<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/NCT04425850</url>
  </required_header>
  <id_info>
    <org_study_id>IVERCAR</org_study_id>
    <nct_id>NCT04425850</nct_id>
  </id_info>
  <brief_title>USEFULNESS of Topic Ivermectin and Carrageenan to Prevent Contagion of Covid 19</brief_title>
  <acronym>IVERCAR</acronym>
  <official_title>USEFULNESS of Topic Ivermectin and Carrageenan to Prevent Contagion of Covid Among Healthy People and Health Personnel</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Eurnekian Public Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Eurnekian Public 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>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Estimation of the prevalence and contagiousness of undocumented novel coronavirus infections&#xD;
      is critical for understanding the overall prevalence and pandemic potential of this disease.&#xD;
&#xD;
      It is estimated that 86% of all infections were undocumented [95% credible interval (CI):&#xD;
      82-90%] before the 23 January 2020 travel restrictions. The transmission rate of undocumented&#xD;
      infections per person was 55% the transmission rate of documented infections (95% CI:&#xD;
      46-62%), yet, because of their greater numbers, undocumented infections were the source of&#xD;
      79% of the documented cases.&#xD;
&#xD;
      Ivermectin + Carrageenan, taking advantage of their virucidal effects, are aimed at reducing&#xD;
      the contagion.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      CONTAGION COURSE Estimation of the prevalence and contagiousness of undocumented novel&#xD;
      coronavirus infections is critical for understanding the overall prevalence and pandemic&#xD;
      potential of this disease.&#xD;
&#xD;
      Observations of reported infection within China, in conjunction with mobility data, a&#xD;
      networked dynamic metapopulation model, and Bayesian inference, to infer critical&#xD;
      epidemiological characteristics associated with SARS-CoV-2, including the fraction of&#xD;
      undocumented infections and their contagiousness, have been attempted. The rapid geographic&#xD;
      spread of SARS-CoV-2 indicate that containment of this virus will be particularly&#xD;
      challenging.&#xD;
&#xD;
      DISSEMINATION BY DROPLETS For COVID-19, the salivary gland could be an important source of&#xD;
      the virus in saliva and would generate infectious saliva on a sustained basis.&#xD;
&#xD;
      ACE2 expression in the minor salivary glands was higher than in the lungs, suggesting that&#xD;
      the salivary glands is a potential target for COVID-19.&#xD;
&#xD;
      The positive rate of COVID-19 in the patients' saliva can reach 91.7%, and the saliva samples&#xD;
      can also culture the live virus.&#xD;
&#xD;
      In addition to mobility restrictions of people, the World Health Organization and the&#xD;
      Governments have prescribed maintaining an inter-personal distance of 1.5 or 2 m (about 6&#xD;
      feet) from each other in order to minimize the risk of contagion through the droplets that we&#xD;
      usually disseminate around us from nose and mouth. However, recently published studies&#xD;
      support the hypothesis of virus transmission over a distance of 2 m from an infected person.&#xD;
      Researchers have proved the higher aerosol and surface stability of SARS-COV-2 as compared&#xD;
      with SARS-COV-1 (with the virus remaining viable and infectious in aerosol for hours) and&#xD;
      that airborne transmission of SARS-CoV can occur besides close-distance contacts. Indeed,&#xD;
      there is reasonable evidence about the possibility of SARS-COV-2 airborne transmission due to&#xD;
      its persistence into aerosol droplets in a viable and infectious form. Based on the available&#xD;
      knowledge and epidemiological observations, it is plausible that small particles containing&#xD;
      the virus may diffuse in indoor environments covering distances up to 10 m from the emission&#xD;
      sources, thus representing a kind of aerosol transmission. On-field studies carried out&#xD;
      inside Wuhan Hospitals showed the presence of SARS-COV-2 RNA in air samples collected in the&#xD;
      hospitals and also in the surroundings, leading to the conclusion that the airborne route has&#xD;
      to be considered an important pathway for viral diffusion. Similar findings are reported in&#xD;
      analyses concerning air samples collected at the Nebraska University Hospital. On March 16th,&#xD;
      we have released a Position Paper emphasizing the airborne route as a possible additional&#xD;
      factor for interpreting the anomalous COVID-19 outbreaks in northern Italy, ranked as one of&#xD;
      the most polluted areas in Europe and characterized by high particulate matter (PM)&#xD;
      concentrations. The available information on the SARS-COV-2 spreading supports the hypothesis&#xD;
      of airborne diffusion of infected droplets from person to person at a distance greater than&#xD;
      two meters (6 feet). The inter-personal distance of 2 m can be reasonably considered as an&#xD;
      effective protection only if everybody wears face masks in daily life activities.&#xD;
&#xD;
      IVERMECTIN CONCENTRATION IN SALIVARY GLANDS The concentration of ivermectin was tested in&#xD;
      different tissues, in different studies, both in animals and human beings. The concentration&#xD;
      in salivary glands proved to be adequately acceptable.&#xD;
&#xD;
      CARRAGEENAN VIRUCIDAL EFFECTS Iota Carrageenan is widely used in gastronomic, cosmetic and&#xD;
      pharmacologic industry.&#xD;
&#xD;
      Recently, its intrinsic virucidal effectas were proved over a variety of virus (herpes&#xD;
      simplex, Japanese Encephalitis, Rhinovirus, etc.).&#xD;
&#xD;
      Its mechanism of action is preventing virus adsorption to host cells. By applying both drugs&#xD;
      topically, 5 times per day, in nasal and oral mucosae, we try to reduce contagion.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 1, 2020</start_date>
  <completion_date type="Actual">August 10, 2020</completion_date>
