Superinfection and Hyperinflammatory Phenotype in COVID-19 (Coronavirus Disease 2019) Pneumonia Patients

Study Overview
=================
Brief Summary
-----------------
Patients suffering from COVID-19 (Coronavirus Disease 2019) pneumonia are prone to bacterial and mycotic superinfection. According to existing evidence, the prevalence of superinfection is about 8% to 14% (95% CI 5-26%). However, the percentage of patients treated for superinfection is as high as 80%. There can be multiple reasons for this difference.

Detailed Description
-----------------
The inflammatory markers, such as C-reactive protein (CRP), procalcitonin (PCT), presepsin (PSP), interleukin-6 (IL-6) frequently used as diagnostic tools in COVID-19 (Coronavirus Disease 2019), are usually increased in these patients. This increase is a result of activation of systemic inflammatory cascade, part of COVID-19 pathophysiologic pathway. This can escalate to state known as COVID-19 associated hyperinflamation (COV-HI). In addition, current diagnostic tools for diagnosing HAP/VAP (hospital-acquired pneumonia and ventilator-associated pneumonia) are often limited in patients with COVID-19 pneumonia. The current method of choice for superinfection diagnosing is BAL (Bronchoalveolar Lavage). The COV-HI phenotype (COV-HI: CRP > 150 mg/L, or doubling within 24 h from greater than 50 mg/L, or ferritin concentration > 1500 ug/L) is associated with significantly worse course of illness and higher mortality rates. These inflammatory markers may be used preferentially as prognostication tools, not bacterial superinfection markers. The intention of this project is to investigate the role of currently used inflammatory biomarkers. Or eventually, to discover new parameters associated with superinfection proven by BAL.

Official Title
-----------------
Superinfection and Hyperinflammatory Phenotype in COVID-19 (Coronavirus Disease 2019) Pneumonia Patients (SUPER-HI) - Prospective Observational Study

Conditions
-----------------
COVID-19 Pneumonia, Superinfection Lung

Intervention / Treatment
-----------------
* Diagnostic Test: Inflammatory markers sampling


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: admission on ICU age more than 18 years COVID-19 pneumonia criteria fulfilled Exclusion Criteria: none -

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with COVID-19 pneumonia without superinfection<br>Patients with confirmed COVID-19 pneumonia not fulfilling criteria for diagnosis HAP/VAP (International ERS/ESICM/ESCMID/ALAT guidelines for the management of hospital-acquired pneumonia and ventilator-associated pneumonia ) | Diagnostic Test: Inflammatory markers sampling<br>* Laboratory sampling: Haematology: complete blood count, reticulocytes, IFP, PT, aPTT, fibrinogen, D-dimer Biochemical profile: urea, creatinine, bilirubin, ALT, AST, GGT, CK, LD, ferritin, troponin Inflammation markers IL-6, PCT (procalcitonin), CRP (C-reactive protein), PSP (presepsin) BALF (bronchoalveolar lavage fluid) processing protocol: microbiology: microscopic examination, standard cultivation test biochemistry: albumin, total protein Pathology: cytology PCR: a. Multiplex PCR b. SARS-CoV-2 RNA load<br>|
| Patients with COVID-19 pneumonia with superinfection<br>Patients with confirmed COVID-19 pneumonia fulfilling criteria for diagnosis HAP/VAP (International ERS/ESICM/ESCMID/ALAT guidelines for the management of hospital-acquired pneumonia and ventilator-associated pneumonia ) | Diagnostic Test: Inflammatory markers sampling<br>* Laboratory sampling: Haematology: complete blood count, reticulocytes, IFP, PT, aPTT, fibrinogen, D-dimer Biochemical profile: urea, creatinine, bilirubin, ALT, AST, GGT, CK, LD, ferritin, troponin Inflammation markers IL-6, PCT (procalcitonin), CRP (C-reactive protein), PSP (presepsin) BALF (bronchoalveolar lavage fluid) processing protocol: microbiology: microscopic examination, standard cultivation test biochemistry: albumin, total protein Pathology: cytology PCR: a. Multiplex PCR b. SARS-CoV-2 RNA load<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Inflammatory markers dynamics in participants with superinfection in COVID-19 pneumonia | To investigate the role of inflammatory markers (CRP, PCP, PSP, IL-6) as diagnostic tools for superinfection in COVID-19 pneumonia patients. | 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality from any cause | To assess the association between hyperinflammatory phenotype and course of illness and mortality rates in COVID-19 pneumonia patients. | 28, 60, 90, 180, 360 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
COVID-19, superinfection, inflammatory markers