xml: <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/NCT05993143</url>
    </required_header>
    <id_info>
      <org_study_id>IVER-303</org_study_id>
      <nct_id>NCT05993143</nct_id>
    </id_info>
    <brief_title>Ivermectin to Prevent SARS-CoV-2 (COVID-19) Hospitalisation in Subjects Over 50</brief_title>
    <official_title>A Multicentre, Phase III, Double-blind, Randomised, Parallel, Placebo-controlled Trial to Assess Efficacy and Safety of Early Administration of Ivermectin During 3 Consecutive Days to Prevent SARS CoV-2 (COVID-19) Hospitalisation in Adults Older Than 50 Years of Age</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Insud Pharma</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Insud Pharma</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>
        The primary objective of this study is to assess the efficacy of early administration of&#xD;
        ivermectin for three consecutive days to prevent SARS-CoV-2 hospitalisation in adults older&#xD;
        than 50 years of age. Secondary objectives include assessing the efficacy of an early&#xD;
        administration of ivermectin for three consecutive days to prevent SARS-CoV-2 disease&#xD;
        progression in adults older than 50 years of age and evaluating the safety and tolerability&#xD;
        of ivermectin in SARS-CoV-2 infected adults older than 50 years of age.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This is a randomised, double-blind, placebo-controlled, multicentre trial in parallel groups.&#xD;
        During the screening/enrollment phase (Visit 1.1 to Visit 1.3) informed consent will be&#xD;
        obtained and the screening procedures will be performed. A rapid antigen-based test will be&#xD;
        offered to all patients who do not have a polymerase chain reaction (PCR) or a rapid&#xD;
        antigen-based test result at screening (each of these tests may be considered a part of the&#xD;
        standard procedure of the site). Eligible subjects will be randomised 1:1 to receive&#xD;
        ivermectin or placebo. The subjects will be dispensed investigational product (IP), based on&#xD;
        their body weight, and will take the first dose of IP at site. The subjects will receive&#xD;
        portable pulse oximeters for peripheral capillary oxygen saturation (SpO2) monitoring at&#xD;
        home. The treatment phase will last 3 days and include an on-site Visit 1.3 and phone call&#xD;
        Visits 2 and 3 which will be performed on the following 2 days. PCR test or rapid antigen&#xD;
        test results will be communicated to subjects as soon as available. Subjects with negative&#xD;
        COVID-19 PCR test or rapid antigen test results will be withdrawn from the trial unless they&#xD;
        have a positive rapid antigen test or COVID-19 PCR test result a few days later. The subjects&#xD;
        will be followed up until Day 28.&#xD;
  &#xD;
        During the follow-up, the subjects will have phone call Visits 4 to 9 every other day,&#xD;
        followed by Visit 10 after one week (Day 21). The subjects will be asked to measure oxygen&#xD;
        saturation as well as body temperature during all phone call visits and report the respective&#xD;
        results to the investigator. The on-site Visit 11 is the last visit (Day 28). The subjects&#xD;
        will return IPs (including empty and partially empty containers) and pulse oximeters.&#xD;
  &#xD;
        In addition, the subjects will be provided with a contact number available 24/7 to contact&#xD;
        the investigator if their condition worsens. In case of health condition worsening (dyspnoea,&#xD;
        fever [body temperature ≥ 37.8°C] lasting for more than 6 days, SpO2 ≤ 95% or any other&#xD;
        worsening criteria based on the investigator's judgement) confirmed during the phone call&#xD;
        visit, the subjects will have an unscheduled visit at the site.&#xD;
  &#xD;
        The subjects will be hospitalised if they fulfill any of the following criteria: pneumonia&#xD;
        confirmed by chest X-ray; SpO2 ≤ 94% or partial pressure of oxygen in blood (PO2) &lt; 80 mmHg&#xD;
        in gasometry; respiratory frequency &gt; 20 rpm; fever (body temperature ≥ 37.8°C) for more than&#xD;
        6 days plus one of the following analytic parameters: C-reactive protein (CRP) &gt; 5 mg/dL,&#xD;
        ferritin &gt; 500 ng/mL or D dimer &gt; 700 ng/mL. If there is any other condition that requires&#xD;
        hospitalisation as per investigator judgement, the condition has to be documented in detail&#xD;
        in the subject's file including a description whether the hospitalisation was performed due&#xD;
        to SARS-CoV-2 infection.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Terminated</overall_status>
    <why_stopped>
      Study was stopped because no statistically significant difference was observed in the interim&#xD;
