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
Primary Purpose
COVID-19
Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
casirivimab+imdevimab
Sponsored by
About this trial
This is an interventional treatment trial for COVID-19 focused on measuring Coronavirus disease 2019 (COVID-19), Severe acute respiratory syndrome coronavirus 2 (SARS-COV-2), coronavirus
Eligibility Criteria
Key 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
Key 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
Sites / Locations
- State University of New York at Stony Brook
- Le Bonheur Children's Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
casirivimab+imdevimab
Arm Description
Outcomes
Primary Outcome Measures
Concentrations of casirivimab+imdevimab in serum over time
Proportion of patients with treatment-emergent serious adverse events (SAEs)
Proportion of patients with infusion-related reactions
Proportion of patients with hypersensitivity reactions
Secondary Outcome Measures
Incidence of anti-drug antibodies (ADA) to casirivimab+imdevimab over time
Incidence of neutralizing antibodies (NAb) to casirivimab+imdevimab over time
Full Information
NCT ID
NCT05092581
First Posted
October 22, 2021
Last Updated
July 26, 2022
Sponsor
Regeneron Pharmaceuticals
1. Study Identification
Unique Protocol Identification Number
NCT05092581
Brief Title
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
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Terminated
Why Stopped
Emerging SARS-CoV-2 variants impacting susceptibility to study drug
Study Start Date
December 16, 2021 (Actual)
Primary Completion Date
June 9, 2022 (Actual)
Study Completion Date
June 9, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Regeneron Pharmaceuticals
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19
Keywords
Coronavirus disease 2019 (COVID-19), Severe acute respiratory syndrome coronavirus 2 (SARS-COV-2), coronavirus
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
2 (Actual)
8. Arms, Groups, and Interventions
Arm Title
casirivimab+imdevimab
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
casirivimab+imdevimab
Other Intervention Name(s)
REGN-COV2, REGN10933, REGN10987, REGEN-COV™, Ronapreve™
Intervention Description
Single dose weight-based equivalent administered intravenously (IV)
Primary Outcome Measure Information:
Title
Concentrations of casirivimab+imdevimab in serum over time
Time Frame
Through day 169
Title
Proportion of patients with treatment-emergent serious adverse events (SAEs)
Time Frame
Through day 29
Title
Proportion of patients with infusion-related reactions
Time Frame
Through day 4
Title
Proportion of patients with hypersensitivity reactions
Time Frame
Through day 29
Secondary Outcome Measure Information:
Title
Incidence of anti-drug antibodies (ADA) to casirivimab+imdevimab over time
Time Frame
Through day 169
Title
Incidence of neutralizing antibodies (NAb) to casirivimab+imdevimab over time
Time Frame
Through day 169
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Minute
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key 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
Key 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trial Management
Organizational Affiliation
Regeneron Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
State University of New York at Stony Brook
City
Stony Brook
State/Province
New York
ZIP/Postal Code
11794
Country
United States
Facility Name
Le Bonheur Children's Hospital
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38103
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing
IPD Sharing Time Frame
When Regeneron has received marketing authorization from major health authorities (e.g., FDA, European Medicines Agency (EMA), Pharmaceuticals and Medical Devices Agency (PMDA), etc.) for the product and indication, has made the study results publicly available (e.g., scientific publication, scientific conference, clinical trial registry), has the legal authority to share the data, and has ensured the ability to protect participant privacy.
IPD Sharing Access Criteria
Qualified researchers can submit a proposal for access to individual patient or aggregate level data from a Regeneron-sponsored clinical trial through Vivli. Regeneron's Independent Research Request Evaluation Criteria can be found at: https://www.regeneron.com/sites/default/files/Regeneron-External-Data-Sharing-Policy-and-Independent-Research-Request-Evaluation-Criteria.pdf
IPD Sharing URL
https://vivli.org/
Learn more about this trial
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
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