<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/NCT04480138</url>
  </required_header>
  <id_info>
    <org_study_id>PEGI.20.003</org_study_id>
    <nct_id>NCT04480138</nct_id>
  </id_info>
  <brief_title>Pegylated Interferon - α2b With SARSCoV- 2 (COVID-19)</brief_title>
  <official_title>A Phase II, Multicenter, Open-label, Randomized, Comparator Controlled Study to Evaluate the Efficacy and Safety of Pegylated Interferon - α2b in the Treatment of Adult Patients Diagnosed With SARS-CoV2 (COVID-19)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Zydus Lifesciences Limited</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Zydus Lifesciences Limited</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 is a phase II, multicenter, open-label, randomized, comparator-controlled study to&#xD;
      evaluate the efficacy and safety of Pegylated Interferon -α2b in the treatment of adult&#xD;
      patients diagnosed with SARS-CoV2 (COVID-19).Initial 1 mcg/kg of Pegylated Interferon-α2b&#xD;
      will be administered on day 1. After safety evaluation of first dose, next dose (second dose)&#xD;
      1 mcg/kg on day 8 will be administered with recommended standard care during the trial.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a phase II, multicenter, open-label, randomized, comparator-controlled study to&#xD;
      evaluate the efficacy and safety of Pegylated Interferon -α2b in the treatment of adult&#xD;
      patients diagnosed with SARS-CoV2 (COVID-19).Moderate COVID-19 subjects will be randomly&#xD;
      assigned to receive test arm or reference arm in a 1:1 ratio.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Due to non availability of eligible subjects and slow recruitment&#xD;
  </why_stopped>
  <start_date type="Actual">August 11, 2020</start_date>
  <completion_date type="Actual">June 21, 2021</completion_date>
  <primary_completion_date type="Actual">June 21, 2021</primary_completion_date>
  <phase>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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Clinical status of subject on a 7-point ordinal scale</measure>
    <time_frame>Week 2</time_frame>
    <description>Not hospitalized, no limitations on activities.&#xD;
Not hospitalized, limitation on activities.&#xD;
Hospitalized, not requiring supplemental oxygen.&#xD;
Hospitalized, requiring supplemental oxygen.&#xD;
Hospitalized, on non-invasive ventilation or high flow oxygen devices.&#xD;
Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO).&#xD;
Death.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>PCR test</measure>
    <time_frame>Week 2 and Week 4</time_frame>
    <description>PCR for SARS-CoV-2 in pharyngeal swab</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Supplemental Oxygen</measure>
    <time_frame>Week 2 and Week 4</time_frame>
    <description>Occurrence of supplemental Oxygen</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mechanical Ventilation</measure>
    <time_frame>Week 2 and Week 4</time_frame>
    <description>Occurrence of Mechanical Ventilation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of Treatment-Emergent Adverse Events</measure>
    <time_frame>Week 2 and Week 4</time_frame>
    <description>Occurence of Adverse events</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>C-reactive protein (CRP)</measure>
    <time_frame>Week 2 and Week 4</time_frame>
    <description>Inflammatory Biomarker</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Interleukin 6 (IL-6)</measure>
    <time_frame>Week 2 and Week 4</time_frame>
    <description>Inflammatory Biomarker</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>D-dimer</measure>
    <time_frame>Week 2 and Week 4</time_frame>
    <description>Inflammatory Biomarker</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Interferon gamma</measure>
    <time_frame>Week 2 and Week 4</time_frame>
    <description>type II class of interferons</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ferritin</measure>
    <time_frame>Week 2 and Week 4</time_frame>
    <description>proteins</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>TNF alpha</measure>
    <time_frame>Week 2 and Week 4</time_frame>
    <description>Inflammatory Biomarker</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Interleukin 1-β</measure>
    <time_frame>Week 2 and Week 4</time_frame>
    <description>Inflammatory Biomarker</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">7</enrollment>
  <condition>Covid19</condition>
  <arm_group>
    <arm_group_label>Pegylated Interferon-α2b + Standard of care</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Test :- Pegylated Interferon-α2b + Standard of care (SOC)&#xD;
Pegylated Interferon-α2b-Initial 1 mcg/kg will be administered on day 1. After safety evaluation of first dose, next dose (second dose) 1 mcg/kg on day 8 will be administered along with the recommended standard of care at the time of conduct of trial.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard of Care</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Control: Standard of care&#xD;
Standard of care treatment will be provided as per regulatory recommendation and approval.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Pegylated Interferon-α2b</intervention_name>
    <description>1 mcg/kg on day 1 and day 8 after safety evaluations.</description>
    <arm_group_label>Pegylated Interferon-α2b + Standard of care</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Standard of Care</intervention_name>
    <description>Standard of care as per local authority</description>
    <arm_group_label>Pegylated Interferon-α2b + Standard of care</arm_group_label>
    <arm_group_label>Standard of Care</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Ability to comprehend and willingness to sign a written ICF for the study.&#xD;
&#xD;
          2. Male or non-pregnant females, ≥18 years of age at the time of enrolment.&#xD;
&#xD;
          3. Understands and agrees to comply with planned study procedures.&#xD;
&#xD;
          4. Agrees to the collection of pharyngeal swabs and blood sample as per protocol.&#xD;
&#xD;
          5. Has laboratory-confirmed SARS-CoV-2 infection as determined by PCR, or other&#xD;
             commercial or public health assay in any specimen within one week&#xD;
&#xD;
          6. Patients with SpO2 &gt; 93% and respiratory rate &lt;30 breaths/min.&#xD;
&#xD;
          7. Illness of any duration, and at least one of the following:&#xD;
&#xD;
               1. Radiographic infiltrates by imaging (chest x-ray)&#xD;
&#xD;
               2. Clinical assessment (evidence of rales/crackles or other clinical symptoms on&#xD;
                  exam).&#xD;
&#xD;
          8. Women of childbearing potential must agree to use at least one primary form of&#xD;
             contraception&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. ALT/AST &gt;5 times the upper limit of normal.&#xD;
&#xD;
          2. Patients with respiratory rate &lt;20 breaths/min and normal SpO2 with confirmed&#xD;
             SARS-CoV-2 infection as determined by PCR (Mild COVID-19 subjects).&#xD;
&#xD;
          3. Patients with respiratory rate ≥30 breaths/min and SpO2 at rest ≤93% (Severe COVID-19&#xD;
             subjects).&#xD;
&#xD;
          4. Stage ≥4 severe chronic kidney disease or requiring dialysis (i.e. eGFR &lt;30&#xD;
             mL/min/1.73 m2).&#xD;
&#xD;
          5. Pregnant or breast feeding.&#xD;
&#xD;
          6. Allergy to any study medication or usage of test drug during last 14 days prior to&#xD;
             screening&#xD;
&#xD;
          7. Severe co-morbidity (e.g. uncontrolled hypertension and uncontrolled DM, systemic&#xD;
             disease which affect the vital organs severity, immunocompromised patients etc.) as&#xD;
             per investigator's assessment.&#xD;
&#xD;
          8. Comorbid condition like myocardial infarction or heart failure within 90 days of&#xD;
             recruitment.&#xD;
&#xD;
          9. Prolong QT interval (&gt;450 ms).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <gender_based>Yes</gender_based>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Dr Deven Parmar, MD</last_name>
    <role>Study Director</role>
    <affiliation>Cadila Healthcare Ltd.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Avant Sante site 2</name>
      <address>
        <city>Zapopan</city>
        <state>Jalisco</state>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Avant Sante Site 1</name>
      <address>
        <city>Monterrey</city>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Mexico</country>
  </location_countries>
  <verification_date>June 2021</verification_date>
  <study_first_submitted>July 20, 2020</study_first_submitted>
  <study_first_submitted_qc>July 20, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 21, 2020</study_first_posted>
  <last_update_submitted>July 8, 2022</last_update_submitted>
  <last_update_submitted_qc>July 8, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">July 12, 2022</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>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Interferons</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/NCT04480138
org study id: PEGI.20.003
nct id: NCT04480138
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This is a phase II, multicenter, open-label, randomized, comparator-controlled study to
      evaluate the efficacy and safety of Pegylated Interferon -α2b in the treatment of adult
      patients diagnosed with SARS-CoV2 (COVID-19).Initial 1 mcg/kg of Pegylated Interferon-α2b
      will be administered on day 1. After safety evaluation of first dose, next dose (second dose)
      1 mcg/kg on day 8 will be administered with recommended standard care during the trial.
