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Study of Remdesivir in Participants 18 Years Old and Younger With COVID-19 (CARAVAN)

Primary Purpose

COVID-19

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Remdesivir
Sponsored by
Gilead Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for COVID-19

Eligibility Criteria

undefined - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Arm Type

Experimental

Arm Label

Remdesivir (RDV)

Arm Description

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

Outcomes

Primary Outcome Measures

Proportion of Participants Experiencing any Treatment-Emergent Adverse Events
Proportion of Participants Experiencing any Treatment-Emergent Graded Laboratory Abnormalities
Plasma Concentrations of Remdesivir (RDV) and Metabolites
Plasma concentrations will be drawn as follows: (1) for cohorts 1-4 and cohort 8 on Day 2, and Day 3, Day 5 is optional; (2) for cohorts 5-7 on Day 2 or Day 3.

Secondary Outcome Measures

Change From Baseline in Oxygenation Use
Change From Baseline in the Use of Mechanical Ventilation or Extracorporeal Membrane Oxygenation (ECMO)
Clinical Improvement on a 7-point Ordinal Scale
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.
Time (days) to Discharge From Hospital
Days to First Confirmed Negative Polymerase Chain Reaction (PCR) Result
Confirmed negative PCR is defined by 2 consecutive negative PCR results.
Change From Baseline in Severe Acute Respiratory Syndrome Coronavirus (SARS-CoV-2) Viral Load
Bilirubin Concentrations in < 14-day-old Participants
Clinical Improvement Based on Scoring Using the Pediatric Early Warning Score (PEWS) Improvement Scale
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.
Plasma Concentrations of Sulfobutylether β-cyclodextrin Sodium (SBECD)
Plasma concentrations will be drawn as follows: (1) for cohorts 1-4 and cohort 8 on Day 2, and Day 3, Day 5 is optional; (2) for cohorts 5-7 on Day 2 or Day 3.
Proportion of Participants With Concomitant Use of Medications other than RDV for Treatment of Coronavirus Disease 2019 (COVID-19)

Full Information

First Posted
June 8, 2020
Last Updated
June 29, 2023
Sponsor
Gilead Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT04431453
Brief Title
Study of Remdesivir in Participants 18 Years Old and Younger With COVID-19
Acronym
CARAVAN
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
July 21, 2020 (Actual)
Primary Completion Date
February 10, 2023 (Actual)
Study Completion Date
February 10, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Gilead Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The goals of this clinical study are to learn more about the study drug, remdesivir, and how safe it is in participants 18 years old and younger with coronavirus disease 2019 (COVID-19).
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 Cohort 8: < 12 years and weight ≥ 40 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
59 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Remdesivir (RDV)
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Remdesivir
Other Intervention Name(s)
GS-5734™, Veklury®
Intervention Description
Administered as an intravenous infusion
Primary Outcome Measure Information:
Title
Proportion of Participants Experiencing any Treatment-Emergent Adverse Events
Time Frame
First dose date up to Day 30 Follow-up Assessment
Title
Proportion of Participants Experiencing any Treatment-Emergent Graded Laboratory Abnormalities
Time Frame
First dose date up to Day 30 Follow-up Assessment
Title
Plasma Concentrations of Remdesivir (RDV) and Metabolites
Description
Plasma concentrations will be drawn as follows: (1) for cohorts 1-4 and cohort 8 on Day 2, and Day 3, Day 5 is optional; (2) for cohorts 5-7 on Day 2 or Day 3.
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
Secondary Outcome Measure Information:
Title
Change From Baseline in Oxygenation Use
Time Frame
Baseline, up to Day 30 Follow-up Assessment
Title
Change From Baseline in the Use of Mechanical Ventilation or Extracorporeal Membrane Oxygenation (ECMO)
Time Frame
Baseline, up to Day 30 Follow-up Assessment
Title
Clinical Improvement on a 7-point Ordinal Scale
Description
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.
Time Frame
First dose date up to 10 days
Title
Time (days) to Discharge From Hospital
Time Frame
First dose date up to Day 30 Follow-up Assessment
Title
Days to First Confirmed Negative Polymerase Chain Reaction (PCR) Result
Description
Confirmed negative PCR is defined by 2 consecutive negative PCR results.
Time Frame
First dose date up to 10 days
Title
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)
Title
Bilirubin Concentrations in < 14-day-old Participants
Time Frame
First dose date up to 10 days
Title
Clinical Improvement Based on Scoring Using the Pediatric Early Warning Score (PEWS) Improvement Scale
Description
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.
Time Frame
First dose date up to 10 days
Title
Plasma Concentrations of Sulfobutylether β-cyclodextrin Sodium (SBECD)
Description
Plasma concentrations will be drawn as follows: (1) for cohorts 1-4 and cohort 8 on Day 2, and Day 3, Day 5 is optional; (2) for cohorts 5-7 on Day 2 or Day 3.
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
Title
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

