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Purpose

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.

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
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Remdesivir (RDV) 		Participants will receive RDV up to 10 days. The RDV dose administered in each cohort is as follows: Cohort 1: intravenous (IV) RDV 200 mg on Day 1 followed by IV RDV 100 mg daily Cohorts 2-5: IV RDV 5 mg/kg on Day 1 followed by IV RDV 2.5 mg/kg daily Cohorts 6-7: IV RDV at a dose to be determined based on RDV exposure data from Cohort 5 Cohort 8: IV RDV 200 mg on Day 1 followed by IV RDV 100 mg daily
  • Drug: Remdesivir
    Administered as an intravenous infusion
    Other names:
    • GS-5734™
    • Veklury®

Recruiting Locations

Montefiore Medical Center
Bronx, New York 10467

More Details

Status
Recruiting
Sponsor
Gilead Sciences

Study Contact

Gilead Clinical Study Information Center
1-833-445-3230 (GILEAD-0)
GileadClinicalTrials@gilead.com

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.