Dose-Finding, Safety, and Efficacy Study of XVR011 Added to Standard of Care in Patients Hospitalised for COVID-19

NCT04884295 | Terminated Phase 1 DMC FDA Drug

• 2 other identifiers: EXEVIR01012020-005299-36
• Study Type: interventional
• Target: 27
• Locations: 3 countries
• Sites: 6

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.

Conditions

Covid19

Outcome Measures

Primary Outcomes (1)

• Proportion of subjects with Adverse Events (all and serious)

  Phase 1

  Through Day 29

Secondary Outcomes (7)

• Total duration of oxygen supplementation

  Through Day 29

• Proportion of subjects requiring mechanical ventilation and/or ICU transfer

  Through Day 29

• Proportion of subjects with COVID-19 related symptoms

  Through Day 29

• All-cause mortality rate

  Through Day 29

• Change from baseline in the viral load (RT-qPCR) of nasopharyngeal samples

  Up to Day 8/ Day of Discharge

Other Outcomes (4)

• Maximum serum concentration (Cmax)

  Through Day 29

• Area under the serum concentration-time curve (AUC)

  Through Day 29

• Serum terminal elimination half-life (t1/2)

  Through Day 29

Study Arms (1)

XVR011

EXPERIMENTAL

Single Ascending Dose with 3 dose cohorts: low dose - medium dose - high dose (Phase 1)

Drug: XVR011

Interventions

XVR011 DRUG

Single dose of XVR011 via intravenous (IV) infusion

XVR011

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%.

You may not qualify if:

• 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.

Sponsors & Collaborators

• ExeVir Bio BV: lead

Study Sites (6)

Investigative Site

Ghent, Belgium

Location

Investigative Site

Liège, Belgium

Location

Investigative site

Mechelen, Belgium

Location

Investigative site

Milan, Italy

Location

Investigative Site

Roma, Italy

Location

Investigative site

Chisinau, Moldova

Location

MeSH Terms

Conditions

COVID-19

Interventions

XVR011

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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)

Study Record Dates

• First Submitted: May 6, 2021
• First Posted: May 12, 2021
• Study Start: August 26, 2021
• Primary Completion: March 18, 2022
• Study Completion: March 18, 2022
• Last Updated: April 15, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

BE (3); MO (1); IT (2)