Covid 19 Research using Clinical Trials (Home Page)
IC14, a monoclonal antibody against CD14Wiki
Developed by Shray Alag
Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation
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D012128 | Respiratory Distress Syndrome, Adult NIH | 0.09 |
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There is one clinical trial.
Clinical Trials
This protocol proposes to use IC14, a recombinant chimeric monoclonal antibody (mAb)
recognizing human CD14, to block CD14-mediated cellular activation in patients early in the
development of ARDS. The binding of IC14 to human CD14 prevents CD14 from participating in
the recognition of PAMPs and DAMPs due to SARS-CoV-2 infection. The putative mechanism of
action of IC14 in ARDS is blockade of PAMP and DAMP interactions with CD14, thus attenuating
the inflammatory cascade that leads to increased endothelial and epithelial permeability and
injury resulting in alveolar injury and fluid accumulation characteristic of ARDS.
IC14 is a chimeric monoclonal antibody that binds to CD14 with high affinity and inhibits
signaling via membrane and soluble CD14. Blocking CD14 with IC14 treatment in normal
volunteers strongly inhibits systemic inflammation in response to bacterial endotoxin (LPS).
University of Washington conducted a small NIH-funded pilot trial of IC14 treatment in 13
patients with ARDS, which suggested that IC14 treatment reduced alveolar inflammation and
decreased BAL cytokines. IC14 was also the subject of IND 105803 for a phase 2 study of ARDS
from all causes which we propose to revise for the COVID-19 indication.
A dosing regimen for IC14 with favorable pharmacokinetics supporting once daily intravenous
dosing has been defined, making this an acceptable treatment for hospitalized patients. Two
pharmacodynamic biomarkers can be used that are related to CD14, measurements of sCD14 (serum
at baseline; urine at baseline and follow up) as well as a CD14 fragment (sCD14-ST;
presepsin). A CD14 target engagement assay is available.
Therefore, because of the central role of CD14 in the amplification of lung inflammatory
responses leading to severe lung injury and the safety record of IC14 in humans, we propose
to have an open-label protocol to test the safety and potential efficacy of IC14 treatment in
preventing the progression of severe respiratory disease in patients hospitalized with
COVID-19.
NCT04346277 COVID ARDS, Human Ards SARS-CoV2 Biological: IC14, a monoclonal antibody against CD14
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