SEVERITY SCORE FOR COVID-19 PNEUMONIA

NCT ID: NCT04372199

Last Updated: 2020-05-01

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 248 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-04-29
• Study Completion Date: 2020-05-27

Brief 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.

Conditions

COVID; Pneumonia

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

OTHER

Sponsor Role: lead

Responsible Party

Massimo Montalto

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Massimo Montalto

Roma, , Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Massimo Montalto, Professor

Role: CONTACT

massimo.montalto@unicatt.it

+39 06 30155948

Facility Contacts

Massimo Montalto, Professor

Role: primary

massimo.montalto@unicatt.it

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

3112

Identifier Type: -

Identifier Source: org_study_id