Natural History of Systemic and Nasal Mucosal Immunity to Influenza and SARS-CoV-2 in Adults After Vaccination
NCT04794829
COVID-19, Coronaviridae Infections
Bethesda, Maryland, United States
View Trial DetailsNCT Number: NCT04481620
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.
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Notify Me18 year and older
All sexes
Observational
CHU Bordeaux, Bordeaux, France
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: Day 30 following the initial chest CT
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
Time frame: Day 30 following the initial chest CT
the occurrence of an orotracheal intubation within 30 days following the initial chest CT (binary: yes/no)
Time frame: Day 30 following the initial chest CT
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)
Time frame: Month 1
the average length of stay in hospital (days)
Time frame: Day 30 following the initial chest CT
mortality within 30 days following the initial chest CT (binary: yes/no)
Time frame: Day 30 following the initial chest CT
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)
University Hospital, Bordeaux
Other
Evelopment and Validation of a Prediction Model for the Transition From Mild to Moderate Form of COVID-19, Using Data From Chest CT
Acronym: PREDICTCovid19
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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