xml: <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/NCT05996744</url>
    </required_header>
    <id_info>
      <org_study_id>GS-US-611-6464</org_study_id>
      <secondary_id>2023-503282-27</secondary_id>
      <nct_id>NCT05996744</nct_id>
    </id_info>
    <brief_title>Study of Obeldesivir in Children and Adolescents With COVID-19</brief_title>
    <official_title>A Phase 2/3 Single-Arm, Open-label Study to Evaluate the Safety, Pharmacokinetics and Efficacy of Obeldesivir in Pediatric Participants 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 goal of this clinical study is to learn more about the safety and tolerability of&#xD;
        obeldesivir (ODV) in children and adolescents with coronavirus disease 2019 (COVID-19).&#xD;
  &#xD;
        The primary objectives are to evaluate the plasma pharmacokinetics (PK), safety and&#xD;
        tolerability of ODV in pediatric participants with COVID-19.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Pediatric participants will be enrolled as follows:&#xD;
  &#xD;
          -  Cohort 1: ≥ 6 years to &lt; 18 years and weight ≥ 40 kg&#xD;
  &#xD;
          -  Cohort 2: ≥ 6 years to &lt; 18 years and weight ≥ 20 kg to &lt; 40 kg&#xD;
  &#xD;
          -  Cohort 3: ≥ 2 years 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 5: ≥ 14 days to &lt; 28 days of age, gestational age (GA) ≥ 37 weeks and weight ≥&#xD;
             2.5 kg&#xD;
  &#xD;
          -  Cohort 6: 0 days to &lt; 14 days of age, GA ≥ 37 weeks and birth weight ≥ 2.5 kg&#xD;
  &#xD;
          -  Cohort 7: 0 days to &lt; 56 days of age, GA &lt; 37 weeks and birth weight ≥ 1.5 kg&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 2023</start_date>
    <completion_date type="Anticipated">June 2027</completion_date>
    <primary_completion_date type="Anticipated">June 2027</primary_completion_date>
    <phase>Phase 2/Phase 3</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</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>Pharmacokinetic (PK) Parameter: AUC0-12 of Obeldesivir (ODV) Metabolite, GS-441524</measure>
      <time_frame>Cohorts 1 and 2: Day 3 and 5</time_frame>
      <description>AUC0-12 is defined as the area under the concentration versus time curve from time 0 to time 12 hours.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>PK Parameter: Cmax of ODV Metabolite, GS-441524</measure>
      <time_frame>Cohorts 1 and 2: Day 3 and 5</time_frame>
      <description>Cmax is defined as maximum observed concentration of drug.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>PK Parameter: Ctrough of ODV Metabolite, GS-441524</measure>
      <time_frame>Cohorts 1 and 2: Day 3 and 5</time_frame>
      <description>Ctrough is defined as concentration at the end of the dosing interval.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Percentage of Participants Experiencing Treatment-Emergent Adverse Events (AEs) by Day 35</measure>
      <time_frame>First dose date up to Day 5 plus 30 days</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities by Day 35</measure>
      <time_frame>First dose date up to Day 5 plus 30 days</time_frame>
    </primary_outcome>
    <secondary_outcome>
      <measure>Time to Sustained Alleviation of Targeted Coronavirus Disease 2019 (COVID-19) Symptoms by Day 35</measure>
      <time_frame>First dose date up to Day 35</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change from Baseline in Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Viral Load at Day 5</measure>
      <time_frame>Baseline, Day 5</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Proportion of Participants Who Require Supplemental Oxygen Support by Day 35</measure>
      <time_frame>First dose date up to Day 35</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Percentage of Participants With Palatability and Acceptability for Each Formulation as Measured by Questionnaire Scores</measure>
      <time_frame>Day 5</time_frame>
      <description>Palatability and acceptability assessed by a numeric response between numbers 1-5. Higher scores indicate better palatability and acceptability.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Proportion of Participants with Concomitant Use of Medications Other Than Remdesivir (RDV) and Obeldesivir (ODV) for Treatment of COVID-19 by Day 35</measure>
      <time_frame>First dose date up to Day 35</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Proportion of Participants with COVID-19-Related Hospitalization or All-Cause Death by Day 35</measure>
      <time_frame>First dose date up to Day 35</time_frame>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">52</enrollment>
