<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/NCT04475120</url>
  </required_header>
  <id_info>
    <org_study_id>4220</org_study_id>
    <nct_id>NCT04475120</nct_id>
  </id_info>
  <brief_title>Efficacy and Safety of Liposomal Lactoferrin in COVID-19 Patients With Mild-to-Moderate Disease and in COVID-19 Asymptomatic Patients</brief_title>
  <official_title>Interventional Pilot Study to Assess the Use of Oral and Intra-nasal Liposomal Lactoferrin in COVID-19 Patients With Mild-to-Moderate Disease and in COVID-19 Asymptomatic Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Rome Tor Vergata</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Rome Tor Vergata</source>
  <oversight_info>
    <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>
      COVID-19 is considered an ongoing international global health problem which already caused 12&#xD;
      million confirmed cases. No specific effective treatment has been identified so far, and&#xD;
      available supportive therapies are intended just to severe patients. Asymptomatic and mildly&#xD;
      symptomatic patients remain a transmission reservoir, with possible evolution to the most&#xD;
      severe disease form, without a clear treatment indication.&#xD;
&#xD;
      Lactoferrin (Lf) is a multifunctional glycoprotein, belonging to transferrin family, secreted&#xD;
      by exocrine glands and neutrophils and present in all human secretion. The pleiotropic&#xD;
      activity of Lf is mainly based on its four different functions: chelate two ferric iron per&#xD;
      molecule, interact with anionic molecules, enter inside nucleus and modulate iron&#xD;
      homeostasis. The ability to chelate two ferric ions per molecule is associated to the&#xD;
      inhibition of reactive oxygen species formation as well as this sequestration of iron,&#xD;
      pivotal for bacterial and viral replication, is at the basis of its antibacterial and&#xD;
      antiviral activity. Moreover, Lf exerts its antiviral activity against the majority of the&#xD;
      tested viruses by binding to heparan sulphate, while against few viruses by interacting with&#xD;
      surface components of viral particles. The capability of Lf to exert antiviral activity, by&#xD;
      binding to host cells or viral particles or both, strengthens the idea that this glycoprotein&#xD;
      is &quot;an important brick in the mucosal wall, effective against viral attacks&quot;. Lf was able to&#xD;
      block the binding of the spike protein to host cells, indicating that Lf exerted its&#xD;
      inhibitory function at the viral attachment stage. The current accepted model suggests that&#xD;
      Lf could block viral entry by interacting with heparan sulfate proteoglycans (HSPGs), which&#xD;
      mediate the transport of extracellular virus particles from the low affinity anchoring sites&#xD;
      to the high affinity specific entry as ACE-2.&#xD;
&#xD;
      Investigators performed a prospective, interventional pilot study to assess the efficacy of&#xD;
      liposomal lactoferrin in COVID-19 patients with mild-to moderate disease and in COVID-19&#xD;
      asymptomatic patients.&#xD;
&#xD;
      Secondary objectives evaluated the safety and tolerability of liposomal lactoferrin for oral&#xD;
      and intra-nasal use.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      COVID-19 is considered an ongoing international global health problem which already caused 12&#xD;
      million confirmed cases. No specific effective treatment has been identified so far, and&#xD;
      available supportive therapies are intended just to severe patients. Asymptomatic and mildly&#xD;
      symptomatic patients remain a transmission reservoir, with possible evolution to the most&#xD;
      severe disease form, without a clear treatment indication.&#xD;
&#xD;
      Lactoferrin (Lf) is a multifunctional glycoprotein, belonging to transferrin family, secreted&#xD;
      by exocrine glands and neutrophils and present in all human secretion. The pleiotropic&#xD;
      activity of Lf is mainly based on its four different functions: chelate two ferric iron per&#xD;
      molecule, interact with anionic molecules, enter inside nucleus and modulate iron&#xD;
      homeostasis. The ability to chelate two ferric ions per molecule is associated to the&#xD;
      inhibition of reactive oxygen species formation as well as this sequestration of iron,&#xD;
      pivotal for bacterial and viral replication, is at the basis of its antibacterial and&#xD;
      antiviral activity.&#xD;
&#xD;
      Moreover, Lf exerts its antiviral activity against the majority of the tested viruses by&#xD;
      binding to heparan sulphate, while against few viruses by interacting with surface components&#xD;
      of viral particles. The capability of Lf to exert antiviral activity, by binding to host&#xD;
      cells or viral particles or both, strengthens the idea that this glycoprotein is &quot;an&#xD;
      important brick in the mucosal wall, effective against viral attacks&quot;. Lf was able to block&#xD;
      the binding of the spike protein to host cells, indicating that Lf exerted its inhibitory&#xD;
      function at the viral attachment stage. The current accepted model suggests that Lf could&#xD;
      block viral entry by interacting with heparan sulfate proteoglycans (HSPGs), which mediate&#xD;
      the transport of extracellular virus particles from the low affinity anchoring sites to the&#xD;
      high affinity specific entry as ACE-2.&#xD;
&#xD;
      Investigators performed a prospective, interventional, pilot study to assess the efficacy of&#xD;
      liposomal lactoferrin in COVID-19 patients with mild-to moderate disease and in COVID-19&#xD;
      asymptomatic patients.&#xD;
&#xD;
      Secondary objectives evaluated the safety and tolerability of liposomal lactoferrin for oral&#xD;
      and intra-nasal use.&#xD;
&#xD;
      Investigators conducted a parallel 3 group clinical trial to investigate the effect and&#xD;
      tolerability of a liposomal bLf formulation as a supplementary nutraceutical agent in COVID19&#xD;
      patients. A total of 92 COVID19 patients, 25/92 asymptomatic and 67/92 mild-to-moderate, were&#xD;
      recruited and divided into 3 groups according to the administered regimen: 32/92 COVID-19&#xD;
      patients, 14 hospitalised and 18 in home-based isolation, received oral and intranasal&#xD;
      liposomal bLF supplement; 32 COVID-19 hospitalised patients were treated with&#xD;
      hydroxychloroquine, azitromicin and lopinavir/darunavir as standard of care treatment (SOC);&#xD;
      twenty eight COVID-19 patients, in home-based isolation did not take any medication against&#xD;
      COVID-19. Furthermore, a group of 32 healthy subjects with negative COVID19 rRT-PCR was added&#xD;
      as a control group for ancillary analysis.&#xD;
&#xD;
      Thirty-two patients (14 hospitalised and 18 in home-based isolation) belonging to the first&#xD;
      group received oral and intranasal liposomal bLf. BLf capsules for oral use containing 100 mg&#xD;
      of bLf encapsulated in liposome while bLf nasal spray had about 8 mg/ml of bLf encapsulated&#xD;
