<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/NCT04469114</url>
  </required_header>
  <id_info>
    <org_study_id>34810620.0.1001.0071</org_study_id>
    <nct_id>NCT04469114</nct_id>
  </id_info>
  <brief_title>Tofacitinib in Hospitalized Patients With COVID-19 Pneumonia</brief_title>
  <official_title>A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-design Trial of Tofacitinib in Hospitalized Participants With COVID-19 Pneumonia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hospital Israelita Albert Einstein</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Pfizer</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Hospital Israelita Albert Einstein</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Tofacitinib suppresses pro-inflammatory signaling that may be important pathogenetically to&#xD;
      progression to more severe lung disease and acute respiratory distress syndrome (ARDS) in&#xD;
      patients with COVID-19. The purpose of the study is to assess the safety and efficacy of&#xD;
      tofacitinib plus standard pharmacologic and supportive measures in treating hospitalized&#xD;
      participants with COVID-19 pneumonia.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      COVID-19 is a viral disease caused by a novel coronavirus, severe acute respiratory syndrome&#xD;
      coronavirus 2 (SARS-CoV-2), that can cause severe pneumonia and ARDS. Respiratory viral load&#xD;
      may peak within 5 days after onset, while symptoms are still mild. Many patients rapidly&#xD;
      (within 1 to 2 weeks of infection) develop dyspnea and pneumonia and require hospitalization&#xD;
      for respiratory support.&#xD;
&#xD;
      Preliminary clinical data from COVID-19 patients indicate that severe symptoms with&#xD;
      SARS-CoV-2 infection are associated with an exaggerated immune response driven by interleukin&#xD;
      (IL)-6 IL-10, tumor necrosis factor (TNF)α, and other cytokines. The ultimate result is&#xD;
      progressive destruction of the alveolar epithelium leading to pneumonia and/or ARDS.&#xD;
      Moreover, the exudative phase of ARDS is thought to be due to an influx of myeloid cells&#xD;
      (neutrophils and macrophages) and elevations of inflammatory cytokines, with higher levels of&#xD;
      both IL-6 and IL-8 levels being correlated with increased mortality. Therefore,&#xD;
      immunomodulatory therapy may be beneficial in reducing the deleterious effects of lung&#xD;
      inflammation and mitigating progressive lung injury.&#xD;
&#xD;
      Tofacitinib is an inhibitor of Janus kinase (JAKs) 1 and 3, with partial selectivity to JAK&#xD;
      2. Tofacitinib suppresses pro-inflammatory signaling that may be important pathogenetically&#xD;
      to progression to more severe lung disease and ARDS in patients with COVID-19.&#xD;
&#xD;
      The purpose of the study is to assess the safety and efficacy of tofacitinib plus standard&#xD;
      pharmacologic and supportive measures in treating hospitalized participants with COVID-19&#xD;
      pneumonia.&#xD;
&#xD;
      Participants with laboratory confirmed SARS-CoV-2 infection as determined by a positive PCR,&#xD;
      who have agreed to participate, will be screened within 72h hours after admission to the&#xD;
      hospital to determine eligibility.&#xD;
&#xD;
      Eligible participants will be randomized on Day 1 to the tofacitinib plus standard of care&#xD;
      treatment group or the placebo plus standard of care treatment group in a 1:1 ratio,&#xD;
      stratified by site. Participants will receive treatment for up to 14 days or until discharge&#xD;
      from the hospital, whichever is earlier.&#xD;
&#xD;
      Participants will be assessed daily (up to Day 28) while hospitalized for clinical, safety,&#xD;
      and laboratory parameters. Follow-up visits will occur on Day 14 and on Day 28.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 16, 2020</start_date>
  <completion_date type="Actual">January 9, 2021</completion_date>
  <primary_completion_date type="Actual">January 9, 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>
  </study_design_info>
  <primary_outcome>
    <measure>Death or respiratory failure until Day 28</measure>
    <time_frame>28 days</time_frame>
    <description>1, 2 or 3 on the 8-point National Institute of Allergy and Infectious Diseases (NIAID) ordinal scale of disease severity. The minimum value is 1 (worst outcome) and the maximum value is 8 (best outcome).&#xD;
Death.&#xD;
Hospitalized, on invasive mechanical ventilation or ECMO.&#xD;
Hospitalized, on non-invasive ventilation or high-flow oxygen devices.&#xD;
Hospitalized, requiring supplemental oxygen.&#xD;
Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise).&#xD;
Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care.&#xD;
Not hospitalized, limitation on activities and/or requiring home oxygen.&#xD;
Not hospitalized, with no limitations on activities.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>National Institute of Allergy and Infectious Diseases (NIAID) ordinal scale of disease severity at Day 14</measure>
    <time_frame>14 days</time_frame>
    <description>NIAID ordinal scale of disease severity</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Status of alive and not on mechanical ventilation or ECMO at Day 14 and 28 NIAID ordinal scale of disease severity at Day 14</measure>
    <time_frame>14 and 28 days</time_frame>
