NCT04516915

IMU-838 and Oseltamivir in the Treatment of COVID-19

Prospective, Randomized, Parallel-Group, Open-Label Study to Evaluate the Efficacy and Safety of IMU-838, in Combination With Oseltamivir, in Adults With COVID-19

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 38 (actual)
• Sponsor: University Hospitals Coventry and Warwickshire NHS Trust · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Covid 19

Interventions

Type	Name	Description
DRUG	IMU-838	IMU-838 twice daily at 22.5mg doses for 14 days
DRUG	Oseltamivir	Oseltamivir twice daily at 75mg doses for 14 days

Timeline

• Start date: 2020-06-15
• Primary completion: 2022-05-20
• Completion: 2022-09-21
• First posted: 2020-08-18
• Last updated: 2023-08-22

Locations

1 site across 1 country: United Kingdom