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).
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
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
59
Administered as an intravenous infusion
Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs)
TEAEs were defined as any AEs with an onset date on or after the study drug start date and no later than 30 days after permanent discontinuation of study drug and/or any AEs leading to premature discontinuation of study drug.
Time frame: From first dose date (Day 1) up to follow-up assessment (maximum duration: 30 days)
Percentage of Participants With Treatment-Emergent Graded Laboratory Abnormalities
Treatment-emergent graded laboratory abnormalities were defined as values that increase at least 1 toxicity grade from baseline at any time post baseline up to and including the date of last dose of study drug plus 30 days. The laboratory abnormalities were graded using division of allergy and infectious diseases (DAIDS) scale. DAIDS scale is used to grade the severity of adult and pediatric unwanted medical events. Grade 1: mild event, Grade 2: moderate event, Grade: serious event, Grade 4: potentially life-threatening event.
Time frame: From first dose date (Day 1) up to follow-up assessment (maximum duration: 30 days)
Pharmacokinetic (PK) Parameter: Cmax of Remdesivir and Its Metabolites GS-704277 and GS-441524 at Steady State
Cmax is defined as maximum plasma concentration of drug. Plasma concentrations were drawn as follows: (1) for Cohorts 1-4 and 8 on Day 2 and Day 3 with Day 5 as optional; (2) for Cohorts 5-7 on Day 2 or Day 3.
Time frame: Day 2: end of infusion and 4 hours post end of infusion, Day 3: pre-infusion and 2 hours post end of infusion, and Day 5: middle of infusion and 6 hours post end of infusion; infusion duration: 30 minutes to 2 hours
PK Parameter: AUCtau of Remdesivir and Its Metabolites GS-704277 and GS-441524 at Steady State
AUCtau is defined as area under the concentration versus time curve over the dosing interval. Plasma concentrations were drawn as follows: (1) for Cohorts 1-4 and 8 on Day 2 and Day 3 with Day 5 as optional; (2) for Cohorts 5-7 on Day 2 or Day 3.
Time frame: Day 2: end of infusion and 4 hours post end of infusion, Day 3: pre-infusion and 2 hours post end of infusion, and Day 5: middle of infusion and 6 hours post end of infusion; infusion duration: 30 minutes to 2 hours
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Children's Hospital of Alabama
Birmingham, Alabama, United States
Children's Hospital Los Angeles
Los Angeles, California, United States
Ronald Reagan University of California, Los Angeles Medical Center
Los Angeles, California, United States
Valley Children's Hospital
Madera, California, United States
UC Davis Medical center
Sacramento, California, United States
Rady Children's Hospital San Diego
San Diego, California, United States
Tampa General Hospital (Inpatient Visits)
Tampa, Florida, United States
Ann & Robert H. Lurie Children's Hospital
Chicago, Illinois, United States
Norton Children's Hospital
Louisville, Kentucky, United States
Tulane University School of Medicine
New Orleans, Louisiana, United States
...and 22 more locations
Percentage of Participants With Clinical Improvement on a 7-point Ordinal Scale Score
Clinical improvement was defined as ≥ 1-point and ≥ 2-point improvement from Baseline clinical status or recovery or discharged alive on 7-point ordinal scale. Recovery was defined as an improvement from a Baseline score of 2 - 5 to a score of 6 or 7 or an improvement from a Baseline score of 6 to 7 on the ordinal scale. The ordinal scale was used for the assessment of the clinical status at a given day using a 7-point ordinal scale with an increasing score indicating improvement. Scale: 1=Death, 2=Hospitalized, on invasive mechanical ventilation or ECMO, 3=Hospitalized, on non-invasive ventilation or high flow oxygen devices, 4=Hospitalized, requiring low flow supplemental oxygen, 5=Hospitalized, not requiring supplemental oxygen-requiring ongoing medical care COVID-19 related or otherwise), 6=Hospitalized, not requiring supplemental oxygen-no longer required ongoing medical care (other than RDV administration), 7=Not hospitalized. The 95% CI was based on the Clopper-Pearson method.