      analysis. With high vaccine rates in those over 50 and an expected low incidence, it would not&#xD;
      be feasible to complete recruitment within a short period.&#xD;
    </why_stopped>
    <start_date type="Actual">January 18, 2021</start_date>
    <completion_date type="Actual">July 21, 2021</completion_date>
    <primary_completion_date type="Actual">July 21, 2021</primary_completion_date>
    <phase>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>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
      <masking_description>Test (Ivermectin) and reference (placebo) tablets will be identical in size, colour, taste and appearance. The packaging and labelling will not allow for any distinction between the test and reference drug.</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Hospitalisation due to SARS-CoV-2</measure>
      <time_frame>day 1 to day 28</time_frame>
      <description>Percentage of subjects requiring SARS-CoV-2 hospitalisation during 28 days after first IP administration.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Change in subjects' clinical status</measure>
      <time_frame>day 1, 2, 3, 4, 6, 8, 10, 12, 14, 21 and 28</time_frame>
      <description>Efficacy of an early administration of Ivermectin for three consecutive days to prevent SARS-CoV-2 disease progression in adults older than 50 years of age.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Occurrence of any adverse event related to Ivermectin treatment</measure>
      <time_frame>day 1, 2, 3, 4, 6, 8, 10, 12, 14, 21 and 28</time_frame>
      <description>Evaluation of safety and tolerability of Ivermectin in SARS CoV 2 infected adults older than 50 years of age</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Actual">249</enrollment>
    <condition>COVID-19</condition>
    <condition>SARS-CoV-2</condition>
    <arm_group>
      <arm_group_label>Ivermectin (test product)</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Ivermectin 9 mg and 18 mg immediate-released tablets to be taken orally once daily during 3 days at 600 µg/kg/day ± 120 µg/kg/day depending on their body weight.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Placebo (reference product)</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>Placebo tablets to be taken orally once daily during 3 days.</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Ivermectin</intervention_name>
      <description>Round and white tablets</description>
      <arm_group_label>Ivermectin (test product)</arm_group_label>
      <other_name>Ivermectin 9 mg and 18 mg</other_name>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Placebo</intervention_name>
      <description>Round and white tablets</description>
      <arm_group_label>Placebo (reference product)</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Male or female adult &gt; 50 years of age&#xD;
  &#xD;
            2. SARS-CoV-2 infection diagnosed either through a rapid antigen-based test or an RNA&#xD;
               based reverse-transcription polymerase chain reaction (RT-PCR) diagnostic test&#xD;
               performed in nasopharyngeal sample&#xD;
  &#xD;
            3. Onset of COVID-19 symptoms &lt; 120 hours (5 days) prior to screening&#xD;
  &#xD;
            4. Written informed consent&#xD;
  &#xD;
            5. For females of childbearing potential only: They must declare that they did not intend&#xD;
               to become pregnant in the last month prior to screening and they do not intend to&#xD;
               become pregnant for one month following the last IP administration. For males who have&#xD;
               partners of childbearing potential: Willing to use condoms until 3 months after last&#xD;
               IP intake.&#xD;
  &#xD;
            6. Negative result for urine pregnancy test (women of childbearing potential only)&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Intake of Ivermectin within 30 days before screening&#xD;
  &#xD;
            2. Routine intake of antivirals, including antiretroviral treatment&#xD;
  &#xD;
            3. Allergy, hypersensitivity or contraindication to Ivermectin, metabolites or excipients&#xD;
  &#xD;
            4. Subjects with symptoms of disease severity (dyspnoea, SpO2 ≤ 94%)&#xD;
  &#xD;
            5. Subjects requiring hospitalisation for any reason.&#xD;
  &#xD;
            6. Epidemiological risk or suspicion of being infected by Loa loa or other filariases&#xD;
  &#xD;
            7. Previous enrolment in this trial or participation in any other drug investigational&#xD;
               trial within the past 30 days (or five half-lives of IP whichever is longer) prior to&#xD;
               screening&#xD;
  &#xD;
            8. Weight &lt; 50 kg&#xD;
  &#xD;
            9. Pregnancy or lactation&#xD;
  &#xD;
           10. Inability to take oral medications&#xD;
  &#xD;