      in liposome. BLf, contained in both products, was tested by SDS-PAGE and silver nitrate&#xD;
      staining and its purity was about 95%. The bLf iron saturation was about 5% as detected via&#xD;
      optical spectroscopy at 468 nm based on an extinction coefficient of 0.54 (100% iron&#xD;
      saturation, 1% solution). The scheduled dose treatment of liposomal bLf for oral use was 1gr&#xD;
      per day for 30 days (10 capsules per day) in addition to the same formulation intranasally&#xD;
      administered 3 times daily (a total of about 16 mg/nostril) Thirty-two hospitalized patients&#xD;
      belonging to the second group were only treated with SOC regimen according to the national&#xD;
      guidelines at the time of the enrollment: lopinavir/ritonavir cps 200/50 mg, 2x2/day&#xD;
      (alternatively darunavir 800 mg 1 cp/day+ritonavir 100 mg 1 cp/day or darunavir/cobicistat&#xD;
      800/150 mg 1 cp/day), chloroquine 500 mg, 1x2/day or hydroxychloroquine cp 200 mg, 1x2/day.&#xD;
      SOC regimen lasted from 5 to 20 days, with timing to be established according to clinical&#xD;
      course.&#xD;
&#xD;
      Twenty-eight patients, in home-based isolation, belonging to the third group did not receive&#xD;
      any therapy.&#xD;
&#xD;
      A control group, comprising 32 healthy volunteers, did not receive any treatment or placebo.&#xD;
&#xD;
      Blood samples and clinical assessments were evaluated at baseline (T0), after 15 days (T1)&#xD;
      and after 30 days (T2).&#xD;
&#xD;
      Eligible patients were over 20 years old, with a confirmed positivity to COVID-19 at the&#xD;
      naso-oro-pharyngeal swab.&#xD;
&#xD;
      Exclusion criteria included pregnant and lactating women, patients taking nitric oxide and&#xD;
      nitrates, patients with reported allergy to milk proteins, patients with a previous history&#xD;
      of bronchial hyperactivity and patients with pre-existing respiratory diseases.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 15, 2020</start_date>
  <completion_date type="Actual">July 2, 2020</completion_date>
  <primary_completion_date type="Actual">July 2, 2020</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Rate of viral clearance Time to viral clearance</measure>
    <time_frame>30 days</time_frame>
    <description>time to naso-oro-pharingeal swab negativization</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Time to clinical improvement</measure>
    <time_frame>30 days</time_frame>
    <description>time to improvement of clinical symptoms and blood parameters</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">92</enrollment>
  <condition>Covid19</condition>
  <arm_group>
    <arm_group_label>Liposomal Lacroferrin</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Thirty-two patients (14 hospitalised and 18 in home-based isolation) belonging to the first group received oral and intranasal liposomal bLf. BLf capsules for oral use containing 100 mg of bLf encapsulated in liposome while bLf nasal spray had about 8 mg/ml of bLf encapsulated in liposome. BLf, contained in both products, was tested by SDS-PAGE and silver nitrate staining and its purity was about 95%. The bLf iron saturation was about 5% as detected via optical spectroscopy at 468 nm based on an extinction coefficient of 0.54 (100% iron saturation, 1% solution). The scheduled dose treatment of liposomal bLf for oral use was 1gr per day for 30 days (10 capsules per day) in addition to the same formulation intranasally administered 3 times daily (a total of about 16 mg/nostril)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>SOC therapy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Thirty-two hospitalized patients belonging to the second group were only treated with SOC regimen according to the national guidelines at the time of the enrollment: lopinavir/ritonavir cps 200/50 mg, 2x2/day (alternatively darunavir 800 mg 1 cp/day+ritonavir 100 mg 1 cp/day or darunavir/cobicistat 800/150 mg 1 cp/day), chloroquine 500 mg, 1x2/day or hydroxychloroquine cp 200 mg, 1x2/day. SOC regimen lasted from 5 to 20 days, with timing to be established according to clinical course.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Home-based isolation</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Twenty-eight patients, in home-based isolation, belonging to the third group did not receive any therapy.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Healthy volunteers</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>A control group, comprising 32 healthy volunteers, did not receive any treatment or placebo.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>liposomal lactoferrin</intervention_name>
    <description>oral and intra-nasal formulation</description>
    <arm_group_label>Liposomal Lacroferrin</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>SOC therapy</intervention_name>
    <description>oral administration</description>
    <arm_group_label>SOC therapy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Eligible patients were over 20years old, with a confirmed positivity to COVID-19 at the&#xD;
        oropharyngeal swab&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        pregnant and lactating women, patients taking nitric oxide and nitrates, patients with&#xD;
        reported allergy to milk proteins, patients with a previous history of bronchial&#xD;
        hyperactivity and patients with pre-existing respiratory diseases. COVID-19 patients&#xD;
        requiring intensive care or mechanical ventilation were excluded.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>University of Rome Tor Vergata</name>
      <address>
        <city>Rome</city>
        <zip>00133</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <verification_date>May 2021</verification_date>
  <study_first_submitted>July 16, 2020</study_first_submitted>
  <study_first_submitted_qc>July 16, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 17, 2020</study_first_posted>
  <last_update_submitted>May 12, 2021</last_update_submitted>
  <last_update_submitted_qc>May 12, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">May 14, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Rome Tor Vergata</investigator_affiliation>
    <investigator_full_name>Elena Campione</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </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>Lactoferrin</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_info_type>Study Protocol</ipd_info_type>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04475120
org study id: 4220
nct id: NCT04475120
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
is us export: No
COVID-19 is considered an ongoing international global health problem which already caused 12
      million confirmed cases. No specific effective treatment has been identified so far, and
      available supportive therapies are intended just to severe patients. Asymptomatic and mildly
      symptomatic patients remain a transmission reservoir, with possible evolution to the most
      severe disease form, without a clear treatment indication.

