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NCT04462757: SCIL_COV19

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

Terminated Phase 2 Last updated 30 April 2021
What this trial tests

Phase 2 trial testing Anakinra 100Mg/0.67Ml Inj Syringe in COVID-19 in 5 participants. Terminated before completion.

Timeline
28 May 2020
Primary endpoint
31 August 2020
23 December 2020

Quick facts

Lead sponsorUniversity of Manchester
PhasePhase 2
StatusTerminated
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposehealth services research
Enrollment5
Start date28 May 2020
Primary completion31 August 2020
Estimated completion23 December 2020
Sites2 locations across United Kingdom

Drugs / interventions tested

Conditions studied

Sponsor

University of Manchester

Who can join

18 and older, any sex, with COVID-19. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

  1. NETosis and the Immune System in COVID-19: Mechanisms and Potential Treatments.
    Gillot C, Favresse J, Mullier F, Lecompte T, et al · · 2021 · cited 39× · PMID 34421600 · DOI 10.3389/fphar.2021.708302
  2. Perspectives on anti-IL-1 inhibitors as potential therapeutic interventions for severe COVID-19.
    Geng J, Wang F, Huang Z, Chen X, et al · · 2021 · cited 23× · PMID 33926774 · DOI 10.1016/j.cyto.2021.155544
  3. Biologic Drugs for Rheumatoid Arthritis in the Context of Biosimilars, Genetics, Epigenetics and COVID-19 Treatment.
    Bonek K, Roszkowski L, Massalska M, Maslinski W, et al · · 2021 · cited 19× · PMID 33557301 · DOI 10.3390/cells10020323
  4. Cellular and Molecular Immunology Approaches for the Development of Immunotherapies against the New Coronavirus (SARS-CoV-2): Challenges to Near-Future Breakthroughs.
    Melgaço JG, Brito E Cunha D, Azamor T, da Silva AMV, et al · · 2020 · cited 10× · PMID 33426096 · DOI 10.1155/2020/8827670
  5. Repurposing of drugs targeting the cytokine storm induced by SARS-CoV-2.
    Ng WH, Tang PCH, Mahalingam S, Liu X. · · 2023 · cited 7× · PMID 36394425 · DOI 10.1111/bph.15987

Verify or expand the search:

Other trials of Anakinra 100Mg/0.67Ml Inj Syringe

Trials testing the same drug.

Other recruiting trials for COVID-19

Currently open trials in the same condition.

Other University of Manchester trials

Trials by the same sponsor.

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