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

Phase 1

• Conditions: Subjects hospitalised for COVID 19; MedDRA version: 23.0Level: LLTClassification code 10084382Term: Coronavirus disease 2019System Organ Class: 100000004862; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2020-005299-36-PT
• Lead Sponsor: ExeVir Bio BV

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-05-07
• Last Update Posted: 29 July 2024

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

Exclusion Criteria

- Has respiratory rate >= 30 per minute, or heart rate = 125 per minute at hospitalisation.
- Has severe COVID-19 requiring non-invasive or invasive mechanical 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 subjects.
- Has received an investigational or approved vaccination against SARS-CoV-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.
- 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