The Natural History of Hospitalized COVID-19 Patients

NCT04424992 | Recruiting DMC

• 1 other identifier: STORM
• Study Type: observational
• Target: 1,433
• Locations: 1 country
• Sites: 1

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.

Conditions

Sars-CoV2

Keywords

Coronavirus; sars-covid-2; coronavirus infection

Outcome Measures

Primary Outcomes (1)

• Covid19 infection clinical evolution

  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.

  Until patient discharge from the hospital (approximately 1 year)

Secondary Outcomes (7)

• Risk factors for intra-hospital mortality

  Until patient discharge from the hospital (approximately 1 year)

• The impact of a fragility index (IF)

  Until patient discharge from the hospital (approximately 1 year)

• Prognostic score

  Until patient discharge from the hospital (approximately 1 year).

• The lung sequelae of SARS-COV-2 pneumonia

  Until patient discharge from the hospital (approximately 1 year)

• The accuracy of IF in elderly patients

  Until patient discharge from the hospital (approximately 1 year)

Study Arms (1)

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.

Interventions

Observational cohort study on the natural history of hospitalized SARS-COV-2 patients. OTHER

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 related patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

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

You may not qualify if:

• \. Age less than 18 years

Sponsors & Collaborators

• University of Milano Bicocca: lead

Study Sites (1)

ASST Monza-Ospedale San Gerardo

Monza, Italy

RECRUITING

Related Publications (6)

• Onder G, Rezza G, Brusaferro S. Case-Fatality Rate and Characteristics of Patients Dying in Relation to COVID-19 in Italy. JAMA. 2020 May 12;323(18):1775-1776. doi: 10.1001/jama.2020.4683. No abstract available.

  PMID: 32203977 BACKGROUND

• Wu Z, McGoogan JM. Characteristics of and Important Lessons From the Coronavirus Disease 2019 (COVID-19) Outbreak in China: Summary of a Report of 72 314 Cases From the Chinese Center for Disease Control and Prevention. JAMA. 2020 Apr 7;323(13):1239-1242. doi: 10.1001/jama.2020.2648. No abstract available.

  PMID: 32091533 BACKGROUND

• Friesecke S, Stecher SS, Gross S, Felix SB, Nierhaus A. Extracorporeal cytokine elimination as rescue therapy in refractory septic shock: a prospective single-center study. J Artif Organs. 2017 Sep;20(3):252-259. doi: 10.1007/s10047-017-0967-4. Epub 2017 Jun 6.

  PMID: 28589286 BACKGROUND

• Yuan FF, Tanner J, Chan PK, Biffin S, Dyer WB, Geczy AF, Tang JW, Hui DS, Sung JJ, Sullivan JS. Influence of FcgammaRIIA and MBL polymorphisms on severe acute respiratory syndrome. Tissue Antigens. 2005 Oct;66(4):291-6. doi: 10.1111/j.1399-0039.2005.00476.x.

  PMID: 16185324 BACKGROUND

• Squillace N, Cogliandro V, Rossi E, Bellelli G, Pozzi M, Luppi F, Lettino M, Strepparava MG, Ferrarese C, Pollastri E, Ricci E, Bonfanti P; STORM Long-COVID Team. A multidisciplinary approach to screen the post-COVID-19 conditions. BMC Infect Dis. 2023 Jan 24;23(1):54. doi: 10.1186/s12879-023-08006-4.

  PMID: 36694110 DERIVED

• Coppadoro A, Benini A, Fruscio R, Verga L, Mazzola P, Bellelli G, Carbone M, Mulinacci G, Soria A, Noe B, Beck E, Di Sciacca R, Ippolito D, Citerio G, Valsecchi MG, Biondi A, Pesci A, Bonfanti P, Gaudesi D, Bellani G, Foti G. Helmet CPAP to treat hypoxic pneumonia outside the ICU: an observational study during the COVID-19 outbreak. Crit Care. 2021 Feb 24;25(1):80. doi: 10.1186/s13054-021-03502-y.

  PMID: 33627169 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Serum from COVID+ patients

MeSH Terms

Conditions

Coronavirus Infections

Condition Hierarchy (Ancestors)

Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections

Central Study Contacts

Paolo Bonfanti

CONTACT

+39 039 233 9310; paolo.bonfanti@unimib.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 4, 2020
• First Posted: June 11, 2020
• Study Start: February 28, 2020
• Primary Completion: December 28, 2025
• Study Completion: December 31, 2025
• Last Updated: July 25, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)