<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/NCT04504240</url>
  </required_header>
  <id_info>
    <org_study_id>10000753/980</org_study_id>
    <nct_id>NCT04504240</nct_id>
  </id_info>
  <brief_title>Role of Famotidine in the Clinical Improvement of COVID-19 Patients.</brief_title>
  <official_title>Role of Famotidine in the Clinical Recovery and Symptomatic Improvement of COVID-19 Patients.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Chattogram General Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>M Abdur Rahim Medical College and Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>First Affiliated Hospital Xi'an Jiaotong University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Chattogram General Hospital</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>
      This study is aimed to investigate the effect of Famotidine in the clinical recovery of&#xD;
      COVID-19 patients. COVID19 is a worldwide pandemic. Hence SARS-CoV-2 is a novel virus; there&#xD;
      is no specific medication against it. Like other countries of the world, Besides antiviral&#xD;
      drugs, immunosuppressive agents, and symptomatic therapy like H2 receptor blocker FAMOTIDINE&#xD;
      came to the limelight due to its role in reducing the symptoms of COVID-19 patients. The&#xD;
      study will include COVID-19 participants to confirm by RT PCR or an HRCT chest. Detail&#xD;
      history of each participant with comorbidity will be taken and will be examined carefully.&#xD;
      The hospitalized patients admitted to the HDU/ICU units will be enrolled in this study.&#xD;
      Critically ill patients who require ventilator support will not be included in this study.&#xD;
      The outcome of the Famotidine treatment will be evaluated and compared with a control group.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 1, 2020</start_date>
  <completion_date type="Actual">April 15, 2021</completion_date>
  <primary_completion_date type="Actual">April 15, 2021</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Time to Clinical Improvement (TTCI)</measure>
    <time_frame>Following randomization 30days.</time_frame>
    <description>Time to clinical improvement (TTCI) was defined as time from randomization to National Early Warning Score 2 (NEWS2) Score of ≤2 maintained for 24 Hours.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Time to symptomatic recovery.</measure>
    <time_frame>Following randomization 30 days.</time_frame>
    <description>Time to Symptomatic recovery was defined as the duration (in days) that required for the relief of the COVID-19 symptoms from the day of hospitalization.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Mortality Rate</measure>
    <time_frame>Following randomization 30 days.</time_frame>
    <description>Mortality Rate in percentage in study groups.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of ICU Stay.</measure>
    <time_frame>Following randomization 30 days.</time_frame>
    <description>Duration of ICU Stay in days.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total hospital stay.</measure>
    <time_frame>Following randomization 30 days.</time_frame>
    <description>Time from randomization to hospital discharge or &quot;Ready for discharge&quot; (as evidenced by normal body temperature and respiratory rate, and stable oxygen saturation on ambient Air or ≤4L supplemental oxygen).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to clinical failure or death.</measure>
    <time_frame>Following randomization 30 days.</time_frame>
    <description>Time to clinical failure, defined as the time from randomization to the first occurrence of death, mechanical ventilation or withdrawal (whichever occurs first).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to Viral clearance / COVID-19 recovery.</measure>
    <time_frame>Following randomization 60 days.</time_frame>
    <description>This was defined as the duration (in days) from the first positive PCR to the first negative PCR (Confirmed by a repeat negative PCR after 7days) for SARS-Cov-2 infection following hospital discharge.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">208</enrollment>
  <condition>Covid19</condition>
  <arm_group>
    <arm_group_label>Group A: FAMOTIDINE treatment group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>FAMOTIDINE 40mg to 60mg 8hourly in an empty stomach along with other treatments.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group B: Control group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Treatment as given with a PPI.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Famotidine 20 MG</intervention_name>
    <description>Famotidine; tablet Famotac 20mg oral form.</description>
    <arm_group_label>Group A: FAMOTIDINE treatment group</arm_group_label>
    <arm_group_label>Group B: Control group</arm_group_label>
    <other_name>Famotac 20mg</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  SARS-CoV-2 infection confirmed by RT PCR or CT Chest.&#xD;
&#xD;
          -  Severe COVID-19 patients require hospitalization under HDU/ICU.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with severe and/or uncontrolled medical conditions with significantly&#xD;
             compromised organ function.&#xD;
&#xD;
          -  Patients who were hospitalized from the before due to other reasons.&#xD;
&#xD;
          -  Contraindication / possible drug interaction with Famotidine with existing therapy.&#xD;
&#xD;
          -  Immunocompromised patients.&#xD;
&#xD;
