IONIC study -IMU838 and Oseltamivir in treatment of Novel Coronavirus [COVID-19]
Research type
Research Study
Full title
Prospective, Randomized, Parallel-Group, Open-Label Study to Evaluate the Efficacy and Safety of IMU-838, in Combination with Oseltamivir, in Adults with Coronavirus Disease COVID-19
IRAS ID
282532
Contact name
Ramesh Arasaradnam
Contact email
Sponsor organisation
University Hospital Coventry & Warwickshire
Eudract number
2020-001805-21
ISRCTN Number
ISRCTN53038326
Duration of Study in the UK
1 years, 0 months, 0 days
Research summary
Research Summary
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 over-stretched as it has been predicted that nearly 2 million people in the UK may require hospital care in the coming months. Considering this scenario, therapies which may only have a moderate impact on survival or on hospital resources could be worthwhile.\n\nTherefore, the IONIC study aims to provide reliable efficacy for the use of the experimental drug IMU-838 used in combination with an antiviral therapy (Oseltamivir) for confirmed COVID 19 patients receiving the usual standard of care. This will be a two armed study (n=120, 60 in each arm) with patients either receiving IMU-838 and oseltamivir plus standard care OR only oseltamivir plus standard care. The study period will comprise of a screening period, a 14-day treatment period, and up to a 14-day follow-up period evaluating the efficacy of IONIC intervention in comparison to Oseltamivir alone. The outcome measure will be time to clinical improvement based on a 7 point ordinal scale. This will be a trial hosted by University Hospital Coventry & Warwickshire. All patients over 18 (who are not pregnant) who are admitted to hospital with a confirmed case of COVID 19 will be eligible.
Summary of Results
Due to recruitment difficulties, only 38 consented patients were randomised to the trial between 22/Jun/2020 and 20/May/2022. Five participants withdrew from the trial; however, this did not affect the trial primary outcome since withdrawal happened on or after hospital discharge. Four patients from the control arm and one patient from the treatment arm were not discharged from hospital within 14 days. The control arm has 9 patients with heart disease, lung disease or diabetes in comparison with 6 patients in the treatment arm, however, all these patients were discharged before 14 days of hospitalisation. The patients that stayed in hospital beyond 14 days had none of the three conditions. A proportional hazards survival analysis showed that there was no significant difference in the primary outcome, time to clinical improvement, between treatment arms, after adjusting for age, clinical status at hospital entry and COVID-19 comorbidities. The IONIC trial had low power, of around 39%, due to the lower-than-expected recruitment.
REC name
Wales REC 1
REC reference
20/WA/0146
Date of REC Opinion
15 May 2020
REC opinion
Further Information Favourable Opinion