Sars-Cov-2
Conditions
Interventions
Product Name: IMU-838
Pharmaceutical Form: Tablet
INN or Proposed INN: Vidofludimus calcium
CAS Number: 1354012-90-0
Current Sponsor code: VIDO-06, IM90838, SC90838
Other descriptive name: Vidofludimu
Sponsors
University Hospital Coventry & Warwickshire
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Male or non-pregnant female patients at least 18 years old 2.Severe Acute Respiratory Syndrome Coronavirus (SARS-CoV)-2 infection ?Confirmed cases: prospective participants who tests 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 = 5 days before randomization. ?Probable/Suspected case: prospective participitants who have been in contact with a confirmed case of COVID-19, AND has mild to severe Covid-19 clinical symptoms AND radiographic 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 Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 60 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 60
Exclusion criteria
Exclusion criteria: 1.General exclusion criteria •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 2.Concomitant Medication or Medical History: ?If the attending clinician believes that there is a specific contra-indication to the IONIC intervention (see Appendix 3; section 9.1.2) ?Patient has a medical or concomitant disease history preventing him to participate ( for further information please see; Appendix 3 in protocol) 3.COVID-19 related exclusion criteria •Participation in any other interventional clinical trial for an experimental treatment for COVID-19
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy of IONIC Intervention (IMU-838 plus Oseltamivir and standard care) vs. Oseltamivir and standard care in adult subjects with COVID-19 in relation to time-to-clinical improvement.;Secondary Objective: Secondary objectives 1.To evaluate safety and tolerability of IONIC intervention vs. Oseltamivir in adult subjects with COVID-19. 2.To determine the effects of IONIC Intervention on improvement of at least two points in clinical status scale 3.To assess the effects of IONIC Intervention vs. Oseltamivir on the need for invasive ventilation, renal replacement therapy or ECMO 4.To assess the effects of IONIC Intervention vs. Oseltamivir on the length of hospital and intensive care unit (ICU) stay 5.To assess the effects of (IONIC Intervention) vs. Oseltamivir the time from treatment initiation to death ;Primary end point(s): Time-to-clinical improvement;defined as the time from randomisation to a 2-point improvement on 7-point ordinal scale, or discharge from hospital ordeath (whichever occurs first). A clinically significant difference, defined as a difference of at least a two-point improvement on the WHO ordinal scale. ;Timepoint(s) of evaluation of this end point: Clinical status will be confirmed daily from randomisation to day 14, hospital discharge, or death (which ever occurs sooner), with the worst score for that day recorded. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Adverse events (AEs) and serious adverse events (SAEs), including COVID-19 worsening and incidence of laboratory abnormalities Proportion of patients with two-point change on WHO ordinal scale at Day 7, 14 and 28 (± 2 days) Proportion of patients free of invasive ventilation, renal replacement therapy or ECMO at Day 7 and 14 Hospital length of stay and Length of stay in Intensive care Mortality at Day 28 Time from treatment initiation to death (days) ;Timepoint(s) of evaluation of this end point: AE and SAE l status will be confirmed uptill day 28 from randomisation Clinical status will be confirmed remotely once discharged up till 28 days | — |
Countries
United Kingdom
Contacts
Public ContactKavi Sharma
University Hospital Coventry & Warwickshire NHS Trust
Outcome results
None listed