NCT05092581TerminatedPhase 1
A Phase 1b, Open-Label, Single Dose Study Assessing the Pharmacokinetics, Safety, Tolerability, and Efficacy of Intravenous Anti-Spike(s) SARS-CoV-2 Monoclonal Antibodies (Casirivimab+Imdevimab) for the Treatment of Pediatric Patients Hospitalized Due to COVID-19
Regeneron Pharmaceuticals2 sites in 1 country2 target enrollmentStarted: December 16, 2021Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Terminated
- Sponsor
- Regeneron Pharmaceuticals
- Enrollment
- 2
- Locations
- 2
- Primary Endpoint
- Concentrations of casirivimab+imdevimab in serum over time
Study Overview
Brief Summary
The primary objectives of the study are:
- To characterize the concentrations of casirivimab+imdevimab in serum over time
- To evaluate the safety and tolerability of casirivimab+imdevimab
The secondary objective of the study is:
• To assess the immunogenicity of casirivimab+imdevimab
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 1 Minute to 17 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
- •Has symptoms consistent with COVID-19, as determined by the investigator, with onset ≤ 14 days before dosing
- •Hospitalized due to COVID-19
- •Provide informed consent signed by study patient or legally acceptable representative/guardian
Exclusion Criteria
- •In the opinion of the investigator, unlikely to survive for >96 hours from screening
- •Neonates having gestational age of <29 weeks and weight <1.1 kg
- •Receiving extracorporeal membrane oxygenation (ECMO)
- •Has new-onset stroke or seizure disorder during hospitalization
- •Initiated on renal replacement therapy due to COVID-19
- •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
- •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
- •Members of the clinical site study team and/or their immediate family
- •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.
- •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 Inclusion/ Exclusion criteria apply
Arms & Interventions
casirivimab+imdevimab
Experimental
Intervention: casirivimab+imdevimab (Drug)
Outcomes
Primary Outcomes
Concentrations of casirivimab+imdevimab in serum over time
Time Frame: Through day 169
Proportion of patients with infusion-related reactions
Time Frame: Through day 4
Proportion of patients with treatment-emergent serious adverse events (SAEs)
Time Frame: Through day 29
Proportion of patients with hypersensitivity reactions
Time Frame: Through day 29
Secondary Outcomes
- Incidence of anti-drug antibodies (ADA) to casirivimab+imdevimab over time(Through day 169)
- Incidence of neutralizing antibodies (NAb) to casirivimab+imdevimab over time(Through day 169)
Investigators
Study Sites (2)
Loading locations...
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