Status:
TERMINATED
Dose-Finding, Safety, and Efficacy Study of XVR011 Added to Standard of Care in Patients Hospitalised for COVID-19
Lead Sponsor:
ExeVir Bio BV
Conditions:
Covid19
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 26 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 18 2022
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT04884295
Start Date
August 26 2021
End Date
March 18 2022
Last Update
April 15 2022
Active Locations (6)
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1
Investigative Site
Ghent, Belgium
2
Investigative Site
Liège, Belgium
3
Investigative site
Mechelen, Belgium
4
Investigative site
Milan, Italy