Print

Purpose

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).

Condition

Eligibility

Eligible Ages
Under 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • 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 - f) Cohort 8: < 12 years of age and weight at screening ≥ 40 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).

Exclusion Criteria

  • 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/1.73m^2 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. - On renal replacement therapies (intermittent hemodialysis (iHD), peritoneal dialysis (PD), continuous renal replacement therapy (CRRT)). Note: Other protocol defined Inclusion/Exclusion criteria may apply

Study Design

Phase
Phase 2/Phase 3
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Single Group Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Remdesivir (RDV), Cohort 1: Age 12 to <18 Years and Weight ≥40 kg 		Participants will receive RDV 200 mg, intravenous (IV) infusion on Day 1 followed by RDV 100 mg, IV infusion, daily, up to 10 days.
  • Drug: Remdesivir
    Administered as an intravenous infusion
    Other names:
    • GS-5734™
    • Veklury®
Experimental
RDV, Cohort 2: Age ≥ 28 Days to < 18 Years and Weight ≥ 20 kg to < 40 kg 		Participants will receive RDV 5 mg/kg, IV infusion on Day 1 followed by RDV 2.5 mg/kg mg, IV infusion, daily, up to 10 days.
  • Drug: Remdesivir
    Administered as an intravenous infusion
    Other names:
    • GS-5734™
    • Veklury®
Experimental
RDV, Cohort 3: Age ≥ 28 Days to < 18 Years and Weight ≥ 12 kg to < 20 kg 		Participants will receive RDV 5 mg/kg, IV infusion on Day 1 followed by RDV 2.5 mg/kg mg, IV infusion, daily, up to 10 days.
  • Drug: Remdesivir
    Administered as an intravenous infusion
    Other names:
    • GS-5734™
    • Veklury®
Experimental
RDV, Cohort 4: Age ≥ 28 Days to < 18 Years and Weight ≥ 3 kg to < 12 kg 		Participants will receive RDV 5 mg/kg, IV infusion on Day 1 followed by RDV 2.5 mg/kg mg, IV infusion, daily, up to 10 days.
  • Drug: Remdesivir
    Administered as an intravenous infusion
    Other names:
    • GS-5734™
    • Veklury®
Experimental
RDV, Cohort 5: Age ≥14 - <28 Days of Age, Gestational Age >37 Weeks, and Weight at Baseline ≥2.5 kg 		Participants will receive RDV 5 mg/kg, IV infusion on Day 1 followed by RDV 2.5 mg/kg mg, IV infusion, daily, up to 10 days.
  • Drug: Remdesivir
    Administered as an intravenous infusion
    Other names:
    • GS-5734™
    • Veklury®
Experimental
RDV, Cohort 6: Age 0 to < 14 Days of Age, Gestational Age > 37 Weeks, and Birth Weight ≥ 2.5 kg 		Participants will receive RDV 2.5 mg/kg, IV infusion on Day 1 followed by RDV 1.25 mg/kg mg, IV, daily, up to 10 days.
  • Drug: Remdesivir
    Administered as an intravenous infusion
    Other names:
    • GS-5734™
    • Veklury®
Experimental
RDV, Cohort 7: Age 0 to < 56 Days of Age, Gestational Age ≤ 37 Weeks, and Birth Weight ≥ 1.5 kg 		Participants will receive RDV 2.5 mg/kg, IV infusion on Day 1 followed by RDV 1.25 mg/kg mg, IV, daily, up to 10 days.
  • Drug: Remdesivir
    Administered as an intravenous infusion
    Other names:
    • GS-5734™
    • Veklury®
Experimental
RDV, Cohort 8: < 12 Years and Weight ≥ 40 kg 		Participants will receive RDV 200 mg, IV infusion on Day 1 followed by RDV 100 mg, IV infusion daily up to 10 days.
  • Drug: Remdesivir
    Administered as an intravenous infusion
    Other names:
    • GS-5734™
    • Veklury®

More Details

Status
Completed
Sponsor
Gilead Sciences

Study Contact

Detailed Description

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 - Cohort 8: < 12 years and weight ≥ 40 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

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.