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

COVID-19 Pneumonia Clinical Trial

— SUPER-HI  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04867161
• Other study ID #: 146/20
• Status: Recruiting
• Start date: December 21, 2020
• Est. completion date: December 31, 2022

Study information

• Verified date: June 2022
• Source: Brno University Hospital
• Contact: Jan Maláska
• Phone: +420532232009
• Email: jan.malaska[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

Inclusion Criteria:

1. admission on ICU

2. age more than 18 years

3. COVID-19 pneumonia criteria fulfilled

Exclusion Criteria: none

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Related Conditions & MeSH terms

• COVID-19
• COVID-19 Pneumonia
• Pneumonia

Intervention

Diagnostic Test:
• Inflammatory markers sampling
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

Locations

Country	Name	City	State
Czechia	University Hospital Brno	Brno

Sponsors (2)

Lead Sponsor	Collaborator
Brno University Hospital	Masaryk University

Country where clinical trial is conducted

Czechia, 

References & Publications (5)

Keddie S, Ziff O, Chou MKL, Taylor RL, Heslegrave A, Garr E, Lakdawala N, Church A, Ludwig D, Manson J, Scully M, Nastouli E, Chapman MD, Hart M, Lunn MP. Laboratory biomarkers associated with COVID-19 severity and management. Clin Immunol. 2020 Dec;221:108614. doi: 10.1016/j.clim.2020.108614. Epub 2020 Oct 22. — View Citation

Lansbury L, Lim B, Baskaran V, Lim WS. Co-infections in people with COVID-19: a systematic review and meta-analysis. J Infect. 2020 Aug;81(2):266-275. doi: 10.1016/j.jinf.2020.05.046. Epub 2020 May 27. — View Citation

Manson JJ, Crooks C, Naja M, Ledlie A, Goulden B, Liddle T, Khan E, Mehta P, Martin-Gutierrez L, Waddington KE, Robinson GA, Ribeiro Santos L, McLoughlin E, Snell A, Adeney C, Schim van der Loeff I, Baker KF, Duncan CJA, Hanrath AT, Lendrem BC, De Soyza A, Peng J, J'Bari H, Greenwood M, Hawkins E, Peckham H, Marks M, Rampling T, Luintel A, Williams B, Brown M, Singer M, West J, Jury EC, Collin M, Tattersall RS. COVID-19-associated hyperinflammation and escalation of patient care: a retrospective longitudinal cohort study. Lancet Rheumatol. 2020 Oct;2(10):e594-e602. doi: 10.1016/S2665-9913(20)30275-7. Epub 2020 Aug 21. — View Citation

Rawson TM, Moore LSP, Zhu N, Ranganathan N, Skolimowska K, Gilchrist M, Satta G, Cooke G, Holmes A. Bacterial and Fungal Coinfection in Individuals With Coronavirus: A Rapid Review To Support COVID-19 Antimicrobial Prescribing. Clin Infect Dis. 2020 Dec 3;71(9):2459-2468. doi: 10.1093/cid/ciaa530. Review. — View Citation

WHO Working Group on the Clinical Characterisation and Management of COVID-19 infection. A minimal common outcome measure set for COVID-19 clinical research. Lancet Infect Dis. 2020 Aug;20(8):e192-e197. doi: 10.1016/S1473-3099(20)30483-7. Epub 2020 Jun 12. Review. Erratum in: Lancet Infect Dis. 2020 Oct;20(10):e250. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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