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Status unknownNCT04372199Updated May 1, 2020

SEVERITY SCORE FOR COVID-19 PNEUMONIA

An observational study in COVID and Pneumonia, sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS. Status unknown at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-05-01.

Sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Observational

The sponsor has not verified this record recently (last verified Apr 2020), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
248
Ages
18 Years and older
Sex
All
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Study summary

The outbreak of the coronavirus disease 2019 (COVID-19), first merged in China in December 2019, is now becoming a Public Health Emergency, recently confirmed as a pandemic disease by the World Health Organization.

In particular, since February 2020, a rapidly growing number of cases has been identified in Italy.

The clinical picture of ranges from asymptomatic cases, mild upper respiratory tract infections to severe pneumonia with respiratory failure and death. In most severe cases, COVID-19 disease may be complicated by acute respiratory distress syndrome (ARDS), septic shock and multiorgan failure.

It results fundamental to early identify those subjects who rapidly may worsen their clinical status, often requiring an intensive care unit (ICU) admission.

It has been showed that, mainly in more severe forms of SARS-Cov-2 disease, there is the development of an hyperinflammatory status resembling a cytokine storm syndrome, as already reported in SARS patients.

A recent study by Haung et al. reported that patients with COVID-19 infection showed high amounts of IL1B, IFN-gamma, IP10 and MCP1, probably linked to activated T-helper1 (Th1) cell responses. Those requiring ICU admission had higher levels of cytokines than those subjects not requiring ICU admission, thus suggesting that cytokine storm was associated with disease severity.

A similarity between cytokine profile of COVID-19 disease and secondary haemophagocytic syndrome (sHLH) has been reported. Therefore, it was suggested to screen all patients with severe COVID-19 infection both for hyperinflammatory markers (like ferritin), and the HScore commonly used to generate a probability for diagnosis of sHLH (8), which includes some laboratory parameters like triglycerides, fibrinogen, ferritin, serum aspartate aminostransferase.

Based on our experience on patients affected by pneumonia from Covid19, we have observed that those subjects with a more severe prognosis might have some predictive markers. We intend to verify if these markers can identify those subjects with Covid19 infection who need a more intensive therapy and to find a prognosis score.

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Conditions studied

  • COVID
  • Pneumonia

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In context

Pneumonia

2,072 studies on the registry are indexed under Pneumonia; 286 are open to participants now.

This study's planned enrollment of 248 is above the median of 200 across 699 observational studies indexed under Pneumonia.

Browse Pneumonia studies →

Lead sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS is the lead sponsor of 948 studies on the registry; 537 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

The study sample will be constituted by inpatients cases of COVID-19 admitted to Internal Medicine Department of Fondazione Policlinico A. Gemelli IRCCS.

Eligibility criteria

Inclusion Criteria: Patients with diagnosis of pneumonia, confirmed by chest imaging, Covid-19 test positive

Exclusion Criteria: Age lower than 18 years, pregnancy or breast-feeding

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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
248 participants (estimated)
Target follow-up
1 Month
Patient registry
Yes
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What researchers measure

Primary outcomes

  1. To identify the best predictors of critical coronavirus pneumonia and to realize a simple severity score able to early classify high-risk individuals admitted to Internal Medicine Department for COVID-19 disease, needing an intensive approach

    Time frame: 1 month

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Study locations

1 of 1 sites recruiting
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References and documents

Study documents

  • Protocol and statistical analysis plan · Apr 17, 2020

Documents are hosted by the registry — open the source record to download them.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 1, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04372199
Responsible party
Massimo Montalto (Professor, Fondazione Policlinico Universitario Agostino Gemelli IRCCS) — Principal investigator
First posted
May 1, 2020
Start date
Apr 29, 2020
Primary completion
May 27, 2020 (estimated)
Completion
May 27, 2020 (estimated)
Last update
May 1, 2020

Study contacts

Massimo Montalto, Professor
Contact
massimo.montalto@unicatt.it
+39 06 30155948

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Apr 2020. You cannot join it, but the record below documents what was studied.

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