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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON23631

Enrollment

250

Registered

2020-05-07

Start date

2020-04-23

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

coronavirus

Interventions

None listed

Eligibility

Inclusion criteria

Inclusion criteria: - Hospitalized patient with PCR confirmed COVID-19 infection - Eighteen years or older

Exclusion criteria

Exclusion criteria: - Not able to give consent by representative of the subject

Design outcomes

Primary

Measure	Time frame
Biomarker profiles or signature which correlate with future clinical progression of patients infected with SARS-CoV-2 to multi-organ failure and acute severe lung injury requiring mechanical ventilation.	—

Secondary

Measure	Time frame
The kinetics of: - Circulating soluble serum biomarkers of innate, adaptive and inflammatory immune responses, in order to decipher and validate biomarker signatures of disease severity and risk of acute disease progression. - Circulating cellular immune responses, focusing on the distribution of various immune subsets (granulocytes, lymphocytes, monocytic and innate populations) and the innate responses to bacterial or viral motifs (LPS, CpG and PolyIC) and polyclonal and/or specific adaptive immune responses (PHA and SARS-CoV-2). - Circulating cellular immune responses, focusing on the distribution and quantitation of >250 leukocyte subsets, including 20-25 different innate myeloid cells (granulocyte, monocyte, and dendritic cell subsets, etc.), >85 CD4 T-cell subsets, >45 CD8-NK cell subsets, and >115 B-cell & plasma cell subsets. Special attention will be given to the B-cell system, particularly to minor clonal subsets and the kinetics of expanded plasma cell subsets, down to levels of 0.1 cell per µL. - Nasal and lung (using cells from lung aspirates) cellular immune responses, focusing on the distribution of various immune subsets (granulocytes, lymphocytes, monocytic and innate populations) and their activation status based on surface markers by mass cytometry (>40 marker panel). Nasal metabolomics. - Antibody glycosylation: Total IgG Fc glycosylation and SARS-CoV-19 specific IgG Fc glycosylation profiles (Fc glycosylation as general biomarker of immune activation, SARS-CoV-19 specific IgG Fc glycosylation as co-marker for development of immunity, see parameter “SARS-CoV2 specific serology - Serum glycan profile, anti-glycan IgG/IgM profiles - RNA expression profiles in whole blood to allow for pathway analysis and characterize different inflammatory responses. Particularly sepsis response phenotypes (e.g. glucosteroid receptor signaling pathway, T cell exhaustion) for the ICU patients. - Viral load, focusing on measured cycle-threshold (Ct) value kinetics	—

Measure

Time frame

The kinetics of: - Circulating soluble serum biomarkers of innate, adaptive and inflammatory immune responses, in order to decipher and validate biomarker signatures of disease severity and risk of acute disease progression. - Circulating cellular immune responses, focusing on the distribution of various immune subsets (granulocytes, lymphocytes, monocytic and innate populations) and the innate responses to bacterial or viral motifs (LPS, CpG and PolyIC) and polyclonal and/or specific adaptive immune responses (PHA and SARS-CoV-2). - Circulating cellular immune responses, focusing on the distribution and quantitation of >250 leukocyte subsets, including 20-25 different innate myeloid cells (granulocyte, monocyte, and dendritic cell subsets, etc.), >85 CD4 T-cell subsets, >45 CD8-NK cell subsets, and >115 B-cell & plasma cell subsets. Special attention will be given to the B-cell system, particularly to minor clonal subsets and the kinetics of expanded plasma cell subsets, down to levels of 0.1 cell per µL. - Nasal and lung (using cells from lung aspirates) cellular immune responses, focusing on the distribution of various immune subsets (granulocytes, lymphocytes, monocytic and innate populations) and their activation status based on surface markers by mass cytometry (>40 marker panel). Nasal metabolomics. - Antibody glycosylation: Total IgG Fc glycosylation and SARS-CoV-19 specific IgG Fc glycosylation profiles (Fc glycosylation as general biomarker of immune activation, SARS-CoV-19 specific IgG Fc glycosylation as co-marker for development of immunity, see parameter “SARS-CoV2 specific serology - Serum glycan profile, anti-glycan IgG/IgM profiles - RNA expression profiles in whole blood to allow for pathway analysis and characterize different inflammatory responses. Particularly sepsis response phenotypes (e.g. glucosteroid receptor signaling pathway, T cell exhaustion) for the ICU patients. - Viral load, focusing on measured cycle-threshold (Ct) value kinetics

—

Contacts

Public ContactAnna Roukens

Leiden University Medical Center

a.h.e.roukens@lumc.nl+31715262613

Outcome results