Covid19
Conditions
Brief summary
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.
Interventions
DRUGXVR011
Single dose of XVR011 via intravenous (IV) infusion
Sponsors
ExeVir Bio BV
Study design
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Intervention 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)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of subjects with Adverse Events (all and serious) | Through Day 29 | Phase 1 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of subjects with COVID-19 related symptoms | Through Day 29 | Phase 1 |
| All-cause mortality rate | Through Day 29 | Phase 1 |
| Change from baseline in the viral load (RT-qPCR) of nasopharyngeal samples | Up to Day 8/ Day of Discharge | Phase 1 |
| Time to recovery (i.e., clinical status reaching level 1 to 3 of the 8-point ordinal scale) | Through Day 29 | Phase 1 |
| Time to hospital discharge | Through Day 29 | Phase 1 |
| Total duration of oxygen supplementation | Through Day 29 | Phase 1 |
| Proportion of subjects requiring mechanical ventilation and/or ICU transfer | Through Day 29 | Phase 1 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Serum terminal elimination half-life (t1/2) | Through Day 29 | Phase 1 |
| Incidence of anti-drug antibody (ADA) to XVR011 | Through Day 29 | Phase 1 |
| Maximum serum concentration (Cmax) | Through Day 29 | Phase 1 |
| Area under the serum concentration-time curve (AUC) | Through Day 29 | Phase 1 |
Countries
Belgium, Italy, Moldova
Outcome results
None listed