<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/NCT04463420</url>
  </required_header>
  <id_info>
    <org_study_id>IR.BMSU.REC.1399.176</org_study_id>
    <nct_id>NCT04463420</nct_id>
  </id_info>
  <brief_title>Safety and Efficacy of PHR 160 Spray on the Outcomes of Patients With COVID-19</brief_title>
  <official_title>Safety and Efficacy of PHR 160 Spray on the Outcomes of Patients With COVID-19 a Multi-center Randomized Blinding Clinical Trial Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Baqiyatallah Medical Sciences University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Baqiyatallah Medical Sciences University</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 a multi-center randomized, controlled, and blinded clinical trial study that&#xD;
      will be performed in four medical-educational centers. In this study, the samples will be&#xD;
      selected from among patients with SARS-CoV-2 as easy access and based on entry criteria and&#xD;
      will be randomly divided into two groups, including a control group and an intervention&#xD;
      group. The study will be conducted in four medical centers. From each center, 56 definitive&#xD;
      Corona patients will be selected, who will be randomly divided into two groups of 28, for a&#xD;
      total of 224 patients will enter the study. In the intervention group, in addition to&#xD;
      receiving the test spray, Patients will also receive standard treatment&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">August 15, 2020</start_date>
  <completion_date type="Anticipated">December 15, 2020</completion_date>
  <primary_completion_date type="Anticipated">November 15, 2020</primary_completion_date>
  <phase>N/A</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, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Dyspnea</measure>
    <time_frame>up to 14 days</time_frame>
    <description>shortness of breath measured by Visual analog scale (VAS) dyspnea score. The minimum score is zero means shortness of breath and the highest score is 10 means the maximum intensity of shortness of breath.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>long of hospitalization</measure>
    <time_frame>up to 28 days</time_frame>
    <description>The length of time the patient is hospitalized after the diagnosis of COVID-19</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Radiological Treatment Response</measure>
    <time_frame>up to 14 days</time_frame>
    <description>CT scans help determine how much the lungs are affected by COVID-19.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mortality</measure>
    <time_frame>Up to 28 days</time_frame>
    <description>In-hospital mortality</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Allergic drug</measure>
    <time_frame>up to 14 days</time_frame>
    <description>There will be known allergic reactions to the drugs.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Laboratory Treatment Response</measure>
    <time_frame>up to 14 days</time_frame>
    <description>Normal blood cell count and CRP count (normal laboratory range)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>O2 saturation without supplemental oxygen</measure>
    <time_frame>up to 14 days</time_frame>
    <description>Using an oximeter pulse, the amount of oxygen saturation is measured. If the patient is receiving oxygen, first cut off the oxygen for 5 minutes and then measure. If the oxygen drops below 90 degrees, oxygen therapy will be re-established immediately.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>drug reactions Adverse</measure>
    <time_frame>Up to 14 days</time_frame>
    <description>Complications in both groups should be evaluated and evaluated during treatment.&#xD;
protective response that serves to clear the trachea, bronchi, and/or lungs of irritants and secretions that measured by Physical examination.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">224</enrollment>
  <condition>COVID-19</condition>
  <arm_group>
    <arm_group_label>Test Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Intervention group: : Hydroxychloroquine 400 mg only on the first day / one naproxen 250 mg every 12 hours for 5 days / 500 mg azithromycin on the first day and 250 mg on the second to fifth days / 40 mg famotidine every 12 hours for 5 days / 25 mg prednisolone daily for 5 days / PHR160 spray one hour oral puff with Demyar ten times a day for ten days in a row, for ten days.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control Group</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Control group: Hydroxychloroquine 400 mg only on the first day / one naproxen 250 mg every 12 hours for 5 days / 500 mg azithromycin on the first day and 250 mg on the second to fifth days / 40 mg famotidine every 12 hours for 5 days Daily / 25 mg prednisolone daily for 5 days / placebo spray one hourly oral puff ten times a day for ten days in a row, for ten days</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>PHR160 Spray</intervention_name>
    <description>One puff spray per hour containing 300 mg of the drug will be given to patients. This treatment lasts up to 10 days.</description>
    <arm_group_label>Test Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>participants will receive a placebo spray every hour. This process will continue for 10 days.</description>
    <arm_group_label>Control Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Standard treatment</intervention_name>
    <description>: Hydroxychloroquine 400 mg only on the first day / one naproxen 250 mg every 12 hours for 5 days / 500 mg azithromycin on the first day and 250 mg on the second to fifth days / 40 mg famotidine every 12 hours for 5 days / 25 mg prednisolone daily for 5 days</description>
    <arm_group_label>Control Group</arm_group_label>
    <arm_group_label>Test Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Conscious consent to participate in the study&#xD;
&#xD;
          -  Patients 18 to 75 years of age with COVID-19 who have been diagnosed with PCR.&#xD;
&#xD;
          -  Strong clinical suspicion of covid 19 with positive findings in CT Scan&#xD;
&#xD;
          -  Shortness of breath&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with HIV&#xD;
&#xD;
          -  Patients with cancer undergoing chemotherapy&#xD;
&#xD;
