<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/NCT04410510</url>
  </required_header>
  <id_info>
    <org_study_id>CS002-COVID19</org_study_id>
    <nct_id>NCT04410510</nct_id>
  </id_info>
  <brief_title>P2Et Extract in the Symptomatic Treatment of Subjects With COVID-19</brief_title>
  <official_title>Study of the P2Et Extract Obtained From Caesalpinia Spinosa in the Symptomatic Treatment of Subjects With COVID-19 at the Hospital Universitario San Ignacio, Colombia.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hospital Universitario San Ignacio</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Pontificia Universidad Javeriana</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Hospital Universitario San Ignacio</source>
  <oversight_info>
    <has_dmc>No</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>
      Antioxidants, and particularly polyphenols, have shown protection in respiratory pathologies,&#xD;
      which is related to the decrease in the severity of the clinical picture and suppression of&#xD;
      inflammation. This suppression of inflammation may be related to the inhibition of NF-kB&#xD;
      polyphenols, where its activation is related to the stimulation of 150 stimuli including&#xD;
      cytokines (IL-1β, IL-6, THF-α, GM-CSF, MCP-1), TLRs, among others. There may be other&#xD;
      additional mechanisms that can help control virus-induced respiratory pathologies, among&#xD;
      which are the regulation of reactive oxygen species (ROS) associated with tissue destruction&#xD;
      caused by the virus and a selective antiviral action can be reported. direct.&#xD;
&#xD;
      The standardized P2Et extract obtained from C. spinosa, by the Immunobiology Group of the&#xD;
      Pontificia Universidad Javeriana, is highly antioxidant, decreases lipid peroxidation and&#xD;
      tissue damage and induces complete autophagy in stressed or tumor cells. The induction of a&#xD;
      full autophagic flow could inhibit the replication of beta-coronaviruses like SARS-CoV-2.&#xD;
      Furthermore, P2Et can decrease the factors involved in tissue damage by reducing IL-6 and&#xD;
      decrease ILC2 cells of the lung in animals with lung metastases (unpublished data).&#xD;
&#xD;
      These antecedents suggest that the supplementation of patients with COVID-19 with the extract&#xD;
      P2Et, could improve their general condition and decrease the inflammatory mediators and the&#xD;
      viral load.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Phytomedicines have been used in multiple pathologies such as cancer, diabetes, HIV and&#xD;
      respiratory pathologies, in which the inflammatory component is characterized. The extracts&#xD;
      of these phytomedicines have a high antioxidant capacity related to the fact that their&#xD;
      constituents are compounds of the polyphenol type, and this antioxidant mechanism has been&#xD;
      related in part to the antiviral action they present.&#xD;
&#xD;
      Particularly, in respiratory pathologies such as SARS-CoV, MERS-CoV, and Covid-19, an&#xD;
      important inflammatory component is observed. Patients infected with COVID-19 have high&#xD;
      amounts of IL1-, IFN-γ, IP-10, and MCP-1, which are likely to trigger the Th1 cellular&#xD;
      response. Furthermore, patients requiring ICU admission have higher concentrations of G-CSF,&#xD;
      IP-10, MCP-1, MIP1-, and TNF-α, suggesting that cytokine storm is associated with the&#xD;
      severity of the clinical picture.&#xD;
&#xD;
      Antioxidants, and particularly polyphenols, have shown protection in respiratory pathologies,&#xD;
      which is related to the decrease in the severity of the clinical picture and suppression of&#xD;
      inflammation. This suppression of inflammation may be related to the inhibition of NF-kB&#xD;
      polyphenols, where its activation is related to the stimulation of 150 stimuli including&#xD;
      cytokines (IL-1β, IL-6, THF-α, GM-CSF, MCP-1), TLRs, among others. There may be other&#xD;
      additional mechanisms that can help control virus-induced respiratory pathologies, among&#xD;
      which are the regulation of reactive oxygen species (ROS) associated with tissue destruction&#xD;
      caused by the virus and a selective antiviral action can be reported direct.&#xD;
&#xD;
      The standardized P2Et extract obtained from C. spinosa, by the Immunobiology Group of the&#xD;
      Pontificia Universidad Javeriana, is highly antioxidant, decreases lipid peroxidation and&#xD;
      tissue damage and induces complete autophagy in stressed or tumor cells. The induction of a&#xD;
