COVID-19 Clinical Trial
— SCIL_COV19Official title:
Subcutaneous and Intravenous IL-1Ra (Anakinra) in COVID-19 Infection - Feasibility & Pharmacokinetics/Pharmacodynamics Study
Verified date | April 2021 |
Source | University of Manchester |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 5 |
Est. completion date | December 23, 2020 |
Est. primary completion date | August 31, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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). |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Manchester Univesity NHS Foundation Trust | Manchester | |
United Kingdom | Salford Royal NHS Foundation Tust | Salford |
Lead Sponsor | Collaborator |
---|---|
University of Manchester |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Plasma IL-1Ra levels | Plasma IL-1Ra levels from Day 1 to Day 7 following administration of SC anakinra in patients with SARS-CoV-2 | 1 week | |
Primary | Plasma IL-6 levels | Plasma IL-6 levels from Day 1 to Day 7 following administration of SC anakinra in patients with SARS-CoV-2 | 1 week | |
Secondary | Plasma markers | Plasma markers including IL-6 from Day 1 to Day 14 in all participants | 2 weeks | |
Secondary | Plasma markers | Plasma markers including CRP from Day 1 to Day 14 in all participants | 2 weeks | |
Secondary | Plasma markers | Plasma markers including CXCL9 from Day 1 to Day 14 in all participants | 2 weeks | |
Secondary | Plasma markers | Plasma markers including IL-1 from Day 1 to Day 14 in all participants | 2 weeks | |
Secondary | Plasma markers | Plasma markers including IL-2 from Day 1 to Day 14 in all participants | 2 weeks | |
Secondary | Plasma markers | Plasma markers including HMBG-1 from Day 1 to Day 14 in all participants | 2 weeks | |
Secondary | Plasma markers | Plasma markers including IL-33 from Day 1 to Day 14 in all participants | 2 weeks | |
Secondary | Safety Endpoints related to the Serious adverse reactions of the IMP | Safety endpoints include: a. Severe fatal or life-threatening serious adverse reactions (duration of IMP plus 30h from last dose). |
2 weeks | |
Secondary | Safety Endpoints related to the anaphylactic reactions of the IMP | Safety endpoints include: b. Anaphylactic/anaphylactoid reactions (duration of IMP plus 30h from last dose). |
2 weeks | |
Secondary | Safety Endpoints related to neutropenia caused by the IMP | Safety endpoints include: c. Severe neutropenia (< 1.5 x 109 /L) (duration of IMP) |
2 weeks | |
Secondary | Safety Endpoints related to any severe laboratory abnormalities | Safety endpoints include: d. IMP related severe laboratory abnormalities (duration of IMP) |
2 weeks | |
Secondary | Feasibility endpoints related to IMP and deviations | Feasibility endpoints include protocol deviations in terms of timing and delivery of scheduled medication. | 2 weeks | |
Secondary | Exploratory Data on Clinical efficacy by time to recovery | Exploratory data on clinical efficacy as defined by: a. Time to recovery defined by hospital discharge or improvement of two points on the ordinal scale: not hospitalised; hospitalised without need for supplemental oxygen; requiring supplemental oxygen; requiring HFNC or non-invasive mechanical ventilation; requiring ECMO or mechanical intervention; dead. Improvement mechanical ventilation (from recruitment to time of ventilation) |
4 weeks | |
Secondary | Exploratory Data on Clinical efficacy | Exploratory data on clinical efficacy as defined by: b. Ventilation free days (at 28 days) |
4 weeks | |
Secondary | Exploratory Data on Clinical efficacy of the ordinal scale | Exploratory data on clinical efficacy as defined by: c. Status on the above ordinal scale (at 14 and 28 days) |
4 weeks |
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