COVID-19 Study of 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
- Conditions
- COVID-19
- Interventions
- Drug: casirivimab+imdevimab
- Registration Number
- NCT05092581
- Lead Sponsor
- Regeneron Pharmaceuticals
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 2
- 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
Key
-
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)
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Has new-onset stroke or seizure disorder during hospitalization
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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
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Members of the clinical site study team and/or their immediate family
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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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description casirivimab+imdevimab casirivimab+imdevimab -
- Primary Outcome Measures
Name Time Method Concentrations of casirivimab+imdevimab in serum over time Through day 169 Proportion of patients with infusion-related reactions Through day 4 Proportion of patients with treatment-emergent serious adverse events (SAEs) Through day 29 Proportion of patients with hypersensitivity reactions Through day 29
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (2)
Le Bonheur Children's Hospital
🇺🇸Memphis, Tennessee, United States
State University of New York at Stony Brook
🇺🇸Stony Brook, New York, United States