      full autophagic flow could inhibit the replication of beta-coronaviruses like SARS-CoV-2.&#xD;
      Furthermore, P2Et can decrease the factors involved in tissue damage by reducing IL-6 and&#xD;
      decrease ILC2 cells of the lung in animals with lung metastases (unpublished data).&#xD;
&#xD;
      These antecedents suggest that the supplementation of patients with COVID-19 with the extract&#xD;
      P2Et, could improve their general condition and decrease the inflammatory mediators and the&#xD;
      viral load.&#xD;
&#xD;
      The primary outcome is to evaluate the efficacy of P2Et in reducing the length of hospital&#xD;
      stay of patients with clinical suspicion or confirmed case of COVID-19&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">September 30, 2020</start_date>
  <completion_date type="Anticipated">November 30, 2021</completion_date>
  <primary_completion_date type="Actual">June 30, 2021</primary_completion_date>
  <phase>Phase 2/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>
    <intervention_model_description>This is a randomized, double-blind, placebo-controlled study to demonstrate the efficacy and safety of P2Et (Caesalpinia spinosa extract) treatment in patients with a clinical diagnosis of Covid-19 infection when added to standard therapy.</intervention_model_description>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>Triple (Participant, Care Provider, Investigator)</masking>
    <masking_description>100 patients will be randomized in a 1: 1 ratio (50 in each group)</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Evaluate the efficacy of P2Et in reducing the length of hospital stay of patients with clinical suspicion or confirmed case of COVID-19</measure>
    <time_frame>30 days</time_frame>
    <description>Proportion of patients who reduce the time in the hospital</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Efficacy of P2Et in reducing the time to clinically significant improvement in patients with clinical suspicion or confirmed case of COVID-19</measure>
    <time_frame>30 days</time_frame>
    <description>Efficacy of P2Et in reducing the time to clinically significant improvement in patients with clinical suspicion or confirmed case of COVID-19</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of patients with clinical suspicion or confirmed case of COVID-19, who achieve clinical improvement after 14 days of treatment</measure>
    <time_frame>30 days</time_frame>
    <description>Evaluate the efficacy of P2Et in increasing the proportion of patients with clinical suspicion or confirmed case of COVID-19, who achieve clinical improvement after 14 days of treatment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of patients with clinical suspicion or confirmed case of COVID-19, who achieve clinical improvement after 28 days of treatment</measure>
    <time_frame>30 days</time_frame>
    <description>Evaluate the efficacy of P2Et in increasing the proportion of patients with clinical suspicion or confirmed case of COVID-19, who achieve clinical improvement after 28 days of treatment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Efficacy of P2Et in reducing the proportion of hospitalized patients with clinical suspicion or confirmed case of COVID-19 who require admission to the ICU due to worsening clinical symptoms.</measure>
    <time_frame>30 days</time_frame>
    <description>Assess the efficacy of P2Et in reducing the proportion of hospitalized patients with clinical suspicion or confirmed case of COVID-19 who require admission to the ICU due to worsening clinical symptoms.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Efficacy of P2Et in reducing the proportion of patients with clinical suspicion or confirmed case of COVID-19 who die from the disease.</measure>
    <time_frame>30 days</time_frame>
    <description>Evaluate the efficacy of P2Et in reducing the proportion of patients with clinical suspicion or confirmed case of COVID-19 who die from the disease.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability) of the P2Et in patients with COVID-19</measure>
    <time_frame>30 days</time_frame>
    <description>Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability) of the P2Et in patients with COVID-19</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">100</enrollment>
  <condition>COVID</condition>
  <condition>Coronavirus Infection</condition>
  <condition>SARS-CoV 2</condition>