Time frame: Day 10
Time (Days) to Discharge From Hospital
Time to discharge was the duration from the first dose date to getting discharged from the hospital.
Time frame: From first dose date (Day 1) up to follow-up assessment (maximum duration: 30 days)
Number of Participants With Change From Baseline in Oxygenation Use
Oxygen support status was derived from the 7-point ordinal scale score, 1 = death; 2 = invasive mechanical ventilation; 3 = high flow oxygen; 4 = low flow oxygen; 5 or 6 = room air; 7 = discharge. Change from Baseline for participants with oxygenation use status as '3=High Flow Oxygen', '4=Low Flow Oxygen' and '5=Room Air' at Baseline.
Time frame: Day 10
Number of Participants With Change From Baseline in the Use of Mechanical Ventilation or Extracorporeal Membrane Oxygenation (ECMO)
Mechanical ventilation status was derived from the 7-point ordinal scale score, 1 = death; 2 = invasive mechanical ventilation; 3 = high flow oxygen; 4 = low flow oxygen; 5 or 6 = room air; 7 = discharge.
Time frame: Day 10
Days to First Confirmed Negative Polymerase Chain Reaction (PCR) Result
Confirmed negative PCR is defined by as 2 consecutive negative PCR results or negative result at the last available sample for participants who completed or discontinued from the study. The assessment were done for the samples: nasal/oropharyngeal (OP), nasopharyngeal (NP)/oropharyngeal (OP), endotracheal (ET) aspirates, and rectal/fecal swabs.
Time frame: From first dose date (Day 1) up to follow-up assessment (maximum duration: 30 days)
Change From Baseline in Severe Acute Respiratory Syndrome Coronavirus (SARS-CoV-2) Viral Load Up to Day 10 or Up to the First Confirmed Negative PCR Result
Change from baseline in SARS-CoV-2 viral load up to Day 10 or up to the first negative PCR result with confirmation (whichever comes first) were reported. The assessment were done for the samples: nasal/oropharyngeal (OP) samples, nasopharyngeal (NP)/OP samples, endotracheal (ET) aspirates, and rectal/fecal swabs.
Time frame: Baseline, Day 10, and Day of Discharge (Day 10 or before)
Bilirubin Concentrations in < 14-day-old Participants
Time frame: From first dose date (Day 1) up to follow-up assessment (maximum duration: 30 days)
Percentage of Participants With Clinical Improvement Based on Scoring Using the Pediatric Early Warning Score (PEWS) Improvement Scale
The PEWS was measured by 3 components, where 1= behavior, 2= perfusion assessed by capillary refill and heart rate, and 3= respiratory status assessed by respiratory rate, effort, and oxygen requirement. The score ranged between 0 to 9 point, with higher score representing the highest severity level. A negative change from baseline value indicated an improvement. Data are reported for participants with a PEWS behavior score ≥ 2 at baseline, and a ≥ 2-point improvement (indicated by a decrease) in PEWS behavior score by Day 10, participants with a PEWS behavior score ≥ 1 at baseline, with ≥ 1-point improvement in PEWS behavior score by Day 10 and participants who recovered in PEWS behavior, defined as a Baseline score of 1 through 3 improved to a score of 0.
Time frame: Day 10
Plasma Concentrations of Sulfobutylether β-cyclodextrin Sodium (SBECD)
Plasma concentrations were drawn as follows: (1) for Cohorts 1-4 and 8 on Day 2 and Day 3, with Day 5 as optional; (2) for Cohorts 5-7 on Day 2 or Day 3.
Time frame: Day 2: end of infusion and 4 hours post end of infusion, Day 3: pre-infusion and 2 hours post end of infusion, and Day 5: middle of infusion and 6 hours post end of infusion; infusion duration: 30 minutes to 2 hours
Percentage of Participants With Concomitant Use of Medications Other Than RDV for Treatment of COVID-19
Participants who received at least one concomitant non-study COVID-19 medication from the first day of RDV treatment through the 30-day Follow-up visit or early withdrawal are reported.
Time frame: first dose date (Day 1) up to follow-up assessment (maximum duration: 30 days)