Covid19Phase 1/2NCT04884295
Dose-Finding, Safety, and Efficacy Study of XVR011 Added to Standard of Care in Patients Hospitalised for COVID-19
A Phase 1/2 study testing XVR011 in people with Covid19, run by ExeVir Bio BV at 6 sites in 3 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Covid19
- What is being tested?
- XVR011
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 6 sitesin 3 countries
- Study dates
- 26 Aug 2021to 18 Mar 2022
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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%.
Who cannot join
- 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
Trial locations and contacts
6 sites in 3 countries.
6 sites in 3 countries
Belgium3 sites
Investigative Site
Ghent
Investigative Site
Liège
Investigative site
Mechelen
About this study
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)
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.
- Conditions
- Covid19
- Being tested
- XVR011
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
XVR011Drug
Single dose of XVR011 via intravenous (IV) infusion
| Study group | Role | What they receive |
|---|---|---|
| XVR011 | Experimental | Single Ascending Dose with 3 dose cohorts: low dose - medium dose - high dose (Phase 1) Receives: Drug: XVR011 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of subjects with Adverse Events (all and serious)
Phase 1
Measured: Through Day 29
Secondary outcomes (7)
Total duration of oxygen supplementation
Phase 1
Measured: Through Day 29
Proportion of subjects requiring mechanical ventilation and/or ICU transfer
Phase 1
Measured: Through Day 29
Proportion of subjects with COVID-19 related symptoms
Phase 1
Measured: Through Day 29
All-cause mortality rate
Phase 1
Measured: Through Day 29
Change from baseline in the viral load (RT-qPCR) of nasopharyngeal samples
Phase 1
Measured: 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
Measured: Through Day 29
Time to hospital discharge
Phase 1
Measured: Through Day 29
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2021
- Study start26 Aug 2021
- Primary completion18 Mar 2022
- Study completion18 Mar 2022
Why it 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.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- 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)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- ExeVir Bio BV
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04884295
- Sponsor's protocol ID
- EXEVIR0101
- Other IDs
- 2020-005299-36
- Status last verified
- Apr 2022
- First submitted
- 6 May 2021
- Last updated
- 15 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT04884295
- Acronym / sponsor ID
- EXEVIR0101
- Conditions
- Covid19
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason 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.
- Enrolment
- 27 participants (actual)
- Lead sponsor
- ExeVir Bio BVIndustry (pharma, biotech, devices)
- Study start
- 26 Aug 2021 (actual)
- Primary completion
- 18 Mar 2022 (actual)
- Study completion
- 18 Mar 2022 (actual)
- First posted
- 12 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- 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)
| Arm | Type | Receives |
|---|---|---|
| XVR011 | Experimental | Drug: XVR011Single Ascending Dose with 3 dose cohorts: low dose - medium dose - high dose (Phase 1) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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%.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| XVR011Single dose of XVR011 via intravenous (IV) infusion | Drug | XVR011 |
Primary outcome
Proportion of subjects with Adverse Events (all and serious)
Time frame: Through Day 29
Phase 1
7 secondary outcomes
Total duration of oxygen supplementation
Time frame: Through Day 29
Proportion of subjects requiring mechanical ventilation and/or ICU transfer
Time frame: Through Day 29
Proportion of subjects with COVID-19 related symptoms
Time frame: Through Day 29
All-cause mortality rate
Time frame: Through Day 29
Change from baseline in the viral load (RT-qPCR) of nasopharyngeal samples
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)
Time frame: Through Day 29
Time to hospital discharge
Time frame: Through Day 29
Results and safety
The study was stopped early (reason given: 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.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
6 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing XVR011 in people with Covid19, run by ExeVir Bio BV at 6 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 15 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Belgium, Italy, Moldova. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: 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.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of subjects with Adverse Events (all and serious) (time frame: Through Day 29). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2022.