drugset / Trial / NCT04431453

Study of Remdesivir in Participants Below 18 Years Old With COVID-19

NCT04431453

Phase 2/3 Completed 59 enrolled Gilead Sciences
Non-randomizedSingle-groupOpen-labelTreatment

Summary

The goals of this clinical study are to learn more about the study drug, remdesivir, and how safe it is in participants less than 18 years old with coronavirus disease 2019 (COVID-19).

Timeline

Start
2020-07-21
Primary completion
2023-02-10
Completion
2023-02-10

Publications

  • Background Ahmed A, Rojo P, Agwu A, Kimberlin D, Deville J, Mendez-Echevarria A, et al. Remdesivir Treatment for COVID-19 in Hospitalized Children: CARAVAN Interim Results [Presentation]. European Congress of Clinical Microbiology & Infectious Diseases (ECCMID) 2022; 2022 23-26 April; Lisbon, Portugal and Online.
  • Background Ahmed A, Rojo P, Agwu A, Kimberlin D, Deville J, Mendez-Echevarria A, et al. Remdesivir Treatment for COVID-19 in Hospitalized Children: CARAVAN Interim Results [Presentation]. Virtual Conference on Retroviruses and Opportunistic Infections (CROI) 2022; 2022c 12-16 February.
  • Background Munoz F, Muller W, Ahmed A, Kimberlin D, Mendez-Echevarria A, Chen JS, et al. Safety and efficacy of Remdesivir in a pediatric COVID-19 population (CROI) [Abstract 617]. Topics in antiviral medicine 2021;29 (1):237.
  • Background Pikora C, Bamford A, Luzuriaga K, Wiznia A, Rojo Conejo P, Muller B, et al. Challenges of remdesivir pediatric development for SARS-CoV-2 infection in a pandemic. 12th International Workshop on HIV Pediatrics; 2020 November 16-17; Virtual Event.

Drugs

EvaluationDrugModalityDoseRoute
Subject Remdesivir Small molecule 1.25 mg/kg Intravenous
Subject Remdesivir Small molecule 2.5 mg/kg Intravenous
Subject Remdesivir Small molecule 100 mg Intravenous

Indications