Study Details

Participation Requirements

Age

0 - 18 Years

Sex

ALL

Healthy Volunteers

Medical Condition

COVID-19

Gender

N/A

Date

July 2020 - February 2023

Study Type

INTERVENTIONAL

Study Phase

PHASE2, PHASE3

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

Valley Children's Hospital

Madera, California, United States, 93636

UC Davis Medical center

Sacramento, California, United States, 95817

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

Children's Minnesota

Minneapolis, Minnesota, United States, 55404

NYC Health + Hospitals/Jacobi Medical Center

Bronx, New York, United States, 10461

Montefiore Medical Center

Bronx, New York, United States, 10467

Northwell Health-Cohen Children's Medical Center

New Hyde Park, New York, United States, 11040

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

Children's Medical Center

Dallas, Texas, United States, 75235

Texas Children's Hospital

Houston, Texas, United States, 77030

Azienda Ospedaliero Universitaria Meyer

Florence, Italy, 50139

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 Universitari Vall D'Hebron

Barcelona, Spain, 8035

Hospital Sant Joan de Déu

Esplugues de llobregat, Spain, 8950

Hospital General Universitario Gregorio Maranon

Madrid, Spain, 28009

Hospital Universitario 12 de Octubre

Madrid, Spain, 28041

Hospital Universitario La Paz