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The Natural History of Hospitalized COVID-19 Patients (STORM)

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ClinicalTrials.gov Identifier: NCT04424992
Recruitment Status : Active, not recruiting
First Posted : June 11, 2020
Last Update Posted : June 11, 2020
Sponsor:
Information provided by (Responsible Party):
University of Milano Bicocca

Brief Summary:
This is an observational study. The aim is to describe the natural history and clinical evolution over time of hospitalized patients affected by Severe Acute Respiratory Syndrome-Coronavirus-2 (SARS-COV-2) infection, including the genetic pathology of the disease and improve therapeutic procedures.

Condition or disease Intervention/treatment
Sars-CoV2 Other: Observational cohort study on the natural history of hospitalized SARS-COV-2 patients.

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Study Type : Observational
Actual Enrollment : 1433 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Observational Cohort Study on the Natural History of Hospitalized SARS-COV-2 Patients: the STORM Trial
Actual Study Start Date : February 23, 2020
Actual Primary Completion Date : April 10, 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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
Serum from COVID+ patients


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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
Study Population
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).
Criteria

Inclusion Criteria:

  1. Clinical and / or radiological diagnosis of lung infection with COVID-19;
  2. Positive test for SARS-CoV-2 infection.

Exclusion Criteria:

1. Age less than 18 years


Information from the National Library of Medicine

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


Locations
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Italy
ASST Monza-Ospedale San Gerardo
Monza, Italy
Sponsors and Collaborators
University of Milano Bicocca
Publications:
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Responsible Party: University of Milano Bicocca
ClinicalTrials.gov Identifier: NCT04424992    
Other Study ID Numbers: STORM
First Posted: June 11, 2020    Key Record Dates
Last Update Posted: June 11, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Milano Bicocca:
Coronavirus
sars-covid-2
coronavirus infection