<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/NCT04433988</url>
  </required_header>
  <id_info>
    <org_study_id>RC-6-2020</org_study_id>
    <nct_id>NCT04433988</nct_id>
  </id_info>
  <brief_title>Efficacy of Pentoxifylline as Add on Therapy in COVID19 Patients</brief_title>
  <official_title>Efficacy of Pentoxifylline as Add on Therapy in COVID19 Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sadat City University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Sadat City 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>
      With potential antiviral effects on severe acute respiratory syndrome (SARS) and as a&#xD;
      methyl-xanthine derived inhibitor of phosphodiesterase-4, pentoxifylline basically functions&#xD;
      as a hemorrheologic agent for a better circulation and oxygenation and exerts unique effects&#xD;
      on immune modulation, inflammation and oxidative stress. As the main regulator of cAMP&#xD;
      metabolism, posphodiesterase-4 plays a key role in proinflammatory and immune cells.&#xD;
      Pentoxifylline plays its anti-inflammatory role by reducing the production of proinflammatory&#xD;
      cytokines such as TNF-a, IL-1 and IL-6. Given its unique impacts on immune modulation,&#xD;
      homeostasis and fibrinolysis and its supportive effects on oxidative stress and organ&#xD;
      failure, pentoxifylline can constitute a multipurpose and generally-safe adjuvant therapy for&#xD;
      COVID-19 patients.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Institutional problems&#xD;
  </why_stopped>
  <start_date type="Actual">November 13, 2022</start_date>
  <completion_date type="Actual">December 30, 2022</completion_date>
  <primary_completion_date type="Actual">December 30, 2022</primary_completion_date>
  <phase>Phase 1/Phase 2</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>Primary Outcome</measure>
    <time_frame>7 days</time_frame>
    <description>Number of Participants need hospitalization</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Respiratory infection</measure>
    <time_frame>7 days</time_frame>
    <description>Incidence of any acute respiratory infection</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Serious Adverse Events</measure>
    <time_frame>7 days</time_frame>
    <description>Absolute and relative frequencies of Serious Adverse Events</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>COVID</condition>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>100 patients will receive standard treatment plus placebo</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Pentoxifylline group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>100 patients will receive standard treatment plus pentoxifylline 1200 mg/day</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Pentoxifylline</intervention_name>
    <description>Pentoxifylline 400 mg SR tablet</description>
    <arm_group_label>Pentoxifylline group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Placebo tablet</description>
    <arm_group_label>Control group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Positive COVID-19 test&#xD;
&#xD;
          -  Age &gt;/= 18 y.o.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Allergic reaction to Pentoxifylline&#xD;
&#xD;
          -  Ongoing anticoagulation&#xD;
&#xD;
          -  History of GI bleeding&#xD;
&#xD;
          -  History of Seizures&#xD;
&#xD;
          -  Cardiac or other vascular stents&#xD;
&#xD;
          -  History of severe renal disease&#xD;
&#xD;
          -  History of intracranial hemorrhage.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Faculty of Medicine</name>
      <address>
        <city>Shibīn Al Kawm</city>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>January 2023</verification_date>
  <study_first_submitted>June 13, 2020</study_first_submitted>
  <study_first_submitted_qc>June 13, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 16, 2020</study_first_posted>
  <last_update_submitted>January 16, 2023</last_update_submitted>
  <last_update_submitted_qc>January 16, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">January 18, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Sadat City University</investigator_affiliation>
    <investigator_full_name>Mahmoud Samy Abdallah</investigator_full_name>
    <investigator_title>Lecturer of Clinical Pharmacy, PhD.</investigator_title>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pentoxifylline</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
  </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/NCT04433988
org study id: RC-6-2020
nct id: NCT04433988
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
With potential antiviral effects on severe acute respiratory syndrome (SARS) and as a
      methyl-xanthine derived inhibitor of phosphodiesterase-4, pentoxifylline basically functions
      as a hemorrheologic agent for a better circulation and oxygenation and exerts unique effects
      on immune modulation, inflammation and oxidative stress. As the main regulator of cAMP
      metabolism, posphodiesterase-4 plays a key role in proinflammatory and immune cells.
      Pentoxifylline plays its anti-inflammatory role by reducing the production of proinflammatory
      cytokines such as TNF-a, IL-1 and IL-6. Given its unique impacts on immune modulation,
      homeostasis and fibrinolysis and its supportive effects on oxidative stress and organ
      failure, pentoxifylline can constitute a multipurpose and generally-safe adjuvant therapy for
      COVID-19 patients.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Investigator)
measure: Primary Outcome
time frame: 7 days
description: Number of Participants need hospitalization
measure: Respiratory infection
time frame: 7 days
description: Incidence of any acute respiratory infection
measure: Serious Adverse Events
time frame: 7 days
description: Absolute and relative frequencies of Serious Adverse Events
arm group label: Control group
arm group type: Placebo Comparator
description: 100 patients will receive standard treatment plus placebo
arm group label: Pentoxifylline group
arm group type: Experimental
description: 100 patients will receive standard treatment plus pentoxifylline 1200 mg/day
intervention type: Drug
intervention name: Pentoxifylline
description: Pentoxifylline 400 mg SR tablet
arm group label: Pentoxifylline group
intervention type: Drug
intervention name: Placebo
description: Placebo tablet
arm group label: Control group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: No
facility: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Sadat City University
investigator full name: Mahmoud Samy Abdallah
investigator title: Lecturer of Clinical Pharmacy, PhD.
mesh term: Pentoxifylline
sharing ipd: Yes
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)