This is a 2 part study where the first part (Phase 1) evaluates the safety of XVR011 and aims to identify the recommended Phase 2 dose. The second part (Phase 2) follows after the part 1 and evaluates whether XVR011 added to standard of care in patients hospitalised for mild to moderate COVID-19 is a safe, well tolerated, and effective treatment. Part 1 (Phase 1) is completed as per protocol. The sponsor does not intend to start Part 2 (Phase 2) due to change in company strategy for phase 2 design.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
27
Single dose of XVR011 via intravenous (IV) infusion
Investigative Site
Ghent, Belgium
Investigative Site
Liège, Belgium
Investigative site
Mechelen, Belgium
Investigative site
Milan, Italy
Investigative Site
Proportion of subjects with Adverse Events (all and serious)
Phase 1
Time frame: Through Day 29
Total duration of oxygen supplementation
Phase 1
Time frame: Through Day 29
Proportion of subjects requiring mechanical ventilation and/or ICU transfer
Phase 1
Time frame: Through Day 29
Proportion of subjects with COVID-19 related symptoms
Phase 1
Time frame: Through Day 29
All-cause mortality rate
Phase 1
Time frame: Through Day 29
Change from baseline in the viral load (RT-qPCR) of nasopharyngeal samples
Phase 1
Time frame: Up to Day 8/ Day of Discharge
Time to recovery (i.e., clinical status reaching level 1 to 3 of the 8-point ordinal scale)
Phase 1
Time frame: Through Day 29
Time to hospital discharge
Phase 1
Time frame: Through Day 29
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Roma, Italy
Investigative site
Chisinau, Moldova