           11. At least one of the following acute/chronic disease or deficiency:&#xD;
  &#xD;
                 1. History of bone marrow transplant or haematopoietic systems diseases&#xD;
  &#xD;
                 2. Moderate or severe liver disease (Child Pugh score ≥ B or ALT [alanine&#xD;
                    transaminase] or AST [aspartate transaminase] &gt; 3 times upper limit as determined&#xD;
                    at screening visit), severe cholestasis, cirrhosis or severe hepatic failure&#xD;
  &#xD;
                 3. Transplanted patient under immunosuppressive treatment, disease that may need&#xD;
                    immunosuppressive treatments or other medical conditions that under the judgement&#xD;
                    of investigator would not benefit the patient to be included (including but not&#xD;
                    limited to psoriasis, G6PD (glucose-6-phosphate dehydrogenase) deficiency,&#xD;
                    porphyria, history of diverticulosis, seizure disorder, concurrent malignancy&#xD;
                    requiring chemotherapy, ongoing skin infection (e.g. pyodermitis) or evidence of&#xD;
                    current tuberculosis including latent untreated tuberculosis)&#xD;
  &#xD;
                 4. Ophthalmological or recent/ongoing neurological diseases&#xD;
  &#xD;
           12. Active cardiac disease or a history of cardiac dysfunction including any of the&#xD;
               following:&#xD;
  &#xD;
                 1. History of angina pectoris, symptomatic pericarditis, or myocardial infarction&#xD;
                    within 12 months prior to screening&#xD;
  &#xD;
                 2. History of congestive heart failure (New York Heart Association functional&#xD;
                    classification III-IV)&#xD;
  &#xD;
           13. Concomitant use of barbiturates, sodium oxybate, valproic acid or warfarin&#xD;
  &#xD;
           14. Laboratory abnormalities relevant for the trial, including but not limited to:&#xD;
               neutropenia &lt; 500/mm3, thrombocytopenia &lt; 100,000/mm3&#xD;
  &#xD;
           15. Any other significant disease, disorder or finding which, in the opinion of the&#xD;
               investigator, may significantly increase the risk to the subject because of&#xD;
               participation in the study, affect the ability of the subject to participate in the&#xD;
               study or impair interpretation of the study data&#xD;
  &#xD;
           16. Employees of the investigator or clinical trial site, with direct involvement in the&#xD;
               proposed trial or other studies under the direction of that investigator or clinical&#xD;
               trial site, as well as family members of the employees or the principal investigator&#xD;
  &#xD;
           17. Persons committed to an institution by virtue of an order issued either by the&#xD;
               judicial or other authorities&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>50 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Hospital de Poniente</name>
        <address>
          <city>El Ejido</city>
          <state>Almeria</state>
          <zip>04700</zip>
          <country>Spain</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Hospital Universitari Germans Trias i Pujol</name>
        <address>
          <city>Badalona</city>
          <state>Barcelona</state>
          <zip>08916</zip>
          <country>Spain</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Hospital General de Granollers</name>
        <address>
          <city>Granollers</city>
          <state>Barcelona</state>
          <zip>08402</zip>
          <country>Spain</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Hospital San Pedro</name>
        <address>
          <city>Logroño</city>
          <state>La Rioja</state>
          <zip>26006</zip>
          <country>Spain</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>HM Montepríncipe</name>
        <address>
          <city>Boadilla del Monte</city>
          <state>Madrid</state>
          <zip>28660</zip>
          <country>Spain</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>HM Puerta del Sur</name>
        <address>
          <city>Móstoles</city>
          <state>Madrid</state>
          <zip>28938</zip>
          <country>Spain</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>HM Torrelodones</name>
        <address>
          <city>Torrelodones</city>
          <state>Madrid</state>
          <zip>28250</zip>
          <country>Spain</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Clínica Universidad de Navarra</name>
        <address>
          <city>Pamplona</city>
          <state>Navarra</state>
          <zip>31008</zip>
          <country>Spain</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Complejo Hospitalario Universitario A Coruña-CHUAC</name>
        <address>
          <city>A Coruña</city>