    <description>Categories 3 to 8 in the National Institute of Allergy and Infectious Diseases (NIAID) ordinal scale of disease severity at Day 14 and Day 28</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Status of requiring supplemental oxygen at Day 28</measure>
    <time_frame>28 days</time_frame>
    <description>Categories 1 to 4 in the National Institute of Allergy and Infectious Diseases (NIAID) ordinal scale of disease severity</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Status of being alive and not hospitalized at Day 14 and 28</measure>
    <time_frame>14 and 28 days</time_frame>
    <description>Categories 7 and 8 in the National Institute of Allergy and Infectious Diseases (NIAID) ordinal scale of disease severity</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>National Institute of Allergy and Infectious Diseases (NIAID) ordinal scale of disease severity at Day 14 NIAID ordinal scale of disease severity at Day 28</measure>
    <time_frame>28 days</time_frame>
    <description>NIAID ordinal scale of disease severity</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients with cure</measure>
    <time_frame>28 days</time_frame>
    <description>Number of patients with resolution of fever, cough, and need for ventilatory or oxygen support.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients at the ICU or on ventilatory support at Day 28</measure>
    <time_frame>28 days</time_frame>
    <description>Number of patients at the ICU or on ventilatory support</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of days free from mechanical ventilation at 28 days</measure>
    <time_frame>28 days</time_frame>
    <description>Number of days free from mechanical ventilation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of days in hospital</measure>
    <time_frame>28 days</time_frame>
    <description>Number of days in hospital</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of days in ICU</measure>
    <time_frame>28 days</time_frame>
    <description>Number of days in ICU</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Death or respiratory failure at Day 28</measure>
    <time_frame>28 days</time_frame>
    <description>Categories 1 to 3 in the National Institute of Allergy and Infectious Diseases (NIAID)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">289</enrollment>
  <condition>Covid19</condition>
  <arm_group>
    <arm_group_label>Tofacitinib</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Tofacitinib 10mg twice daily for 14 days or until hospital discharge</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo twice daily for 14 days or until hospital discharge</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Tofacitinib 10 mg</intervention_name>
    <description>Tofacitinib 10mg administered orally twice daily for 14 days or until hospital discharge</description>
    <arm_group_label>Tofacitinib</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Tofacitinib-matching placebo administered orally twice daily for 14 days or until hospital discharge</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Male or female participants older than 18 years&#xD;
&#xD;
          2. Laboratory-confirmed novel coronavirus (SARS-CoV-2) infection as determined by&#xD;
             polymerase chain reaction (PCR) prior to Day 1.&#xD;
&#xD;
          3. Evidence of pneumonia assessed by radiographic imaging (chest x-ray or chest CT scan).&#xD;
&#xD;
          4. Hospitalized for less than 72 hours and receiving supportive care for COVID-19&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Require non-invasive ventilation, invasive mechanical ventilation, or extracorporeal&#xD;
             membrane oxygenation (ECMO) on Day 1 at the time of randomization&#xD;
&#xD;
          2. History of or known current thrombosis. Only if current thrombosis is suspected by the&#xD;
             investigator, imaging testing is recommended (per local guidance) to exclude&#xD;
             thrombosis.&#xD;
&#xD;
          3. Have a personal or first-degree family history of blood clotting disorders.&#xD;
&#xD;
          4. Participants who are immunocompromised, with known immunodeficiencies, or taking&#xD;
             potent immunosuppressive agents (eg, azathioprine, cyclosporine).&#xD;
&#xD;
          5. Participants with any current malignancy or lymphoproliferative disorders that&#xD;
             requires active treatment&#xD;
&#xD;
          6. Severe hepatic impairment, defined as Child-Pugh class C.&#xD;
&#xD;
          7. Severe anemia (hemoglobin &lt;8 g/dL).&#xD;
&#xD;
          8. Absolute lymphocyte count &lt;500 cells/mm;&#xD;
&#xD;
          9. Absolute neutrophil count &lt;1000 cells/mm.&#xD;
&#xD;
         10. Known allergy to tofacitinib.&#xD;
&#xD;
         11. Other medical or psychiatric condition including recent (within the past year) or&#xD;
             active suicidal ideation/behavior or laboratory abnormality that may increase the risk&#xD;
             associated with study participation or, in the investigator's judgment, make the&#xD;
             participant inappropriate for the study.&#xD;
&#xD;
         12. Suspected or known active systemic bacterial, fungal, or viral infections (with the&#xD;
             exception of COVID-19) including but not limited to: active herpes zoster infection;&#xD;
