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…
ID
Source
Brief title
Condition
- Viral infectious disorders
- Respiratory tract infections
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main endpoint is the identification of pro-inflammatory biomarkers in the
development of acute severe lung injury and multi-organ failure in infection
with SARS-CoV-2
Secondary outcome
See protocol section 8.1.2 Secondary study parameters/endpoints
Background summary
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. 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.
Study objective
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.
Study design
Prospective Observational Cohort Study
Study burden and risks
The burden of this study for the participants is related to extra blood samples
and nasal swabs. Therefore, we assume the risk to be 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.
Albinusdreef 2
Leiden 2333ZA
NL
Albinusdreef 2
Leiden 2333ZA
NL
Listed location countries
Age
Inclusion criteria
hospitalized patients
- Hospitalized patient with PCR confirmed COVID-19 infection
- Eighteen years or older
healthy volunteers
- Not-hospitalized
- Sixty years or older
- Sars-CoV-2 serology negative
mild infection
- Positive SARS-CoV-2 PCR test from the GGD
- No or limited symptoms of a viral airway infection (fever, cough, dyspnea,
rhinorroea, myalgia, anosmia) at the time of inclusion
- Age 18 years or older
Exclusion criteria
Patients and healthy controls
- Not able to give consent by the healthy volunteer, or the patient or patients
representative
Healthy controls
- Symptoms of viral airway infection (e.g. fever, cough, rhinorroea,
dyspnea) at screening or inclusion
Group of infected individuals with little or no symptoms:
- Having received vaccination against SARS-CoV-2 or previous confirmed
infection with SARS-CoV-2.
- Not being able to come to LUMC by own transportation to donate samples.
Design
Recruitment
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL73740.058.20 |