      Lactoferrin (Lf) is a multifunctional glycoprotein, belonging to transferrin family, secreted
      by exocrine glands and neutrophils and present in all human secretion. The pleiotropic
      activity of Lf is mainly based on its four different functions: chelate two ferric iron per
      molecule, interact with anionic molecules, enter inside nucleus and modulate iron
      homeostasis. The ability to chelate two ferric ions per molecule is associated to the
      inhibition of reactive oxygen species formation as well as this sequestration of iron,
      pivotal for bacterial and viral replication, is at the basis of its antibacterial and
      antiviral activity. Moreover, Lf exerts its antiviral activity against the majority of the
      tested viruses by binding to heparan sulphate, while against few viruses by interacting with
      surface components of viral particles. The capability of Lf to exert antiviral activity, by
      binding to host cells or viral particles or both, strengthens the idea that this glycoprotein
      is "an important brick in the mucosal wall, effective against viral attacks". Lf was able to
      block the binding of the spike protein to host cells, indicating that Lf exerted its
      inhibitory function at the viral attachment stage. The current accepted model suggests that
      Lf could block viral entry by interacting with heparan sulfate proteoglycans (HSPGs), which
      mediate the transport of extracellular virus particles from the low affinity anchoring sites
      to the high affinity specific entry as ACE-2.

