IMU838 and oseltamivir in the treatment of COVID-19
- Conditions
- COVID-19 (SARS-CoV-2 infection)Infections and Infestations
- Registration Number
- ISRCTN53038326
- Lead Sponsor
- niversity Hospitals Coventry and Warwickshire NHS Trust
- Brief Summary
2022 Protocol article in https://pubmed.ncbi.nlm.nih.gov/36396307/ (added 18/11/2022)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 38
1. Male or non-pregnant female patients at least 18 years old
2. Severe Acute Respiratory Syndrome Coronavirus (SARS-CoV)-2 infection
2.1. 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 <= 5 days before randomization
2.2. Probable/Suspected case: prospective participants 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:
3.1. 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
1. General exclusion criteria:
1.1. Allergic or hypersensitivity to the IMU-838, oseltamivir, or any of the ingredients
1.2. Pregnant or breastfeeding or with the intention to become pregnant during the study
1.3. Participants who cannot take trial medication orally
2. Concomitant medication or medical history:
2.1. If the attending clinician believes that there is a specific contraindication to the IONIC intervention (see Appendix 3; section 9.1.2 in protocol)
2.2. 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:
3.1. Participation in any other interventional clinical trial for an experimental treatment for COVID-19
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Time-to-clinical improvement; defined as the time from randomization to a 2-point improvement on a 7-point ordinal scale, or discharge from hospital or death (whichever occurs first). A clinically significant difference is defined as a difference of at least a 2-point improvement on the WHO ordinal scale; Timepoint(s): 14 days after randomization
- Secondary Outcome Measures
Name Time Method