drugset / Trial / NCT04462757

SCIL-1Ra in COVID-19 Feasibility & PK/PD

NCT04462757

Phase 2 Terminated 5 enrolled University of Manchester
RandomizedParallel-groupOpen-labelHealth-services research

Summary

The current COVID-19 pandemic is a worldwide healthcare crisis. Of concern is the large number of patients that are/will require mechanical ventilation, and the associated strain that this will place on healthcare resources. At present, there are no specific therapeutic interventions directed at COVID-19 infection. However, observational data suggest that there is a subgroup of patients that demonstrate a hyperinflammatory response in response to COVID-19 and have a higher requirement for Critical Care and higher mortality. There is a strong case for the use of the naturally occurring anti-inflammatory cytokine interleukin-1 receptor antagonist (IL-1Ra) in these patients. Anakinra is a recombinant form of IL-1Ra that is licensed for clinical use. Success of use of anakinra in COVID-19 trials will be greatly enhanced by robust scientific evidence and established pharmacokinetics which inform the most effective dosing regimens. The latter is especially important when, as in the case of anakinra, drug supplies are limited, the drug has short half-life and clinical ease of application is critical.

Timeline

Start
2020-05-28
Primary completion
2020-08-31
Completion
2020-12-23

Drugs

EvaluationDrugModalityDoseRoute
Comparator Anakinra Protein / enzyme biologic 100 mg Subcutaneous

Indications