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 COVID-19

ExeVir Bio BV0 sites279 target enrollmentMarch 29, 2021

Overview

No summary available.

Registry

who.int

Start Date

March 29, 2021

End Date

TBD

Last Updated

4 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•\- Is \=18 years of age inclusive, at the time of signing the informed consent.
•\- Has ongoing SARS\-CoV\-2 infection confirmed by positive RT\-PCR test and/or positive antigen test in a timeframe consistent with the current symptoms.
•\- 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% (via pulse oximetry) on room air at rest.
•\- Informed Consent
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1\.2 Adults (18\-64 years) yes
•F.1\.2\.1 Number of subjects for this age range 112

•\- Has a resting respiratory rate \>\= 30 per minute, or heart rate \= 125 per minute at hospitalisation.
•\- Has severe COVID\-19 requiring non\-invasive (e.g. high flow) or
•invasive mechanical ventilation and/or intensive care treatment.
•\- Has ongoing clinically significant thromboembolic event or
•coagulopathy, according to clinical, laboratory and/or radiological
•assessment.
•\- Has any other medical condition, which in the opinion of the
•Investigator, would impact the safety of the subjects.
•\- Has received an investigational or approved vaccination against SARS\-CoV\-2 within 14 days before study treatment start.
•\- Has known allergy or hypersensitivity reaction to any monoclonal