT composite severity score
Time frame: 1 month
Accuracy of deep-learning based score
Time frame: 1 month
Predictive values of deep-learning based diagnostic algorithms
Time frame: 1 month
Dice similarity coefficient between manual and automated segmentation of lung disease abnormalities
Time frame: 1 month
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 21 Jan 2026.
- Background: PubMed 32101510Ai T, Yang Z, Hou H, Zhan C, Chen C, Lv W, Tao Q, Sun Z, Xia L. Correlation of Chest CT and RT-PCR Testing for Coronavirus Disease 2019 (COVID-19) in China: A Report of 1014 Cases. Radiology. 2020 Aug;296(2):E32-E40. doi: 10.1148/radiol.2020200642. Epub 2020 Feb 26.
- Background: PubMed 32171076Zhou F, Yu T, Du R, Fan G, Liu Y, Liu Z, Xiang J, Wang Y, Song B, Gu X, Guan L, Wei Y, Li H, Wu X, Xu J, Tu S, Zhang Y, Chen H, Cao B. Clinical course and risk factors for mortality of adult inpatients with COVID-19 in Wuhan, China: a retrospective cohort study. Lancet. 2020 Mar 28;395(10229):1054-1062. doi: 10.1016/S0140-6736(20)30566-3. Epub 2020 Mar 11.
- Background: PubMed 32147516Ko WC, Rolain JM, Lee NY, Chen PL, Huang CT, Lee PI, Hsueh PR. Arguments in favour of remdesivir for treating SARS-CoV-2 infections. Int J Antimicrob Agents. 2020 Apr;55(4):105933. doi: 10.1016/j.ijantimicag.2020.105933. Epub 2020 Mar 6. No abstract available.
- Results publication: PubMed 34184935Revel MP, Boussouar S, de Margerie-Mellon C, Saab I, Lapotre T, Mompoint D, Chassagnon G, Milon A, Lederlin M, Bennani S, Moliere S, Debray MP, Bompard F, Dangeard S, Hani C, Ohana M, Bommart S, Jalaber C, El Hajjam M, Petit I, Fournier L, Khalil A, Brillet PY, Bellin MF, Redheuil A, Rocher L, Bousson V, Rousset P, Gregory J, Deux JF, Dion E, Valeyre D, Porcher R, Jilet L, Abdoul H. Study of Thoracic CT in COVID-19: The STOIC Project. Radiology. 2021 Oct;301(1):E361-E370. doi: 10.1148/radiol.2021210384. Epub 2021 Jun 29.
- Individual participant dataSharing planned: No
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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.
Marie-Pierre REVEL, MD,PhD principal investigator
Assistance Publique - Hôpitaux de Paris
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 Assistance Publique - Hôpitaux de Paris at 1 site 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 2 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 21 Jan 2026. 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 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?
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?
Predictive values of CT criteria (time frame: 1 month). 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 NCT04355507, which also lists 4 linked publications.
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 21 Jan 2026.