COVID-19PREDICTCovid19NCT04481620
Development and Validation of a Prediction Model for the Transition From Mild to Moderate Form of COVID-19, Using Data From Chest CT
An observational study of COVID-19, run by University Hospital, Bordeaux at 7 sites in France.
Trial summary
Only 5% of patients infected with COVID-19 develop severe or critical Coronavirus disease 2019 (COVID-19) and there is no reliable risk stratification tool for non-severe COVID-19 patients at admission. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19
- How many people
- 1,329 participants
- Where
- 7 sitesFrance
- Study dates
- 31 Aug 2020to 4 May 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with suspicion of Covid-19
Who may be able to join
- First chest CT, assessed for respiratory symptoms, without injection of contrast agent for respiratory symptoms, and whose results of the CT subjective visual analysis are compatible or typical of COVID-19
- biological diagnosis of COVID-19 (RT-PCR) or clinical suspicion (cough and / or dyspnea and / or fever and / or need to use oxygen therapy as part of routine care) at the time of the examination
- Authorization of the patient for the processing of his personal data, except CNIL exemption
Who cannot join
- Patient with a moderate (oxygen between 3 and 5 L / min to achieve saturation greater than 97% and a respiratory rate <25 / min without the need for invasive ventilation), severe form (oxygen therapy> 5L / min to obtain a SpO2> 97%) or critical form (need to resort to ventilation and / or orotracheal intubation) at the date of the first chest CT
- Age < 18 years old
- Patient deprived of liberty by judicial decision
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
France7 sites
CHU Bordeaux
Bordeaux
Clinique Bordeaux Nord
Bordeaux
Clinique Saint Augustin
Bordeaux
CHU de Grenoble Alpes
Grenoble
Hôpital Arnaud-de-Villeneuve CHU de Montpellier
Montpellier
Hôpitaux de Brabois CHU de Nancy
Nancy
Hôpital de la Milétrie CHU de Poitiers
Poitiers
About this study
Official title: Evelopment and Validation of a Prediction Model for the Transition From Mild to Moderate Form of COVID-19, Using Data From Chest CT
Only 5% of patients infected with COVID-19 develop severe or critical Coronavirus disease 2019 (COVID-19) and there is no reliable risk stratification tool for non-severe COVID-19 patients at admission.
Finding a way to predict which patients with an initial mild to moderate presentation of COVID-19 would develop severe or critical form of COVID-19 according to CT-scan data, simple clinical and biological parameters is challenging. In this multicentric study, the study aims to construct a predictive score for early identification of cases at high risk of progression to moderate, severe or critical COVID-19 combining simple clinical and biological parameters and qualitative, quantitative or artificial intelligence (AI) data from the initial CT from non-severe patients.
Read the detailed description
A few numbers of patients infected with Coronavirus disease 2019 (COVID-19) rapidly develop acute respiratory distress leading to respiratory failure, with high short-term mortality rates. However, only 5% of patients infected with COVID-19 are concerned by this pejorative evolution. At present, there is no reliable risk stratification tool for non-severe COVID-19 patients at admission.
Chest computed tomography (CT) is widely used for the management of COVID-19 pneumonia because of its availability and quickness. The standard of reference for confirming COVID-19 relies on microbiological tests but these tests might not be available in an emergency setting and their results are not immediately available, contrary to CT. In addition to its role for early diagnosis, CT has a prognostic role through evaluating the extent of COVID-19 lung abnormalities.
Finding a way to predict which patients with an initial mild to moderate presentation of COVID-19 would develop severe or critical form of COVID-19 according to CT-scan data, simple clinical and biological parameters is challenging. In this multicentric study, the study aims to construct a predictive score for early identification of cases at high risk of progression to moderate, severe or critical COVID-19 combining simple clinical and biological parameters and qualitative, quantitative or artificial intelligence (AI) data from the initial CT from non-severe patients. The final objective is to organize optimal patient management in the appropriate health structure.
