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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- STATUS
- Recruiting
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- participants needed
- 52
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- sponsor
- Gilead Sciences
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 | 18 years and younger |
| Treatment | Remdesivir |
| Clinical Study Identifier | NCT04431453 |
| Sponsor | Gilead Sciences |
| Last Modified on | 19 February 2024 |
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.
Learn moreIf you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
Learn moreComplete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.
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