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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

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

1 Minute - 17 Years (Child)All SexesDoes not accept healthy volunteers

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

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

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

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