- Conditions
- COVID-19
- Keywords
- COVID-19, SARS-CoV-2, CT, prediction score, prognosis, mild-to moderate form
- Medical subject headings
- COVID-19
What is being measured
The primary outcome is the main question the study is designed to answer.
occurrence of significant clinical degradation
The primary outcome is defined by the occurrence of significant clinical degradation within 30 days following the initial chest CT.
Significant clinical degradation is defined by the transition from the mild to the moderate form of COVID-19, i.e., according to the WHO criteria, the requirement of oxygen between 3 and 5 L / min to achieve saturation greater than 97% and a respiratory rate <25 / min without the need for invasive ventilation.
Measured: Day 30 following the initial chest CT
Secondary outcomes (6)
occurrence of a severe form
the occurrence of a severe form, defined by the need for oxygen therapy greater than 5L / min to obtain a percutaneous oxygen saturation greater than 97%, within 30 days following the initial chest CT
Measured: Day 30 following the initial chest CT
occurrence of an orotracheal intubation
the occurrence of an orotracheal intubation within 30 days following the initial chest CT (binary: yes/no)
Measured: Day 30 following the initial chest CT
occurrence of an Acute Respiratory Distress Syndrom
the occurrence of an Acute Respiratory Distress Syndrom according to the Berlin criteria (JAMA 2012) within 30 days following the initial chest CT (binary: yes/no)
Measured: Day 30 following the initial chest CT
average length of stay in hospital
the average length of stay in hospital (days)
Measured: Month 1
mortality
mortality within 30 days following the initial chest CT (binary: yes/no)
Measured: Day 30 following the initial chest CT
evolution of the imaging parameters
evolution of the imaging parameters of the successive thoracic CT scans in the acute phase of COVID-19, in patients with a positive diagnosis of COVID-19 (positive RT-PCR or positive serology)
Measured: Day 30 following the initial chest CT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2020
- Study start31 Aug 2020
- Primary completion4 May 2021
- Study completion4 May 2021
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 University Hospital, BordeauxThe 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
- 1,329 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Collaborators
- Programme Hospitalier de Recherche Clinique Inter-Régionale (PHRC-I)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04481620
- Sponsor's protocol ID
- CHUBX 2020/23
- Acronym
- PREDICTCovid19
- Status last verified
- Apr 2022
- First submitted
- 20 Jul 2020
- Last updated
- 12 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zysman M, Asselineau J, Saut O, Frison E, Oranger M, Maurac A, Charriot J, Achkir R, Regueme S, Klein E, Bommart S, Bourdin A, Dournes G, Casteigt J, Blum A, Ferretti G, Degano B, Thiebaut R, Chabot F, Berger P, Laurent F, Benlala I. Development and external validation of a prediction model for the transition from mild to moderate or severe form of COVID-19. Eur Radiol. 2023 Dec;33(12):9262-9274. doi: 10.1007/s00330-023-09759-x. Epub 2023 Jul 5.
PubMed 37405504
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evelopment and Validation of a Prediction Model for the Transition From Mild to Moderate Form of COVID-19, Using Data From Chest CT
- ClinicalTrials.gov ID
- NCT04481620
- Acronym / sponsor ID
- PREDICTCovid19 / CHUBX 2020/23
- Conditions
- COVID-19
- Keywords
- COVID-19, SARS-CoV-2, CT, prediction score, prognosis, mild-to moderate form
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,329 participants (actual)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Collaborators
- Programme Hospitalier de Recherche Clinique Inter-Régionale (PHRC-I)
- Study start
- 31 Aug 2020 (actual)
- Primary completion
- 4 May 2021 (actual)
- Study completion
- 4 May 2021 (actual)
- First posted
- 22 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.
Only 5% of patients infected with COVID-19 develop severe or critical Coronavirus disease 2019 (COVID-19) and there is no reliable risk stratification tool for non-severe COVID-19 patients at admission.
Finding a way to predict which patients with an initial mild to moderate presentation of COVID-19 would develop severe or critical form of COVID-19 according to CT-scan data, simple clinical and biological parameters is challenging. In this multicentric study, the study aims to construct a predictive score for early identification of cases at high risk of progression to moderate, severe or critical COVID-19 combining simple clinical and biological parameters and qualitative, quantitative or artificial intelligence (AI) data from the initial CT from non-severe patients.