      Investigators performed a prospective, interventional pilot study to assess the efficacy of
      liposomal lactoferrin in COVID-19 patients with mild-to moderate disease and in COVID-19
      asymptomatic patients.

      Secondary objectives evaluated the safety and tolerability of liposomal lactoferrin for oral
      and intra-nasal use.
COVID-19 is considered an ongoing international global health problem which already caused 12
      million confirmed cases. No specific effective treatment has been identified so far, and
      available supportive therapies are intended just to severe patients. Asymptomatic and mildly
      symptomatic patients remain a transmission reservoir, with possible evolution to the most
      severe disease form, without a clear treatment indication.

      Lactoferrin (Lf) is a multifunctional glycoprotein, belonging to transferrin family, secreted
      by exocrine glands and neutrophils and present in all human secretion. The pleiotropic
      activity of Lf is mainly based on its four different functions: chelate two ferric iron per
      molecule, interact with anionic molecules, enter inside nucleus and modulate iron
      homeostasis. The ability to chelate two ferric ions per molecule is associated to the
      inhibition of reactive oxygen species formation as well as this sequestration of iron,
      pivotal for bacterial and viral replication, is at the basis of its antibacterial and
      antiviral activity.

      Moreover, Lf exerts its antiviral activity against the majority of the tested viruses by
      binding to heparan sulphate, while against few viruses by interacting with surface components
      of viral particles. The capability of Lf to exert antiviral activity, by binding to host
      cells or viral particles or both, strengthens the idea that this glycoprotein is "an
      important brick in the mucosal wall, effective against viral attacks". Lf was able to block
      the binding of the spike protein to host cells, indicating that Lf exerted its inhibitory
      function at the viral attachment stage. The current accepted model suggests that Lf could
      block viral entry by interacting with heparan sulfate proteoglycans (HSPGs), which mediate
      the transport of extracellular virus particles from the low affinity anchoring sites to the
      high affinity specific entry as ACE-2.

      Investigators performed a prospective, interventional, pilot study to assess the efficacy of
      liposomal lactoferrin in COVID-19 patients with mild-to moderate disease and in COVID-19
      asymptomatic patients.

      Secondary objectives evaluated the safety and tolerability of liposomal lactoferrin for oral
      and intra-nasal use.

      Investigators conducted a parallel 3 group clinical trial to investigate the effect and
      tolerability of a liposomal bLf formulation as a supplementary nutraceutical agent in COVID19
      patients. A total of 92 COVID19 patients, 25/92 asymptomatic and 67/92 mild-to-moderate, were
      recruited and divided into 3 groups according to the administered regimen: 32/92 COVID-19
      patients, 14 hospitalised and 18 in home-based isolation, received oral and intranasal
      liposomal bLF supplement; 32 COVID-19 hospitalised patients were treated with
      hydroxychloroquine, azitromicin and lopinavir/darunavir as standard of care treatment (SOC);
      twenty eight COVID-19 patients, in home-based isolation did not take any medication against
      COVID-19. Furthermore, a group of 32 healthy subjects with negative COVID19 rRT-PCR was added
      as a control group for ancillary analysis.

