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

COVID-19 Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05092581
• Other study ID #: R10933-10987-COV-2114
• Secondary ID: 2021-004535-84
• Status: Terminated
• Phase: Phase 1
• Start date: December 16, 2021
• Est. completion date: June 9, 2022

Study information

• Verified date: July 2022
• Source: Regeneron Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: June 9, 2022
• Est. primary completion date: June 9, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Minute to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• COVID-19

Intervention

Drug:
• casirivimab+imdevimab
Single dose weight-based equivalent administered intravenously (IV)

Locations

Country	Name	City	State
United States	Le Bonheur Children's Hospital	Memphis	Tennessee
United States	State University of New York at Stony Brook	Stony Brook	New York

Sponsors (1)

Lead Sponsor	Collaborator
Regeneron Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Concentrations of casirivimab+imdevimab in serum over time		Through day 169
Primary	Proportion of patients with treatment-emergent serious adverse events (SAEs)		Through day 29
Primary	Proportion of patients with infusion-related reactions		Through day 4
Primary	Proportion of patients with hypersensitivity reactions		Through day 29
Secondary	Incidence of anti-drug antibodies (ADA) to casirivimab+imdevimab over time		Through day 169
Secondary	Incidence of neutralizing antibodies (NAb) to casirivimab+imdevimab over time		Through day 169