Phase 3
N=59
Study of Remdesivir in Participants Below 18 Years Old With COVID-19
COVID-19
Bottom Line
View on ClinicalTrials.gov: NCT04431453 ↗Enrolled (actual)
59
Serious AEs
21.4%
Results posted
Dec 2023
Primary outcome: Primary: Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) — 91.7; 58.3; 75.0; 58.3 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Remdesivir (Drug)
- Age
- Pediatric, Adult
- Sex
- All
- Sponsor
- Gilead Sciences
- Primary completion
- Feb 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) |
91.7; 58.3; 75.0; 58.3; 66.7; 80.0 | — |
| PRIMARY Percentage of Participants With Treatment-Emergent Graded Laboratory Abnormalities |
100; 83.3; 91.7; 90.9; 100; 80 | — |
| PRIMARY Pharmacokinetic (PK) Parameter: Cmax of Remdesivir and Its Metabolites GS-704277 and GS-441524 at Steady State |
4108.7; 6003.5; 5980.1; 5192.9; 4829.0; 4235.7 | — |
| PRIMARY PK Parameter: AUCtau of Remdesivir and Its Metabolites GS-704277 and GS-441524 at Steady State |
2630.1; 3937.9; 6752.1; 3625.7; 2650.3; 2519.6 | — |
| SECONDARY Percentage of Participants With Clinical Improvement on a 7-point Ordinal Scale Score |
50.0; 91.7; 100.0; 58.3; 33.3; 80.0 | — |
| SECONDARY Time (Days) to Discharge From Hospital |
12; 7; 5; 7; NA; 10 | — |
| SECONDARY Number of Participants With Change From Baseline in Oxygenation Use |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Number of Participants With Change From Baseline in the Use of Mechanical Ventilation or Extracorporeal Membrane Oxygenation (ECMO) |
0; 0; 0; 0; 0; 1 | — |
| SECONDARY Days to First Confirmed Negative Polymerase Chain Reaction (PCR) Result |
NA; 5; 7; NA; 10; NA | — |
| SECONDARY 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 |
-3.01; 0; -2.36; -1.76; -4.65; -1.56 | — |
| SECONDARY Bilirubin Concentrations in < 14-day-old Participants |
— | — |
| SECONDARY Percentage of Participants With Clinical Improvement Based on Scoring Using the Pediatric Early Warning Score (PEWS) Improvement Scale |
33.3; 83.3; 75.0; 42.9; 0; 66.7 | — |
| SECONDARY Plasma Concentrations of Sulfobutylether β-cyclodextrin Sodium (SBECD) |
217.7; 173.0; 187.8; 138.3; NA; 156.6 | — |
| SECONDARY Percentage of Participants With Concomitant Use of Medications Other Than RDV for Treatment of COVID-19 |
100.0; 100.0; 83.3; 83.3; 66.7; 100.0 | — |
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).
Eligibility Criteria
Key Inclusion Criteria
- Aged 37 weeks and weight at screening ≥ 2.5 kg
- d) Cohort 6: 0 days to 37 weeks and birth weight of ≥ 2.5 kg
- e) Cohort 7: 0 days to 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
Data sourced from ClinicalTrials.gov (NCT04431453). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.