Study to Evaluate the Safety Tolerability Pharmacokinetics and Efficacy of Remdesivir (GS-5734 ) in Participants From Birth to < 18 Years of Age With Coronavirus Disease 2019 (COVID-19)

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Recruiting
participants needed

52
sponsor

Gilead Sciences

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Updated on 19 February 2024

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PCR test

covid-19

SARS

coronavirus infection

remdesivir

acute respiratory syndrome (sars)

Summary

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.

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

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

Details

Condition	Covid 19
Age	18years or below
Treatment	Remdesivir
Clinical Study Identifier	NCT04431453
Sponsor	Gilead Sciences
Last Modified on	19 February 2024

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Eligibility		Yes	No	Not Sure
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
	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
	Note: Other protocol defined Inclusion/Exclusion criteria may apply

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Study to Evaluate the Safety Tolerability Pharmacokinetics and Efficacy of Remdesivir (GS-5734 ) in Participants From Birth to < 18 Years of Age With Coronavirus Disease 2019 (COVID-19)