             known active tuberculosis or history of inadequately treated tuberculosis; known B&#xD;
             hepatitis, C hepatitis, or HIV.&#xD;
&#xD;
         13. Have received any of these within 4 weeks prior to the first dose of study&#xD;
             intervention: any JAK inhibitors, potent immunosuppressants, or any biologic agents&#xD;
             including IL-6 inhibitors (eg, tocilizumab) or IL-1 inhibitors (eg, anakinra) within&#xD;
             the past 30 days; any potent cytochrome P450 inducer, such as rifampin, within the&#xD;
             past 28 days or 5 half-lives, whichever is longer.&#xD;
&#xD;
         14. Have received estrogen-containing contraception or treatment with herbal supplements&#xD;
             within 48 hours prior to the first dose of study intervention.&#xD;
&#xD;
         15. Have received treatment with corticosteroids equivalent to prednisone or&#xD;
             methylprednisolone &gt;20 mg/day for equal or more than 14 consecutive days prior to&#xD;
             screening.&#xD;
&#xD;
         16. Current participation in other trials.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Centro de Pesquisa Clínica do Coração</name>
      <address>
        <city>Aracaju</city>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitário São Francisco de Assis Na Providência de Deu</name>
      <address>
        <city>Bragança Paulista</city>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Irmandade do Sr. Bom Jesus dos Passos da Santa Casa de Misericórdia de Bragança Paulista</name>
      <address>
        <city>Bragança Paulista</city>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital do Coração do Brasil</name>
      <address>
        <city>Brasilia</city>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Instituto de Pesquisa Clínica de Campinas</name>
      <address>
        <city>Campinas</city>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Regional do Litoral Norte</name>
      <address>
        <city>Caraguatatuba</city>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Unimed Fortaleza Sociedade Corporativa Médica LTD</name>
      <address>
        <city>Fortaleza</city>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Regional Jorge Rossmann</name>
      <address>
        <city>Itanhaem</city>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Bruno Born</name>
      <address>
        <city>Lajeado</city>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital São Vicente de Paulo</name>
      <address>
        <city>Passo Fundo</city>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Israelita Albert Einstein</name>
      <address>
        <city>Sao Paulo</city>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fundação Faculdade Regional de Medicina de São José do Rio Preto</name>
      <address>
        <city>São José Do Rio Preto</city>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Regional de Registro</name>
      <address>
        <city>São José Dos Campos</city>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Regional de São José dos Campos</name>
      <address>
        <city>São José Dos Campos</city>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Beneficência Portuguesa</name>
      <address>
        <city>São Paulo</city>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>BP Mirante</name>
      <address>
        <city>São Paulo</city>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Instituto do Coração</name>
      <address>
        <city>São Paulo</city>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 10, 2020</study_first_submitted>
  <study_first_submitted_qc>July 10, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 13, 2020</study_first_posted>
  <last_update_submitted>August 2, 2021</last_update_submitted>
  <last_update_submitted_qc>August 2, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">August 9, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>COVID-19</mesh_term>
    <mesh_term>Pneumonia</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Tofacitinib</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04469114
org study id: 34810620.0.1001.0071
nct id: NCT04469114
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
is us export: Yes
Tofacitinib suppresses pro-inflammatory signaling that may be important pathogenetically to
      progression to more severe lung disease and acute respiratory distress syndrome (ARDS) in
      patients with COVID-19. The purpose of the study is to assess the safety and efficacy of
      tofacitinib plus standard pharmacologic and supportive measures in treating hospitalized
      participants with COVID-19 pneumonia.
COVID-19 is a viral disease caused by a novel coronavirus, severe acute respiratory syndrome
      coronavirus 2 (SARS-CoV-2), that can cause severe pneumonia and ARDS. Respiratory viral load
      may peak within 5 days after onset, while symptoms are still mild. Many patients rapidly
      (within 1 to 2 weeks of infection) develop dyspnea and pneumonia and require hospitalization
      for respiratory support.

      Preliminary clinical data from COVID-19 patients indicate that severe symptoms with
      SARS-CoV-2 infection are associated with an exaggerated immune response driven by interleukin
      (IL)-6 IL-10, tumor necrosis factor (TNF)α, and other cytokines. The ultimate result is
      progressive destruction of the alveolar epithelium leading to pneumonia and/or ARDS.
