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

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 279

Inclusion Criteria

- 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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 167

Exclusion Criteria

- 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
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.
- Has renal impairment with estimated creatinine clearance < 60
mL/min/1.73 m2 .
- Has morbid obesity (body mass index > 35 kg/m2), uncontrolled
diabetes, cardiac insufficiency, uncontrolled high blood pressure, or any clinically significant (in the opinion of the Investigator) hepatic,
pulmonary, gastrointestinal, genitourinary, endocrine, immunologic,
metabolic, neurologic, or haematological disease.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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