Biomarker-based Early Anti-inflammatory Therapy for severe COVID-19

Rationale:
The clinical risk factors that predispose to the development of acute severe lung injury in COVID-19 are higher age, obesity, diabetes mellitus and a medical history of heart or lung disease [1]. Besides these known factors, the underlying mechanisms that lead to increased inflammation that appears to be the mechanism of acute severe lung disease and multi-organ failure, remain largely unknown. The inflammatory cytokine IL-6 is increased in patients, and several clinical trials have now been registered which plan to investigate the effect of the anti-IL-6 monoclonal antibody tocilizumab, as an inhibitor of inflammation in COVID-19.
According to the observations of the Chinese patients in Wuhan and other epicentres of the pandemic, and confirmed by our own observations, progression towards severe lung injury and multi-organ failure occurs around one week after onset of symptoms. Beside the known risk factors that somewhat help clinicians predict which patients are vulnerable, in this study, pro-inflammatory biomarker profiles, including IL-6, will be used to stratify these patients in a more substantiated manner. The specific biomarker profiles which are associated with the development of acute severe lung disease, can be targeted in new and patient specific treatments for COVID-19, to prevent further deterioration.

Objectives:
- Identifying the pro-inflammatory biomarker profile in the pathophysiology of acute sever lung disease in SARS-CoV-2 infection, and using this profile to identify the patients who are at risk of developing acute severe lung disease and multi-organ failure.
- Identifying cellular immune biomarkers that predict higher chance to develop acute severe lung disease in SARS-CoV-2 infection, both at admission and during monitoring.

Study design:
Prospective Observational Cohort Study

Study population:
Patients with PCR confirmed COVID-19 admitted to the hospital, who are 18 years or older

Main study parameters/endpoints:
The main endpoint is the identification of pro-inflammatory biomarkers and cellular immune biomarkers in the development of acute severe lung injury and multi-organ failure in infection with SARS-CoV-2

Nature and extent of the burden and risks associated with participation, benefit and group relatedness:
The burden of this study for the participants is related to extra blood samples and nasal swabs. Therefore, the risk is negligible and the burden minimal. The study is group related as we only plan to investigate the population with COVID-19 admitted to the hospital.

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During hospital admission: every Monday, Wednesday and Friday and 6 weeks after hospital stay.

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