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 enrollmentMay 27, 2021

Overview

No summary available.

Registry

who.int

Start Date

May 27, 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 7 days prior to screening
•\- Requires hospitalisation for medical care.
•\- Has oxygen saturation \> 93% (via pulse oximetry) on room air or with oxygen supplementation.
•\- 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 respiratory rate \>\= 30 per minute, or heart rate \>\= 125 per minute at hospitalisation.
•\- Has severe COVID\-19 requiring invasive ventilation and/or intensive care.
•\- Has ongoing clinically significant thromboembolic event, according to Investigator.
•\- Has any other medical condition, which in the opinion of the Investigator, would impact the safety of the patient.
•\- Has received an investigational or approved vaccination against SARSCoV\-2 within 30 days before study treatment start.
•\- Has known allergy or hypersensitivity reaction to any monoclonal antibody or to any components of study treatment.
•\- For WOCBP:o Pregnancy or a positive urine pregnancy test o Breastfeeding
•Exclusion Criteria only Applicable to Part 1
•\- Has received or is receiving concomitant treatment with medicinal products with potential or demonstrated anti SARS CoV 2 (antiviral) activity, including but not limited to remdesivir, within 30 days prior to
•the study treatment administration.