          -  Pregnancy, Pulmonary Tuberculosis, AIDS&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>16 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Abu Taiub Mohammed Mohiuddin Chowdhury, MBBS, MD</last_name>
    <role>Study Chair</role>
    <affiliation>First Affiliated Hospital Xi'an Jiaotong University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Chattogram General Hospital</name>
      <address>
        <city>Chittagong</city>
        <zip>4000</zip>
        <country>Bangladesh</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>M. Abdur Rahim Medical College Hospital</name>
      <address>
        <city>Dinājpur</city>
        <country>Bangladesh</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Bangladesh</country>
  </location_countries>
  <verification_date>October 2021</verification_date>
  <study_first_submitted>August 6, 2020</study_first_submitted>
  <study_first_submitted_qc>August 6, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 7, 2020</study_first_posted>
  <last_update_submitted>October 23, 2021</last_update_submitted>
  <last_update_submitted_qc>October 23, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">October 26, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>First Affiliated Hospital Xi'an Jiaotong University</investigator_affiliation>
    <investigator_full_name>Abu Taiub Mohammed Mohiuddin Chowdhury</investigator_full_name>
    <investigator_title>Doctoral Resident</investigator_title>
  </responsible_party>
  <keyword>COVID 19</keyword>
  <keyword>Famotidine</keyword>
  <keyword>Bangladesh</keyword>
  <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>Famotidine</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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/NCT04504240
org study id: 10000753/980
nct id: NCT04504240
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This study is aimed to investigate the effect of Famotidine in the clinical recovery of
      COVID-19 patients. COVID19 is a worldwide pandemic. Hence SARS-CoV-2 is a novel virus; there
      is no specific medication against it. Like other countries of the world, Besides antiviral
      drugs, immunosuppressive agents, and symptomatic therapy like H2 receptor blocker FAMOTIDINE
      came to the limelight due to its role in reducing the symptoms of COVID-19 patients. The
      study will include COVID-19 participants to confirm by RT PCR or an HRCT chest. Detail
      history of each participant with comorbidity will be taken and will be examined carefully.
      The hospitalized patients admitted to the HDU/ICU units will be enrolled in this study.
      Critically ill patients who require ventilator support will not be included in this study.
      The outcome of the Famotidine treatment will be evaluated and compared with a control group.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Time to Clinical Improvement (TTCI)
time frame: Following randomization 30days.
description: Time to clinical improvement (TTCI) was defined as time from randomization to National Early Warning Score 2 (NEWS2) Score of ≤2 maintained for 24 Hours.
measure: Time to symptomatic recovery.
time frame: Following randomization 30 days.
description: Time to Symptomatic recovery was defined as the duration (in days) that required for the relief of the COVID-19 symptoms from the day of hospitalization.
measure: Mortality Rate
time frame: Following randomization 30 days.
description: Mortality Rate in percentage in study groups.
measure: Duration of ICU Stay.
time frame: Following randomization 30 days.
description: Duration of ICU Stay in days.
measure: Total hospital stay.
time frame: Following randomization 30 days.
description: Time from randomization to hospital discharge or "Ready for discharge" (as evidenced by normal body temperature and respiratory rate, and stable oxygen saturation on ambient Air or ≤4L supplemental oxygen).
measure: Time to clinical failure or death.
time frame: Following randomization 30 days.
description: Time to clinical failure, defined as the time from randomization to the first occurrence of death, mechanical ventilation or withdrawal (whichever occurs first).
measure: Time to Viral clearance / COVID-19 recovery.
time frame: Following randomization 60 days.
description: This was defined as the duration (in days) from the first positive PCR to the first negative PCR (Confirmed by a repeat negative PCR after 7days) for SARS-Cov-2 infection following hospital discharge.
arm group label: Group A: FAMOTIDINE treatment group
arm group type: Experimental
description: FAMOTIDINE 40mg to 60mg 8hourly in an empty stomach along with other treatments.
arm group label: Group B: Control group
arm group type: Active Comparator
description: Treatment as given with a PPI.
intervention type: Drug
intervention name: Famotidine 20 MG
description: Famotidine; tablet Famotac 20mg oral form.
arm group label: Group A: FAMOTIDINE treatment group
arm group label: Group B: Control group
other name: Famotac 20mg
criteria: 
gender: All
minimum age: 16 Years
maximum age: 80 Years
healthy volunteers: No
last name: Abu Taiub Mohammed Mohiuddin Chowdhury, MBBS, MD
role: Study Chair
affiliation: First Affiliated Hospital Xi'an Jiaotong University
facility: 
facility: 
country: Bangladesh
responsible party type: Principal Investigator
investigator affiliation: First Affiliated Hospital Xi'an Jiaotong University
investigator full name: Abu Taiub Mohammed Mohiuddin Chowdhury
investigator title: Doctoral Resident
mesh term: COVID-19
mesh term: Famotidine
sharing ipd: No