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

• Conditions: Superinfection Lung; COVID-19 Pneumonia
• Interventions: Diagnostic Test: Inflammatory markers sampling

• Registration Number: NCT04867161
• Lead Sponsor: Brno University Hospital

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.

Study Timeline

• Study Start: 2020-12-21
• Study First Submitted: 2021-04-27
• Study First Submitted QC: 2021-04-28
• Study First Posted: 2021-04-30
• Primary Completion: 2021-12-31
• Status Verified: 2022-06
• Last Update Submitted: 2022-06-29
• Last Update Posted: 2022-06-30
• Study Completion: 2022-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

1. admission on ICU
2. age more than 18 years
3. COVID-19 pneumonia criteria fulfilled

Exclusion Criteria

none

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with COVID-19 pneumonia without superinfection	Inflammatory markers sampling	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 )
Patients with COVID-19 pneumonia with superinfection	Inflammatory markers sampling	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 )

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University Hospital Brno; 🇨🇿 Brno, Czechia