    <condition>COVID-19</condition>
    <arm_group>
      <arm_group_label>Obeldesivir (ODV)</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants will receive ODV for 5 days. The ODV dose to be administered in each cohort based on age and weight as follows:&#xD;
  Cohort 1: ODV, tablets, 350 mg twice daily (BID)&#xD;
  Cohort 2: ODV, tablets, 175 mg BID&#xD;
  Cohorts 3-7: ODV doses will be determined based on available PK data.</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Obeldesivir</intervention_name>
      <description>Tablet administered orally with or without food</description>
      <arm_group_label>Obeldesivir (ODV)</arm_group_label>
      <other_name>GS-5245</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Key Inclusion Criteria:&#xD;
  &#xD;
            -  Individual or legal guardian willing and able to provide written informed consent&#xD;
               prior to performing study procedures. Individuals will provide assent, if possible, in&#xD;
               accordance with local requirements and investigator's discretion.&#xD;
  &#xD;
            -  Aged &lt; 18 years who meet one of the following weight criteria and gestational age (GA)&#xD;
               criteria where applicable:&#xD;
  &#xD;
                 -  Cohort 1: ≥ 6 years to &lt; 18 years and weight ≥ 40 kg&#xD;
  &#xD;
                 -  Cohort 2: ≥ 6 years to &lt; 18 years and weight ≥ 20 kg to &lt; 40 kg&#xD;
  &#xD;
                 -  Cohort 3: ≥ 2 years 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 5: ≥ 14 days to &lt; 28 days of age, GA ≥ 37 weeks and weight ≥ 2.5 kg&#xD;
  &#xD;
                 -  Cohort 6: 0 days to &lt; 14 days of age, GA ≥ 37 weeks and birth weight ≥ 2.5 kg&#xD;
  &#xD;
                 -  Cohort 7: 0 days to &lt; 56 days of age, GA &lt; 37 weeks and birth weight ≥ 1.5 kg&#xD;
  &#xD;
            -  Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection confirmed by&#xD;
               polymerase chain reaction (PCR) or an alternative molecular diagnostic assay ≤ 5 days&#xD;
               before screening.&#xD;
  &#xD;
            -  Initial onset of coronavirus disease 2019 (COVID-19) signs/symptoms ≤ 5 days before&#xD;
               screening with ≥ 1 sign/symptom such as fever, cough, fatigue, shortness of breath,&#xD;
               sore throat, headache, myalgia/arthralgia present at screening.&#xD;
  &#xD;
            -  Presence of ≥ 1 characteristic or underlying medical condition associated with an&#xD;
               increased risk of developing severe illness due to COVID-19.&#xD;
  &#xD;
          Key Exclusion Criteria:&#xD;
  &#xD;
            -  Anticipated access to and use of authorized or approved COVID-19 therapies during the&#xD;
               current COVID-19 illness &lt; 5 days after screening (therapies including but not limited&#xD;
               to nirmatrelvir/ritonavir, molnupiravir, intravenous RDV, monoclonal antibodies).&#xD;
  &#xD;
            -  Vaccination for SARS-CoV-2 or self-reported history of SARS-CoV-2 infection &lt; 4 months&#xD;
               prior to screening.&#xD;
  &#xD;
            -  Received any approved, authorized, or investigational direct acting antiviral drug&#xD;
               against SARS-CoV-2 for the treatment of COVID-19 &lt; 28 days or &lt; 5 half-lives,&#xD;
               whichever is longer, before enrollment.&#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>
    <overall_contact>
      <last_name>Gilead Clinical Study Information Center</last_name>
      <phone>1-833-445-3230 (GILEAD-0)</phone>
      <email>GileadClinicalTrials@gilead.com</email>
    </overall_contact>
    <link>
      <url>https://www.gileadclinicaltrials.com/study?nctid=NCT05996744</url>
      <description>Gilead Clinical Trials Website</description>
    </link>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 14, 2023</study_first_submitted>
    <study_first_submitted_qc>August 14, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 18, 2023</study_first_posted>
    <last_update_submitted>September 6, 2023</last_update_submitted>
    <last_update_submitted_qc>September 6, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 8, 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>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05996744
  org study id: GS-US-611-6464
  secondary id: 2023-503282-27
  nct id: NCT05996744
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: Yes
  is fda regulated device: No
  The goal of this clinical study is to learn more about the safety and tolerability of
        obeldesivir (ODV) in children and adolescents with coronavirus disease 2019 (COVID-19).
  
