Ignite Creation Date:
2024-05-06 @ 2:38 PM
Last Modification Date:
2024-10-26 @ 1:34 PM
Study NCT ID:
NCT04372199
Status:
UNKNOWN
Last Update Posted:
2020-05-01
First Post:
2020-04-29
Brief Title:
SEVERITY SCORE FOR COVID-19 PNEUMONIA
Sponsor:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Organization:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Study Overview
Official Title:
VALIDATION OF A SEVERITY SCORE TO IDENTIFY PATIENTS ADMITTED FOR COVID-19 PNEUMONIA AT HIGH RISK FOR AN INTENSIVE APPROACH
Status:
UNKNOWN
Status Verified Date:
2020-04
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None