<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04431453</url>
  </required_header>
  <id_info>
    <org_study_id>GS-US-540-5823</org_study_id>
    <secondary_id>2020-001803-17</secondary_id>
    <nct_id>NCT04431453</nct_id>
  </id_info>
  <brief_title>Study of Remdesivir in Participants 18 Years Old and Younger With COVID-19</brief_title>
  <acronym>CARAVAN</acronym>
  <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 &lt; 18 Years of Age With COVID-19</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Gilead Sciences</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Gilead Sciences</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The goals of this clinical study are to learn more about the study drug, remdesivir, and how&#xD;
      safe it is in participants 18 years old and younger with coronavirus disease 2019 (COVID-19).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Pediatric participants will be enrolled as follows:&#xD;
&#xD;
      Pediatric participants ≥ 28 days to &lt; 18 years old:&#xD;
&#xD;
        -  Cohort 1: ≥ 12 years to &lt; 18 years and weight ≥ 40 kg&#xD;
&#xD;
        -  Cohort 2: ≥ 28 days to &lt; 18 years and weight ≥ 20 kg to &lt; 40 kg&#xD;
&#xD;
        -  Cohort 3: ≥ 28 days to &lt; 18 years and weight ≥ 12 kg to &lt; 20 kg&#xD;
&#xD;
        -  Cohort 4: ≥ 28 days to &lt; 18 years and weight ≥ 3 kg to &lt; 12 kg&#xD;
&#xD;
        -  Cohort 8: &lt; 12 years and weight ≥ 40 kg&#xD;
&#xD;
      Term neonatal participants 0 days to &lt; 28 days old:&#xD;
&#xD;
        -  Cohort 5: ≥ 14 days to &lt; 28 days of age, gestational age &gt; 37 weeks and weight at&#xD;
           screening ≥ 2.5 kg&#xD;
&#xD;
        -  Cohort 6: 0 days to &lt; 14 days of age, gestational age &gt; 37 weeks and birth weight ≥ 2.5&#xD;
           kg&#xD;
&#xD;
      Preterm neonates and infants 0 days to &lt; 56 days old:&#xD;
&#xD;
        -  Cohort 7: 0 days to &lt; 56 days of age, gestational age ≤ 37 weeks and birth weight ≥ 1.5&#xD;
           kg&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 21, 2020</start_date>
  <completion_date type="Actual">February 10, 2023</completion_date>
  <primary_completion_date type="Actual">February 10, 2023</primary_completion_date>
  <phase>Phase 2/Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>Yes</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Proportion of Participants Experiencing any Treatment-Emergent Adverse Events</measure>
    <time_frame>First dose date up to Day 30 Follow-up Assessment</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Proportion of Participants Experiencing any Treatment-Emergent Graded Laboratory Abnormalities</measure>
    <time_frame>First dose date up to Day 30 Follow-up Assessment</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Plasma Concentrations of Remdesivir (RDV) and Metabolites</measure>
    <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</time_frame>
    <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.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Oxygenation Use</measure>
    <time_frame>Baseline, up to Day 30 Follow-up Assessment</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in the Use of Mechanical Ventilation or Extracorporeal Membrane Oxygenation (ECMO)</measure>
    <time_frame>Baseline, up to Day 30 Follow-up Assessment</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical Improvement on a 7-point Ordinal Scale</measure>
    <time_frame>First dose date up to 10 days</time_frame>
    <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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time (days) to Discharge From Hospital</measure>
    <time_frame>First dose date up to Day 30 Follow-up Assessment</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Days to First Confirmed Negative Polymerase Chain Reaction (PCR) Result</measure>
    <time_frame>First dose date up to 10 days</time_frame>
    <description>Confirmed negative PCR is defined by 2 consecutive negative PCR results.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Severe Acute Respiratory Syndrome Coronavirus (SARS-CoV-2) Viral Load</measure>
    <time_frame>Baseline, up to 10 days or up to the first confirmed negative PCR results (whichever comes first)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Bilirubin Concentrations in &lt; 14-day-old Participants</measure>
    <time_frame>First dose date up to 10 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical Improvement Based on Scoring Using the Pediatric Early Warning Score (PEWS) Improvement Scale</measure>
    <time_frame>First dose date up to 10 days</time_frame>
    <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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Plasma Concentrations of Sulfobutylether β-cyclodextrin Sodium (SBECD)</measure>
    <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</time_frame>
    <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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of Participants With Concomitant Use of Medications other than RDV for Treatment of Coronavirus Disease 2019 (COVID-19)</measure>
    <time_frame>First dose date up to Day 30 Follow-up Assessment</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">59</enrollment>
  <condition>COVID-19</condition>
  <arm_group>
    <arm_group_label>Remdesivir (RDV)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive RDV up to 10 days. The RDV dose administered in each cohort is as follows:&#xD;
Cohort 1: intravenous (IV) RDV 200 mg on Day 1 followed by IV RDV 100 mg daily&#xD;
Cohorts 2-5: IV RDV 5 mg/kg on Day 1 followed by IV RDV 2.5 mg/kg daily&#xD;
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&#xD;
Cohort 8: IV RDV 200 mg on Day 1 followed by IV RDV 100 mg daily</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Remdesivir</intervention_name>
    <description>Administered as an intravenous infusion</description>
    <arm_group_label>Remdesivir (RDV)</arm_group_label>
    <other_name>GS-5734™</other_name>
    <other_name>Veklury®</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Key Inclusion Criteria:&#xD;
&#xD;
          -  Aged &lt; 18 years of age who meet one of the following weight criteria (where permitted&#xD;
             according to local law and approved nationally and by relevant institutional review&#xD;
             board (IRB) or independent ethics committee (IEC)).&#xD;
&#xD;
               -  a) Cohort 1: ≥ 12 years to &lt; 18 years of age and weight at screening ≥ 40 kg&#xD;
&#xD;
               -  b) Cohorts 2-4: ≥ 28 days to &lt; 18 years of age and weight at screening ≥ 3 kg and&#xD;
                  &lt; 40 kg&#xD;
&#xD;
               -  c) Cohort 5: ≥ 14 days to &lt; 28 days of age, gestational age &gt; 37 weeks and weight&#xD;
                  at screening ≥ 2.5 kg&#xD;
&#xD;
               -  d) Cohort 6: 0 days to &lt; 14 days of age, gestational age &gt; 37 weeks and birth&#xD;
                  weight of ≥ 2.5 kg&#xD;
&#xD;
               -  e) Cohort 7: 0 days to &lt; 56 days of age, gestational age ≤ 37 weeks and birth&#xD;
                  weight of ≥ 1.5 kg&#xD;
&#xD;
               -  f) Cohort 8: &lt; 12 years of age and weight at screening ≥ 40 kg&#xD;
&#xD;
          -  Severe acute respiratory syndrome coronavirus (SARS-CoV-2) infection confirmed by&#xD;
             polymerase chain reaction (PCR)&#xD;
&#xD;
          -  Hospitalized and requiring medical care for coronavirus disease 2019 (COVID-19)&#xD;
&#xD;
        Key Exclusion Criteria:&#xD;
&#xD;
          -  Concurrent treatment with other agents with actual or possible direct antiviral&#xD;
             activity against SARS-CoV-2 &lt; 24 hours prior to study drug dosing&#xD;
&#xD;
          -  Alanine Aminotransferase (ALT) or aspartate aminotransferase (AST) &gt; 5 X upper limit&#xD;
             of normal (ULN)&#xD;
&#xD;
          -  Estimated glomerular filtration rate (eGFR) &lt; 30 mL/min/1.73m^2 using Schwartz formula&#xD;
             for individuals ≥ 1 year of age&#xD;
&#xD;
          -  Creatinine above protocol specified thresholds for &lt; 1 year of age&#xD;
&#xD;
          -  Positive pregnancy test at Screening only for female of child bearing potential. Note:&#xD;
             If female participants who become pregnant during the study or are discovered to be&#xD;
             pregnant after receiving at least one dose may continue study drug, after discussion&#xD;
             with the investigator&#xD;
&#xD;
          -  On renal replacement therapies (intermittent hemodialysis (iHD), peritoneal dialysis&#xD;
             (PD), continuous renal replacement therapy (CRRT))&#xD;
&#xD;
        Note: Other protocol defined Inclusion/Exclusion criteria may apply&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Gilead Study Director</last_name>
    <role>Study Director</role>
    <affiliation>Gilead Sciences</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Children's Hospital of Alabama</name>
      <address>
        <city>Birmingham</city>
        <state>Alabama</state>
        <zip>35233</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Children's Hospital Los Angeles</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90027</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ronald Reagan University of California, Los Angeles Medical Center</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90095</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Valley Children's Hospital</name>
      <address>
        <city>Madera</city>
        <state>California</state>
        <zip>93636</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UC Davis Medical center</name>
      <address>
        <city>Sacramento</city>
        <state>California</state>
        <zip>95817</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rady Children's Hospital San Diego</name>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <zip>92123</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tampa General Hospital (Inpatient Visits)</name>
      <address>
        <city>Tampa</city>
        <state>Florida</state>
        <zip>33606</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ann &amp; Robert H. Lurie Children's Hospital</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60611</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Norton Children's Hospital</name>
      <address>
        <city>Louisville</city>
        <state>Kentucky</state>
        <zip>40202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tulane University School of Medicine</name>
      <address>
        <city>New Orleans</city>
        <state>Louisiana</state>
        <zip>70112</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Johns Hopkins Children's Center</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21287</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Boston Children's Hospital</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02115</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Spectrum Health/Helen De Vos Children's Hospital</name>
      <address>
        <city>Grand Rapids</city>
        <state>Michigan</state>
        <zip>49503</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Children's Minnesota</name>
      <address>
        <city>Minneapolis</city>
        <state>Minnesota</state>
        <zip>55404</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>NYC Health + Hospitals/Jacobi Medical Center</name>
      <address>
        <city>Bronx</city>
        <state>New York</state>
        <zip>10461</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Montefiore Medical Center</name>
      <address>
        <city>Bronx</city>
        <state>New York</state>
        <zip>10467</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Northwell Health-Cohen Children's Medical Center</name>
      <address>
        <city>New Hyde Park</city>
        <state>New York</state>
        <zip>11040</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Carolinas Medical Center-Levine Children's Hospital</name>
      <address>
        <city>Charlotte</city>
        <state>North Carolina</state>
        <zip>28203</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lehigh Valley Hospital/Lehigh Valley Health Network (LVH/LVHN)</name>
      <address>
        <city>Allentown</city>
        <state>Pennsylvania</state>
        <zip>18103</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Christopher's Hospital for Children</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19134</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Children's Medical Center</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75235</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Texas Children's Hospital</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Azienda Ospedaliero Universitaria Meyer</name>
      <address>
        <city>Florence</city>
        <zip>50139</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Azienda Ospedaliera di Padova - Dipartimento Salute della Donna e del Bambino</name>
      <address>
        <city>Padova</city>
        <zip>35128</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UO Clinica Pediatrica, Ospedale Pietro Barilla - AOU di Parma</name>
      <address>
        <city>Parma</city>
        <zip>43126</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitari Vall D'Hebron</name>
      <address>
        <city>Barcelona</city>
        <zip>8035</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Sant Joan de Déu</name>
      <address>
        <city>Esplugues de llobregat</city>
        <zip>8950</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital General Universitario Gregorio Maranon</name>
      <address>
        <city>Madrid</city>
        <zip>28009</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario 12 de Octubre</name>
      <address>
        <city>Madrid</city>
        <zip>28041</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario La Paz</name>
      <address>
        <city>Madrid</city>
        <zip>28041</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Clínico Universitario de Santiago</name>
      <address>
        <city>Santiago de Compostela</city>
        <zip>15706</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Alder Hey Children's NHS Foundation Trust</name>
      <address>
        <city>Liverpool</city>
        <zip>L12 2AP</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Italy</country>
    <country>Spain</country>
    <country>United Kingdom</country>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://www.gileadclinicaltrials.com/study/?id=GS-US-540-5823</url>
    <description>Gilead Clinical Trials Website</description>
  </link>
  <verification_date>June 2023</verification_date>
  <study_first_submitted>June 8, 2020</study_first_submitted>
  <study_first_submitted_qc>June 11, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 16, 2020</study_first_posted>
  <last_update_submitted>June 29, 2023</last_update_submitted>
  <last_update_submitted_qc>June 29, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">July 3, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>COVID-19</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Remdesivir</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_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_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_time_frame>18 months after study completion</ipd_time_frame>
    <ipd_access_criteria>A secured external environment with username, password, and RSA code.</ipd_access_criteria>
    <ipd_url>https://www.gileadclinicaltrials.com/transparency-policy#Commitment</ipd_url>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04431453
org study id: GS-US-540-5823
secondary id: 2020-001803-17
nct id: NCT04431453
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
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).
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
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Proportion of Participants Experiencing any Treatment-Emergent Adverse Events
time frame: First dose date up to Day 30 Follow-up Assessment
measure: Proportion of Participants Experiencing any Treatment-Emergent Graded Laboratory Abnormalities
time frame: First dose date up to Day 30 Follow-up Assessment
measure: 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
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.
measure: Change From Baseline in Oxygenation Use
time frame: Baseline, up to Day 30 Follow-up Assessment
measure: Change From Baseline in the Use of Mechanical Ventilation or Extracorporeal Membrane Oxygenation (ECMO)
time frame: Baseline, up to Day 30 Follow-up Assessment
measure: Clinical Improvement on a 7-point Ordinal Scale
time frame: First dose date up to 10 days
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.
measure: Time (days) to Discharge From Hospital
time frame: First dose date up to Day 30 Follow-up Assessment
measure: Days to First Confirmed Negative Polymerase Chain Reaction (PCR) Result
time frame: First dose date up to 10 days
description: Confirmed negative PCR is defined by 2 consecutive negative PCR results.
measure: 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)
measure: Bilirubin Concentrations in < 14-day-old Participants
time frame: First dose date up to 10 days
measure: Clinical Improvement Based on Scoring Using the Pediatric Early Warning Score (PEWS) Improvement Scale
time frame: First dose date up to 10 days
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.
measure: 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
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.
measure: 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
arm group label: Remdesivir (RDV)
arm group type: Experimental
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: Remdesivir
description: Administered as an intravenous infusion
arm group label: Remdesivir (RDV)
other name: GS-5734™
other name: Veklury®
criteria: 
gender: All
minimum age: N/A
maximum age: 18 Years
healthy volunteers: No
last name: Gilead Study Director
role: Study Director
affiliation: Gilead Sciences
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country: Italy
country: Spain
country: United Kingdom
country: United States
url: https://www.gileadclinicaltrials.com/study/?id=GS-US-540-5823
description: Gilead Clinical Trials Website
responsible party type: Sponsor
mesh term: COVID-19
mesh term: Remdesivir
sharing ipd: Yes
ipd 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 info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd time frame: 18 months after study completion
ipd access criteria: A secured external environment with username, password, and RSA code.
ipd url: https://www.gileadclinicaltrials.com/transparency-policy#Commitment