E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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E.1.1.1 | Medical condition in easily understood language |
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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 | PT |
E.1.2 | Classification code | 10051905 |
E.1.2 | Term | Coronavirus infection |
E.1.2 | System Organ Class | 10021881 - Infections and infestations |
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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 |
• To characterize the concentrations of casirivimab+imdevimab in serum over time • To evaluate the safety and tolerability of casirivimab+imdevimab |
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E.2.2 | Secondary objectives of the trial |
• To assess the immunogenicity of casirivimab+imdevimab |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Has SARS-CoV-2 positive antigen or molecular diagnostic test ≤72 hours prior to study enrollment Note: historical record of positive result is acceptable as long as the sample was collected ≤72 hours prior to enrollment 2. Has symptoms consistent with COVID-19, as determined by the investigator, with onset ≤ 14 days before dosing 3. Hospitalized due to COVID-19 4. Provide informed consent signed by study patient or legally acceptable representative/guardian
Note: Other protocol-defined Inclusion Criteria apply |
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E.4 | Principal exclusion criteria |
1. In the opinion of the investigator, unlikely to survive for >96 hours from screening 2. Neonates having gestational age of <29 weeks and weight <1.1 kg 3. Receiving extracorporeal membrane oxygenation (ECMO) 4. Has new-onset stroke or seizure disorder during hospitalization 5. Initiated on renal replacement therapy due to COVID-19 6. Has circulatory shock requiring vasopressors on dosing day Note: Patients who require vasopressors for sedation-related hypotension or reasons other than circulatory shock may be eligible in this study 7. Participation in a clinical research study, including any double-blind study, evaluating an investigational product within 30 days and less than 5 half-lives of the investigational product prior to the screening visit 8. Members of the clinical site study team and/or their immediate family 9. Plans to receive an investigational or approved SARS-CoV-2 vaccine within 90 days after study drug administration based on current Centers for Disease Control vaccination guidelines (CDC, 2021). Refer to the latest CDC guidance for any updates. Note: Patients who have already completed vaccination prior to study enrollment may be allowed in the study. 10. Prior use (within 90 days prior to study drug administration) or current use of any investigational, authorized, or approved passive antibody for prophylaxis of SARS-CoV-2 infection, including convalescent plasma, convalescent sera, hyperimmune globulin, or other monoclonal antibodies (eg, bamlanivimab and etesevimab, sotrovimab)
Note: Other protocol-defined Exclusion Criteria apply |
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E.5 End points |
E.5.1 | Primary end point(s) |
1. Concentrations of casirivimab+imdevimab in serum over time 2. Proportion of patients with treatment-emergent serious adverse events (SAEs) 3. Proportion of patients with infusion-related reactions 4. Proportion of patients with hypersensitivity reactions |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
1. Through day 169 2. Through day 29 3. Through day 4 4. Through day 29 |
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E.5.2 | Secondary end point(s) |
1. Incidence of anti-drug antibodies (ADA) to casirivimab+imdevimab over time 2. Incidence of neutralizing antibodies (NAb) to casirivimab+imdevimab over time |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
1. Through day 169 2. Through day 169 |
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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 | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
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 | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | Yes |
E.7.1.3.1 | Other trial type description |
pharmacokinetic (PK) profile |
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E.7.2 | Therapeutic exploratory (Phase II) | No |
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 | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
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 | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 1 |
E.8.3 |
Will this trial be conducted at a single site globally?
| No |
E.8.4 | Will this trial be conducted at multiple sites globally? | Yes |
E.8.6 Trial involving sites outside the EEA |
E.8.6.2 | Trial being conducted completely outside of the EEA | Yes |
E.8.6.3 | Specify the countries outside of the EEA in which trial sites are planned |
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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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E.8.9 Initial estimate of the duration of the trial |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 5 |
E.8.9.2 | In all countries concerned by the trial days | 24 |