<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/NCT04475991</url>
  </required_header>
  <id_info>
    <org_study_id>DI/20/407/04/38</org_study_id>
    <nct_id>NCT04475991</nct_id>
  </id_info>
  <brief_title>Safety and Efficacy of Maraviroc and/or Favipiravir With Standard Therapy in Severe COVID-19 Adults</brief_title>
  <acronym>COMVIVIR</acronym>
  <official_title>Phase2, Randomized, Controlled Study to Evaluate the Efficacy and Safety of Maraviroc and/or Favipiravir Plus Standard Therapy in Adult Patients With Severe Non-critical COVID-19&quot;</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hospital General de México Dr. Eduardo Liceaga</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>CCINSHAE. Secretaría de Salud. México</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Centro de Investigación en. Enfermedades Infecciosas, Mexico</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Hospital General de México Dr. Eduardo Liceaga</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>
      Phase 2, randomized, open-label study to evaluate the safety and efficacy of maraviroc,&#xD;
      favipiravir, and both drugs administered along with currently used therapy in hospitalized&#xD;
      patients with pulmonary SARS-CoV-2 (Severe Acute Respiratory Syndrome Coronavirus 2)&#xD;
      infection (COVID-19)&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The COVID-19 pandemic (Coronavirus Disease-19) caused by SARS-CoV-2 (Severe Acute Respiratory&#xD;
      Syndrome Coronavirus 2) has caused more that 10 million infections worldwide, with a general&#xD;
      mortality of 6%. Multiple studies have found that the hyperinflammatory immune response&#xD;
      induced by SARS-CoV-2 is one of the main causes of severity and death in infected patients.&#xD;
      In severe COVID-19 patients, an association was found between pneumonitis and/or ARDS (Acute&#xD;
      Severe Respiratory Syndrome), increased serum levels of cytokines and chemokines, extensive&#xD;
      lung damage and microthrombosis. Studies of both gene expression in lungs and blood cytokines&#xD;
      and chemokines have related chemokine signaling clusters with COVID-19 severity, being CCL3,&#xD;
      CCL4 and CCL7 (CC chemokine ligands 3, 4 and 7) particularly interesting. All these are CCR5&#xD;
      (CC chemokine receptor 5) ligands. A strategy to modulate activation and trafficking of&#xD;
      leukocytes to the lungs is by blocking CCR5 by using maraviroc (MVC), which has shown capable&#xD;
      of modulating conditions of generalized inflammation. Along with a good regulation of the&#xD;
      immune response, an antiviral that helps to reduce the viral load must be considered.&#xD;
      Favipiravir (FPV) has shown to be capable to reduce the time of viral clearance by half.&#xD;
      Hence, we propose that the conjoint use of MVC and FPV could help to reduce the progression&#xD;
      of severe hospitalized COVID-19 patients to critical by decreasing the percentage of patients&#xD;
      in need of mechanical respiratory support or death by at least 30%. This is a randomized,&#xD;
      controlled clinical trial that besides evaluating the safety and efficacy of MVC+FPV to avoid&#xD;
      progression in severe COVID-19 patients as a primary endpoint, is also aimed at other&#xD;
      secondary endpoints: A) Evaluate the activation of CCR5 in peripheral blood lymphocytes,&#xD;
      monocytes, and neutrophils. B) Find possible modifications in the ongoing chemokine and&#xD;
      cytokine storm in serum, particularly IL-6, IL-1b, (interleukins 6 and 1 beta) TNF (tumor&#xD;
      necrosis factor), IFNa, IFNg (interferons alpha and gamma), VEGF (vascular endothelial growth&#xD;
      factor), CXCL10 (CXC chemokine ligand 10), CCL7, CCL3, and CCL5 (CC chemokine ligands 7, 3&#xD;
      and 5), C) Search for alterations in the patterns of activation, trafficking, and exhaustion&#xD;
      of peripheral blood lymphocytes, monocytes and neutrophils, and D) Determine if it has an&#xD;
      effect in viral loads in saliva. 100 severe patients tested positive for SARS-CoV-2 will be&#xD;
      randomized in 4 treatment arms:&#xD;
&#xD;
      Arm A: Currently used therapy (CT) only, Enoxaparin, dexamethasone, and antibiotics if&#xD;
      associated bacteremia is present, as per currently used at Hospital General de México &quot;Dr.&#xD;
      Eduardo Liceaga&quot;).&#xD;
&#xD;
      Arm B: CT+MVC Arm C: CT+FPV Arm D: CT+MVC+FPV&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    No more patients complying the selection criteria were available for recruitment&#xD;
  </why_stopped>
  <start_date type="Actual">July 13, 2021</start_date>
  <completion_date type="Actual">March 25, 2022</completion_date>
  <primary_completion_date type="Actual">March 15, 2022</primary_completion_date>
  <phase>Phase 2</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>100 participants will be included and allocated in 4 groups of 25 each [Currently used therapy (CT), Maraviroc+CT, Favipiravir+CT and Maraviroc+Favipiravir+CT]. Subjects will be randomized using EPIDAT 4.2</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Patients free of mechanical ventilation or death</measure>
    <time_frame>28 days post start</time_frame>
    <description>Percentage of patients free of mechanical ventilation or death</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Patients free of mechanical ventilation or death</measure>
    <time_frame>5 days post start</time_frame>
    <description>Percentage of patients free of mechanical ventilation or death</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time of clinical improvement</measure>
    <time_frame>15 days post start</time_frame>
    <description>Time of improvement in at least 2 items of the 8-item World Health Organization (WHO) ordinal scale for COVID-19 in days.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of change in phosphorylated CCR5</measure>
    <time_frame>Day 10-1</time_frame>
    <description>Rate of change (Delta) in lymphocytes, monocytes and neutrophils with phosphorylated CCR5 as per measured by parameters of flow cytometry.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of change in peripheral blood levels of proinflammatory cytokines and chemokines</measure>
    <time_frame>Day 10-1</time_frame>
    <description>Rate of change (Delta) in peripheral blood levels of proinflammatory cytokines and chemokines [IL-6, IL-1b, TNF, IFNa, IFNg, VEGF, GM-CSF (granulocyte-macrophage colony stimulating factor), CCL2, CCL3, CCL4, CCL5, CXCL10 and CCL7], as per measured by parameters of flow cytometry</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in the trafficking and activation pattern of peripheral leukocytes</measure>
    <time_frame>Day 10-1</time_frame>
    <description>Statistically significant change in the expression of activation [phosphorylated CCR5,CD38, CD126, CD127, CD25, CD86, CD83, CD40 (clusters of differentiation 38, 126, 127, 25, 86 and 40), HLA-DR (Human Leukocyte Antigen-DR isotype), Granzyme B, Perforin, CD107A, CD123, gp130, CD95], trafficking [CCR5, CCR2, CCR6, CCR7, CXCR1, CXCR3 , CXCR5, (CXC chemokine receptors 1, 3 and 5), CX3CR1 (CX3C chemokine receptor] and exhaustion (PD1, programmed death-1 receptor) markers in peripheral blood lymphocytes, neutrophils and monocytes, as per measured by parameters of flow cytometry.</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">19</enrollment>
  <condition>COVID-19</condition>
  <arm_group>
    <arm_group_label>Currently used therapy (CT) only</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Treatment currently used at Hospital General de México &quot;Dr. Eduardo Liceaga&quot; for non-critical COVID patients: Enoxaparin, dexamethasone, and antibiotics if associated bacteremia is present.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Maraviroc+CT</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Maraviroc AND treatment currently used at Hospital General de México &quot;Dr. Eduardo Liceaga&quot; for non-critical COVID patients.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Favipiravir+CT</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Favipiravir AND treatment currently used at Hospital General de México &quot;Dr. Eduardo Liceaga&quot; for non-critical COVID patients.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Maraviroc+Favipiravir+CT</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Maraviroc AND Favipiravir AND treatment currently used at Hospital General de México &quot;Dr. Eduardo Liceaga&quot; for non-critical COVID patients</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Maraviroc + Currently used therapy</intervention_name>
    <description>Maraviroc tablets. 300 mg bid, given orally for a 10 day period AND CT (Enoxaparin, dexamethasone, and antibiotics if associated bacteremia is present, as per currently used at Hospital General de México &quot;Dr. Eduardo Liceaga&quot;)</description>
    <arm_group_label>Maraviroc+CT</arm_group_label>
    <other_name>MVC+CT</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Curently used therapy for COVID-19 non-critical patients</intervention_name>
    <description>Enoxaparin, dexamethasone, and antibiotics if associated bacteremia is present, as per currently used at Hospital General de México &quot;Dr. Eduardo Liceaga&quot;</description>
    <arm_group_label>Currently used therapy (CT) only</arm_group_label>
    <other_name>CT only</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Favipiravir + Currently used therapy</intervention_name>
    <description>Favipiravir tablets 200 mg. given orally for a 7 day period. 1600 mg bid on day 1 and 600 mg tid days 2-7 AND CT (Enoxaparin, dexamethasone, and antibiotics if associated bacteremia is present, as per currently used at Hospital General de México &quot;Dr. Eduardo Liceaga&quot;).</description>
    <arm_group_label>Favipiravir+CT</arm_group_label>
    <other_name>FPV+CT</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Maraviroc+Favipiravir+CT</intervention_name>
    <description>Maraviroc tablets. 300 mg bid, given orally for a 10 day period AND Favipiravir tablets 200 mg. given orally for the first 7 days. 1600 mg bid on day 1 and 600 mg tid days 2-7 AND CT (Enoxaparin, dexamethasone, and antibiotics if associated bacteremia is present, as per currently used at Hospital General de México &quot;Dr. Eduardo Liceaga&quot;&quot;)</description>
    <arm_group_label>Maraviroc+Favipiravir+CT</arm_group_label>
    <other_name>MVC+FPV+CT</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  With severe non-critical stage of COVID at the time of admission.&#xD;
&#xD;
          -  Patients tested positive for SARS-CoV-2 confirmed by PCR (Polymerase Chain Reaction)&#xD;
             or quick antigen test&#xD;
&#xD;
          -  Within the first 12 days post appearance of symptoms&#xD;
&#xD;
          -  With at least one of the following risk factors: Diabetes mellitus (DM), obesity&#xD;
             (BMI&gt;30, hypertension, age &gt; 65 years.&#xD;
&#xD;
          -  Respiratory rate 25-34/min and no signs of respiratory distress.&#xD;
&#xD;
          -  With at least two of the following indicators of severity: SpO2 81-90%, PaFi 150-300&#xD;
             mmHg, FiO2&gt;60% , lung damage in thorax radiographic image =&gt; 25% as determined by RALE&#xD;
             score (an equivalent to 2-4).&#xD;
&#xD;
          -  Normal liver function (Considered up to a fivefold increase above the normal limits of&#xD;
             hepatic transaminases)&#xD;
&#xD;
          -  Signed informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnant or lactating women&#xD;
&#xD;
          -  Patients already participating in another clinical study&#xD;
&#xD;
          -  Oxygen saturation &lt; 70% (ambient)&#xD;
&#xD;
          -  Clinical evidence of an infectious disease different from COVID at the time of&#xD;
             admission&#xD;
&#xD;
          -  Chronic kidney failure&#xD;
&#xD;
          -  Coronary disease&#xD;
&#xD;
          -  Glomerular filtration rate &lt; 30ml/min/1.73 m2 and known history of preexisting chronic&#xD;
             renal failure (Chronic kidney disease stages 4-5)&#xD;
&#xD;
          -  Known history of HCV, HBV and/or clinical signs of hepatic liver failure.&#xD;
&#xD;
          -  Any type of cancer&#xD;
&#xD;
          -  HIV and/or any anti retroviral treatment&#xD;
&#xD;
          -  Inability to freely decide to participate&#xD;
&#xD;
          -  Psychotropics treatment&#xD;
&#xD;
          -  Erythromycin treatment&#xD;
&#xD;
          -  Polydrug use (Defined as more than two addictions combined)&#xD;
&#xD;
          -  With transplant background&#xD;
&#xD;
          -  With any autoimmune disorder&#xD;
&#xD;
          -  With known hypersensibility to maraviroc and/or favipiravir&#xD;
&#xD;
          -  On invasive mechanical ventilation at the time of randomization&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>María Luisa Hernández-Medel, MD</last_name>
    <role>Study Chair</role>
    <affiliation>Hospital General de México Dr. Eduardo Liceaga</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hospital General de México &quot;Dr. Eduardo Liceaga&quot;</name>
      <address>
        <city>Mexico City</city>
        <state>Cdmx</state>
        <zip>06720</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Mexico</country>
  </location_countries>
  <verification_date>May 2022</verification_date>
  <study_first_submitted>July 15, 2020</study_first_submitted>
  <study_first_submitted_qc>July 15, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 17, 2020</study_first_posted>
  <last_update_submitted>May 31, 2022</last_update_submitted>
  <last_update_submitted_qc>May 31, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">June 3, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Hospital General de México Dr. Eduardo Liceaga</investigator_affiliation>
    <investigator_full_name>María Luisa Hernández-Medel</investigator_full_name>
    <investigator_title>Researcher</investigator_title>
  </responsible_party>
  <keyword>COVID-19</keyword>
  <keyword>CCR5</keyword>
  <keyword>Cytokine storm</keyword>
  <keyword>Maraviroc</keyword>
  <keyword>Favipiravir</keyword>
  <keyword>RdRP inhibitors</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>Maraviroc</mesh_term>
    <mesh_term>Favipiravir</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Inter-institutional exchange of data</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_time_frame>Information will be shared upon completion of the study for collaborative purposes</ipd_time_frame>
    <ipd_access_criteria>Upon request</ipd_access_criteria>
  </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/NCT04475991
org study id: DI/20/407/04/38
nct id: NCT04475991
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
is us export: No
Phase 2, randomized, open-label study to evaluate the safety and efficacy of maraviroc,
      favipiravir, and both drugs administered along with currently used therapy in hospitalized
      patients with pulmonary SARS-CoV-2 (Severe Acute Respiratory Syndrome Coronavirus 2)
      infection (COVID-19)
The COVID-19 pandemic (Coronavirus Disease-19) caused by SARS-CoV-2 (Severe Acute Respiratory
      Syndrome Coronavirus 2) has caused more that 10 million infections worldwide, with a general
      mortality of 6%. Multiple studies have found that the hyperinflammatory immune response
      induced by SARS-CoV-2 is one of the main causes of severity and death in infected patients.
      In severe COVID-19 patients, an association was found between pneumonitis and/or ARDS (Acute
      Severe Respiratory Syndrome), increased serum levels of cytokines and chemokines, extensive
      lung damage and microthrombosis. Studies of both gene expression in lungs and blood cytokines
      and chemokines have related chemokine signaling clusters with COVID-19 severity, being CCL3,
      CCL4 and CCL7 (CC chemokine ligands 3, 4 and 7) particularly interesting. All these are CCR5
      (CC chemokine receptor 5) ligands. A strategy to modulate activation and trafficking of
      leukocytes to the lungs is by blocking CCR5 by using maraviroc (MVC), which has shown capable
      of modulating conditions of generalized inflammation. Along with a good regulation of the
      immune response, an antiviral that helps to reduce the viral load must be considered.
      Favipiravir (FPV) has shown to be capable to reduce the time of viral clearance by half.
      Hence, we propose that the conjoint use of MVC and FPV could help to reduce the progression
      of severe hospitalized COVID-19 patients to critical by decreasing the percentage of patients
      in need of mechanical respiratory support or death by at least 30%. This is a randomized,
      controlled clinical trial that besides evaluating the safety and efficacy of MVC+FPV to avoid
      progression in severe COVID-19 patients as a primary endpoint, is also aimed at other
      secondary endpoints: A) Evaluate the activation of CCR5 in peripheral blood lymphocytes,
      monocytes, and neutrophils. B) Find possible modifications in the ongoing chemokine and
      cytokine storm in serum, particularly IL-6, IL-1b, (interleukins 6 and 1 beta) TNF (tumor
      necrosis factor), IFNa, IFNg (interferons alpha and gamma), VEGF (vascular endothelial growth
      factor), CXCL10 (CXC chemokine ligand 10), CCL7, CCL3, and CCL5 (CC chemokine ligands 7, 3
      and 5), C) Search for alterations in the patterns of activation, trafficking, and exhaustion
      of peripheral blood lymphocytes, monocytes and neutrophils, and D) Determine if it has an
      effect in viral loads in saliva. 100 severe patients tested positive for SARS-CoV-2 will be
      randomized in 4 treatment arms:

      Arm A: Currently used therapy (CT) only, Enoxaparin, dexamethasone, and antibiotics if
      associated bacteremia is present, as per currently used at Hospital General de México "Dr.
      Eduardo Liceaga").

      Arm B: CT+MVC Arm C: CT+FPV Arm D: CT+MVC+FPV
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: 100 participants will be included and allocated in 4 groups of 25 each [Currently used therapy (CT), Maraviroc+CT, Favipiravir+CT and Maraviroc+Favipiravir+CT]. Subjects will be randomized using EPIDAT 4.2
primary purpose: Treatment
masking: None (Open Label)
measure: Patients free of mechanical ventilation or death
time frame: 28 days post start
description: Percentage of patients free of mechanical ventilation or death
measure: Patients free of mechanical ventilation or death
time frame: 5 days post start
description: Percentage of patients free of mechanical ventilation or death
measure: Time of clinical improvement
time frame: 15 days post start
description: Time of improvement in at least 2 items of the 8-item World Health Organization (WHO) ordinal scale for COVID-19 in days.
measure: Rate of change in phosphorylated CCR5
time frame: Day 10-1
description: Rate of change (Delta) in lymphocytes, monocytes and neutrophils with phosphorylated CCR5 as per measured by parameters of flow cytometry.
measure: Rate of change in peripheral blood levels of proinflammatory cytokines and chemokines
time frame: Day 10-1
description: Rate of change (Delta) in peripheral blood levels of proinflammatory cytokines and chemokines [IL-6, IL-1b, TNF, IFNa, IFNg, VEGF, GM-CSF (granulocyte-macrophage colony stimulating factor), CCL2, CCL3, CCL4, CCL5, CXCL10 and CCL7], as per measured by parameters of flow cytometry
measure: Change in the trafficking and activation pattern of peripheral leukocytes
time frame: Day 10-1
description: Statistically significant change in the expression of activation [phosphorylated CCR5,CD38, CD126, CD127, CD25, CD86, CD83, CD40 (clusters of differentiation 38, 126, 127, 25, 86 and 40), HLA-DR (Human Leukocyte Antigen-DR isotype), Granzyme B, Perforin, CD107A, CD123, gp130, CD95], trafficking [CCR5, CCR2, CCR6, CCR7, CXCR1, CXCR3 , CXCR5, (CXC chemokine receptors 1, 3 and 5), CX3CR1 (CX3C chemokine receptor] and exhaustion (PD1, programmed death-1 receptor) markers in peripheral blood lymphocytes, neutrophils and monocytes, as per measured by parameters of flow cytometry.
arm group label: Currently used therapy (CT) only
arm group type: Active Comparator
description: Treatment currently used at Hospital General de México "Dr. Eduardo Liceaga" for non-critical COVID patients: Enoxaparin, dexamethasone, and antibiotics if associated bacteremia is present.
arm group label: Maraviroc+CT
arm group type: Experimental
description: Maraviroc AND treatment currently used at Hospital General de México "Dr. Eduardo Liceaga" for non-critical COVID patients.
arm group label: Favipiravir+CT
arm group type: Experimental
description: Favipiravir AND treatment currently used at Hospital General de México "Dr. Eduardo Liceaga" for non-critical COVID patients.
arm group label: Maraviroc+Favipiravir+CT
arm group type: Experimental
description: Maraviroc AND Favipiravir AND treatment currently used at Hospital General de México "Dr. Eduardo Liceaga" for non-critical COVID patients
intervention type: Drug
intervention name: Maraviroc + Currently used therapy
description: Maraviroc tablets. 300 mg bid, given orally for a 10 day period AND CT (Enoxaparin, dexamethasone, and antibiotics if associated bacteremia is present, as per currently used at Hospital General de México "Dr. Eduardo Liceaga")
arm group label: Maraviroc+CT
other name: MVC+CT
intervention type: Procedure
intervention name: Curently used therapy for COVID-19 non-critical patients
description: Enoxaparin, dexamethasone, and antibiotics if associated bacteremia is present, as per currently used at Hospital General de México "Dr. Eduardo Liceaga"
arm group label: Currently used therapy (CT) only
other name: CT only
intervention type: Drug
intervention name: Favipiravir + Currently used therapy
description: Favipiravir tablets 200 mg. given orally for a 7 day period. 1600 mg bid on day 1 and 600 mg tid days 2-7 AND CT (Enoxaparin, dexamethasone, and antibiotics if associated bacteremia is present, as per currently used at Hospital General de México "Dr. Eduardo Liceaga").
arm group label: Favipiravir+CT
other name: FPV+CT
intervention type: Drug
intervention name: Maraviroc+Favipiravir+CT
description: Maraviroc tablets. 300 mg bid, given orally for a 10 day period AND Favipiravir tablets 200 mg. given orally for the first 7 days. 1600 mg bid on day 1 and 600 mg tid days 2-7 AND CT (Enoxaparin, dexamethasone, and antibiotics if associated bacteremia is present, as per currently used at Hospital General de México "Dr. Eduardo Liceaga"")
arm group label: Maraviroc+Favipiravir+CT
other name: MVC+FPV+CT
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: María Luisa Hernández-Medel, MD
role: Study Chair
affiliation: Hospital General de México Dr. Eduardo Liceaga
facility: 
country: Mexico
responsible party type: Principal Investigator
investigator affiliation: Hospital General de México Dr. Eduardo Liceaga
investigator full name: María Luisa Hernández-Medel
investigator title: Researcher
mesh term: COVID-19
mesh term: Maraviroc
mesh term: Favipiravir
sharing ipd: Yes
ipd description: Inter-institutional exchange of data
ipd info type: Study Protocol
ipd info type: Informed Consent Form (ICF)
ipd info type: Clinical Study Report (CSR)
ipd time frame: Information will be shared upon completion of the study for collaborative purposes
ipd access criteria: Upon request