  <condition>COVID19</condition>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Lopinavir / ritonavir * Capsules 200/50 mg 400/100 mg every 12 hours for 7 to 14 days Hydroxychloroquine * Tab 200 mg Tab Load 400 mg every 12 hours the first day, follow 200 mg every 12 hours for 10 days Placebo capsule equivalent to 250mg of excipient every 12 hours for 14 days</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Intervention group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Lopinavir / ritonavir * Capsules 200/50 mg 400/100 mg every 12 hours for 7 to 14 days Hydroxychloroquine * Tab 200 mg Tab Load 400 mg every 12 hours the first day, follow 200 mg every 12 hours for 10 days P2Et active extract capsule equivalent to 250mg of P2Et every 12 hours for 14 days</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>P2Et (Caesalpinia spinosa extract)</intervention_name>
    <description>P2Et active extract capsule equivalent to 250mg of P2Et every 12 hours for 14 days + Standard Care</description>
    <arm_group_label>Intervention group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Placebo capsule equivalent to 250mg of excipients of P2Et every 12 hours for 14 days + Standard Care</description>
    <arm_group_label>Control group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adults over 18 years old.&#xD;
&#xD;
          -  Diagnosis (suspected or confirmed) of COVID-19 infection, with In-hospital management&#xD;
             indication according to the Colombian Consensus of care, diagnosis and management of&#xD;
             SARS-COV-2 / COVID-19 infection in health care establishments (Trujillo, 2020).&#xD;
             Recommendations based on expert consensus and informed by evidence and the&#xD;
             recommendations of the Ministry of Health and Social Protection for April 2020.&#xD;
&#xD;
        All patients who enter the HUSI with a clinical diagnosis of COVID-19 are eligible to enter&#xD;
        the study if they present at least one of the following indicators of respiratory&#xD;
        compromise:&#xD;
&#xD;
          -  Hypoxemia with supplemental oxygen requirements.&#xD;
&#xD;
          -  Severe pneumonia: Suspicion of respiratory infection, failure of 1 organ,&#xD;
&#xD;
          -  SaO2 ambient air &lt;90% or respiratory rate&gt; 30 resp / min.&#xD;
&#xD;
          -  ARDS Acute Respiratory Distress Syndrome. Clinical findings, radiographic bilateral&#xD;
             infiltrates + oxygenation deficit: Mild: 200 mmHg &lt;PaO2 / FiO2 &lt;300 mmHg. Moderate:&#xD;
             100 mmHg &lt;PaO2 / FiO2 &lt;200 mmHg. Serious: PaO2 / FiO2 &lt;100 mmHg. If PaO2 not available&#xD;
             SaO2 / FiO2.&#xD;
&#xD;
          -  Sepsis: Defined as organic dysfunction and can be identified as an acute change in the&#xD;
             SOFA scale&gt; 2 points. Quick SOFA (qSOFA) with 2 of the following 3 clinical variables&#xD;
             can identify seriously ill patients: Glasgow 13 or lower, a systolic pressure of 100&#xD;
             mmHg or lower and respiratory rate of 22 / min or higher. Organic insufficiency can&#xD;
             manifest with the following alterations: Acute confusional state, Respiratory&#xD;
             insufficiency, Reduction in the volume of diuresis, Tachycardia, Coagulopathy,&#xD;
             Metabolic acidosis, Lactate elevation.&#xD;
&#xD;
          -  Septic shock: arterial hypotension that persists after resuscitation volume and that&#xD;
             requires vasopressors to maintain MAP&gt; 65 mmHg and lactate&gt; 2 mmol / L (18 mg / dL) in&#xD;
             the absence of hypovolemia.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Negative laboratory diagnostic test for COVID-19, before randomization.&#xD;
&#xD;
          -  Pregnancy.&#xD;
&#xD;
          -  History of allergic reactions attributed to polyphenol type compounds similar to those&#xD;
             found in green tea.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Margarita Manrrique, MD, MSc</last_name>
    <phone>5946161</phone>
    <phone_ext>2475</phone_ext>
    <email>mmmanrique@husi.org.co</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Angel Garcia, MD. MSc. PhD(c)</last_name>
    <phone>3208320</phone>
    <phone_ext>4025</phone_ext>
    <email>aagarcia@husi.org.co</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Hospital Universitario San Ignacio</name>
      <address>
        <city>Bogotá</city>
        <country>Colombia</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ivonne Sabogal, BSc</last_name>
    </contact>
  </location>
  <location_countries>
    <country>Colombia</country>
  </location_countries>
  <verification_date>August 2021</verification_date>
  <study_first_submitted>May 27, 2020</study_first_submitted>
  <study_first_submitted_qc>May 29, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 1, 2020</study_first_posted>
