Clinical trial NCT04884295: 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
Overall status: TERMINATED
Phase: PHASE1
PHASE2
Conditions: Covid19
Lead sponsor: ExeVir Bio BV
Sponsor class: INDUSTRY
First posted: 2021-05-12
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SEQUENTIAL
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)
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Proportion of subjects with Adverse Events (all and serious)
timeFrame: Through Day 29
Secondary outcomes:
measure: Total duration of oxygen supplementation
timeFrame: Through Day 29
measure: Proportion of subjects requiring mechanical ventilation and/or ICU transfer
timeFrame: Through Day 29
measure: Proportion of subjects with COVID-19 related symptoms
timeFrame: Through Day 29
measure: All-cause mortality rate
timeFrame: Through Day 29
measure: Change from baseline in the viral load (RT-qPCR) of nasopharyngeal samples
timeFrame: Up to Day 8/ Day of Discharge
measure: Time to recovery (i.e., clinical status reaching level 1 to 3 of the 8-point ordinal scale)
timeFrame: Through Day 29
measure: Time to hospital discharge
timeFrame: Through Day 29
Other outcomes:
measure: Maximum serum concentration (Cmax)
timeFrame: Through Day 29
measure: Area under the serum concentration-time curve (AUC)
timeFrame: Through Day 29
measure: Serum terminal elimination half-life (t1/2)
timeFrame: Through Day 29
measure: Incidence of anti-drug antibody (ADA) to XVR011
timeFrame: Through Day 29
Locations:
city: Ghent
country: Belgium
facility: Investigative Site
city: Liège
country: Belgium
facility: Investigative Site
city: Mechelen
country: Belgium
facility: Investigative site
city: Milano
country: Italy
facility: Investigative site
city: Roma
country: Italy
facility: Investigative Site
city: Chisinau
country: Moldova, Republic of
facility: Investigative site
Study officials:
References: