CARAVAN study

VEKLURY helped improve clinical status in patients hospitalized with COVID-19 as young as 28 days old who weighed ≥3 kg1

Recovery was reported for a majority of pediatric patients treated with VEKLURY1

The CARAVAN study (GS-US-540-5823) was a single-arm, open-label, phase 2/3 clinical trial to evaluate safety, tolerability, and pharmacokinetics of up to 10 days of treatment with VEKLURY in pediatric patients with mild, moderate, or severe COVID-19. Pediatric patients had confirmed positive results for SARS-CoV-2 infection, were ≥28 days old, and weighed ≥3 kg.1

Study design1,2

A graphic showing the CARAVAN study design A graphic showing the CARAVAN study design

At baseline, the median age was 7 years and patients had a range of COVID-19 severity:

  • 13 patients (25%) were on room air
  • 10 patients (19%) were on low-flow oxygen
  • 18 patients (34%) were on noninvasive ventilation or high-flow oxygen
  • 12 patients (23%) were on invasive mechanical ventilation

Safety parameters in the CARAVAN study1

The safety of VEKLURY was evaluated in pediatric patients

Laboratory abnormalities (Grades 3–4) reported in ≥3% of pediatric patients

Laboratory parameter abnormality VEKLURY(N=53)
ALT increased 4%
APTT increased 7%
Creatinine increased 10%
Direct bilirubin increased 9%
eGFR decreased 18%
Glucose increased 4%
Glycosuria 4%
Hemoglobin decreased 18%
Lymphocytes decreased 6%
Potassium decreased 4%
Proteinuria 6%
Prothrombin time increased 7%
WBC count decreased 4%

APTT=activated partial thromboplastin time; WBC=white blood cell.

Baseline characteristics1

Characteristic VEKLURY(N=53)
Median age (IQR), y 7 (2-12)
Median weight (range), kg 25 (4-192)
Female sex, % 57
Race or ethnic group, %
White 70
Black 30
Hispanic or Latinx 44
Respiratory support at baseline, n (%)
Invasive mechanical ventilation 12 (23)
Noninvasive ventilation or high-flow oxygen 18 (34)
Low-flow oxygen 10 (19)
Room air 13 (25)
Overall median duration of symptoms (IQR), days 5 (3-7)
Hospitalization prior to first dose of VEKLURY (IQR), days 1 (1-3)

IQR=interquartile range.

7-point ordinal scale1,3

Patient clinical status was assessed on a 7-point ordinal scale with a lower score indicating greater clinical severity.


A graphic showing the patient's clinical status assessed on a 7-point ordinal scale A graphic showing the patient's clinical status assessed on a 7-point ordinal scale

ECMO=extracorporeal membrane oxygenation.

See VEKLURY data on disease progression and recovery time

ACTT-1 STUDY

See clinical outcomes for VEKLURY in high-risk patients

OUTPATIENT STUDY

Important Safety Information

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Contraindication

  • VEKLURY is contraindicated in patients with a history of clinically significant hypersensitivity reactions to VEKLURY or any of its components.

Warnings and precautions

  • Hypersensitivity, including infusion-related and anaphylactic reactions: Hypersensitivity, including infusion-related and anaphylactic reactions, has been observed during and following administration of VEKLURY; most reactions occurred within 1 hour. Monitor patients during infusion and observe for at least 1 hour after infusion is complete for signs and symptoms of hypersensitivity as clinically appropriate. Symptoms may include hypotension, hypertension, tachycardia, bradycardia, hypoxia, fever, dyspnea, wheezing, angioedema, rash, nausea, diaphoresis, and shivering. Slower infusion rates (maximum infusion time of up to 120 minutes) can potentially prevent these reactions. If a severe infusion-related hypersensitivity reaction occurs, immediately discontinue VEKLURY and initiate appropriate treatment (see Contraindications).
  • Increased risk of transaminase elevations: Transaminase elevations have been observed in healthy volunteers and in patients with COVID-19 who received VEKLURY; these elevations have also been reported as a clinical feature of COVID-19. Perform hepatic laboratory testing in all patients (see Dosage and administration). Consider discontinuing VEKLURY if ALT levels increase to >10x ULN. Discontinue VEKLURY if ALT elevation is accompanied by signs or symptoms of liver inflammation.
  • Risk of reduced antiviral activity when coadministered with chloroquine or hydroxychloroquine: Coadministration of VEKLURY with chloroquine phosphate or hydroxychloroquine sulfate is not recommended based on data from cell culture experiments, demonstrating potential antagonism, which may lead to a decrease in the antiviral activity of VEKLURY.