This is a phase II, multicenter, open-label, randomized, comparator-controlled study to
      evaluate the efficacy and safety of Pegylated Interferon -α2b in the treatment of adult
      patients diagnosed with SARS-CoV2 (COVID-19).Moderate COVID-19 subjects will be randomly
      assigned to receive test arm or reference arm in a 1:1 ratio.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change in Clinical status of subject on a 7-point ordinal scale
time frame: Week 2
description: Not hospitalized, no limitations on activities.
Not hospitalized, limitation on activities.
Hospitalized, not requiring supplemental oxygen.
Hospitalized, requiring supplemental oxygen.
Hospitalized, on non-invasive ventilation or high flow oxygen devices.
Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO).
Death.
measure: PCR test
time frame: Week 2 and Week 4
description: PCR for SARS-CoV-2 in pharyngeal swab
measure: Supplemental Oxygen
time frame: Week 2 and Week 4
description: Occurrence of supplemental Oxygen
measure: Mechanical Ventilation
time frame: Week 2 and Week 4
description: Occurrence of Mechanical Ventilation
measure: Incidence of Treatment-Emergent Adverse Events
time frame: Week 2 and Week 4
description: Occurence of Adverse events
measure: C-reactive protein (CRP)
time frame: Week 2 and Week 4
description: Inflammatory Biomarker
measure: Interleukin 6 (IL-6)
time frame: Week 2 and Week 4
description: Inflammatory Biomarker
measure: D-dimer
time frame: Week 2 and Week 4
description: Inflammatory Biomarker
measure: Interferon gamma
time frame: Week 2 and Week 4
description: type II class of interferons
measure: Ferritin
time frame: Week 2 and Week 4
description: proteins
measure: TNF alpha
time frame: Week 2 and Week 4
description: Inflammatory Biomarker
measure: Interleukin 1-β
time frame: Week 2 and Week 4
description: Inflammatory Biomarker
arm group label: Pegylated Interferon-α2b + Standard of care
arm group type: Experimental
description: Test :- Pegylated Interferon-α2b + Standard of care (SOC)
Pegylated Interferon-α2b-Initial 1 mcg/kg will be administered on day 1. After safety evaluation of first dose, next dose (second dose) 1 mcg/kg on day 8 will be administered along with the recommended standard of care at the time of conduct of trial.
arm group label: Standard of Care
arm group type: Active Comparator
description: Control: Standard of care
Standard of care treatment will be provided as per regulatory recommendation and approval.
intervention type: Drug
intervention name: Pegylated Interferon-α2b
description: 1 mcg/kg on day 1 and day 8 after safety evaluations.
arm group label: Pegylated Interferon-α2b + Standard of care
intervention type: Other
intervention name: Standard of Care
description: Standard of care as per local authority
arm group label: Pegylated Interferon-α2b + Standard of care
arm group label: Standard of Care
criteria: 
gender: All
gender based: Yes
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Dr Deven Parmar, MD
role: Study Director
affiliation: Cadila Healthcare Ltd.
facility: 
facility: 
country: Mexico
responsible party type: Sponsor
mesh term: COVID-19
mesh term: Interferons
sharing ipd: No