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
NCT05092581 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 2
Last updated 2025-10-14
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
Conditions
Interventions
- DRUG
-
casirivimab+imdevimab
Single dose weight-based equivalent administered intravenously (IV)
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Clinical Trial Management · Regeneron Pharmaceuticals
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 1 Minute
- Max Age
- 17 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2021-12-16
- Primary Completion
- 2022-06-09
- Completion
- 2022-06-09
- FDA Drug
- Yes
Countries
- United States
Study Locations
More Related Trials
-
COVID-19 Study to Evaluate Safety, Tolerability, and Efficacy of REGN14256+Imdevimab for the Treatment of COVID-19 Adult and Adolescent Patients Without Risk Factors for Progression to Severe Disease
NCT05081388 ·Status: TERMINATED ·Phase: PHASE1/PHASE2
-
Use of Monoclonal Antibodies for the Treatment of Mild to Moderate COVID-19 in Non-Hospitalized Setting
NCT04840459 ·Status: UNKNOWN ·Phase: PHASE2
-
COVID-19 Study Assessing the Efficacy and Safety of Anti-Spike SARS CoV-2 Monoclonal Antibodies for Prevention of SARS CoV-2 Infection Asymptomatic in Healthy Adults and Adolescents Who Are Household Contacts to an Individual With a Positive SARS-CoV-2 RT-PCR Assay
NCT04452318 ·Status: COMPLETED ·Phase: PHASE3
-
Safety, Tolerability, and Pharmacokinetics of Clesrovimab (MK-1654) in Infants (MK-1654-002)
NCT03524118 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
A Study to Evaluate MVC-COV1901 Vaccine Against COVID-19 in Adolescents
NCT04951388 ·Status: COMPLETED ·Phase: PHASE2
-
Safety, Tolerability, and Efficacy of Anti-Spike (S) SARS-CoV-2 Monoclonal Antibodies for Hospitalized Adult Patients With COVID-19
NCT04426695 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
A Study to Evaluate the Safety, Tolerability, and Immunogenicity of MVC-COV1901 or MVC-COV1901(Beta) Against COVID-19
NCT05216601 ·Status: COMPLETED ·Phase: PHASE1
-
A Phase 1b/2a Randomized, Double-Blind, Placebo-controlled, Dose-escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of MEDI8897, a Monoclonal Antibody With an Extended Half-life Against Respiratory Syncytial Virus, in Healthy Preterm Infants
NCT02290340 ·Status: COMPLETED ·Phase: PHASE1
-
Safety and Immunogenicity Trial of MPV/S-2P SARS-CoV-2 Vaccine in Adults
NCT06441968 ·Status: COMPLETED ·Phase: PHASE1
-
Study Assessing the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of Repeated Subcutaneous Doses of Anti-Spike (S) SARS-CoV-2 Monoclonal Antibodies (REGN10933+REGN10987) in Adult Volunteers as Related to COVID-19
NCT04519437 ·Status: COMPLETED ·Phase: PHASE1
-
Safety and Tolerability of Regeneron Anti-SARS-CoV-2 Monoclonal Antibody/Ies in Adult Healthy Volunteers as Related to COVID-19
NCT05293678 ·Status: COMPLETED ·Phase: PHASE1
-
A Study to Learn About New COVD-19 RNA Vaccine Candidates for New Variants in Healthy Individuals
NCT05997290 ·Status: COMPLETED ·Phase: PHASE2/PHASE3
-
Randomized, Single-blinded, Multicenter Trial Comparing the Immune Response to a 2nd Booster Dose of COVID-19 mRNA Vaccine (Pfizer-BioNTech) or Sanofi /GSK B.1.351 Adjuvanted Vaccine in Adults
NCT05405283 ·Status: UNKNOWN ·Phase: PHASE3
-
Phase 2/3 Heterologous Boosting Study With Different Dose Levels of Monovalent SARS-CoV-2 rS Vaccines
NCT05925127 ·Status: COMPLETED ·Phase: PHASE2/PHASE3
-
Study to Evaluate Safety, Tolerability and Pharmacokinetics of IDB-011
NCT06925919 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE1
-
Safety Study of a Monoclonal Antibody to Respiratory Syncytial Virus (RSV) in Children Hospitalized With RSV Infection
NCT00192504 ·Status: COMPLETED ·Phase: PHASE1
-
A Study on the Safety and Immune Response of Investigational COVID-19 mRNA Vaccines in Healthy Adults
NCT05960097 ·Status: COMPLETED ·Phase: PHASE2
-
Study of Monovalent and Bivalent Recombinant Protein Vaccines Against COVID-19 in Adults 18 Years of Age and Older
NCT04904549 ·Status: COMPLETED ·Phase: PHASE3
-
Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Neutralizing Antibody BGB-DXP593 in Participants With Mild-to-Moderate Coronavirus Disease 2019 (COVID-19)
NCT04551898 ·Status: COMPLETED ·Phase: PHASE2
-
A Phase 1 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of MEDI8897 in Healthy Adults
NCT02114268 ·Status: COMPLETED ·Phase: PHASE1
-
A Study to Evaluate Immunogenicity and Safety of MVC-COV1901 Compared With AZD1222 Against COVID-19 in Adults
NCT05011526 ·Status: COMPLETED ·Phase: PHASE3
-
Evaluate the Safety and Immunogenicity of Ad5 COVID-19 Vaccines for Booster Use in Children Aged 6-17 Years.
NCT05330871 ·Status: UNKNOWN ·Phase: PHASE2
-
Inpatient Treatment of COVID-19 With Anti-Coronavirus Immunoglobulin (ITAC)
NCT04546581 ·Status: COMPLETED ·Phase: PHASE3
-
Safety and Efficacy of Dupilumab for Treatment of Hospitalized COVID-19 Patients
NCT04920916 ·Status: COMPLETED ·Phase: PHASE2
-
Safety, Tolerability and Immunogenicinity of a Coronavirus-Like Particle COVID-19 Vaccine in Adults Aged 18-55 Years.
NCT04450004 ·Status: COMPLETED ·Phase: PHASE1