Summary

Eligibility
for people ages up to 18 years (full criteria)
Location
at UCLA
Dates
study started
estimated completion

Description

Summary

The primary objectives of this study are to evaluate the safety, tolerability, and pharmacokinetics (PK) of remdesivir (RDV) in participants with laboratory-confirmed coronavirus disease 2019 (COVID-19) aged 0 days to < 18 years.

Official Title

A Phase 2/3 Single-Arm, Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of Remdesivir (GS-5734™) in Participants From Birth to < 18 Years of Age With COVID-19

Details

Pediatric participants will be enrolled as follows:

Pediatric participants ≥ 28 days to < 18 years old:

  • Cohort 1: ≥ 12 years to < 18 years and weight ≥ 40 kg
  • Cohort 2: ≥ 28 days to < 18 years and weight ≥ 20 kg to < 40 kg
  • Cohort 3: ≥ 28 days to < 18 years and weight ≥ 12 kg to < 20 kg
  • Cohort 4: ≥ 28 days to < 18 years and weight ≥ 3 kg to < 12 kg

Term neonatal participants 0 days to < 28 days old:

  • Cohort 5: ≥ 14 days to < 28 days of age, gestational age > 37 weeks and weight at screening ≥ 2.5 kg
  • Cohort 6: 0 days to < 14 days of age, gestational age > 37 weeks and birth weight ≥ 2.5 kg

Preterm neonates and infants 0 days to < 56 days old:

  • Cohort 7: 0 days to < 56 days of age, gestational age ≤ 37 weeks and birth weight ≥ 1.5 kg

Keywords

COVID-19 Remdesivir Remdesivir (RDV)

Eligibility

You can join if…

Open to people ages up to 18 years

  • Aged < 18 years of age who meet one of the following weight criteria (where permitted according to local law and approved nationally and by relevant institutional review board (IRB) or independent ethics committee (IEC)).
  • a) Cohort 1: ≥ 12 years to < 18 years of age and weight at screening ≥ 40 kg
  • b) Cohorts 2-4: ≥ 28 days to < 18 years of age and weight at screening ≥ 3 kg and < 40 kg
  • c) Cohort 5: ≥ 14 days to < 28 days of age, gestational age > 37 weeks and weight at screening ≥ 2.5 kg
  • d) Cohort 6: 0 days to < 14 days of age, gestational age > 37 weeks and birth weight of ≥ 2.5 kg
  • e) Cohort 7: 0 days to < 56 days of age, gestational age ≤ 37 weeks and birth weight of ≥ 1.5 kg
  • Severe acute respiratory syndrome coronavirus (SARS-CoV-2) infection confirmed by polymerase chain reaction (PCR)
  • Hospitalized and requiring medical care for coronavirus disease 2019 (COVID-19)

You CAN'T join if...

  • Concurrent treatment with other agents with actual or possible direct antiviral activity against SARS-CoV-2 < 24 hours prior to study drug dosing
  • Alanine Aminotransferase (ALT) or aspartate aminotransferase (AST) > 5 X upper limit of normal (ULN)
  • Estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73m2 using Schwartz formula for individuals ≥ 1 year of age

  • Creatinine above protocol specified thresholds for < 1 year of age
  • Positive pregnancy test at Screening only for female of child bearing potential. Note: If female participants who become pregnant during the study or are discovered to be pregnant after receiving at least one dose may continue study drug, after discussion with the investigator

Note: Other protocol defined Inclusion/Exclusion criteria may apply

Locations

  • Ronald Reagan University of California, Los Angeles Medical Center accepting new patients
    Los Angeles California 90095 United States
  • Rady Children's Hospital San Diego accepting new patients
    San Diego California 92123 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Gilead Sciences
ID
NCT04431453
Phase
Phase 2/3
Study Type
Interventional
Last Updated