The Natural History of Hospitalized COVID-19 Patients (STORM)
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|ClinicalTrials.gov Identifier: NCT04424992|
Recruitment Status : Recruiting
First Posted : June 11, 2020
Last Update Posted : August 3, 2022
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|Condition or disease||Intervention/treatment|
|Sars-CoV2||Other: Observational cohort study on the natural history of hospitalized SARS-COV-2 patients.|
|Study Type :||Observational|
|Estimated Enrollment :||1433 participants|
|Official Title:||Observational Cohort Study on the Natural History of Hospitalized SARS-COV-2 Patients: the STORM Trial|
|Actual Study Start Date :||February 28, 2020|
|Actual Primary Completion Date :||December 28, 2021|
|Estimated Study Completion Date :||May 2023|
Covid19 infection related patients
The patients enrolled in the study are all patients with clinical and microbiological diagnosis of COVID-19 infection hospitalized since February 23, 2020 at San Gerardo Hospital (ASST-Monza).
Other: Observational cohort study on the natural history of hospitalized SARS-COV-2 patients.
Describe the natural history and clinical evolution of hospitalized patients over time affected by SARS-COV-2 infection, understand the pathogenesis of the disease and improve the aids and therapeutic procedures.
- Covid19 infection clinical evolution [ Time Frame: Until patient discharge from the hospital (approximately 1 year) ]Description over time of hospitalized patients suffering from SARS-COV-2 infection to better understand the pathogenesis of the disease and improve the controls and therapeutic procedures.
- Risk factors for intra-hospital mortality [ Time Frame: Until patient discharge from the hospital (approximately 1 year) ]Identify risk factors for intra-hospital mortality in hospital wards COVID + patients.
- The impact of a fragility index (IF) [ Time Frame: Until patient discharge from the hospital (approximately 1 year) ]Assess the impact of a fragility index (IF) on the clinical course of COVID + patients.
- Prognostic score [ Time Frame: Until patient discharge from the hospital (approximately 1 year). ]Build a prognostic score through which it is possible define a stratification that orients, according to the state of hospitalization, the therapeutic choices.
- The lung sequelae of SARS-COV-2 pneumonia [ Time Frame: Until patient discharge from the hospital (approximately 1 year) ]Differentiate the lung sequelae related to the evolution of viral damage from those of cheater / volutrauma connected to non-invasive (NIV-CPAP) or invasive (MV) ventilation methods.
- The accuracy of IF in elderly patients [ Time Frame: Until patient discharge from the hospital (approximately 1 year) ]Assess the accuracy of IF in elderly patients in terms of clinical outcomes compared to one clinical evaluation based on age and co-morbidity.
- Coagulation system anomalies [ Time Frame: Until patient discharge from the hospital (approximately 1 year) ]Describe the anomalies of the coagulation system, which appear on patients affected by SARS-COV-2 pneumonia.
- The impact of the prone position on the oxygenation [ Time Frame: Until patient discharge from the hospital (approximately 1 year) ]Description of the impact of the prone position in terms of increased oxygenation of the patient suffering from SARS-COV-2 pneumonia as an index lung recruitment.
Biospecimen Retention: Samples With DNA
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
|Sampling Method:||Non-Probability Sample|
- Clinical and / or radiological diagnosis of lung infection with COVID-19;
- Positive test for SARS-CoV-2 infection.
1. Age less than 18 years
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04424992
|Contact: Paolo Bonfanti||+39 039 233 email@example.com|
|ASST Monza-Ospedale San Gerardo||Recruiting|
|Contact: Paolo Bonfanti|
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
|Responsible Party:||University of Milano Bicocca|
|Other Study ID Numbers:||
|First Posted:||June 11, 2020 Key Record Dates|
|Last Update Posted:||August 3, 2022|
|Last Verified:||July 2022|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|