Detailed description
A few numbers of patients infected with Coronavirus disease 2019 (COVID-19) rapidly develop acute respiratory distress leading to respiratory failure, with high short-term mortality rates. However, only 5% of patients infected with COVID-19 are concerned by this pejorative evolution. At present, there is no reliable risk stratification tool for non-severe COVID-19 patients at admission.
Chest computed tomography (CT) is widely used for the management of COVID-19 pneumonia because of its availability and quickness. The standard of reference for confirming COVID-19 relies on microbiological tests but these tests might not be available in an emergency setting and their results are not immediately available, contrary to CT. In addition to its role for early diagnosis, CT has a prognostic role through evaluating the extent of COVID-19 lung abnormalities.
Finding a way to predict which patients with an initial mild to moderate presentation of COVID-19 would develop severe or critical form of COVID-19 according to CT-scan data, simple clinical and biological parameters is challenging. In this multicentric study, the study aims to construct a predictive score for early identification of cases at high risk of progression to moderate, severe or critical COVID-19 combining simple clinical and biological parameters and qualitative, quantitative or artificial intelligence (AI) data from the initial CT from non-severe patients. The final objective is to organize optimal patient management in the appropriate health structure.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with suspicion of Covid-19
Key inclusion criteria (3 listed)
- First chest CT, assessed for respiratory symptoms, without injection of contrast agent for respiratory symptoms, and whose results of the CT subjective visual analysis are compatible or typical of COVID-19
- biological diagnosis of COVID-19 (RT-PCR) or clinical suspicion (cough and / or dyspnea and / or fever and / or need to use oxygen therapy as part of routine care) at the time of the examination
- Authorization of the patient for the processing of his personal data, except CNIL exemption
Key exclusion criteria (3 listed)
- Patient with a moderate (oxygen between 3 and 5 L / min to achieve saturation greater than 97% and a respiratory rate <25 / min without the need for invasive ventilation), severe form (oxygen therapy> 5L / min to obtain a SpO2> 97%) or critical form (need to resort to ventilation and / or orotracheal intubation) at the date of the first chest CT
- Age < 18 years old
- Patient deprived of liberty by judicial decision
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
occurrence of significant clinical degradation
Time frame: Day 30 following the initial chest CT
The primary outcome is defined by the occurrence of significant clinical degradation within 30 days following the initial chest CT. Significant clinical degradation is defined by the transition from the mild to the moderate form of COVID-19, i.e., according to the WHO criteria, the requirement of oxygen between 3 and 5 L / min to achieve saturation greater than 97% and a respiratory rate <25 / min without the need for invasive ventilation.
6 secondary outcomes
occurrence of a severe form
Time frame: Day 30 following the initial chest CT
occurrence of an orotracheal intubation
Time frame: Day 30 following the initial chest CT
occurrence of an Acute Respiratory Distress Syndrom
Time frame: Day 30 following the initial chest CT
average length of stay in hospital
Time frame: Month 1
mortality
Time frame: Day 30 following the initial chest CT
evolution of the imaging parameters
Time frame: Day 30 following the initial chest CT
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 12 Apr 2022.
- Derived from this study: PubMed 37405504Zysman M, Asselineau J, Saut O, Frison E, Oranger M, Maurac A, Charriot J, Achkir R, Regueme S, Klein E, Bommart S, Bourdin A, Dournes G, Casteigt J, Blum A, Ferretti G, Degano B, Thiebaut R, Chabot F, Berger P, Laurent F, Benlala I. Development and external validation of a prediction model for the transition from mild to moderate or severe form of COVID-19. Eur Radiol. 2023 Dec;33(12):9262-9274. doi: 10.1007/s00330-023-09759-x. Epub 2023 Jul 5.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
7 sites 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 University Hospital, Bordeaux at 7 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: finished, as of the sponsor's last update on 12 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 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?
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?
occurrence of significant clinical degradation (time frame: Day 30 following the initial chest CT). 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 NCT04481620, 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 12 Apr 2022.