      Thirty-two patients (14 hospitalised and 18 in home-based isolation) belonging to the first
      group received oral and intranasal liposomal bLf. BLf capsules for oral use containing 100 mg
      of bLf encapsulated in liposome while bLf nasal spray had about 8 mg/ml of bLf encapsulated
      in liposome. BLf, contained in both products, was tested by SDS-PAGE and silver nitrate
      staining and its purity was about 95%. The bLf iron saturation was about 5% as detected via
      optical spectroscopy at 468 nm based on an extinction coefficient of 0.54 (100% iron
      saturation, 1% solution). The scheduled dose treatment of liposomal bLf for oral use was 1gr
      per day for 30 days (10 capsules per day) in addition to the same formulation intranasally
      administered 3 times daily (a total of about 16 mg/nostril) Thirty-two hospitalized patients
      belonging to the second group were only treated with SOC regimen according to the national
      guidelines at the time of the enrollment: lopinavir/ritonavir cps 200/50 mg, 2x2/day
      (alternatively darunavir 800 mg 1 cp/day+ritonavir 100 mg 1 cp/day or darunavir/cobicistat
      800/150 mg 1 cp/day), chloroquine 500 mg, 1x2/day or hydroxychloroquine cp 200 mg, 1x2/day.
      SOC regimen lasted from 5 to 20 days, with timing to be established according to clinical
      course.

      Twenty-eight patients, in home-based isolation, belonging to the third group did not receive
      any therapy.

      A control group, comprising 32 healthy volunteers, did not receive any treatment or placebo.

      Blood samples and clinical assessments were evaluated at baseline (T0), after 15 days (T1)
      and after 30 days (T2).

      Eligible patients were over 20 years old, with a confirmed positivity to COVID-19 at the
      naso-oro-pharyngeal swab.

      Exclusion criteria included pregnant and lactating women, patients taking nitric oxide and
      nitrates, patients with reported allergy to milk proteins, patients with a previous history
      of bronchial hyperactivity and patients with pre-existing respiratory diseases.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Rate of viral clearance Time to viral clearance
time frame: 30 days
description: time to naso-oro-pharingeal swab negativization
measure: Time to clinical improvement
time frame: 30 days
description: time to improvement of clinical symptoms and blood parameters
arm group label: Liposomal Lacroferrin
arm group type: Experimental
description: Thirty-two patients (14 hospitalised and 18 in home-based isolation) belonging to the first group received oral and intranasal liposomal bLf. BLf capsules for oral use containing 100 mg of bLf encapsulated in liposome while bLf nasal spray had about 8 mg/ml of bLf encapsulated in liposome. BLf, contained in both products, was tested by SDS-PAGE and silver nitrate staining and its purity was about 95%. The bLf iron saturation was about 5% as detected via optical spectroscopy at 468 nm based on an extinction coefficient of 0.54 (100% iron saturation, 1% solution). The scheduled dose treatment of liposomal bLf for oral use was 1gr per day for 30 days (10 capsules per day) in addition to the same formulation intranasally administered 3 times daily (a total of about 16 mg/nostril)
arm group label: SOC therapy
arm group type: Active Comparator
description: Thirty-two hospitalized patients belonging to the second group were only treated with SOC regimen according to the national guidelines at the time of the enrollment: lopinavir/ritonavir cps 200/50 mg, 2x2/day (alternatively darunavir 800 mg 1 cp/day+ritonavir 100 mg 1 cp/day or darunavir/cobicistat 800/150 mg 1 cp/day), chloroquine 500 mg, 1x2/day or hydroxychloroquine cp 200 mg, 1x2/day. SOC regimen lasted from 5 to 20 days, with timing to be established according to clinical course.
arm group label: Home-based isolation
arm group type: No Intervention
description: Twenty-eight patients, in home-based isolation, belonging to the third group did not receive any therapy.
arm group label: Healthy volunteers
arm group type: No Intervention
description: A control group, comprising 32 healthy volunteers, did not receive any treatment or placebo.
intervention type: Drug
intervention name: liposomal lactoferrin
description: oral and intra-nasal formulation
arm group label: Liposomal Lacroferrin
intervention type: Drug
intervention name: SOC therapy
description: oral administration
arm group label: SOC therapy
criteria: 
gender: All
minimum age: 20 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Italy
responsible party type: Principal Investigator
investigator affiliation: University of Rome Tor Vergata
investigator full name: Elena Campione
investigator title: Associate Professor
mesh term: COVID-19
mesh term: Lactoferrin
sharing ipd: Yes
ipd info type: Study Protocol