        The primary objectives are to evaluate the plasma pharmacokinetics (PK), safety and
        tolerability of ODV in pediatric participants with COVID-19.
  Pediatric participants will be enrolled as follows:
  
          -  Cohort 1: ≥ 6 years to < 18 years and weight ≥ 40 kg
  
          -  Cohort 2: ≥ 6 years to < 18 years and weight ≥ 20 kg to < 40 kg
  
          -  Cohort 3: ≥ 2 years 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 5: ≥ 14 days to < 28 days of age, gestational age (GA) ≥ 37 weeks and weight ≥
             2.5 kg
  
          -  Cohort 6: 0 days to < 14 days of age, GA ≥ 37 weeks and birth weight ≥ 2.5 kg
  
          -  Cohort 7: 0 days to < 56 days of age, GA < 37 weeks and birth weight ≥ 1.5 kg
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Pharmacokinetic (PK) Parameter: AUC0-12 of Obeldesivir (ODV) Metabolite, GS-441524
  time frame: Cohorts 1 and 2: Day 3 and 5
  description: AUC0-12 is defined as the area under the concentration versus time curve from time 0 to time 12 hours.
  measure: PK Parameter: Cmax of ODV Metabolite, GS-441524
  time frame: Cohorts 1 and 2: Day 3 and 5
  description: Cmax is defined as maximum observed concentration of drug.
  measure: PK Parameter: Ctrough of ODV Metabolite, GS-441524
  time frame: Cohorts 1 and 2: Day 3 and 5
  description: Ctrough is defined as concentration at the end of the dosing interval.
  measure: Percentage of Participants Experiencing Treatment-Emergent Adverse Events (AEs) by Day 35
  time frame: First dose date up to Day 5 plus 30 days
  measure: Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities by Day 35
  time frame: First dose date up to Day 5 plus 30 days
  measure: Time to Sustained Alleviation of Targeted Coronavirus Disease 2019 (COVID-19) Symptoms by Day 35
  time frame: First dose date up to Day 35
  measure: Change from Baseline in Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Viral Load at Day 5
  time frame: Baseline, Day 5
  measure: Proportion of Participants Who Require Supplemental Oxygen Support by Day 35
  time frame: First dose date up to Day 35
  measure: Percentage of Participants With Palatability and Acceptability for Each Formulation as Measured by Questionnaire Scores
  time frame: Day 5
  description: Palatability and acceptability assessed by a numeric response between numbers 1-5. Higher scores indicate better palatability and acceptability.
  measure: Proportion of Participants with Concomitant Use of Medications Other Than Remdesivir (RDV) and Obeldesivir (ODV) for Treatment of COVID-19 by Day 35
  time frame: First dose date up to Day 35
  measure: Proportion of Participants with COVID-19-Related Hospitalization or All-Cause Death by Day 35
  time frame: First dose date up to Day 35
  arm group label: Obeldesivir (ODV)
  arm group type: Experimental
  description: Participants will receive ODV for 5 days. The ODV dose to be administered in each cohort based on age and weight as follows:
  Cohort 1: ODV, tablets, 350 mg twice daily (BID)
  Cohort 2: ODV, tablets, 175 mg BID
  Cohorts 3-7: ODV doses will be determined based on available PK data.
  intervention type: Drug
  intervention name: Obeldesivir
  description: Tablet administered orally with or without food
  arm group label: Obeldesivir (ODV)
  other name: GS-5245
  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
  last name: Gilead Clinical Study Information Center
  phone: 1-833-445-3230 (GILEAD-0)
  email: GileadClinicalTrials@gilead.com
  url: https://www.gileadclinicaltrials.com/study?nctid=NCT05996744
  description: Gilead Clinical Trials Website
  responsible party type: Sponsor
  mesh term: COVID-19
  sharing ipd: No