  <last_update_submitted>August 6, 2021</last_update_submitted>
  <last_update_submitted_qc>August 6, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">August 10, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Herbal Drug</keyword>
  <keyword>P2Et</keyword>
  <keyword>Caesalpinia spinosa</keyword>
  <keyword>Coronavirus</keyword>
  <keyword>COVID19</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>COVID-19</mesh_term>
    <mesh_term>Coronavirus Infections</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT04410510
org study id: CS002-COVID19
nct id: NCT04410510
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Antioxidants, and particularly polyphenols, have shown protection in respiratory pathologies,
      which is related to the decrease in the severity of the clinical picture and suppression of
      inflammation. This suppression of inflammation may be related to the inhibition of NF-kB
      polyphenols, where its activation is related to the stimulation of 150 stimuli including
      cytokines (IL-1β, IL-6, THF-α, GM-CSF, MCP-1), TLRs, among others. There may be other
      additional mechanisms that can help control virus-induced respiratory pathologies, among
      which are the regulation of reactive oxygen species (ROS) associated with tissue destruction
      caused by the virus and a selective antiviral action can be reported. direct.

      The standardized P2Et extract obtained from C. spinosa, by the Immunobiology Group of the
      Pontificia Universidad Javeriana, is highly antioxidant, decreases lipid peroxidation and
      tissue damage and induces complete autophagy in stressed or tumor cells. The induction of a
      full autophagic flow could inhibit the replication of beta-coronaviruses like SARS-CoV-2.
      Furthermore, P2Et can decrease the factors involved in tissue damage by reducing IL-6 and
      decrease ILC2 cells of the lung in animals with lung metastases (unpublished data).

      These antecedents suggest that the supplementation of patients with COVID-19 with the extract
      P2Et, could improve their general condition and decrease the inflammatory mediators and the
      viral load.
Phytomedicines have been used in multiple pathologies such as cancer, diabetes, HIV and
      respiratory pathologies, in which the inflammatory component is characterized. The extracts
      of these phytomedicines have a high antioxidant capacity related to the fact that their
      constituents are compounds of the polyphenol type, and this antioxidant mechanism has been
      related in part to the antiviral action they present.

      Particularly, in respiratory pathologies such as SARS-CoV, MERS-CoV, and Covid-19, an
      important inflammatory component is observed. Patients infected with COVID-19 have high
      amounts of IL1-, IFN-γ, IP-10, and MCP-1, which are likely to trigger the Th1 cellular
      response. Furthermore, patients requiring ICU admission have higher concentrations of G-CSF,
      IP-10, MCP-1, MIP1-, and TNF-α, suggesting that cytokine storm is associated with the
      severity of the clinical picture.

      Antioxidants, and particularly polyphenols, have shown protection in respiratory pathologies,
      which is related to the decrease in the severity of the clinical picture and suppression of
      inflammation. This suppression of inflammation may be related to the inhibition of NF-kB
      polyphenols, where its activation is related to the stimulation of 150 stimuli including
      cytokines (IL-1β, IL-6, THF-α, GM-CSF, MCP-1), TLRs, among others. There may be other
      additional mechanisms that can help control virus-induced respiratory pathologies, among
      which are the regulation of reactive oxygen species (ROS) associated with tissue destruction
      caused by the virus and a selective antiviral action can be reported direct.

      The standardized P2Et extract obtained from C. spinosa, by the Immunobiology Group of the
      Pontificia Universidad Javeriana, is highly antioxidant, decreases lipid peroxidation and
      tissue damage and induces complete autophagy in stressed or tumor cells. The induction of a
      full autophagic flow could inhibit the replication of beta-coronaviruses like SARS-CoV-2.
      Furthermore, P2Et can decrease the factors involved in tissue damage by reducing IL-6 and
      decrease ILC2 cells of the lung in animals with lung metastases (unpublished data).

      These antecedents suggest that the supplementation of patients with COVID-19 with the extract
      P2Et, could improve their general condition and decrease the inflammatory mediators and the
      viral load.

