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

Phase 1

Terminated

• Conditions: Covid19
• Interventions: Drug: XVR011

• Registration Number: NCT04884295
• Lead Sponsor: ExeVir Bio BV

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-05-06
• Study First Submitted QC: 2021-05-07
• Study First Posted: 2021-05-12
• Study Start: 2021-08-26
• Primary Completion: 2022-03-18
• Study Completion: 2022-03-18
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-08
• Last Update Posted: 2022-04-15

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 27

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
XVR011	XVR011	Single Ascending Dose with 3 dose cohorts: low dose - medium dose - high dose (Phase 1)

Primary Outcome Measures

Name	Time	Method
Proportion of subjects with Adverse Events (all and serious)	Through Day 29	Phase 1

Secondary Outcome Measures

Name	Time	Method
All-cause mortality rate	Through Day 29	Phase 1
Change from baseline in the viral load (RT-qPCR) of nasopharyngeal samples	Up to Day 8/ Day of Discharge	Phase 1
Total duration of oxygen supplementation	Through Day 29	Phase 1
Proportion of subjects requiring mechanical ventilation and/or ICU transfer	Through Day 29	Phase 1
Time to hospital discharge	Through Day 29	Phase 1
Proportion of subjects with COVID-19 related symptoms	Through Day 29	Phase 1
Time to recovery (i.e., clinical status reaching level 1 to 3 of the 8-point ordinal scale)	Through Day 29	Phase 1

Trial Locations

Locations (2)

Investigative site; 🇲🇩 Chisinau, Moldova, Republic of

Investigative Site; 🇮🇹 Roma, Italy