LAST UPDATED
February 06, 2024
Clinicaltrials.gov ID
EudraCT ID
OVERVIEW
A Phase 2/3 Single-Arm, Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of Remdesivir (GS-5734™) in Participants From Birth to < 18 Years of Age With COVID-19 (CARAVAN)
PROTOCOL 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).
View moreParticipation requirements
Age
0 - 18 years
Sex
All
Healthy Volunteers
No
Age
0 - 18 years
Sex
All
Healthy Volunteers
No
Study details
Medical Condition
COVID-19
Gender
N/A
Date
July 2020 - February 2023
Study Type
Interventional
Study Phase
Phase 2, Phase 3
Product
Remdesivir
Eligibility information
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
- f) Cohort 8: < 12 years of age and weight at screening ≥ 40 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.
- On renal replacement therapies (intermittent hemodialysis (iHD), peritoneal dialysis (PD), continuous renal replacement therapy (CRRT)).
- Note: Other protocol defined Inclusion/Exclusion criteria may apply
Locations
Locations (32)
Children's Hospital of Alabama
Birmingham, Alabama, United States, 35233
Children's Hospital Los Angeles
Los Angeles, California, United States, 90027
Ronald Reagan University of California, Los Angeles Medical Center
Los Angeles, California, United States, 90095
Rady Children's Hospital San Diego
San Diego, California, United States, 92123
Tampa General Hospital (Inpatient Visits)
Tampa, Florida, United States, 33606
Ann & Robert H. Lurie Children's Hospital
Chicago, Illinois, United States, 60611
Norton Children's Hospital
Louisville, Kentucky, United States, 40202
Tulane University School of Medicine
New Orleans, Louisiana, United States, 70112
Johns Hopkins Children's Center
Baltimore, Maryland, United States, 21287
Boston Children's Hospital
Boston, Massachusetts, United States, 02115
Spectrum Health/Helen De Vos Children's Hospital
Grand Rapids, Michigan, United States, 49503
Northwell Health-Cohen Children's Medical Center
New Hyde Park, New York, United States, 11040
NYC Health + Hospitals/Jacobi Medical Center
The Bronx, New York, United States, 10461
Carolinas Medical Center-Levine Children's Hospital
Charlotte, North Carolina, United States, 28203
Lehigh Valley Hospital/Lehigh Valley Health Network (LVH/LVHN)
Allentown, Pennsylvania, United States, 18103
St. Christopher's Hospital for Children
Philadelphia, Pennsylvania, United States, 19134
Azienda Ospedaliera di Padova - Dipartimento Salute della Donna e del Bambino
Padova, Italy, 35128
UO Clinica Pediatrica, Ospedale Pietro Barilla - AOU di Parma
Parma, Italy, 43126
Hospital Clínico Universitario de Santiago
Santiago de Compostela, Spain, 15706
Alder Hey Children's NHS Foundation Trust
Liverpool, United Kingdom, L12 2AP
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