The goal of this clinical study is to check if obeldesivir (ODV; GS-5245) is safe and well-tolerated by children with respiratory syncytial virus (RSV) infection. It will also look at how well ODV helps reduce the time it takes for children to feel better and for their RSV symptoms to improve. The primary objectives of this study are: a) to evaluate the safety and tolerability of ODV in pediatric participants with RSV infection; b) To evaluate the efficacy of ODV on time to alleviation of targeted RSV symptoms in pediatric participants with RSV infection.
Pediatric participants will be enrolled as follows: * Cohort 1: Infants and children from 4 weeks postnatal age, weighing ≥ 1.5 kg to \< 40 kg * Cohort 2: Neonates, either born at term or preterm, weighing ≥ 1.5 kg to \< 6 kg
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
4
Administered orally
Administered orally
Percentage of Participants Who Experienced Treatment-Emergent Adverse Events (TEAEs) by Day 28
TEAEs were defined as any adverse events that began on or after the date of first dose of study drug up to the date of last dose of study drug up to Day 28. The percentage of participants who experienced at least one TEAE was assessed from Day 1 through Day 28.
Time frame: Up to Day 28
Percentage of Participants Who Experienced Grade 3 or 4 Treatment-Emergent Laboratory Abnormalities by Day 28
A treatment-emergent laboratory abnormality was defined as an increase of at least 1 toxicity grade from baseline at any time postbaseline up to and including the date of last study drug dose up to Day 28. A treatment-emergent laboratory abnormality severity was graded according to the Division of AIDS (DAIDS) Version 2.1. Grade 0: Values that do not meet the criteria for an abnormality of at least Grade 1;Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe; Grade 4: Potentially life-threatening. The percentage of participants who experienced Grade 3 or 4 laboratory abnormalities was assessed from Day 1 through Day 28.
Time frame: Up to Day 28
Time to Alleviation of Targeted Respiratory Syncytial Virus (RSV) Symptoms by Day 28
Alleviation of targeted RSV symptoms was defined as achievement of 2 consecutive daily assessments with improvement in score by at least 1 point for any targeted RSV symptom with baseline score is \> 1, or no increase in score for any targeted RSV symptom with baseline score of 1, assessed from Day 1 to Day 28. The time to alleviation of targeted RSV symptoms by Day 28 was calculated as the symptom alleviation date minus the first dose date. Targeted RSV symptoms referred to the RSV symptoms (cough, respiratory signs, RSV signs, behavior impact).
Time frame: Up to Day 28
PK Parameter: AUCtau of GS-441524, Metabolite of Obeldesivir
AUCtau is defined as area under the plasma concentration-time curve during a dosing interval (AUCtau) of GS-441524, the active metabolite of obeldesivir.
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Children's of Alabama
Birmingham, Alabama, United States
Midway Medical Clinic
Oneonta, Alabama, United States
Cohen Children's Medical Center Pharmacy New Pavillion
Phoenix, Arizona, United States
Velocity Clinical Research, Phoenix
Phoenix, Arizona, United States
UCLA (Outpatient Clinic)
Los Angeles, California, United States
Alliance Research Institute
Lynwood, California, United States
Paradigm Clinical Research
Modesto, California, United States
Paradigm Clinical Research Centers, LLC
San Diego, California, United States
FOMAT - Jeffrey Kaplan MD Inc Pediatric Medicine
Santa Maria, California, United States
Velocity Clinical Research, Washington DC
Washington D.C., District of Columbia, United States
...and 46 more locations
Time frame: Day 5 (predose, 2.5, and 3.5 hours post-dose)
PK Parameter: Cmax of GS-441524, Metabolite of Obeldesivir
Cmax is defined as maximum plasma concentration of GS-441524, the active metabolite of obeldesivir.
Time frame: Day 1 (0.25, 0.75, and 2 hours post-dose); Day 5 (predose, 2.5, and 3.5 hours post-dose)
PK Parameter: Ctrough of GS-441524, Metabolite of Obeldesivir
Ctrough is defined as the trough observed drug concentration \[measured concentration at predose of Day 5 (taken directly before next administration)\].
Time frame: Day 5: Predose
Change From Baseline in RSV Nasal Swab Viral Load at Day 5
Nasal swab samples was used to assess RSV viral load by reversetranscriptase-quantitative polymerase chain reaction (RT-qPCR), respiratory coinfection by multiplex respiratory pathogen PCR, potential infectious viral titer assessment, and potential resistance testing (by sequencing and/or phenotyping). Baseline was defined as the last available value collected on or prior to first dose of study drug.
Time frame: Baseline, Day 5
Time to Sustained Alleviation of Targeted RSV Symptoms by Day 28
Sustained alleviation of targeted RSV symptoms was defined as 3 daily consecutive assessments (48-hour period) with improvement in score by at least 1 point for any targeted RSV symptom with baseline score is \> 1; or no increase in score for any targeted RSV symptom with baseline score of 1, assessed from Day 1 to Day 28. The time to sustained alleviation of targeted RSV symptoms by Day 28 was calculated as the symptom alleviation date minus the first dose date. Targeted RSV symptoms referred to the RSV symptoms (cough, respiratory signs, RSV signs, behavior impact).
Time frame: Up to Day 28
Time to Resolution of Targeted RSV Symptoms by Day 28
Resolution of targeted RSV symptoms was defined as: for 2 daily consecutive assessments, improvement in score resulting in score of ≤2 for any targeted RSV symptom with baseline score \>2; no increase or an improvement in score resulting in score of ≤2 for any targeted RSV symptom with baseline score of 2; no increase in score for any targeted RSV symptom with baseline score of 1. The time to resolution of targeted RSV symptoms by Day 28 was calculated as the resolution date/time minus the first dose date/time. Targeted RSV symptoms referred to RSV symptoms (cough, respiratory signs, RSV signs, behavior impact).
Time frame: Up to Day 28
Number of Participants With Palatability Questionnaire Response as Assessed by the Caregiver at Days 1 and 5
Caregivers were asked to rate how the study drug tasted to their child. A questionnaire was administered to caregivers to assess palatability. Palatability was assessed by caregivers using a questionnaire on Day 1 and Day 5 with response options: Super Good, Good, Maybe Good or Maybe Bad, Bad, or Super Bad.
Time frame: Days 1 and 5
Number of Participants With Acceptability Questionnaire Response as Assessed by the Caregiver at Days 1 and 5
Caregivers were asked to evaluate how easy it was for children to take the study drug. A questionnaire was administered to caregivers to assess acceptability. Acceptability was assessed by caregivers using a questionnaire with response options: Super Easy, Easy, Maybe Easy or Maybe Hard, Hard, or Super Hard. The questionnaire evaluated how easy it was for children to take the study drug.
Time frame: Days 1 and 5