Coronavirus disease 2019 (COVID-19) MedDRA version: 23.0 Level: PT Classification code 10051905 Term: Coronavirus infection System Organ Class: 10021881 - Infections and infestations
Conditions
Interventions
Product Name: Remdesivir
Product Code: GS-5734
Pharmaceutical Form: Lyophilisate for solution for infusion
INN or Proposed INN: REMDESIVIR
Current Sponsor code: GS-5734
Concentration unit: mg milligra
Sponsors
Gilead Sciences Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Willing and able to provide assent or a parent or legal guardian willing and able to provide written informed consent (participants 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 =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1) Concurrent treatment with other agents with actual or possible direct antiviral activity against SARS-CoV-2 5 X ULN 3) eGFR < 30 mL/min using Schwartz formula for participants = 1 year of age 4)Creatinine above thresholds as described in (see table in Page 27) Protocol for < 1 year of age 5) If < 28 days of age, any major congenital renal anomaly 6) If < 24 hours of age, Apgar score < 5 at 10 minutes 7) Known hypersensitivity to the study drug, the metabolites, or formulation excipient 9) On renal replacement therapies (iHD, PD and CRRT)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the safety and tolerability of remdesivir (RDV ) in participants with laboratory-confirmed COVID-19 aged 0 days to < 18 years To evaluate the pharmacokinetics (PK) of RDV in participants with laboratory-confirmed COVID-19 aged 0 days to < 18 years ;Secondary Objective: The secondary objectives of this study are as follows: To evaluate the efficacy of RDV in participants with laboratory-confirmed COVID-19 aged 0 days to < 18 years To determine the antiviral activity of RDV in participants with laboratory-confirmed COVID-19 aged 0 days to < 18 years Change from baseline in oxygenation use Change from baseline in the use of mechanical ventilation or extra corporeal membrane oxygenation (ECMO) To evaluate clinical improvement using the PEWS scale in participants with laboratory-confirmed COVID-19 aged 0 days to < 18 years Determine sulfobutylether ß-cyclodextrin sodium (SBECD) exposures (where possible) To provide data on use of medications other than RDV for treatment of COVID-19 ;Primary end point(s): The proportion of participants with treatment-emergent adverse events (TEAEs) The proportion of participants with treatment-emergent graded laboratory abnormalities PK assessed by plasma concentrations of RDV and metabolites;Timepoint(s) of evaluation of this end point: Summary of descriptive statistics for each endpoint | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Oxygen usage and ventilation modality and settings Clinical improvement based on scoring using the 7-point Ordinal Scale Time (days) to discharge from hospital Days to the first confirmed negative PCR result, where confirmed is defined as 2 consecutive negative PCR results Change from baseline in SARS-CoV-2 viral load up to Day 10 or up to the first confirmed negative PCR result (whichever comes first) Bilirubin concentrations in < 14-day-old participants Clinical improvement based on scoring using the PEWS Improvement Scale Plasma concentrations of SBECD (where possible) The proportion of participants with concomitant use of medications other than RDV for treatment of COVID-19 ;Timepoint(s) of evaluation of this end point: Summary of descriptive statistics for each endpoint | — |
Countries
Italy, Spain, United Kingdom, United States
Contacts
Public ContactClinical Trials Mailbox
Gilead Sciences International Ltd.
Outcome results
None listed