  <primary_completion_date type="Actual">August 10, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Infected Subjects</measure>
    <time_frame>28 days</time_frame>
    <description>Number of participants testing positive for COVID-19 after inclusion in each arm</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Adverse Events Other Than Those Resulting From Contagion or Disease Progression</measure>
    <time_frame>28 days</time_frame>
    <description>Adverse events reported by subjects of each arm are recorded other than those resulting from contagion or disease progression</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">229</enrollment>
  <condition>Covid19</condition>
  <arm_group>
    <arm_group_label>IVER+</arm_group_label>
    <description>Adults, both genders, no age limit. They will be provided with topical medication, to be used 5 times a day. They will follow standard prophylactic measures and use PPE as suggested by OMS.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>IVER-</arm_group_label>
    <description>Adults, both genders, no age limit They will follow standard prophylactic measures and use PPE suggestions, only.</description>
  </arm_group>
  <intervention>
    <intervention_type>Combination Product</intervention_type>
    <intervention_name>Iota carrageenan nasal spray and Ivermectin oral drops (used as buccal drops)</intervention_name>
    <description>Topical application in the nose and oral cavity</description>
    <arm_group_label>IVER+</arm_group_label>
    <other_name>Nasitral (iota carrageenan nasal spray), Ivercass (ivermectin oral drops)</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Healthy volunteers testing negative for COVID-19 just before inclusion.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion criteria&#xD;
&#xD;
          1. Not younger than 18 years of either sex&#xD;
&#xD;
          2. Health personnel from the Dr. Alberto Eurnekian Interzonal University Hospital&#xD;
&#xD;
          3. No COVID-19 related symptoms&#xD;
&#xD;
          4. Able to understand and give written informed consent&#xD;
&#xD;
        Exclusion criteria&#xD;
&#xD;
          1. Known hypersensitivity or allergy to any component of the product under evaluation&#xD;
&#xD;
          2. Age under 18 years&#xD;
&#xD;
          3. Use of immunosuppressants (including systemic corticosteroids) in the past 30 days.&#xD;
&#xD;
          4. Pregnant or nursing.&#xD;
&#xD;
          5. Patients with other acute infectious diseases.&#xD;
&#xD;
          6. Patients with autoimmune disease and / or decompensated chronic diseases.&#xD;
&#xD;
          7. Unable to fulfill the administrative tasks proposed by the study.&#xD;
&#xD;
          8. Infection with SARSCoV-2 confirmed by PCR or rapid test authorized by ANMAT.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Hospital Eurnekian</name>
      <address>
        <city>Buenos Aires</city>
        <zip>1802</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Argentina</country>
  </location_countries>
  <reference>
    <citation>Harden EA, Falshaw R, Carnachan SM, Kern ER, Prichard MN. Virucidal activity of polysaccharide extracts from four algal species against herpes simplex virus. Antiviral Res. 2009 Sep;83(3):282-9. doi: 10.1016/j.antiviral.2009.06.007. Epub 2009 Jul 1.</citation>
    <PMID>19576248</PMID>
  </reference>
  <reference>
    <citation>Carlucci MJ, Scolaro LA, Noseda MD, Cerezo AS, Damonte EB. Protective effect of a natural carrageenan on genital herpes simplex virus infection in mice. Antiviral Res. 2004 Nov;64(2):137-41. doi: 10.1016/j.antiviral.2004.07.001.</citation>
    <PMID>15498610</PMID>
  </reference>
  <reference>
    <citation>Ashraf S, Prichard R. Ivermectin exhibits potent anti-mitotic activity. Vet Parasitol. 2016 Aug 15;226:1-4. doi: 10.1016/j.vetpar.2016.06.015. Epub 2016 Jun 11.</citation>
    <PMID>27514873</PMID>
  </reference>
  <verification_date>October 2020</verification_date>
  <study_first_submitted>June 8, 2020</study_first_submitted>
  <study_first_submitted_qc>June 8, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 11, 2020</study_first_posted>
  <results_first_submitted>August 13, 2020</results_first_submitted>
  <results_first_submitted_qc>October 15, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">October 19, 2020</results_first_posted>
  <last_update_submitted>October 15, 2020</last_update_submitted>
  <last_update_submitted_qc>October 15, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">October 19, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Eurnekian Public Hospital</investigator_affiliation>
    <investigator_full_name>Hector E Carvallo</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>IVERMECTIN CARRAGEENAN COVID 19</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>Ivermectin</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>May 29, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/50/NCT04425850/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Health personnel</recruitment_details>
      <pre_assignment_details>Once consent was signed, compliance with all the eligibility criteria verified, and inclusion of the subject decided, the investigator assigns corresponding treatment according to the randomization carried out.&#xD;
It includes volunteers for both cohorts, provided they have test negative for COVID 19 in swabs obtained immediately before inclusion.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>IVER+</title>
          <description>Standard prophylactic measures and PPEs + iota carrageenan (nasal and buccal) and ivermectin (buccal)</description>
        </group>
        <group group_id="P2">
          <title>IVER-</title>
          <description>Standard prophylactic measures and PPE only</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="131">Standard prophylactic measures and PPE + iota carrageenan (nasal and buccal) and ivermectin (buccal)</participants>
                <participants group_id="P2" count="98">Standard prophylactic measures and PPE only</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="131"/>
                <participants group_id="P2" count="98"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>IVER+</title>
