IMU-838 and Oseltamivir in the Treatment of COVID-19
Condition: Covid 19
MeSH terms: COVID-19
Study type: Interventional
Phase: Phase 2

Summary: 
      To evaluate whether time-to-improvement is significantly better in IMU-838 plus Oseltamivir
      (IONIC Intervention) and standard care vs. Oseltamivir and standard care in adult subjects
      with coronavirus disease (COVID-19)
    

Detailed description: 
      The IONIC Protocol describes an overarching trial design to provide reliable evidence on the
      efficacy of IMU-838 (vidofludimus calcium) when delivered in combination with an antiviral
      therapy (Oseltamivir) [IONIC Intervention] for confirmed or suspected COVID-19 infection in
      adult patients receiving usual standard of care.

      At present, there are no known treatments for COVID-19. Whilst, the anticipated scale of the
      epidemic is such that hospitals, and particularly intensive care facilities, may be massively
      overstretched. As described by a few models of pandemic spread, up to 50% of the adult
      population may fall sick over a period of 8-12 weeks, of whom around 10% may require
      hospitalisation. This figure could imply nearly 2 million hospital admissions. Considering
      this scenario, therapies which may only have a moderate impact on survival or on hospital
      resources could be worthwhile.

      Critically, the present trial design has been developed with consideration of the front-line
      hospital staff working within an overstretched care system in these unprecedented times. To
      minimise their burden the protocol is deliberately flexible so that it is suitable for a wide
      range of settings, allowing:

        -  a broad range of patients to be enrolled (patient pathway, disease stage or mode of
           diagnosis)

        -  Additional sub-studies may be added to provide more detailed information on side effects
           or sub-categorisation of patient types but these are not the primary objective and are
           not required for participation.

        -  To be able to include more sites: the investigators will initiate the trial as a single
           centre (UHCW) and more sites invited to participate according to the emerging evidence

        -  The investigator have included 'Exploratory and Secondary objectives' in the protocol
           however, in consideration of the circumstances the research activities will emulate
           investigations performed as per standard care/routines care to minimise any burden on
           the delivery teams.

      This is a Phase 2b, randomised, parallel-group, open-label study to assess the efficacy and
      safety of an oral dose of IMU-838 (22.5 mg twice daily [45 mg/day]) plus Oseltamivir (75mg
      twice daily [150mg/day]) (IONIC Intervetion) or Oseltamivir alone (75mg twice daily) in
      hospitalised patients with COVID-19.
    

Intervention name(s): IMU-838; Oseltamivir
Intervention type(s): Drug; Drug
Intervention description(s): IMU-838 twice daily at 22.5mg doses for 14 days; Oseltamivir twice daily at 75mg doses for 14 days
Other intervention name(s): Intervention Arm; Control arm
Intervention MeSH terms: Oseltamivir
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Prospective, Randomized, Parallel-Group, Open-Label Study
Masking: None (Open Label)
Primary purpose: Treatment