E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Subjects hospitalised for COVID 19 |
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E.1.1.1 | Medical condition in easily understood language |
Subjects hospitalised for COVID 19 |
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E.1.1.2 | Therapeutic area | Diseases [C] - Virus Diseases [C02] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 23.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10084382 |
E.1.2 | Term | Coronavirus disease 2019 |
E.1.2 | System Organ Class | 100000004862 |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
Part I To evaluate the safety of a single intravenous XVR011 infusion in subjects hospitalised for COVID 19
Part II To evaluate the efficacy of a single intravenous XVR011 infusion in subjects hospitalised for COVID-19, compared to placebo |
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E.2.2 | Secondary objectives of the trial |
Part I - To evaluate the efficacy of a single intravenous XVR011 infusion in subjects hospitalised for COVID-19 - To evaluate the antiviral activity of a single intravenous XVR011 infusion in subjects hospitalised for COVID-19 Part II - To further evaluate the efficacy of a single intravenous XVR011 infusion in subjects hospitalised for COVID-19, compared to placebo - To evaluate the antiviral activity of a single intravenous XVR011 infusion in subjects hospitalised for COVID-19, compared to placebo - To evaluate the safety of a single intravenous XVR011 infusion in subjects hospitalised for COVID-19, compared to placebo
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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
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E.4 | Principal 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.
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E.5 End points |
E.5.1 | Primary end point(s) |
Part I: - Proportion of subjects with Grade ≥ 3 treatment-related AEs within 28-day FU period - Proportion of subjects with AEs (all and serious) of any grade and independent of causality within 28-day FU period - Proportion of subjects with infusion related reactions within 24 hours of treatment - Proportion of subjects with hypersensitivity reactions within 28-day FU period Part II: - Time to recovery (i.e., clinical status reaching level 1 to 3 of the 8-point ordinal scale) within 28-day FU period
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Part I and II: within 28-day FU period |
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E.5.2 | Secondary end point(s) |
Part I - Time to recovery (i.e., clinical status reaching level 1 to 3 of the 8-point ordinal scale) within 28-day FU period - Total duration of oxygen supplementation within 28-day FU period - Proportion of subjects requiring mechanical ventilation within 28-day FU period - Proportion of subjects requiring ICU transfer within 28-day FU period - Time to hospital discharge - Proportion of subjects with clinical status evolving to each level of the 8-point ordinal scale at Days 2, 3, 4, 8, 15, 22 and Day 29, compared to baseline - Proportion of subjects with COVID-19 related symptoms - All-cause mortality rate within 28-day FU period - Change from baseline (Day 1 pre-dose) in the viral load (RT-qPCR) of nasopharyngeal samples at Day 1, Day3, Day 8 and day of discharge
Part II - Total duration of oxygen supplementation within 28-day FU period - Proportion of subjects requiring mechanical ventilation within 28-day FU period - Proportion of subjects requiring ICU transfer within 28-day FU period - Time to hospital discharge - Proportion of subjects with clinical status evolving to each level of the 8-point ordinal scale at Days 2, 3, 4, 8, 15, 22 and Day 29, compared to baseline - Proportion of subjects with COVID-19 related symptoms - All-cause mortality rate within 28-day FU period - Change from baseline (Day 1 pre-dose) in the viral load (RT-qPCR) of nasopharyngeal samples at Day 1, Day 3, Day 8 and day of discharge - Proportion of subjects with Grade ≥ 3 treatment-related AEs within 28-day FU period - Proportion of subjects with AEs (all and serious) of any grade and independent of causality within 28-day FU period - Proportion of subjects with infusion-related reactions within 24 hours of treatment - Proportion of subjects with hypersensitivity reactions within 28-day FU period
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Part I: within 28-day FU period Part II: within 28-day FU period
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | Yes |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | Yes |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | Yes |
E.7.1.1 | First administration to humans | Yes |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | Yes |
E.8.1.7.1 | Other trial design description |
Part 1 is open-label, single ascending dose. Part 2 is double-blind randomised, placebo-controlled |
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E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 6 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 19 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
Brazil |
Mexico |
South Africa |
United States |
Belgium |
France |
Italy |
Portugal |
Romania |
Spain |
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E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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date of the last visit of the last participant in the study |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 1 |