10. Eligibility

Sex
All
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gilead Study Director
Organizational Affiliation
Gilead Sciences
Official's Role
Study Director
Facility Information:
Facility Name
Children's Hospital of Alabama
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Facility Name
Children's Hospital Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90027
Country
United States
Facility Name
Ronald Reagan University of California, Los Angeles Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
Valley Children's Hospital
City
Madera
State/Province
California
ZIP/Postal Code
93636
Country
United States
Facility Name
UC Davis Medical center
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Facility Name
Rady Children's Hospital San Diego
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Tampa General Hospital (Inpatient Visits)
City
Tampa
State/Province
Florida
ZIP/Postal Code
33606
Country
United States
Facility Name
Ann & Robert H. Lurie Children's Hospital
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Norton Children's Hospital
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
Tulane University School of Medicine
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Facility Name
Johns Hopkins Children's Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
Boston Children's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Spectrum Health/Helen De Vos Children's Hospital
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49503
Country
United States
Facility Name
Children's Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55404
Country
United States
Facility Name
NYC Health + Hospitals/Jacobi Medical Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10461
Country
United States
Facility Name
Montefiore Medical Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States
Facility Name
Northwell Health-Cohen Children's Medical Center
City
New Hyde Park
State/Province
New York
ZIP/Postal Code
11040
Country
United States
Facility Name
Carolinas Medical Center-Levine Children's Hospital
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28203
Country
United States
Facility Name
Lehigh Valley Hospital/Lehigh Valley Health Network (LVH/LVHN)
City
Allentown
State/Province
Pennsylvania
ZIP/Postal Code
18103
Country
United States
Facility Name
St. Christopher's Hospital for Children
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19134
Country
United States
Facility Name
Children's Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75235
Country
United States
Facility Name
Texas Children's Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Azienda Ospedaliero Universitaria Meyer
City
Florence
ZIP/Postal Code
50139
Country
Italy
Facility Name
Azienda Ospedaliera di Padova - Dipartimento Salute della Donna e del Bambino
City
Padova
ZIP/Postal Code
35128
Country
Italy
Facility Name
UO Clinica Pediatrica, Ospedale Pietro Barilla - AOU di Parma
City
Parma
ZIP/Postal Code
43126
Country
Italy
Facility Name
Hospital Universitari Vall D'Hebron
City
Barcelona
ZIP/Postal Code
8035
Country
Spain
Facility Name
Hospital Sant Joan de Déu
City
Esplugues de llobregat
ZIP/Postal Code
8950
Country
Spain
Facility Name
Hospital General Universitario Gregorio Maranon
City
Madrid
ZIP/Postal Code
28009
Country
Spain
Facility Name
Hospital Universitario 12 de Octubre
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
Hospital Universitario La Paz
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
Hospital Clínico Universitario de Santiago
City
Santiago de Compostela
ZIP/Postal Code
15706
Country
Spain
Facility Name
Alder Hey Children's NHS Foundation Trust
City
Liverpool
ZIP/Postal Code
L12 2AP
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Qualified external researchers may request IPD for this study after study completion. For more information, please visit our website at https://www.gileadclinicaltrials.com/transparency-policy#Commitment
IPD Sharing Time Frame
18 months after study completion
IPD Sharing Access Criteria
A secured external environment with username, password, and RSA code.
IPD Sharing URL
https://www.gileadclinicaltrials.com/transparency-policy#Commitment
Links:
URL
https://www.gileadclinicaltrials.com/study/?id=GS-US-540-5823
Description
Gilead Clinical Trials Website

Learn more about this trial

Study of Remdesivir in Participants 18 Years Old and Younger With COVID-19

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