Clinical trial NCT05092581: 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: COVID-19
Keywords: Coronavirus disease 2019 (COVID-19)
Severe acute respiratory syndrome coronavirus 2 (SARS-COV-2)
coronavirus
Lead sponsor: Regeneron Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2021-10-25
Enrollment: 2
Sex: ALL
Minimum age (years): 1
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


Eligibility criteria: Key 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

Key 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 Inclusion/ Exclusion criteria apply

Primary outcomes:
measure: Concentrations of casirivimab+imdevimab in serum over time
timeFrame: Through day 169
measure: Proportion of patients with treatment-emergent serious adverse events (SAEs)
timeFrame: Through day 29
measure: Proportion of patients with infusion-related reactions
timeFrame: Through day 4
measure: Proportion of patients with hypersensitivity reactions
timeFrame: Through day 29
Secondary outcomes:
measure: Incidence of anti-drug antibodies (ADA) to casirivimab+imdevimab over time
timeFrame: Through day 169
measure: Incidence of neutralizing antibodies (NAb) to casirivimab+imdevimab over time
timeFrame: Through day 169
Other outcomes:
Locations:
city: Stony Brook
country: United States
facility: State University of New York at Stony Brook
state: New York
city: Memphis
country: United States
facility: Le Bonheur Children's Hospital
state: Tennessee
Study officials:
affiliation: Regeneron Pharmaceuticals
name: Clinical Trial Management
role: STUDY_DIRECTOR
References: