SARS-CoV-2 InfectionQUANTICO-RETRONCT04534400
Automated Quantification of Radiologic Pulmonary Alteration During Acute Respiratory Failure
An observational study of SARS-CoV-2 Infection and Respiratory Failure With Hypoxia, run by University Hospital, Strasbourg, France at 2 sites in France.
Trial summary
Automated quantification of the pulmonary volume impaired during acute respiratory failure could be helpful to assess patient severity during COVID-19 infection or perioperative medicine, for example. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- SARS-CoV-2 Infection, Respiratory Failure With Hypoxia
- What is being tested?
- thoracic CT-scan
- Type of treatment
- Surgery or procedure
- How many people
- 1,000 participants
- Where
- 2 sitesFrance
- Study dates
- 1 Sep 2020to 1 Mar 2024
- 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
- Adult, Older adult
Study population: Hospitalized patients that underwent a thoracic CT-scan
Who may be able to join
- patient with insurance covering
- patient admitted to the participating hospitals for SARS-CoV-2 infection or postoperative acute hypoxemic respiratory failure between 01/01/2019 and 05/11/2020
Who cannot join
- patient transferred to another hospital than the participating center during the 7 days following the CT scan
Trial locations and contacts
2 sites in 1 country.
France2 sites, 2 recruiting
- Recruiting
HÔPITAUX UNIVERSITAIRES DE STRASBOURG, Hôpital de Hautepierre, Service de Réanimation Médicale
Strasbourg, 67098
Eric NOLL, MD, 33388127076, eric.noll@chru-strasbourg.fr
Pierre DIEMUNSCH, MD, 33388125720, pierre.diemunsch@chru-strasbourg.fr
- Not yet recruiting
Hôpitaux Universitaires de Nancy Service d'anesthésie réanimation Hôpital de Brabois
Vandœuvre-lès-Nancy, 54500
Claude MEISTELMAN, MD, 33383154166, c.meistelman@chru-nancy.fr
Valérie CROISE-LAURENT, MD
About this study
Official title: Automated Quantification of Radiologic Pulmonary Alteration During Acute Respiratory Failure: Application to the COVID-19 Pandemic
Automated quantification of the pulmonary volume impaired during acute respiratory failure could be helpful to assess patient severity during COVID-19 infection or perioperative medicine, for example.
This study aim at assessing the correlation between the amount of radiologic pulmonary alteration and the clinical severity in two clinical situation :
- SARS-CoV-2 infections
- Postoperative hypoxemic acute respiratory failure
- Being tested
- thoracic CT-scan
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
thoracic CT-scanRadiation
Automated measurement
| Study group | Role | What they receive |
|---|---|---|
| Patients with SARS-CoV-2 infection | Not described Receives: Radiation: thoracic CT-scan | |
| Patients with Postoperative hypoxemic respiratory failure | Not described Receives: Radiation: thoracic CT-scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between altered pulmonary volume and ordinal severity scale
Measured: 2 days after CT scan
Secondary outcomes (1)
Correlation between altered pulmonary volume and ordinal severity scale
Measured: 7 days after CT scan
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2020
- Study start1 Sep 2020
- Primary completion1 Mar 2024 (estimated)
- Study completion1 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SARS-CoV-2 InfectionStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe 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
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Collaborators
- VISIBLE PATIENT, E-MEDIA
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04534400
- Sponsor's protocol ID
- 7888
- Acronym
- QUANTICO-RETRO
- Status last verified
- Apr 2023
- First submitted
- 26 Aug 2020
- Last updated
- 18 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Automated Quantification of Radiologic Pulmonary Alteration During Acute Respiratory Failure: Application to the COVID-19 Pandemic
- ClinicalTrials.gov ID
- NCT04534400
- Acronym / sponsor ID
- QUANTICO-RETRO / 7888
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Collaborators
- VISIBLE PATIENT, E-MEDIA
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 1 Mar 2024 (estimated)
- Study completion
- 1 Mar 2024 (estimated)
- First posted
- 1 Sep 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.
Automated quantification of the pulmonary volume impaired during acute respiratory failure could be helpful to assess patient severity during COVID-19 infection or perioperative medicine, for example.
This study aim at assessing the correlation between the amount of radiologic pulmonary alteration and the clinical severity in two clinical situation :
- SARS-CoV-2 infections
- Postoperative hypoxemic acute respiratory failure
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with SARS-CoV-2 infection | – | Radiation: thoracic CT-scan |
| Patients with Postoperative hypoxemic respiratory failure | – | Radiation: thoracic CT-scan |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Hospitalized patients that underwent a thoracic CT-scan
Key inclusion criteria (2 listed)
- patient with insurance covering
- patient admitted to the participating hospitals for SARS-CoV-2 infection or postoperative acute hypoxemic respiratory failure between 01/01/2019 and 05/11/2020
Key exclusion criteria (1 listed)
- patient transferred to another hospital than the participating center during the 7 days following the CT scan
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 |
|---|---|---|
| thoracic CT-scanAutomated measurement | Radiation | Patients with Postoperative hypoxemic respiratory failure, Patients with SARS-CoV-2 infection |
Primary outcome
Correlation between altered pulmonary volume and ordinal severity scale
Time frame: 2 days after CT scan
1 secondary outcome
Correlation between altered pulmonary volume and ordinal severity scale
Time frame: 7 days after CT scan
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2023.
- 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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of SARS-CoV-2 Infection and Respiratory Failure With Hypoxia, run by University Hospital, Strasbourg, France at 2 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 2 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: status not confirmed, as of the sponsor's last update on 18 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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 Eric NOLL, MD (33388127076, eric.noll@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation between altered pulmonary volume and ordinal severity scale (time frame: 2 days after CT scan). 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 18 Apr 2023.