Adverse reactions

  • The most common adverse reaction (≥5% all grades) was nausea.
  • The most common lab abnormalities (≥5% all grades) were increases in ALT and AST.

Dosage and administration

  • Administration should take place under conditions where management of severe hypersensitivity reactions, such as anaphylaxis, is possible.
  • Treatment duration:
    • For patients who are hospitalized, VEKLURY should be initiated as soon as possible after diagnosis of symptomatic COVID-19.
    • For patients who are hospitalized and do not require invasive mechanical ventilation and/or ECMO, the recommended treatment duration is 5 days. If a patient does not demonstrate clinical improvement, treatment may be extended up to 5 additional days, for a total treatment duration of up to 10 days.
    • For patients who are hospitalized and require invasive mechanical ventilation and/or ECMO, the recommended total treatment duration is 10 days.
    • For patients who are not hospitalized, diagnosed with mild-to-moderate COVID-19, and are at high risk for progression to severe COVID-19, including hospitalization or death, the recommended total treatment duration is 3 days. VEKLURY should be initiated as soon as possible after diagnosis of symptomatic COVID-19 and within 7 days of symptom onset for outpatient use.
  • Testing prior to and during treatment: Perform eGFR, hepatic laboratory, and prothrombin time testing prior to initiating VEKLURY and during use as clinically appropriate.
  • Renal impairment: VEKLURY is not recommended in individuals with eGFR <30 mL/min.

Pregnancy and lactation

  • Pregnancy: A pregnancy registry has been established. There are insufficient human data on the use of VEKLURY during pregnancy. COVID-19 is associated with adverse maternal and fetal outcomes, including preeclampsia, eclampsia, preterm birth, premature rupture of membranes, venous thromboembolic disease, and fetal death.
  • Lactation: It is not known whether VEKLURY can pass into breast milk. Breastfeeding individuals with COVID-19 should follow practices according to clinical guidelines to avoid exposing the infant to COVID-19.

INDICATION

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VEKLURY is indicated for the treatment of COVID-19 in adults and pediatric patients (≥28 days old and weighing ≥3 kg) with positive results of SARS-CoV-2 viral testing, who are: VEKLURY is indicated for the treatment of COVID-19 in adults and pediatric patients (≥28 days old and weighing ≥3 kg) with positive results of SARS-CoV-2 viral testing, who are:

  • Hospitalized, or
  • Not hospitalized, have mild-to-moderate COVID-19, and are at high risk for progression to severe COVID-19, including hospitalization or death.

References: 1. Veklury. Prescribing Information. Gilead Sciences, Inc.; 2022. 2. Ahmed A, Rojo P, Agwu A, et al. Remdesivir treatment for COVID-19 in hospitalized children: CARAVAN interim results. Poster presented at: 29th Conference on Retroviruses and Opportunistic Infections; February 12-16, 2022; virtual conference. Accessed August 16, 2022. https://2jg4quetidw2blbbq2ixwziw-wpengine.netdna-ssl.com/wp-content/uploads/sites/2/posters/2022/CROI2022_Poster_744.pdf 3. Study to evaluate the efficacy and safety of remdesivir (GS-5734™) treatment of coronavirus disease 2019 (COVID-19) in an outpatient setting. ClinicalTrials.gov identifier: NCT04501952. August 6, 2020. Updated November 16, 2021. Accessed August 16, 2022. https://clinicaltrials.gov/ct2/show/NCT04501952


View All

INDICATION

View All

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VEKLURY is indicated for the treatment of COVID-19 in adults and pediatric patients (≥28 days old and weighing ≥3 kg) with positive results of SARS-CoV-2 viral testing, who are: VEKLURY is indicated for the treatment of COVID-19 in adults and pediatric patients (≥28 days old and weighing ≥3 kg) with positive results of SARS-CoV-2 viral testing, who are:

  • Hospitalized, or
  • Not hospitalized, have mild-to-moderate COVID-19, and are at high risk for progression to severe COVID-19, including hospitalization or death.

