Natural history of COVID-19 in hospitalized adults
Observational Cohort Study on the Natural History of Hospitalized SARS-COV-2 Patients: the STORM Trial
This project will follow adults hospitalized with COVID-19 to see how the illness and treatments change over time.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1433 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Milano Bicocca Academic / other |
| Locations | 1 site (Monza) |
| Trial ID | NCT04424992 on ClinicalTrials.gov |
What this trial studies
The study prospectively collects clinical, diagnostic, therapeutic, and laboratory data from adults hospitalized with SARS‑CoV‑2 infection using an eCRF on the REDCap platform. Data are organized in a 'stem and leaf' database structure aligned with WHO pandemic data recommendations, with a core dataset and optional 'leaf' modules for specific protocols. The intent is to describe disease course, identify risk strata for fatal events, and inform real-world therapeutic procedures. Enrollment is limited to patients aged 18 and over with clinical or radiological evidence of COVID‑19 and a positive SARS‑CoV‑2 test at the participating center.
Who should consider this trial
Good fit: Adults (18+) hospitalized with clinical or radiological evidence of lung infection and a laboratory-confirmed positive SARS‑CoV‑2 test are ideal candidates.
Not a fit: Children under 18, non-hospitalized patients, or people without a confirmed positive SARS‑CoV‑2 test are not eligible and would not benefit from this protocol.
Why it matters
Potential benefit: If successful, the data could help clinicians predict which hospitalized patients are at higher risk and refine treatment pathways to reduce complications and deaths.
How similar studies have performed: Numerous observational cohorts worldwide have already described the natural history of hospitalized COVID‑19 patients and contributed to risk stratification, so this approach builds on established methods.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Monza
- ASST Monza-Ospedale San Gerardo — Monza, Italy (Recruiting)
Study contacts
- Study coordinator: Paolo Bonfanti
- Email: paolo.bonfanti@unimib.it
- Phone: +39 039 233 9310
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.