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/NCT06004375</url>
    </required_header>
    <id_info>
      <org_study_id>ID</org_study_id>
      <nct_id>NCT06004375</nct_id>
    </id_info>
    <brief_title>THE EFFECT OF ARGININE AND GLUTAMINE ON COVID-19 PATIENTS OUTCOME: A RANDOMIZED CLINICAL TRIAL</brief_title>
    <official_title>THE EFFECT OF ARGININE AND GLUTAMINE ON COVID-19 PATIENTS OUTCOME: A RANDOMIZED CLINICAL TRIAL</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Universitas Sriwijaya</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>M. Djamil General Hospital</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Universitas Sriwijaya</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The goal of this clinical trial is to determine effect of arginine and glutamine on outcome&#xD;
        of COVID-19 patients. The main questions it aims to answer are:&#xD;
  &#xD;
        -to test the effect of oral nutritional supplements containing arginine and glutamine on&#xD;
        covid-19 patients outcome Dr. M. Djamil General Hospital Padang&#xD;
  &#xD;
        Participants will given ONS containing arginine and glutamine. Researchers will compare&#xD;
        intervention group with control group to see if ONS affected outcome of COVID-19 patients&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">May 1, 2021</start_date>
    <completion_date type="Actual">May 30, 2023</completion_date>
    <primary_completion_date type="Actual">May 30, 2023</primary_completion_date>
    <phase>Phase 3</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Triple (Participant, Care Provider, Investigator)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>length of stay</measure>
      <time_frame>3 months</time_frame>
      <description>length of stay of patients in hospital</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Outcome</measure>
      <time_frame>3 months</time_frame>
      <description>Outcome Measures of patients (discharge or dead)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>ICU Admission</measure>
      <time_frame>3 months</time_frame>
      <description>A patient is likely to be admitted to ICU during intervention period</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Il-6 and CRP Levels</measure>
      <time_frame>3 months</time_frame>
      <description>Il-6 and CRP Levels during hospitalization</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Actual">20</enrollment>
    <condition>COVID-19</condition>
    <arm_group>
      <arm_group_label>intervention group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>The intervention group was given a High-Calorie High-Protein + ONS diet containing 4.8 g arginine and 2 g glutamine, namely Neomune 2x 200 cc, purchased from Otsuka Pharmaceutical Co., Ltd</description>
    </arm_group>
    <arm_group>
      <arm_group_label>control group</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>the control was administered with a High-Calorie High-Protein diet + ONS hospital standard.</description>
    </arm_group>
    <intervention>
      <intervention_type>Dietary Supplement</intervention_type>
      <intervention_name>Neomune</intervention_name>
      <description>Neomune containing 4.8 g arginine and 2 g glutamine</description>
      <arm_group_label>control group</arm_group_label>
      <arm_group_label>intervention group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patients confirmed positive for COVID-19&#xD;
  &#xD;
            -  Age over 17 years&#xD;
  &#xD;
            -  The patient can take food orally&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patients with restricted fluid intake&#xD;
  &#xD;
            -  Patients who cannot take food orally&#xD;
  &#xD;
            -  suffering from diabetes mellitus and kidney failure&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>70 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Dr. M. Djamil General Hospital</name>
        <address>
          <city>Padang</city>
          <state>West Sumatera</state>
          <zip>25176</zip>
          <country>Indonesia</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Indonesia</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 19, 2023</study_first_submitted>
    <study_first_submitted_qc>August 19, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 22, 2023</study_first_posted>
    <last_update_submitted>August 19, 2023</last_update_submitted>
    <last_update_submitted_qc>August 19, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 22, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Universitas Sriwijaya</investigator_affiliation>
      <investigator_full_name>Sari Bema Ramdika</investigator_full_name>
      <investigator_title>Ms</investigator_title>
    </responsible_party>
    <keyword>COVID-19</keyword>
    <keyword>Oral Nutrition Supplement</keyword>
    <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/NCT06004375
  org study id: ID
  nct id: NCT06004375
  lead sponsor: 
  collaborator: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this clinical trial is to determine effect of arginine and glutamine on outcome
        of COVID-19 patients. The main questions it aims to answer are:
  
        -to test the effect of oral nutritional supplements containing arginine and glutamine on
        covid-19 patients outcome Dr. M. Djamil General Hospital Padang
  
        Participants will given ONS containing arginine and glutamine. Researchers will compare
        intervention group with control group to see if ONS affected outcome of COVID-19 patients
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Triple (Participant, Care Provider, Investigator)
  measure: length of stay
  time frame: 3 months
  description: length of stay of patients in hospital
  measure: Outcome
  time frame: 3 months
  description: Outcome Measures of patients (discharge or dead)
  measure: ICU Admission
  time frame: 3 months
  description: A patient is likely to be admitted to ICU during intervention period
  measure: Il-6 and CRP Levels
  time frame: 3 months
  description: Il-6 and CRP Levels during hospitalization
  arm group label: intervention group
  arm group type: Experimental
  description: The intervention group was given a High-Calorie High-Protein + ONS diet containing 4.8 g arginine and 2 g glutamine, namely Neomune 2x 200 cc, purchased from Otsuka Pharmaceutical Co., Ltd
  arm group label: control group
  arm group type: Active Comparator
  description: the control was administered with a High-Calorie High-Protein diet + ONS hospital standard.
  intervention type: Dietary Supplement
  intervention name: Neomune
  description: Neomune containing 4.8 g arginine and 2 g glutamine
  arm group label: control group
  arm group label: intervention group
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 70 Years
  healthy volunteers: No
  facility: 
  country: Indonesia
  responsible party type: Principal Investigator
  investigator affiliation: Universitas Sriwijaya
  investigator full name: Sari Bema Ramdika
  investigator title: Ms
  mesh term: COVID-19
  sharing ipd: No