          <description>Adults, both genders, no age limit. They will be provided with topical medication, to be used 5 times a day. PPEs used as suggested by OMS.&#xD;
iota carrageenan: topical use on nasal mucosae&#xD;
Ivermectin: Topical use on oral mucosae</description>
        </group>
        <group group_id="B2">
          <title>IVER-</title>
          <description>Same as IVER+ They will follow PPEs suggestions, only.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="131"/>
            <count group_id="B2" value="98"/>
            <count group_id="B3" value="229"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="42" lower_limit="25" upper_limit="60"/>
                    <measurement group_id="B2" value="39" lower_limit="28" upper_limit="50"/>
                    <measurement group_id="B3" value="40" lower_limit="25" upper_limit="60"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="70"/>
                    <measurement group_id="B2" value="72"/>
                    <measurement group_id="B3" value="142"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="61"/>
                    <measurement group_id="B2" value="26"/>
                    <measurement group_id="B3" value="87"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="131"/>
                    <measurement group_id="B2" value="98"/>
                    <measurement group_id="B3" value="229"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="131"/>
                    <measurement group_id="B2" value="98"/>
                    <measurement group_id="B3" value="229"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Argentina</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="131"/>
                    <measurement group_id="B2" value="98"/>
                    <measurement group_id="B3" value="229"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Infected Subjects</title>
        <description>Number of participants testing positive for COVID-19 after inclusion in each arm</description>
        <time_frame>28 days</time_frame>
        <population>Hispanic</population>
        <group_list>
          <group group_id="O1">
            <title>IVER+</title>
            <description>Standard prophylactic measures and PPEs + topical treatment with iota carrageenan (nasal and buccal) and ivermectin (buccal)</description>
          </group>
          <group group_id="O2">
            <title>IVER-</title>
            <description>Standard prophylactic measures and PPEs only</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Infected Subjects</title>
          <description>Number of participants testing positive for COVID-19 after inclusion in each arm</description>
          <population>Hispanic</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="131"/>
                <count group_id="O2" value="98"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Chi-squared test on the percentage of subjects who contracted COVID-19 in each arm</groups_desc>
            <non_inferiority_type>Other</non_inferiority_type>
            <p_value>&lt; 0.0001</p_value>
            <method>Chi-squared</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Adverse Events Other Than Those Resulting From Contagion or Disease Progression</title>
        <description>Adverse events reported by subjects of each arm are recorded other than those resulting from contagion or disease progression</description>
        <time_frame>28 days</time_frame>
        <population>Hispanic</population>
        <group_list>
          <group group_id="O1">
            <title>IVER+</title>
            <description>Standard prophylactic measures and PPE + Treatment with iota carragenan (nasal and buccal) and ivermectin (buccal only)</description>
          </group>
          <group group_id="O2">
            <title>IVER-</title>
            <description>Standard prophylactic measures and PPE only</description>
          </group>
        </group_list>
        <measure>
          <title>Adverse Events Other Than Those Resulting From Contagion or Disease Progression</title>
          <description>Adverse events reported by subjects of each arm are recorded other than those resulting from contagion or disease progression</description>
          <population>Hispanic</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="131"/>
                <count group_id="O2" value="98"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>30 days</time_frame>
      <desc>Medical examination Chart of adverse events filled in by subjects</desc>
      <group_list>
        <group group_id="E1">
          <title>IVER+</title>
          <description>Standard prophylactic measures and PPEs + topical treatment with iota carrageenan (nasal and buccal) and ivermectin (buccal).</description>
        </group>
        <group group_id="E2">
          <title>IVER-</title>
          <description>Standard prophylactic measures and PPEs only</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="131"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="98"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="131"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="98"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="131"/>
                <counts group_id="E2" subjects_affected="11" subjects_at_risk="98"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Contagion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="131"/>
                <counts group_id="E2" events="11" subjects_affected="11" subjects_at_risk="98"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Dr. Héctor Carvallo</name_or_title>
      <organization>Eurnekian Public Hospital</organization>
      <phone>54144800949</phone>
      <email>hymcarvallo@hotmail.com</email>
    </point_of_contact>
  </clinical_results>
</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/NCT04425850
org study id: IVERCAR
nct id: NCT04425850
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
is us export: No
Estimation of the prevalence and contagiousness of undocumented novel coronavirus infections
      is critical for understanding the overall prevalence and pandemic potential of this disease.

