Study of Remdesivir in Participants 18 Years Old and Younger With COVID-19 (CARAVAN)
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| ClinicalTrials.gov Identifier: NCT04431453 |
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Recruitment Status :
Recruiting
First Posted : June 16, 2020
Last Update Posted : May 9, 2023
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Sponsor:
Gilead Sciences
Information provided by (Responsible Party):
Gilead Sciences
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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).
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| COVID-19 | Drug: Remdesivir | Phase 2 Phase 3 |
Expanded Access : An investigational treatment associated with this study has been approved for sale to the public. More info ...
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
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 62 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 : | June 2023 |
| Estimated Study Completion Date : | June 2023 |
Resource links provided by the National Library of Medicine
MedlinePlus related topics:
COVID-19 (Coronavirus Disease 2019)
| Arm | Intervention/treatment |
|---|---|
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Experimental: Remdesivir (RDV)
Participants will receive RDV up to 10 days. The RDV dose administered in each cohort is as follows:
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Drug: Remdesivir
Administered as an intravenous infusion
Other Names:
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Primary Outcome Measures :
- Proportion of Participants Experiencing any Treatment-Emergent Adverse Events [ Time Frame: First dose date up to Day 30 Follow-up Assessment ]
- Proportion of Participants Experiencing any Treatment-Emergent Graded Laboratory Abnormalities [ Time Frame: First dose date up to Day 30 Follow-up Assessment ]
- 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 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 [ Time Frame: Baseline, up to Day 30 Follow-up Assessment ]
- Change From Baseline in the Use of Mechanical Ventilation or Extracorporeal Membrane Oxygenation (ECMO) [ Time Frame: Baseline, up to Day 30 Follow-up Assessment ]
- 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.
- Time (days) to Discharge From Hospital [ Time Frame: First dose date up to Day 30 Follow-up Assessment ]
- 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.
- 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) ]
- Bilirubin Concentrations in < 14-day-old Participants [ Time Frame: First dose date up to 10 days ]
- 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.
- 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 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) [ 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:
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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
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
| Contact: Gilead Clinical Study Information Center | 1-833-445-3230 (GILEAD-0) | GileadClinicalTrials@gilead.com |
Locations
Show 38 study locations
Sponsors and Collaborators
Gilead Sciences
Investigators
| Study Director: | Gilead Study Director | Gilead Sciences |
Additional Information:
| 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: | May 9, 2023 |
| Last Verified: | May 2023 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
Additional relevant MeSH terms:
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COVID-19 Pneumonia, Viral Pneumonia Respiratory Tract Infections Infections Virus Diseases Coronavirus Infections Coronaviridae Infections Nidovirales Infections |
RNA Virus Infections Lung Diseases Respiratory Tract Diseases Remdesivir Antimetabolites Molecular Mechanisms of Pharmacological Action Antiviral Agents Anti-Infective Agents |