      The primary outcome is to evaluate the efficacy of P2Et in reducing the length of hospital
      stay of patients with clinical suspicion or confirmed case of COVID-19
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: This is a randomized, double-blind, placebo-controlled study to demonstrate the efficacy and safety of P2Et (Caesalpinia spinosa extract) treatment in patients with a clinical diagnosis of Covid-19 infection when added to standard therapy.
primary purpose: Supportive Care
masking: Triple (Participant, Care Provider, Investigator)
masking description: 100 patients will be randomized in a 1: 1 ratio (50 in each group)
measure: Evaluate the efficacy of P2Et in reducing the length of hospital stay of patients with clinical suspicion or confirmed case of COVID-19
time frame: 30 days
description: Proportion of patients who reduce the time in the hospital
measure: Efficacy of P2Et in reducing the time to clinically significant improvement in patients with clinical suspicion or confirmed case of COVID-19
time frame: 30 days
description: Efficacy of P2Et in reducing the time to clinically significant improvement in patients with clinical suspicion or confirmed case of COVID-19
measure: Proportion of patients with clinical suspicion or confirmed case of COVID-19, who achieve clinical improvement after 14 days of treatment
time frame: 30 days
description: Evaluate the efficacy of P2Et in increasing the proportion of patients with clinical suspicion or confirmed case of COVID-19, who achieve clinical improvement after 14 days of treatment
measure: Proportion of patients with clinical suspicion or confirmed case of COVID-19, who achieve clinical improvement after 28 days of treatment
time frame: 30 days
description: Evaluate the efficacy of P2Et in increasing the proportion of patients with clinical suspicion or confirmed case of COVID-19, who achieve clinical improvement after 28 days of treatment
measure: Efficacy of P2Et in reducing the proportion of hospitalized patients with clinical suspicion or confirmed case of COVID-19 who require admission to the ICU due to worsening clinical symptoms.
time frame: 30 days
description: Assess the efficacy of P2Et in reducing the proportion of hospitalized patients with clinical suspicion or confirmed case of COVID-19 who require admission to the ICU due to worsening clinical symptoms.
measure: Efficacy of P2Et in reducing the proportion of patients with clinical suspicion or confirmed case of COVID-19 who die from the disease.
time frame: 30 days
description: Evaluate the efficacy of P2Et in reducing the proportion of patients with clinical suspicion or confirmed case of COVID-19 who die from the disease.
measure: Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability) of the P2Et in patients with COVID-19
time frame: 30 days
description: Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability) of the P2Et in patients with COVID-19
arm group label: Control group
arm group type: Placebo Comparator
description: Lopinavir / ritonavir * Capsules 200/50 mg 400/100 mg every 12 hours for 7 to 14 days Hydroxychloroquine * Tab 200 mg Tab Load 400 mg every 12 hours the first day, follow 200 mg every 12 hours for 10 days Placebo capsule equivalent to 250mg of excipient every 12 hours for 14 days
arm group label: Intervention group
arm group type: Experimental
description: Lopinavir / ritonavir * Capsules 200/50 mg 400/100 mg every 12 hours for 7 to 14 days Hydroxychloroquine * Tab 200 mg Tab Load 400 mg every 12 hours the first day, follow 200 mg every 12 hours for 10 days P2Et active extract capsule equivalent to 250mg of P2Et every 12 hours for 14 days
intervention type: Drug
intervention name: P2Et (Caesalpinia spinosa extract)
description: P2Et active extract capsule equivalent to 250mg of P2Et every 12 hours for 14 days + Standard Care
arm group label: Intervention group
intervention type: Other
intervention name: Placebo
description: Placebo capsule equivalent to 250mg of excipients of P2Et every 12 hours for 14 days + Standard Care
arm group label: Control group
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Margarita Manrrique, MD, MSc
phone: 5946161
phone ext: 2475
email: mmmanrique@husi.org.co
last name: Angel Garcia, MD. MSc. PhD(c)
phone: 3208320
phone ext: 4025
email: aagarcia@husi.org.co
facility: 
status: Recruiting
contact: 
country: Colombia
responsible party type: Sponsor
mesh term: COVID-19
mesh term: Coronavirus Infections
sharing ipd: Undecided