          <zip>15006</zip>
          <country>Spain</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Centro de Atención Primaria Les Corts</name>
        <address>
          <city>Barcelona</city>
          <zip>08028</zip>
          <country>Spain</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Hospital Clínic de Barcelona</name>
        <address>
          <city>Barcelona</city>
          <zip>08036</zip>
          <country>Spain</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Hospital de la Santa Creu i Sant Pau</name>
        <address>
          <city>Barcelona</city>
          <zip>08041</zip>
          <country>Spain</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Hospital Universitario de la Princesa</name>
        <address>
          <city>Madrid</city>
          <zip>28006</zip>
          <country>Spain</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Clínica Universidad de Navarra - Madrid</name>
        <address>
          <city>Madrid</city>
          <zip>28027</zip>
          <country>Spain</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Hospital Clínico San Carlos</name>
        <address>
          <city>Madrid</city>
          <zip>28040</zip>
          <country>Spain</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>HM Sanchinarro</name>
        <address>
          <city>Madrid</city>
          <zip>28050</zip>
          <country>Spain</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Complejo Hospitalario de Navarra</name>
        <address>
          <city>Pamplona</city>
          <zip>31008</zip>
          <country>Spain</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Complejo Asistencial Universitario de Salamanca</name>
        <address>
          <city>Salamanca</city>
          <zip>37007</zip>
          <country>Spain</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Hospital Universitario Virgen de la Macarena</name>
        <address>
          <city>Sevilla</city>
          <zip>41009</zip>
          <country>Spain</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Hospital Universitari de Tarragona Joan XXIII</name>
        <address>
          <city>Tarragona</city>
          <zip>43005</zip>
          <country>Spain</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Spain</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 8, 2023</study_first_submitted>
    <study_first_submitted_qc>August 10, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 15, 2023</study_first_posted>
    <last_update_submitted>August 10, 2023</last_update_submitted>
    <last_update_submitted_qc>August 10, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 15, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>ivermectin</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>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05993143
  org study id: IVER-303
  nct id: NCT05993143
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The primary objective of this study is to assess the efficacy of early administration of
        ivermectin for three consecutive days to prevent SARS-CoV-2 hospitalisation in adults older
        than 50 years of age. Secondary objectives include assessing the efficacy of an early
        administration of ivermectin for three consecutive days to prevent SARS-CoV-2 disease
        progression in adults older than 50 years of age and evaluating the safety and tolerability
        of ivermectin in SARS-CoV-2 infected adults older than 50 years of age.
  This is a randomised, double-blind, placebo-controlled, multicentre trial in parallel groups.
        During the screening/enrollment phase (Visit 1.1 to Visit 1.3) informed consent will be
        obtained and the screening procedures will be performed. A rapid antigen-based test will be
        offered to all patients who do not have a polymerase chain reaction (PCR) or a rapid
        antigen-based test result at screening (each of these tests may be considered a part of the
        standard procedure of the site). Eligible subjects will be randomised 1:1 to receive
        ivermectin or placebo. The subjects will be dispensed investigational product (IP), based on
        their body weight, and will take the first dose of IP at site. The subjects will receive
        portable pulse oximeters for peripheral capillary oxygen saturation (SpO2) monitoring at
        home. The treatment phase will last 3 days and include an on-site Visit 1.3 and phone call
        Visits 2 and 3 which will be performed on the following 2 days. PCR test or rapid antigen
        test results will be communicated to subjects as soon as available. Subjects with negative
        COVID-19 PCR test or rapid antigen test results will be withdrawn from the trial unless they
        have a positive rapid antigen test or COVID-19 PCR test result a few days later. The subjects
        will be followed up until Day 28.