      It is estimated that 86% of all infections were undocumented [95% credible interval (CI):
      82-90%] before the 23 January 2020 travel restrictions. The transmission rate of undocumented
      infections per person was 55% the transmission rate of documented infections (95% CI:
      46-62%), yet, because of their greater numbers, undocumented infections were the source of
      79% of the documented cases.

      Ivermectin + Carrageenan, taking advantage of their virucidal effects, are aimed at reducing
      the contagion.
CONTAGION COURSE Estimation of the prevalence and contagiousness of undocumented novel
      coronavirus infections is critical for understanding the overall prevalence and pandemic
      potential of this disease.

      Observations of reported infection within China, in conjunction with mobility data, a
      networked dynamic metapopulation model, and Bayesian inference, to infer critical
      epidemiological characteristics associated with SARS-CoV-2, including the fraction of
      undocumented infections and their contagiousness, have been attempted. The rapid geographic
      spread of SARS-CoV-2 indicate that containment of this virus will be particularly
      challenging.

      DISSEMINATION BY DROPLETS For COVID-19, the salivary gland could be an important source of
      the virus in saliva and would generate infectious saliva on a sustained basis.

      ACE2 expression in the minor salivary glands was higher than in the lungs, suggesting that
      the salivary glands is a potential target for COVID-19.

      The positive rate of COVID-19 in the patients' saliva can reach 91.7%, and the saliva samples
      can also culture the live virus.

