Efficacy of Intravenous Anakinra and Ruxolitinib During COVID-19 Inflammation

Sponsor
Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer
Study ID
NCT04366232
Phase
PHASE2
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Anakinra alone (stages 2b/3) — DRUG
    Anakinra 300 mg 1/d Intravenous 5 days then dose tapering
  • Anakinra and Ruxolitinib (overcome stage 3) — DRUG
    Anakinra 300 mg od Intravenous (maximum14 days) Ruxolitinib 5 mg bid per os (maximum 28 days)
  • Standard of care — OTHER
    Routine clinical care for Covid-19

Study Details

During SARS-Cov2 infection with serious respiratory implication and high systemic inflammation level, intravenous ANAKINRA alone or associated with RUXOLITINIB for severe cases might reduce inappropriate systemic inflammatory response, improve breathing and decrease occurrence or duration of ARDS and associated mortality.

Key Dates

Start date
Aug 19, 2020
Status verified
Dec 2020
Primary completion
Oct 2, 2020
Completion
Oct 2, 2020

Study Design

Enrollment
2 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Anakinra +/- Ruxolitinib
    According to clinical stage (gradual strategy): * Stage 2b or 3 : Anakinra 300 mg IV * Overcome stage 3 : Anakinra 300 mg IV and Ruxolitinib 5 mg x 2
  • Active Comparator: Standard of care
    Treatment with drugs or procedures in routine clinical practice

Primary Outcome Measure

Biological criteria [ Time Frame: 7 days from enrolment ]

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