      Moreover, the exudative phase of ARDS is thought to be due to an influx of myeloid cells
      (neutrophils and macrophages) and elevations of inflammatory cytokines, with higher levels of
      both IL-6 and IL-8 levels being correlated with increased mortality. Therefore,
      immunomodulatory therapy may be beneficial in reducing the deleterious effects of lung
      inflammation and mitigating progressive lung injury.

      Tofacitinib is an inhibitor of Janus kinase (JAKs) 1 and 3, with partial selectivity to JAK
      2. Tofacitinib suppresses pro-inflammatory signaling that may be important pathogenetically
      to progression to more severe lung disease and ARDS in patients with COVID-19.

      The purpose of the study is to assess the safety and efficacy of tofacitinib plus standard
      pharmacologic and supportive measures in treating hospitalized participants with COVID-19
      pneumonia.

      Participants with laboratory confirmed SARS-CoV-2 infection as determined by a positive PCR,
      who have agreed to participate, will be screened within 72h hours after admission to the
      hospital to determine eligibility.

      Eligible participants will be randomized on Day 1 to the tofacitinib plus standard of care
      treatment group or the placebo plus standard of care treatment group in a 1:1 ratio,
      stratified by site. Participants will receive treatment for up to 14 days or until discharge
      from the hospital, whichever is earlier.

      Participants will be assessed daily (up to Day 28) while hospitalized for clinical, safety,
      and laboratory parameters. Follow-up visits will occur on Day 14 and on Day 28.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Death or respiratory failure until Day 28
time frame: 28 days
description: 1, 2 or 3 on the 8-point National Institute of Allergy and Infectious Diseases (NIAID) ordinal scale of disease severity. The minimum value is 1 (worst outcome) and the maximum value is 8 (best outcome).
Death.
Hospitalized, on invasive mechanical ventilation or ECMO.
Hospitalized, on non-invasive ventilation or high-flow oxygen devices.
Hospitalized, requiring supplemental oxygen.
Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise).
Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care.
Not hospitalized, limitation on activities and/or requiring home oxygen.
Not hospitalized, with no limitations on activities.
measure: National Institute of Allergy and Infectious Diseases (NIAID) ordinal scale of disease severity at Day 14
time frame: 14 days
description: NIAID ordinal scale of disease severity
measure: Status of alive and not on mechanical ventilation or ECMO at Day 14 and 28 NIAID ordinal scale of disease severity at Day 14
time frame: 14 and 28 days
description: Categories 3 to 8 in the National Institute of Allergy and Infectious Diseases (NIAID) ordinal scale of disease severity at Day 14 and Day 28
measure: Status of requiring supplemental oxygen at Day 28
time frame: 28 days
description: Categories 1 to 4 in the National Institute of Allergy and Infectious Diseases (NIAID) ordinal scale of disease severity
measure: Status of being alive and not hospitalized at Day 14 and 28
time frame: 14 and 28 days
description: Categories 7 and 8 in the National Institute of Allergy and Infectious Diseases (NIAID) ordinal scale of disease severity
measure: National Institute of Allergy and Infectious Diseases (NIAID) ordinal scale of disease severity at Day 14 NIAID ordinal scale of disease severity at Day 28
time frame: 28 days
description: NIAID ordinal scale of disease severity
measure: Number of patients with cure
time frame: 28 days
description: Number of patients with resolution of fever, cough, and need for ventilatory or oxygen support.
measure: Number of patients at the ICU or on ventilatory support at Day 28
time frame: 28 days
description: Number of patients at the ICU or on ventilatory support
measure: Number of days free from mechanical ventilation at 28 days
time frame: 28 days
description: Number of days free from mechanical ventilation
measure: Number of days in hospital
time frame: 28 days
description: Number of days in hospital
measure: Number of days in ICU
time frame: 28 days
description: Number of days in ICU
measure: Death or respiratory failure at Day 28
time frame: 28 days
description: Categories 1 to 3 in the National Institute of Allergy and Infectious Diseases (NIAID)
arm group label: Tofacitinib
arm group type: Experimental
description: Tofacitinib 10mg twice daily for 14 days or until hospital discharge
arm group label: Placebo
arm group type: Placebo Comparator
description: Placebo twice daily for 14 days or until hospital discharge
intervention type: Drug
intervention name: Tofacitinib 10 mg
description: Tofacitinib 10mg administered orally twice daily for 14 days or until hospital discharge
arm group label: Tofacitinib
intervention type: Drug
intervention name: Placebo
description: Tofacitinib-matching placebo administered orally twice daily for 14 days or until hospital discharge
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 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: 
country: Brazil
responsible party type: Sponsor
mesh term: COVID-19
mesh term: Pneumonia
mesh term: Tofacitinib
sharing ipd: Undecided