      In addition to mobility restrictions of people, the World Health Organization and the
      Governments have prescribed maintaining an inter-personal distance of 1.5 or 2 m (about 6
      feet) from each other in order to minimize the risk of contagion through the droplets that we
      usually disseminate around us from nose and mouth. However, recently published studies
      support the hypothesis of virus transmission over a distance of 2 m from an infected person.
      Researchers have proved the higher aerosol and surface stability of SARS-COV-2 as compared
      with SARS-COV-1 (with the virus remaining viable and infectious in aerosol for hours) and
      that airborne transmission of SARS-CoV can occur besides close-distance contacts. Indeed,
      there is reasonable evidence about the possibility of SARS-COV-2 airborne transmission due to
      its persistence into aerosol droplets in a viable and infectious form. Based on the available
      knowledge and epidemiological observations, it is plausible that small particles containing
      the virus may diffuse in indoor environments covering distances up to 10 m from the emission
      sources, thus representing a kind of aerosol transmission. On-field studies carried out
      inside Wuhan Hospitals showed the presence of SARS-COV-2 RNA in air samples collected in the
      hospitals and also in the surroundings, leading to the conclusion that the airborne route has
      to be considered an important pathway for viral diffusion. Similar findings are reported in
      analyses concerning air samples collected at the Nebraska University Hospital. On March 16th,
      we have released a Position Paper emphasizing the airborne route as a possible additional
      factor for interpreting the anomalous COVID-19 outbreaks in northern Italy, ranked as one of
      the most polluted areas in Europe and characterized by high particulate matter (PM)
      concentrations. The available information on the SARS-COV-2 spreading supports the hypothesis
      of airborne diffusion of infected droplets from person to person at a distance greater than
      two meters (6 feet). The inter-personal distance of 2 m can be reasonably considered as an
      effective protection only if everybody wears face masks in daily life activities.

      IVERMECTIN CONCENTRATION IN SALIVARY GLANDS The concentration of ivermectin was tested in
      different tissues, in different studies, both in animals and human beings. The concentration
      in salivary glands proved to be adequately acceptable.

      CARRAGEENAN VIRUCIDAL EFFECTS Iota Carrageenan is widely used in gastronomic, cosmetic and
      pharmacologic industry.

      Recently, its intrinsic virucidal effectas were proved over a variety of virus (herpes
      simplex, Japanese Encephalitis, Rhinovirus, etc.).

      Its mechanism of action is preventing virus adsorption to host cells. By applying both drugs
      topically, 5 times per day, in nasal and oral mucosae, we try to reduce contagion.
observational model: Cohort
time perspective: Prospective
measure: Number of Infected Subjects
time frame: 28 days
description: Number of participants testing positive for COVID-19 after inclusion in each arm
measure: Adverse Events Other Than Those Resulting From Contagion or Disease Progression
time frame: 28 days
description: Adverse events reported by subjects of each arm are recorded other than those resulting from contagion or disease progression
arm group label: IVER+
description: Adults, both genders, no age limit. They will be provided with topical medication, to be used 5 times a day. They will follow standard prophylactic measures and use PPE as suggested by OMS.
arm group label: IVER-
description: Adults, both genders, no age limit They will follow standard prophylactic measures and use PPE suggestions, only.
intervention type: Combination Product
intervention name: Iota carrageenan nasal spray and Ivermectin oral drops (used as buccal drops)
description: Topical application in the nose and oral cavity
arm group label: IVER+
other name: Nasitral (iota carrageenan nasal spray), Ivercass (ivermectin oral drops)
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Argentina
citation: Harden EA, Falshaw R, Carnachan SM, Kern ER, Prichard MN. Virucidal activity of polysaccharide extracts from four algal species against herpes simplex virus. Antiviral Res. 2009 Sep;83(3):282-9. doi: 10.1016/j.antiviral.2009.06.007. Epub 2009 Jul 1.
PMID: 19576248
citation: Carlucci MJ, Scolaro LA, Noseda MD, Cerezo AS, Damonte EB. Protective effect of a natural carrageenan on genital herpes simplex virus infection in mice. Antiviral Res. 2004 Nov;64(2):137-41. doi: 10.1016/j.antiviral.2004.07.001.
PMID: 15498610
citation: Ashraf S, Prichard R. Ivermectin exhibits potent anti-mitotic activity. Vet Parasitol. 2016 Aug 15;226:1-4. doi: 10.1016/j.vetpar.2016.06.015. Epub 2016 Jun 11.
PMID: 27514873
responsible party type: Principal Investigator
investigator affiliation: Eurnekian Public Hospital
investigator full name: Hector E Carvallo
investigator title: Principal Investigator
mesh term: COVID-19
mesh term: Ivermectin
sharing ipd: Undecided
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 