Back to resultsDose-Finding, Safety, and Efficacy Study of XVR011 Added to Standard of Care in Patients Hospitalised for COVID-19
Primary Purpose
Covid19
Status
Terminated
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
XVR011
Sponsored by
About this trial
This is an interventional treatment trial for Covid19
Eligibility Criteria
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
Sites / Locations
- Investigative Site
- Investigative Site
- Investigative site
- Investigative site
- Investigative Site
- Investigative site
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
XVR011
Arm Description
Single Ascending Dose with 3 dose cohorts: low dose - medium dose - high dose (Phase 1)
Outcomes
Primary Outcome Measures
Proportion of subjects with Adverse Events (all and serious)
Phase 1
Secondary Outcome Measures
Total duration of oxygen supplementation
Phase 1
Proportion of subjects requiring mechanical ventilation and/or ICU transfer
Phase 1
Proportion of subjects with COVID-19 related symptoms
Phase 1
All-cause mortality rate
Phase 1
Change from baseline in the viral load (RT-qPCR) of nasopharyngeal samples
Phase 1
Time to recovery (i.e., clinical status reaching level 1 to 3 of the 8-point ordinal scale)
Phase 1
Time to hospital discharge
Phase 1
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04884295
Brief Title
Dose-Finding, Safety, and Efficacy Study of XVR011 Added to Standard of Care in Patients Hospitalised for COVID-19
Official Title
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)
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Terminated
Why Stopped
The sponsor does not intend to start Part 2 (Phase 2) due to change in company strategy for phase 2 design. This early end of trial is not due to reasons of safety or lack of efficacy. Part 1 (Phase 1) is completed as per protocol.
Study Start Date
August 26, 2021 (Actual)
Primary Completion Date
March 18, 2022 (Actual)
Study Completion Date
March 18, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ExeVir Bio BV
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Sequential Assignment
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)
Allocation
N/A
Enrollment
27 (Actual)
8. Arms, Groups, and Interventions
Arm Title
XVR011
Arm Type
Experimental
Arm Description
Single Ascending Dose with 3 dose cohorts: low dose - medium dose - high dose (Phase 1)
Intervention Type
Drug
Intervention Name(s)
XVR011
Intervention Description
Single dose of XVR011 via intravenous (IV) infusion
Primary Outcome Measure Information:
Title
Proportion of subjects with Adverse Events (all and serious)
Description
Phase 1
Time Frame
Through Day 29
Secondary Outcome Measure Information:
Title
Total duration of oxygen supplementation
Description
Phase 1
Time Frame
Through Day 29
Title
Proportion of subjects requiring mechanical ventilation and/or ICU transfer
Description
Phase 1
Time Frame
Through Day 29
Title
Proportion of subjects with COVID-19 related symptoms
Description
Phase 1
Time Frame
Through Day 29
Title
All-cause mortality rate
Description
Phase 1
Time Frame
Through Day 29
Title
Change from baseline in the viral load (RT-qPCR) of nasopharyngeal samples
Description
Phase 1
Time Frame
Up to Day 8/ Day of Discharge
Title
Time to recovery (i.e., clinical status reaching level 1 to 3 of the 8-point ordinal scale)
Description
Phase 1
Time Frame
Through Day 29
Title
Time to hospital discharge
Description
Phase 1
Time Frame
Through Day 29
Other Pre-specified Outcome Measures:
Title
Maximum serum concentration (Cmax)
Description
Phase 1
Time Frame
Through Day 29
Title
Area under the serum concentration-time curve (AUC)
Description
Phase 1
Time Frame
Through Day 29
Title
Serum terminal elimination half-life (t1/2)
Description
Phase 1
Time Frame
Through Day 29
Title
Incidence of anti-drug antibody (ADA) to XVR011
Description
Phase 1
Time Frame
Through Day 29
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Investigative Site
City
Ghent
Country
Belgium
Facility Name
Investigative Site
City
Liège
Country
Belgium
Facility Name
Investigative site
City
Mechelen
Country
Belgium
Facility Name
Investigative site
City
Milano
Country
Italy
Facility Name
Investigative Site
City
Roma
Country
Italy
Facility Name
Investigative site
City
Chisinau
Country
Moldova, Republic of
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Dose-Finding, Safety, and Efficacy Study of XVR011 Added to Standard of Care in Patients Hospitalised for COVID-19
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