Important Safety Information

Collapse

Contraindication

  • VEKLURY is contraindicated in patients with a history of clinically significant hypersensitivity reactions to VEKLURY or any of its components.

Warnings and precautions

  • Hypersensitivity, including infusion-related and anaphylactic reactions: Hypersensitivity, including infusion-related and anaphylactic reactions, has been observed during and following administration of VEKLURY; most reactions occurred within 1 hour. Monitor patients during infusion and observe for at least 1 hour after infusion is complete for signs and symptoms of hypersensitivity as clinically appropriate. Symptoms may include hypotension, hypertension, tachycardia, bradycardia, hypoxia, fever, dyspnea, wheezing, angioedema, rash, nausea, diaphoresis, and shivering. Slower infusion rates (maximum infusion time of up to 120 minutes) can potentially prevent these reactions. If a severe infusion-related hypersensitivity reaction occurs, immediately discontinue VEKLURY and initiate appropriate treatment (see Contraindications).
  • Increased risk of transaminase elevations: Transaminase elevations have been observed in healthy volunteers and in patients with COVID-19 who received VEKLURY; these elevations have also been reported as a clinical feature of COVID-19. Perform hepatic laboratory testing in all patients (see Dosage and administration). Consider discontinuing VEKLURY if ALT levels increase to >10x ULN. Discontinue VEKLURY if ALT elevation is accompanied by signs or symptoms of liver inflammation.
  • Risk of reduced antiviral activity when coadministered with chloroquine or hydroxychloroquine: Coadministration of VEKLURY with chloroquine phosphate or hydroxychloroquine sulfate is not recommended based on data from cell culture experiments, demonstrating potential antagonism, which may lead to a decrease in the antiviral activity of VEKLURY.

Adverse reactions

  • The most common adverse reaction (≥5% all grades) was nausea.
  • The most common lab abnormalities (≥5% all grades) were increases in ALT and AST.

Dosage and administration

  • Administration should take place under conditions where management of severe hypersensitivity reactions, such as anaphylaxis, is possible.
  • Treatment duration:
    • For patients who are hospitalized, VEKLURY should be initiated as soon as possible after diagnosis of symptomatic COVID-19.
    • For patients who are hospitalized and do not require invasive mechanical ventilation and/or ECMO, the recommended treatment duration is 5 days. If a patient does not demonstrate clinical improvement, treatment may be extended up to 5 additional days, for a total treatment duration of up to 10 days.
    • For patients who are hospitalized and require invasive mechanical ventilation and/or ECMO, the recommended total treatment duration is 10 days.
    • For patients who are not hospitalized, diagnosed with mild-to-moderate COVID-19, and are at high risk for progression to severe COVID-19, including hospitalization or death, the recommended total treatment duration is 3 days. VEKLURY should be initiated as soon as possible after diagnosis of symptomatic COVID-19 and within 7 days of symptom onset for outpatient use.
  • Testing prior to and during treatment: Perform eGFR, hepatic laboratory, and prothrombin time testing prior to initiating VEKLURY and during use as clinically appropriate.
  • Renal impairment: VEKLURY is not recommended in individuals with eGFR <30 mL/min.

Pregnancy and lactation

  • Pregnancy: A pregnancy registry has been established. There are insufficient human data on the use of VEKLURY during pregnancy. COVID-19 is associated with adverse maternal and fetal outcomes, including preeclampsia, eclampsia, preterm birth, premature rupture of membranes, venous thromboembolic disease, and fetal death.
  • Lactation: It is not known whether VEKLURY can pass into breast milk. Breastfeeding individuals with COVID-19 should follow practices according to clinical guidelines to avoid exposing the infant to COVID-19.

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