          -  Patients receiving Immune Mediators&#xD;
&#xD;
          -  Patients need hospitalization in the intensive care unit&#xD;
&#xD;
          -  Patients with uncontrolled heart, kidney or liver failure&#xD;
&#xD;
          -  Pregnant or lactating women&#xD;
&#xD;
          -  Intolerance to the drugs used in this study (symptoms such as diarrhea, nausea,&#xD;
             vomiting and respiratory problems)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Mohammad Sadegh Bagheri Baghdasht</last_name>
    <phone>0098 9356318204</phone>
    <email>sadegh.bagheri@gmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Mohammad Sadegh Bagheri Baghdasht</name>
      <address>
        <city>Tehran</city>
        <zip>0</zip>
        <country>Iran, Islamic Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Mohammad Sadegh Bagheri Baghdasht</last_name>
      <phone>+989356318204</phone>
      <email>sadegh.bagheri@gmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Iran, Islamic Republic of</country>
  </location_countries>
  <verification_date>November 2020</verification_date>
  <study_first_submitted>July 4, 2020</study_first_submitted>
  <study_first_submitted_qc>July 8, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 9, 2020</study_first_posted>
  <last_update_submitted>November 3, 2020</last_update_submitted>
  <last_update_submitted_qc>November 3, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">November 4, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Baqiyatallah Medical Sciences University</investigator_affiliation>
    <investigator_full_name>Mohammad Sadegh Bagheri Baghdasht</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>COVID-19</mesh_term>
  </condition_browse>
  <!-- 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/NCT04463420
org study id: IR.BMSU.REC.1399.176
nct id: NCT04463420
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This study is a multi-center randomized, controlled, and blinded clinical trial study that
      will be performed in four medical-educational centers. In this study, the samples will be
      selected from among patients with SARS-CoV-2 as easy access and based on entry criteria and
      will be randomly divided into two groups, including a control group and an intervention
      group. The study will be conducted in four medical centers. From each center, 56 definitive
      Corona patients will be selected, who will be randomly divided into two groups of 28, for a
      total of 224 patients will enter the study. In the intervention group, in addition to
      receiving the test spray, Patients will also receive standard treatment
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Dyspnea
time frame: up to 14 days
description: shortness of breath measured by Visual analog scale (VAS) dyspnea score. The minimum score is zero means shortness of breath and the highest score is 10 means the maximum intensity of shortness of breath.
measure: long of hospitalization
time frame: up to 28 days
description: The length of time the patient is hospitalized after the diagnosis of COVID-19
measure: Radiological Treatment Response
time frame: up to 14 days
description: CT scans help determine how much the lungs are affected by COVID-19.
measure: Mortality
time frame: Up to 28 days
description: In-hospital mortality
measure: Allergic drug
time frame: up to 14 days
description: There will be known allergic reactions to the drugs.
measure: Laboratory Treatment Response
time frame: up to 14 days
description: Normal blood cell count and CRP count (normal laboratory range)
measure: O2 saturation without supplemental oxygen
time frame: up to 14 days
description: Using an oximeter pulse, the amount of oxygen saturation is measured. If the patient is receiving oxygen, first cut off the oxygen for 5 minutes and then measure. If the oxygen drops below 90 degrees, oxygen therapy will be re-established immediately.
measure: drug reactions Adverse
time frame: Up to 14 days
description: Complications in both groups should be evaluated and evaluated during treatment.
protective response that serves to clear the trachea, bronchi, and/or lungs of irritants and secretions that measured by Physical examination.
arm group label: Test Group
arm group type: Experimental
description: Intervention group: : Hydroxychloroquine 400 mg only on the first day / one naproxen 250 mg every 12 hours for 5 days / 500 mg azithromycin on the first day and 250 mg on the second to fifth days / 40 mg famotidine every 12 hours for 5 days / 25 mg prednisolone daily for 5 days / PHR160 spray one hour oral puff with Demyar ten times a day for ten days in a row, for ten days.
arm group label: Control Group
arm group type: Placebo Comparator
description: Control group: Hydroxychloroquine 400 mg only on the first day / one naproxen 250 mg every 12 hours for 5 days / 500 mg azithromycin on the first day and 250 mg on the second to fifth days / 40 mg famotidine every 12 hours for 5 days Daily / 25 mg prednisolone daily for 5 days / placebo spray one hourly oral puff ten times a day for ten days in a row, for ten days
intervention type: Drug
intervention name: PHR160 Spray
description: One puff spray per hour containing 300 mg of the drug will be given to patients. This treatment lasts up to 10 days.
arm group label: Test Group
intervention type: Drug
intervention name: Placebo
description: participants will receive a placebo spray every hour. This process will continue for 10 days.
arm group label: Control Group
intervention type: Drug
intervention name: Standard treatment
description: : Hydroxychloroquine 400 mg only on the first day / one naproxen 250 mg every 12 hours for 5 days / 500 mg azithromycin on the first day and 250 mg on the second to fifth days / 40 mg famotidine every 12 hours for 5 days / 25 mg prednisolone daily for 5 days
arm group label: Control Group
arm group label: Test Group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Mohammad Sadegh Bagheri Baghdasht
phone: 0098 9356318204
email: sadegh.bagheri@gmail.com
facility: 
status: Recruiting
contact: 
country: Iran, Islamic Republic of
responsible party type: Principal Investigator
investigator affiliation: Baqiyatallah Medical Sciences University
investigator full name: Mohammad Sadegh Bagheri Baghdasht
investigator title: Principal Investigator
mesh term: COVID-19