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AzTrials

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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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.

France1 site
  • Cochin Hospital

    Paris, 75014

Other trials in France

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 groups in NCT04355507
Study groupRoleWhat they receive
Patients with suspicions of COVID-19 pneumoniaPatients 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.

  1. 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)
  1. 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

  2. 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

  3. Predictive values of deep-learning based diagnostic algorithms

    Sensibility specificity Positive and Negative predictive values of deep-learning based diagnostic algorithms

    Measured: 1 month

  4. 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.

  1. First posted21 Apr 2020
  2. Study start1 Mar 2020
  3. Primary completion16 Oct 2020
  4. Study completion16 Oct 2020

Resources

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)
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 32101510
  • Zhou 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 32171076
  • Ko 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 32147516
  • Revel 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

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.

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