Does subcutaneously(SC) administered of anakinra achieve good penetration in blood and result in reduce inflammation in patients with SARS-CoV-19?

Phase 1

• Conditions: Suspected or confirmed SARS-CoV-2 infection (confirmed by RNA-PCR); MedDRA version: 23.0Level: PTClassification code 10051905Term: Coronavirus infectionSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2020-001636-95-GB
• Lead Sponsor: niversity of Manchester

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-05-04
• Last Update Posted: 22 June 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

•Patient age 18 or above.
•Clinically suspected/proven COVID-19.
• Requiring organ support with one or more of:
oNon-invasive or invasive ventilatory support
oReceiving 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.

Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 15
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 15

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, personal/ professional legal representative or the attending physician are not committed to full active treatment.
•Known condition resulting in ongoing immunosuppression including neutropenia (count < 1.5 x 109/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).

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified