<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/NCT04405271</url>
  </required_header>
  <id_info>
    <org_study_id>5616</org_study_id>
    <nct_id>NCT04405271</nct_id>
  </id_info>
  <brief_title>TAF/FTC for Pre-exposure Prophylaxis of COVID-19 in Healthcare Workers (CoviPrep Study)</brief_title>
  <official_title>Randomized, Double-blind, Placebo-controlled Trial of TAF/FTC for Pre-exposure Prophylaxis of COVID-19 in Healthcare Workers (CoviPrep Study)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hospital Italiano de Buenos Aires</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Sociedad Argentina de Infectología (SADI) (Argentine Society of Infectious Diseases)</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Hospital Italiano de Buenos Aires</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>
      A randomized parallel double-blinded placebo-controlled clinical trial to evaluate the effect&#xD;
      of Emtricitabine/Tenofovir alafenamide (FTC/TAF) compared with placebo on the risk of&#xD;
      developing SARS-CoV-2 disease (COVID-19) in healthcare workers with high transmission risk in&#xD;
      addition to currently recommended control measures.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Randomized, double-blind, placebo-controlled clinical trial. Phase III clinical trial for a&#xD;
      new indication&#xD;
&#xD;
      Rationale One of the most affected subgroups during the current pandemic is represented by&#xD;
      healthcare workers. In Argentina between 14 and 17% of the total COVID-19 cases are&#xD;
      represented by this subgroup. In this sense, it appears as an adequate strategy testing the&#xD;
      efficacy of pharmacological PrEP approaches on top of the currently recommended control&#xD;
      measures.&#xD;
&#xD;
      The use of placebo is warranted for two main reasons: all healthcare workers will be allowed&#xD;
      and encouraged to comply with non-pharmacological infection control measures for the&#xD;
      protection of viral transmission. On the other hand, the use of a blinded placebo is intended&#xD;
      for avoiding relaxation of the non-pharmacological control measures.&#xD;
&#xD;
      Tenofovir has been identified by both docking and in vitro studies as an inhibitor of RdRp&#xD;
      (RNA dependent RNA polymerase) of coronavirus.&#xD;
&#xD;
      FTC/TAF has the additional advantage that is already being used in a pre-exposure prophylaxis&#xD;
      setting and its safety is widely known.&#xD;
&#xD;
      Main objective To evaluate the risk of developing SARS-CoV-2 disease (COVID-19) in healthcare&#xD;
      workers with high transmission risk in addition to currently recommended control measures.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">July 31, 2020</start_date>
  <completion_date type="Anticipated">November 15, 2020</completion_date>
  <primary_completion_date type="Anticipated">November 15, 2020</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>
    <intervention_model_description>Randomized (1:1), double-blind, placebo-controlled clinical trial</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
    <masking_description>The treatment will be the same in both arms: 1 tablet per day will be administered for a total of 12 weeks. Placebo and the active principle will be indistinguishable.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>COVID-19 incident cases</measure>
    <time_frame>During treatment (12 weeks)</time_frame>
    <description>SARS-CoV-2 disease (COVID-19) with or without symptoms at week 12 of treatment as defined by the presence of specific antibodies against the virus. Positive cases will be confirmed by PCR</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of asymptomatic SARS-CoV-2 (Covid-19) infections confirmed by serology</measure>
    <time_frame>During treatment (12 weeks)</time_frame>
    <description>Number of asymptomatic SARS-CoV-2 (Covid-19) infections confirmed by serology</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Severity of symptomatic COVID-19</measure>
    <time_frame>During treatment (12 weeks)</time_frame>
    <description>Severity of symptomatic SARS-CoV-2 (Covid-19) infections as defined by the following categories:&#xD;
Mild symptoms: malaise, fever, cough, arthralgia myalgias,&#xD;
Moderate symptoms: same as above plus shortness of breath&#xD;
Severe symptoms: clinical status requiring admission in Intensive care unit</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Respiratory symptom duration in days</measure>
    <time_frame>During treatment (12 weeks)</time_frame>
    <description>Respiratory symptom duration in days</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Relation between treatments and symptoms duration</measure>
    <time_frame>During treatment (12 weeks)</time_frame>
    <description>Relation between treatments and symptoms duration</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time course of specific IgM/IgG seroconversion</measure>
