IMU-838 and Oseltamivir in the Treatment of COVID-19
IONIC
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
1 other identifier
interventional
38
1 country
1
Brief 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)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Jun 2020
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 15, 2020
CompletedFirst Submitted
Initial submission to the registry
August 10, 2020
CompletedFirst Posted
Study publicly available on registry
August 18, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 20, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
September 21, 2022
CompletedAugust 22, 2023
August 1, 2023
1.9 years
August 10, 2020
August 21, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
To evaluate whether time-to-improvement is significantly better in IMU-838 plus Oseltamivir (IONIC Intervention) vs. Oseltamivir alone in adult subjects with COVID-19
Time-to-clinical improvement; defined as the time from randomisation to a 2-point improvement on the world health organizations 9-point ordinal scale (ranging from 0-8; 0 being no evidence of clinical infection and 8 being death), discharge from hospital, or death (whichever occurs first)
14 days
Secondary Outcomes (5)
To evaluate safety (number of adverse events) and tolerability (laboratory abnormalities) of IMU 838 + Oseltamivir vs. Oseltamivir alone in adult subjects with COVID-19.
28 days
To determine the effects of IONIC Intervention on improvement of at least two points in clinical status scale (from 0 to 8; with 8 being no evidence of clinical infection and 8 being death)
28 days
To assess the effects of IONIC Intervention vs. Oseltamivir on the need for invasive ventilation, renal replacement therapy or ECMO
14 days
To assess the effects of IONIC Intervention vs. Oseltamivir on the length of hospital and intensive care unit (ICU) stay
28 days
To assess the effects of IONIC Intervention vs. Oseltamivir on the time from treatment initiation to death
28 days
Study Arms (2)
IMU-838 + Oseltamivir
EXPERIMENTALLoading dose of IMU-838 followed by 22.5mg BID plus Oseltamivir (75mg BID) for 14 days
Oseltamivir
ACTIVE COMPARATOROseltamivir (75mg BID) for 14 days
Interventions
IMU-838 twice daily at 22.5mg doses for 14 days
Oseltamivir twice daily at 75mg doses for 14 days
Eligibility Criteria
You may qualify if:
- \. Male or non-pregnant female patients at least 18 years old 2. Severe Acute Respiratory Syndrome Coronavirus (SARS-CoV)-2 infection, either:
- Confirmed cases: prospective participants who test positive to a validated specific SARS-CoV-2 nucleic acid test or has the virus identified by electron microscopy or viral culture, as per local trust policy ≤ 7 days before randomisation.
- Probable/Suspected case: prospective participants who may have been in contact with a confirmed case of COVID-19, AND have mild to severe COVID-19 clinical symptoms AND radio-graphic evidence\* of pulmonary infiltrates consistent with COVID-19 disease 3. Moderate to severe COVID-19 requiring hospitalisation defined as: a) Clinical status category 3-5 (inclusive) on the 7-point clinical status category scale as proposed by the World Health Organisation (WHO) master protocol: I. Category 3: hospitalized, no oxygen therapy II. Category 4: hospitalized, oxygen by mask or nasal prongs III. Category 5: hospitalized, non-invasive ventilation or high-flow oxygen \*where routinely available, no tests will be requested for research purpose
You may not qualify if:
- Use of the following concomitant medications is prohibited at Screening Visit and throughout the duration of the trial:
- Use of Oseltamivir for more than 48 hrs prior to the first treatment dose
- Use of antiviral drugs (e.g. nucleoside analogue reverse-transcriptase inhibitors, protease inhibitors, etc.)
- History of long-term or concurrent use of mycophenolate mofetil, methotrexate exceeding 17.5 mg weekly
- Chloroquine or hydroxychloroquine
- Any medication known to significantly increase urinary elimination of uric acid, in particular lesinurad as well as uricosuric drugs such as probenecid
- Treatments for any malignancy, in particular irinotecan, paclitaxel, tretinoin, bosutinib, sorafinib, enasidenib, erlotinib, regorafenib, pazopanib and nilotinib
- Any drug significantly restricting water diuresis, in particular vasopressin and vasopressin analogues
- Use of rosuvastatin at daily doses higher than 10 mg
- Allergic or hypersensitivity to the IMU-838, Oseltamivir, or any of the ingredients
- Pregnant or breastfeeding or with intention to become pregnant during the study
- Participants who cannot take trial medication orally at presentation
- Undergoing active chemotherapy or radiotherapy.
- If the attending clinician believes that there is a specific contra-indication to the IONIC intervention.
- Patient has a medical or concomitant disease history preventing them from participating
- +13 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University Hospitals Coventry and Warwickshire NHS Trustlead
- Immunic AGcollaborator
- University of Warwickcollaborator
- MODEPHARMAcollaborator
Study Sites (1)
University Hospital Coventry and Warwickshire NHS Trust
Coventry, West Midlands, CV22DX, United Kingdom
Related Publications (1)
Sharma K, Berry L, Vryonis E, Ali A, Lara B, Noufaily A, Parsons N, Bradley C, Haley B, Tabuso M, Arasaradnam RP. Prospective, randomised, parallel-group, open-label study to evaluate the effectiveness and safety of IMU-838, in combination with oseltamivir, in adults with COVID-19: the IONIC trial protocol. BMJ Open. 2022 Nov 17;12(11):e055205. doi: 10.1136/bmjopen-2021-055205.
PMID: 36396307DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 10, 2020
First Posted
August 18, 2020
Study Start
June 15, 2020
Primary Completion
May 20, 2022
Study Completion
September 21, 2022
Last Updated
August 22, 2023
Record last verified: 2023-08
Data Sharing
- IPD Sharing
- Will not share