IMU-838 and Oseltamivir in treatment of Novel Coronavirus (COVID-19)

Phase 1

Active, not recruiting

• Conditions: Sars-Cov-2; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2020-001805-21-GB
• Lead Sponsor: niversity Hospital Coventry & Warwickshire

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2020-05-07
• Last Update Posted: 25 May 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 120

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

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified