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Trial record 1 of 12 for:    remdesivir | COVID | Child
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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) (CARAVAN)

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ClinicalTrials.gov Identifier: NCT04431453
Recruitment Status : Recruiting
First Posted : June 16, 2020
Last Update Posted : August 12, 2020
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences

Brief 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.

Condition or disease Intervention/treatment Phase
COVID-19 Drug: Remdesivir Phase 2 Phase 3

Expanded Access : An investigational treatment associated with this study is available outside the clinical trial.   More info ...

Detailed 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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 52 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : July 21, 2020
Estimated Primary Completion Date : February 2021
Estimated Study Completion Date : February 2021

Arm Intervention/treatment
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
  • Cohorts 6-7: IV RDV at a dose to be determined based on RDV exposure data from Cohort 5
Drug: Remdesivir
Administered as an intravenous infusion
Other Names:
  • GS-5734™
  • Veklury®




Primary Outcome Measures :
  1. Proportion of Participants Experiencing any Treatment-Emergent Adverse Events [ Time Frame: First dose date up to Day 30 Follow-up Assessment ]
  2. Proportion of Participants Experiencing any Treatment-Emergent Graded Laboratory Abnormalities [ Time Frame: First dose date up to Day 30 Follow-up Assessment ]
  3. Plasma Concentrations of Remdesivir (RDV) and Metabolites [ Time Frame: Day 2: end of infusion and 4 hours post end of infusion, Day 3: pre-infusion and 2 hours post end of infusion, and Day 5: middle of infusion and 6 hours post end of infusion; infusion duration: 30 minutes to 2 hours ]
    Plasma concentrations will be drawn as follows: (1) for cohorts 1-4 on Day 2, and Day 3, Day 5 is optional; (2) for cohorts 5-7 on Day 2 or Day 3.


Secondary Outcome Measures :
  1. Change From Baseline in Oxygenation Use [ Time Frame: Baseline, up to Day 30 Follow-up Assessment ]
  2. Change From Baseline in the Use of Mechanical Ventilation or Extracorporeal Membrane Oxygenation (ECMO) [ Time Frame: Baseline, up to Day 30 Follow-up Assessment ]
  3. Clinical Improvement on a 7-point Ordinal Scale [ Time Frame: First dose date up to 10 days ]
    The ordinal scale is an assessment of the clinical status at a given day. Each day, the worst score from the previous day will be recorded. The scale is as follows: 1.) Death 2.) Hospitalized, on invasive mechanical ventilation or Extracorporeal Membrane Oxygenation (ECMO) 3.) Hospitalized, on non-invasive ventilation or high flow oxygen devices 4.) Hospitalized, requiring low flow supplemental oxygen 5.) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (coronavirus (COVID-19) related or otherwise) 6.) Hospitalized, not requiring supplemental oxygen - no longer required ongoing medical care (other than per protocol Remdesivir administration) 7.) Not hospitalized.

  4. Time (days) to Discharge From Hospital [ Time Frame: First dose date up to Day 30 Follow-up Assessment ]
  5. Days to First Confirmed Negative Polymerase Chain Reaction (PCR) Result [ Time Frame: First dose date up to 10 days ]
    Confirmed negative PCR is defined by 2 consecutive negative PCR results.

  6. Change From Baseline in Severe Acute Respiratory Syndrome Coronavirus (SARS-CoV-2) Viral Load [ Time Frame: Baseline, up to 10 days or up to the first confirmed negative PCR results (whichever comes first) ]
  7. Bilirubin Concentrations in < 14-day-old Participants [ Time Frame: First dose date up to 10 days ]
  8. Clinical Improvement Based on Scoring Using the Pediatric Early Warning Score (PEWS) Improvement Scale [ Time Frame: First dose date up to 10 days ]
    The PEWS is measured by 3 components, including 1.) behavior, 2.) perfusion assessed by capillary refill and heart rate, and 3.) respiratory status assessed by respiratory rate, effort, and oxygen requirement. The score ranges between zero to 9 point, with 9 point representing the highest severity level.

  9. Plasma Concentrations of Sulfobutylether β-cyclodextrin Sodium (SBECD) [ Time Frame: Day 2: end of infusion and 4 hours post end of infusion, Day 3: pre-infusion and 2 hours post end of infusion, and Day 5: middle of infusion and 6 hours post end of infusion; infusion duration: 30 minutes to 2 hours ]
    Plasma concentrations will be drawn as follows: (1) for cohorts 1-4 on Day 2, and Day 3, Day 5 is optional; (2) for cohorts 5-7 on Day 2 or Day 3.

  10. Proportion of Participants With Concomitant Use of Medications other than RDV for Treatment of Coronavirus Disease 2019 (COVID-19) [ Time Frame: First dose date up to Day 30 Follow-up Assessment ]


Information from the National Library of Medicine

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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  • 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

Note: Other protocol defined Inclusion/Exclusion criteria may apply


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04431453


Contacts
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Contact: Gilead Clinical Study Information Center 1-833-445-3230 (GILEAD-0) GileadClinicalTrials@gilead.com

Locations
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United States, Alabama
Children's Hospital of Alabama Recruiting
Birmingham, Alabama, United States, 35233
United States, Florida
Tampa General Hospital (Inpatient Visits) Recruiting
Tampa, Florida, United States, 33606
United States, Illinois
Ann & Robert H. Lurie Children's Hospital Recruiting
Chicago, Illinois, United States, 60611
United States, Michigan
Children's Hospital of Michigan Not yet recruiting
Detroit, Michigan, United States, 48201
United States, Minnesota
Children's Minnesota Recruiting
Minneapolis, Minnesota, United States, 55404
United States, Nebraska
Children's Hospital and Medical Center Recruiting
Omaha, Nebraska, United States, 68114
United States, New York
NYC Health + Hospitals/Jacobi Medical Center Not yet recruiting
Bronx, New York, United States, 10461
Northwell Health-Cohen Children's Medical Center Recruiting
New Hyde Park, New York, United States, 11040
United States, North Carolina
Carolinas Medical Center-Levine Children's Hospital Recruiting
Charlotte, North Carolina, United States, 28203
United States, Pennsylvania
St. Christopher's Hospital for Children Recruiting
Philadelphia, Pennsylvania, United States, 19134
United States, Texas
Texas Children's Hospital Recruiting
Houston, Texas, United States, 77030
United Kingdom
Alder Hey Children's NHS Foundation Recruiting
Liverpool, United Kingdom, L12 2AP
King's College NHS Foundation Trust Recruiting
London, United Kingdom, SE5 9RS
Sponsors and Collaborators
Gilead Sciences
Investigators
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Study Director: Gilead Study Director Gilead Sciences
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Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT04431453    
Other Study ID Numbers: GS-US-540-5823
2020-001803-17 ( EudraCT Number )
First Posted: June 16, 2020    Key Record Dates
Last Update Posted: August 12, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No