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

niversity Hospitals Coventry and Warwickshire NHS Trust0 sites38 target enrollmentSeptember 23, 2020

Overview

2022 Protocol article in https://pubmed.ncbi.nlm.nih.gov/36396307/ (added 18/11/2022)

Registry

who.int

Start Date

September 23, 2020

End Date

September 21, 2022

Last Updated

2 years ago

Study Type

Interventional

Sex

All

Sponsor

niversity Hospitals Coventry and Warwickshire NHS Trust

•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