Status:
TERMINATED
SCIL-1Ra in COVID-19 Feasibility & PK/PD
Lead Sponsor:
University of Manchester
Conditions:
COVID-19
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 ...
Detailed Description
The investigators plan a small trial of an existing drug in patients with COVID-19 at Salford Royal NHS Foundation Trust (SRFT) and Manchester Foundation Trust (MFT). The investigators will recruit pa...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
May 28 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 23 2020
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT04462757
Start Date
May 28 2020
End Date
December 23 2020
Last Update
April 30 2021
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Manchester Univesity NHS Foundation Trust
Manchester, United Kingdom, M13 9WL
2
Salford Royal NHS Foundation Tust
Salford, United Kingdom, M6 8HD