Study of Remdesivir in Participants 18 Years Old and Younger With COVID-19 (CARAVAN)
COVID-19
About this trial
This is an interventional treatment trial for COVID-19
Eligibility Criteria
Key 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)
Key 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
Sites / Locations
- Children's Hospital of Alabama
- Children's Hospital Los Angeles
- Ronald Reagan University of California, Los Angeles Medical Center
- Valley Children's Hospital
- UC Davis Medical center
- Rady Children's Hospital San Diego
- Tampa General Hospital (Inpatient Visits)
- Ann & Robert H. Lurie Children's Hospital
- Norton Children's Hospital
- Tulane University School of Medicine
- Johns Hopkins Children's Center
- Boston Children's Hospital
- Spectrum Health/Helen De Vos Children's Hospital
- Children's Minnesota
- NYC Health + Hospitals/Jacobi Medical Center
- Montefiore Medical Center
- Northwell Health-Cohen Children's Medical Center
- Carolinas Medical Center-Levine Children's Hospital
- Lehigh Valley Hospital/Lehigh Valley Health Network (LVH/LVHN)
- St. Christopher's Hospital for Children
- Children's Medical Center
- Texas Children's Hospital
- Azienda Ospedaliero Universitaria Meyer
- Azienda Ospedaliera di Padova - Dipartimento Salute della Donna e del Bambino
- UO Clinica Pediatrica, Ospedale Pietro Barilla - AOU di Parma
- Hospital Universitari Vall D'Hebron
- Hospital Sant Joan de Déu
- Hospital General Universitario Gregorio Maranon
- Hospital Universitario 12 de Octubre
- Hospital Universitario La Paz
- Hospital Clínico Universitario de Santiago
- Alder Hey Children's NHS Foundation Trust
Arms of the Study
Arm 1
Experimental
Remdesivir (RDV)
Participants will receive RDV up to 10 days. The RDV dose administered in each cohort is as follows: Cohort 1: intravenous (IV) RDV 200 mg on Day 1 followed by IV RDV 100 mg daily Cohorts 2-5: IV RDV 5 mg/kg on Day 1 followed by IV RDV 2.5 mg/kg daily Cohort 6-7: IV RDV 2.5 mg/kg on Day 1 followed by IV RDV 1.25 mg/kg daily for up to 10 days Cohort 8: IV RDV 200 mg on Day 1 followed by IV RDV 100 mg daily