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

Covid19 Clinical Trial

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)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04884295
• Other study ID #: EXEVIR0101
• Secondary ID: 2020-005299-36
• Status: Terminated
• Phase: Phase 1/Phase 2
• Start date: August 26, 2021
• Est. completion date: March 18, 2022

Study information

• Verified date: April 2022
• Source: ExeVir Bio BV
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 27
• Est. completion date: March 18, 2022
• Est. primary completion date: March 18, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• Covid19

Intervention

Drug:
• XVR011
Single dose of XVR011 via intravenous (IV) infusion

Locations

Country	Name	City	State
Belgium	Investigative Site	Ghent
Belgium	Investigative Site	Liège
Belgium	Investigative site	Mechelen
Italy	Investigative site	Milano
Italy	Investigative Site	Roma
Moldova, Republic of	Investigative site	Chisinau

Sponsors (1)

Lead Sponsor	Collaborator
ExeVir Bio BV

Countries where clinical trial is conducted

Belgium,  Italy,  Moldova, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Maximum serum concentration (Cmax)	Phase 1	Through Day 29
Other	Area under the serum concentration-time curve (AUC)	Phase 1	Through Day 29
Other	Serum terminal elimination half-life (t1/2)	Phase 1	Through Day 29
Other	Incidence of anti-drug antibody (ADA) to XVR011	Phase 1	Through Day 29
Primary	Proportion of subjects with Adverse Events (all and serious)	Phase 1	Through Day 29
Secondary	Total duration of oxygen supplementation	Phase 1	Through Day 29
Secondary	Proportion of subjects requiring mechanical ventilation and/or ICU transfer	Phase 1	Through Day 29
Secondary	Proportion of subjects with COVID-19 related symptoms	Phase 1	Through Day 29
Secondary	All-cause mortality rate	Phase 1	Through Day 29
Secondary	Change from baseline in the viral load (RT-qPCR) of nasopharyngeal samples	Phase 1	Up to Day 8/ Day of Discharge
Secondary	Time to recovery (i.e., clinical status reaching level 1 to 3 of the 8-point ordinal scale)	Phase 1	Through Day 29
Secondary	Time to hospital discharge	Phase 1	Through Day 29