  
        During the follow-up, the subjects will have phone call Visits 4 to 9 every other day,
        followed by Visit 10 after one week (Day 21). The subjects will be asked to measure oxygen
        saturation as well as body temperature during all phone call visits and report the respective
        results to the investigator. The on-site Visit 11 is the last visit (Day 28). The subjects
        will return IPs (including empty and partially empty containers) and pulse oximeters.
  
        In addition, the subjects will be provided with a contact number available 24/7 to contact
        the investigator if their condition worsens. In case of health condition worsening (dyspnoea,
        fever [body temperature ≥ 37.8°C] lasting for more than 6 days, SpO2 ≤ 95% or any other
        worsening criteria based on the investigator's judgement) confirmed during the phone call
        visit, the subjects will have an unscheduled visit at the site.
  
        The subjects will be hospitalised if they fulfill any of the following criteria: pneumonia
        confirmed by chest X-ray; SpO2 ≤ 94% or partial pressure of oxygen in blood (PO2) < 80 mmHg
        in gasometry; respiratory frequency > 20 rpm; fever (body temperature ≥ 37.8°C) for more than
        6 days plus one of the following analytic parameters: C-reactive protein (CRP) > 5 mg/dL,
        ferritin > 500 ng/mL or D dimer > 700 ng/mL. If there is any other condition that requires
        hospitalisation as per investigator judgement, the condition has to be documented in detail
        in the subject's file including a description whether the hospitalisation was performed due
        to SARS-CoV-2 infection.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  masking description: Test (Ivermectin) and reference (placebo) tablets will be identical in size, colour, taste and appearance. The packaging and labelling will not allow for any distinction between the test and reference drug.
  measure: Hospitalisation due to SARS-CoV-2
  time frame: day 1 to day 28
  description: Percentage of subjects requiring SARS-CoV-2 hospitalisation during 28 days after first IP administration.
  measure: Change in subjects' clinical status
  time frame: day 1, 2, 3, 4, 6, 8, 10, 12, 14, 21 and 28
  description: Efficacy of an early administration of Ivermectin for three consecutive days to prevent SARS-CoV-2 disease progression in adults older than 50 years of age.
  measure: Occurrence of any adverse event related to Ivermectin treatment
  time frame: day 1, 2, 3, 4, 6, 8, 10, 12, 14, 21 and 28
  description: Evaluation of safety and tolerability of Ivermectin in SARS CoV 2 infected adults older than 50 years of age
  arm group label: Ivermectin (test product)
  arm group type: Experimental
  description: Ivermectin 9 mg and 18 mg immediate-released tablets to be taken orally once daily during 3 days at 600 µg/kg/day ± 120 µg/kg/day depending on their body weight.
  arm group label: Placebo (reference product)
  arm group type: Placebo Comparator
  description: Placebo tablets to be taken orally once daily during 3 days.
  intervention type: Drug
  intervention name: Ivermectin
  description: Round and white tablets
  arm group label: Ivermectin (test product)
  other name: Ivermectin 9 mg and 18 mg
  intervention type: Drug
  intervention name: Placebo
  description: Round and white tablets
  arm group label: Placebo (reference product)
  criteria: 
  gender: All
  minimum age: 50 Years
  maximum age: N/A
  healthy volunteers: No
  facility: 
  facility: 
  facility: 
  facility: 
  facility: 
  facility: 
  facility: 
  facility: 
  facility: 
  facility: 
  facility: 
  facility: 
  facility: 
  facility: 
  facility: 
  facility: 
  facility: 
  facility: 
  facility: 
  facility: 
  country: Spain
  responsible party type: Sponsor
  mesh term: COVID-19
  mesh term: Ivermectin
  sharing ipd: No