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

No results posted yet for this study

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

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

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05092581 on ClinicalTrials.gov