    <time_frame>During treatment (12 weeks)</time_frame>
    <description>Time course of specific IgM/IgG seroconversion</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">1378</enrollment>
  <condition>Healthcare Workers</condition>
  <condition>COVID-19</condition>
  <condition>SARS-CoV 2</condition>
  <arm_group>
    <arm_group_label>FTC/TAF</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Emtricitabine/Tenofovir alafenamide (FTC/TAF) in 200 mg/25 mg tablets. A dose of 1 tablet per day will be administered for a total of 12 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Identical tablets to the active experimental tablets with the same characteristics and packaging. A dose of 1 tablet per day will be administered for a total of 12 weeks</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Emtricitabine/Tenofovir Alafenamide 200 MG-25 MG Oral Tablet</intervention_name>
    <description>Emtricitabine/Tenofovir alafenamide (FTC/TAF) in 200 mg/25 mg tablets. A dose of 1 tablet per day will be administered for a total of 12 weeks</description>
    <arm_group_label>FTC/TAF</arm_group_label>
    <other_name>FTC/TAF</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>A dose of 1 tablet per day will be administered for a total of 12 weeks.</description>
    <arm_group_label>Placebo</arm_group_label>
    <other_name>Placebo comparator</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Healthcare workers voluntarily deciding to participate in the study&#xD;
&#xD;
          2. Understanding the study purpose&#xD;
&#xD;
          3. Having between 18 and 70 years old&#xD;
&#xD;
          4. Having a high transmission risk for Covid-19. Physicians, nurses, lab technicians,&#xD;
             physical therapists, or cleaning personnel working at COVID-19 areas, hospital&#xD;
             emergency areas, or Intensive care units from healthcare institutions with the direct&#xD;
             assistance of patients with Covid-19.&#xD;
&#xD;
          5. Not having a prior diagnosis of SARS-CoV-2 infection (COVID-19)&#xD;
&#xD;
          6. Having a negative IgM/IgG antibodies test for SARS-CoV-2 (COVID-19) prior to study&#xD;
             entry&#xD;
&#xD;
          7. Negative pregnancy test for childbearing age women within 7 days prior to study entry.&#xD;
&#xD;
          8. Childbearing age males and females should comply with the use of a proven&#xD;
             contraceptive method (double barrier methods, oral contraceptives or contraceptive&#xD;
             hormone implants) during the course of the study and at least one month after study&#xD;
             completion.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Having symptoms compatible with COVID-19&#xD;
&#xD;
          2. Diagnosed HIV infection&#xD;
&#xD;
          3. Current use of Pre-exposure prophylaxis for HIV&#xD;
&#xD;
          4. Diagnosed Hepatitis B infection.&#xD;
&#xD;
          5. Diagnosed renal insufficiency and or current hemodialysis need&#xD;
&#xD;
          6. Diagnosed osteoporosis under pharmacological treatment.&#xD;
&#xD;
          7. Weight &lt; 40kg&#xD;
&#xD;
          8. Current immunosuppressive or serious hematological condition&#xD;
&#xD;
          9. Prior use of pre-exposure prophylaxis for SARS-CoV-2&#xD;
&#xD;
         10. Current pregnancy or pregnancy plan within the study course.&#xD;
&#xD;
         11. Current breastfeeding&#xD;
&#xD;
         12. Known hypersensitivity to any of the study medication components.&#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>
  <overall_official>
    <last_name>Waldo H Belloso, MD</last_name>
    <role>Study Chair</role>
    <affiliation>Hospital Italiano de Buenos Aires</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Ventura Simonovich, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>HIBA</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Esteban Nannini, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Sanatorio Britanico</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Wanda Cornistein, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hospital Austral</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Marcelo Figueiras, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Richmond Laboratorio</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Elvira Zini, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Richmond Laboratorio</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Fernando Riera, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Sanatorio Allende (Córdoba)</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Omar Sued, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>HUESPED</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Santiago Ramirez Borga, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hospital Italiano de La Plata</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Gustavo Costilla Campero, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hospital Padilla (Tucumán)</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Gustavo D Lopardo, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hospital Bernardo Houssay</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Gonzalo Corral, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hospital Alende (Mar del Plata)</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Waldo H Belloso, MD</last_name>
    <phone>+541149590200</phone>
    <email>waldo.belloso@hiba.org.ar</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Gustavo D Lopardo, MD</last_name>
    <phone>+541149590200</phone>
    <email>glopardo@intramed.net</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Sociedad Argentina de Infectología, A. J. Carranza 974</name>
      <address>
        <city>Ciudad Autonoma de Buenos Aires</city>
        <state>Capital Federal</state>
        <zip>C1085</zip>
        <country>Argentina</country>
      </address>
    </facility>
    <contact>
      <last_name>Waldo H Belloso, MD</last_name>
      <phone>+541149590200</phone>
      <email>waldo.belloso@hiba.org.ar</email>
    </contact>
    <contact_backup>
      <last_name>Diego H Giunta, PhD</last_name>
      <phone>+54 9 11 5825-6489</phone>
      <email>diego.giunta@hospitalitaliano.org.ar</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Argentina</country>
  </location_countries>
  <link>
    <url>https://www.argentina.gob.ar/salud/coronavirus-COVID-19/sala-situacion</url>
    <description>Sala de Situación Coronavirus online - Ministerio de Salud de la Nación</description>
  </link>
  <link>
    <url>https://doi.org/10.1016/j.jhin.2020.03.002</url>
    <description>Reasons for healthcare workers becoming infected with novel coronavirus disease 2019 (COVID-19) in China</description>
  </link>
  <link>
    <url>https://doi.org/10.1101/2020.03.18.997585</url>
    <description>Nucleotide Analogues as Inhibitors of SARS-CoV-2 Polymerase</description>
  </link>
  <link>
    <url>https://www.biorxiv.org/content/biorxiv/early/2020/01/31/2020.01.30.927574.full.pdf</url>
    <description>Nucleotide Analogues as Inhibitors of Viral Polymerases</description>
  </link>
  <link>
    <url>https://doi.org/10.1101/2020.04.03.022939</url>
    <description>Triphosphates of the Two Components in DESCOVY and TRUVADA are Inhibitors of the SARS-CoV-2 Polymerase</description>
  </link>
  <link>
    <url>https://www.croiconference.org/abstract/phase-3-discover-study-daily-ftaf-or-ftdf-hiv-preexposure-prophylaxis/</url>
    <description>THE PHASE 3 DISCOVER STUDY: DAILY F/TAF OR F/TDF FOR HIV PREEXPOSURE PROPHYLAXIS</description>
  </link>
  <link>
    <url>https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6808931/</url>
    <description>1962. Renal Outcomes for Participants Taking F/TAF vs. F/TDF for HIV PrEP in the DISCOVER Trial</description>
  </link>
  <reference>
    <citation>Elfiky AA. Anti-HCV, nucleotide inhibitors, repurposing against COVID-19. Life Sci. 2020 May 1;248:117477. doi: 10.1016/j.lfs.2020.117477. Epub 2020 Feb 28.</citation>
    <PMID>32119961</PMID>
  </reference>
  <reference>
    <citation>Castillo-Mancilla JR, Meditz A, Wilson C, Zheng JH, Palmer BE, Lee EJ, Gardner EM, Seifert S, Kerr B, Bushman LR, MaWhinney S, Anderson PL. Reduced immune activation during tenofovir-emtricitabine therapy in HIV-negative individuals. J Acquir Immune Defic Syndr. 2015 Apr 15;68(5):495-501. doi: 10.1097/QAI.0000000000000529.</citation>
    <PMID>25763783</PMID>
  </reference>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>May 26, 2020</study_first_submitted>
  <study_first_submitted_qc>May 26, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 28, 2020</study_first_posted>
  <last_update_submitted>July 27, 2020</last_update_submitted>
  <last_update_submitted_qc>July 27, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 28, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Hospital Italiano de Buenos Aires</investigator_affiliation>
    <investigator_full_name>Waldo Horacio Belloso</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>SARS Virus, SARS-CoV-2, COVID-19, Health Personnel</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>Tenofovir</mesh_term>
    <mesh_term>Emtricitabine</mesh_term>
    <mesh_term>Emtricitabine tenofovir alafenamide</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04405271
org study id: 5616
nct id: NCT04405271
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
is us export: No
A randomized parallel double-blinded placebo-controlled clinical trial to evaluate the effect
      of Emtricitabine/Tenofovir alafenamide (FTC/TAF) compared with placebo on the risk of
      developing SARS-CoV-2 disease (COVID-19) in healthcare workers with high transmission risk in
      addition to currently recommended control measures.
Randomized, double-blind, placebo-controlled clinical trial. Phase III clinical trial for a
      new indication

      Rationale One of the most affected subgroups during the current pandemic is represented by
      healthcare workers. In Argentina between 14 and 17% of the total COVID-19 cases are
      represented by this subgroup. In this sense, it appears as an adequate strategy testing the
      efficacy of pharmacological PrEP approaches on top of the currently recommended control
      measures.

      The use of placebo is warranted for two main reasons: all healthcare workers will be allowed
      and encouraged to comply with non-pharmacological infection control measures for the
      protection of viral transmission. On the other hand, the use of a blinded placebo is intended
      for avoiding relaxation of the non-pharmacological control measures.

      Tenofovir has been identified by both docking and in vitro studies as an inhibitor of RdRp
      (RNA dependent RNA polymerase) of coronavirus.

      FTC/TAF has the additional advantage that is already being used in a pre-exposure prophylaxis
      setting and its safety is widely known.

      Main objective To evaluate the risk of developing SARS-CoV-2 disease (COVID-19) in healthcare
      workers with high transmission risk in addition to currently recommended control measures.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Randomized (1:1), double-blind, placebo-controlled clinical trial
primary purpose: Prevention
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
masking description: The treatment will be the same in both arms: 1 tablet per day will be administered for a total of 12 weeks. Placebo and the active principle will be indistinguishable.
measure: COVID-19 incident cases
time frame: During treatment (12 weeks)
description: SARS-CoV-2 disease (COVID-19) with or without symptoms at week 12 of treatment as defined by the presence of specific antibodies against the virus. Positive cases will be confirmed by PCR
measure: Number of asymptomatic SARS-CoV-2 (Covid-19) infections confirmed by serology
time frame: During treatment (12 weeks)
description: Number of asymptomatic SARS-CoV-2 (Covid-19) infections confirmed by serology
measure: Severity of symptomatic COVID-19
time frame: During treatment (12 weeks)
description: Severity of symptomatic SARS-CoV-2 (Covid-19) infections as defined by the following categories:
Mild symptoms: malaise, fever, cough, arthralgia myalgias,
Moderate symptoms: same as above plus shortness of breath
Severe symptoms: clinical status requiring admission in Intensive care unit
measure: Respiratory symptom duration in days
time frame: During treatment (12 weeks)
description: Respiratory symptom duration in days
measure: Relation between treatments and symptoms duration
time frame: During treatment (12 weeks)
description: Relation between treatments and symptoms duration
measure: Time course of specific IgM/IgG seroconversion
time frame: During treatment (12 weeks)
description: Time course of specific IgM/IgG seroconversion
arm group label: FTC/TAF
arm group type: Experimental
description: Emtricitabine/Tenofovir alafenamide (FTC/TAF) in 200 mg/25 mg tablets. A dose of 1 tablet per day will be administered for a total of 12 weeks.
arm group label: Placebo
arm group type: Placebo Comparator
description: Identical tablets to the active experimental tablets with the same characteristics and packaging. A dose of 1 tablet per day will be administered for a total of 12 weeks
intervention type: Drug
intervention name: Emtricitabine/Tenofovir Alafenamide 200 MG-25 MG Oral Tablet
description: Emtricitabine/Tenofovir alafenamide (FTC/TAF) in 200 mg/25 mg tablets. A dose of 1 tablet per day will be administered for a total of 12 weeks
arm group label: FTC/TAF
other name: FTC/TAF
intervention type: Drug
intervention name: Placebo
description: A dose of 1 tablet per day will be administered for a total of 12 weeks.
arm group label: Placebo
other name: Placebo comparator
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Waldo H Belloso, MD
role: Study Chair
affiliation: Hospital Italiano de Buenos Aires
last name: Ventura Simonovich, MD
role: Principal Investigator
affiliation: HIBA
last name: Esteban Nannini, MD
role: Principal Investigator
affiliation: Sanatorio Britanico
last name: Wanda Cornistein, MD
role: Principal Investigator
affiliation: Hospital Austral
last name: Marcelo Figueiras, MD
role: Principal Investigator
affiliation: Richmond Laboratorio
last name: Elvira Zini, MD
role: Principal Investigator
affiliation: Richmond Laboratorio
last name: Fernando Riera, MD
role: Principal Investigator
affiliation: Sanatorio Allende (Córdoba)
last name: Omar Sued, MD
role: Principal Investigator
affiliation: HUESPED
last name: Santiago Ramirez Borga, MD
role: Principal Investigator
affiliation: Hospital Italiano de La Plata
last name: Gustavo Costilla Campero, MD
role: Principal Investigator
affiliation: Hospital Padilla (Tucumán)
last name: Gustavo D Lopardo, MD
role: Principal Investigator
affiliation: Hospital Bernardo Houssay
last name: Gonzalo Corral, MD
role: Principal Investigator
affiliation: Hospital Alende (Mar del Plata)
last name: Waldo H Belloso, MD
phone: +541149590200
email: waldo.belloso@hiba.org.ar
last name: Gustavo D Lopardo, MD
phone: +541149590200
email: glopardo@intramed.net
facility: 
contact: 
contact backup: 
country: Argentina
url: https://www.argentina.gob.ar/salud/coronavirus-COVID-19/sala-situacion
description: Sala de Situación Coronavirus online - Ministerio de Salud de la Nación
url: https://doi.org/10.1016/j.jhin.2020.03.002
description: Reasons for healthcare workers becoming infected with novel coronavirus disease 2019 (COVID-19) in China
url: https://doi.org/10.1101/2020.03.18.997585
description: Nucleotide Analogues as Inhibitors of SARS-CoV-2 Polymerase
url: https://www.biorxiv.org/content/biorxiv/early/2020/01/31/2020.01.30.927574.full.pdf
description: Nucleotide Analogues as Inhibitors of Viral Polymerases
url: https://doi.org/10.1101/2020.04.03.022939
description: Triphosphates of the Two Components in DESCOVY and TRUVADA are Inhibitors of the SARS-CoV-2 Polymerase
url: https://www.croiconference.org/abstract/phase-3-discover-study-daily-ftaf-or-ftdf-hiv-preexposure-prophylaxis/
description: THE PHASE 3 DISCOVER STUDY: DAILY F/TAF OR F/TDF FOR HIV PREEXPOSURE PROPHYLAXIS
url: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6808931/
description: 1962. Renal Outcomes for Participants Taking F/TAF vs. F/TDF for HIV PrEP in the DISCOVER Trial
citation: Elfiky AA. Anti-HCV, nucleotide inhibitors, repurposing against COVID-19. Life Sci. 2020 May 1;248:117477. doi: 10.1016/j.lfs.2020.117477. Epub 2020 Feb 28.
PMID: 32119961
citation: Castillo-Mancilla JR, Meditz A, Wilson C, Zheng JH, Palmer BE, Lee EJ, Gardner EM, Seifert S, Kerr B, Bushman LR, MaWhinney S, Anderson PL. Reduced immune activation during tenofovir-emtricitabine therapy in HIV-negative individuals. J Acquir Immune Defic Syndr. 2015 Apr 15;68(5):495-501. doi: 10.1097/QAI.0000000000000529.
PMID: 25763783
responsible party type: Principal Investigator
investigator affiliation: Hospital Italiano de Buenos Aires
investigator full name: Waldo Horacio Belloso
investigator title: Principal Investigator
mesh term: COVID-19
mesh term: Tenofovir
mesh term: Emtricitabine
mesh term: Emtricitabine tenofovir alafenamide
sharing ipd: No