Dose-Finding, Safety, and Efficacy Study of XVR011 Added to Standard of Care in Patients Hospitalised for COVID-19

Study Overview
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Brief Summary
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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.

Official Title
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A 2-part Clinical Study Including a First in Human, Open Label, Single Ascending Dose Part (Phase 1) Followed by a Randomised, Double Blind, Placebo-controlled Part (Phase 2) to Evaluate the Efficacy and Safety of XVR011 in Patients Hospitalised for Mild to Moderate Coronavirus Disease 2019 (COVID-19)

Conditions
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Covid19

Intervention / Treatment
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* Drug: XVR011


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Is ≥ 18 years of age. Tested positive for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) by RT-PCR and/or antigen test. Had an onset of COVID-19 symptom(s) within 8 days prior to screening; except for dyspnoea and/or tachypnoea for which an onset within 2 days prior to screening is applicable. Requires hospitalisation for medical care. Has oxygen saturation >= 91%. Exclusion Criteria: Requires non-invasive or invasive mechanical ventilation and/or intensive care. Symptoms consistent with severe COVID-19. Has received a monoclonal antibody, plasma from a person who recovered from COVID-19 or any investigational treatment for COVID-19 within 30 days prior to study treatment. Has received an investigational or approved vaccination against SARS-CoV-2 within 14 days prior to study treatment. NOTE: Other protocol defined inclusion/exclusion criteria apply

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Sequential Assignment
Interventional Model Description: Phase 1 is open-label, single ascending dose (completed per protocol); Phase 2 is double-blind, randomised, placebo-controlled (cancelled due to due to change in company strategy for phase II design)
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: XVR011<br>Single Ascending Dose with 3 dose cohorts: low dose - medium dose - high dose (Phase 1) | Drug: XVR011<br>* Single dose of XVR011 via intravenous (IV) infusion<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of subjects with Adverse Events (all and serious) | Phase 1 | Through Day 29 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total duration of oxygen supplementation | Phase 1 | Through Day 29 | 
| Proportion of subjects requiring mechanical ventilation and/or ICU transfer | Phase 1 | Through Day 29 | 
| Proportion of subjects with COVID-19 related symptoms | Phase 1 | Through Day 29 | 
| All-cause mortality rate | Phase 1 | Through Day 29 | 
| Change from baseline in the viral load (RT-qPCR) of nasopharyngeal samples | Phase 1 | 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 | Through Day 29 | 
| Time to hospital discharge | Phase 1 | Through Day 29 |