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

• Status: Terminated
• Trial end date: 2020-12-23
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Manchester
• Treatments: Interleukin 1 Receptor Antagonist Protein

Criteria

Inclusion Criteria:

• Patient age 18 or above.

• Clinically suspected/proven COVID-19.

• Requiring organ support with one or more of:

• Non-invasive or invasive ventilatory support

• Receiving infusion of vasopressor or inotropes or both.

• No concomitant health problems that, in the opinion of the PI or designee in agreement with the treating clinician, would interfere with participation, administration of study drug or assessment of outcomes including safety.

Exclusion Criteria:

• More than 24h has elapsed since CCU admission.

• Death is deemed to be imminent and inevitable during the next 24h.

• One or more of: the patient, substitute decision-maker or the attending physician are not committed to full active treatment.

• Known condition resulting in ongoing immunosuppression including neutropenia (count < 1.5 x 10^9/L) prior to hospitalisation, malignancy, latent tuberculosis or chronic liver disease (if known).

• Previous or current treatment with anakinra or medication suspected of interacting with anakinra, listed in the drug SmPC, known at the time of trial entry or previous participation in this trial.

• Known to have received active treatment in a clinical trial of an investigational immunomodulatory agent (not including corticosteroids) within 30 days prior to study entry.

• Known to be pregnant or breast feeding or inability to reliably confirm that the patient is not pregnant.

• Known allergy to anakinra or any of the excipients listed in the drug SmPC

• Known allergy to other products that are produced by DNA technology using the micro-organism E. coli (e.g. Escherichia coli derived protein).