<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/NCT04459702</url>
  </required_header>
  <id_info>
    <org_study_id>PRG-043</org_study_id>
    <nct_id>NCT04459702</nct_id>
  </id_info>
  <brief_title>A Study of Combination Therapies to Treat COVID-19 Infection</brief_title>
  <official_title>A Phase IIa Randomized, Controlled Study of Combination Therapies to Treat COVID-19 Infection</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>ProgenaBiome</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Big Corona Ltd.</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>ProgenaBiome</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>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study seeks to determine whether dual or quadruple therapy is more effective in treating&#xD;
      COVID-19.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In this study, patients will be administered either dual or quadruple therapy and have PCR&#xD;
      tests run daily to determine efficacy as indicated by time to non-infectivity&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Was never started&#xD;
  </why_stopped>
  <start_date type="Anticipated">July 2020</start_date>
  <completion_date type="Anticipated">December 2021</completion_date>
  <primary_completion_date type="Anticipated">July 2021</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Efficacy of Treatment by Reduced Symptoms NEWS (National Early Warning System) scores</measure>
    <time_frame>6 months</time_frame>
    <description>Time to reduced symptoms in each treatment group as indicated by NEWS scores, which rate patient status based on a zero to three scale for 8 parameters. These values are added up to create the NEWS score. The lower the NEWS score, the better the patient's clinical condition. Zero is the lowest possible score, whereas 7 or greater represents a high degree of clinical risk.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Efficacy of Treatment by Time to Non-Infectivity</measure>
    <time_frame>10 days</time_frame>
    <description>Time to non-infectivity as measured by PCR testing</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Safety of Dual Therapy as Measured by Symptoms rated on the NEWS (National Early Warning System) sores</measure>
    <time_frame>6 months</time_frame>
    <description>Patient symptoms will be recorded using the NEWS system, which rates patient status based on a zero to three scale for 8 parameters. These values are added up to create the NEWS score. The lower the NEWS score, the better the patient's clinical condition. Zero is the lowest possible score, whereas 7 or greater represents a high degree of clinical risk.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safety of Quadruple Therapy as Measured by Symptoms rated on the NEWS (National Early Warning System) scores.</measure>
    <time_frame>6 months</time_frame>
    <description>Patient symptoms will be recorded using the NEWS system, which rates patient status based on a zero to three scale for 8 parameters. These values are added up to create the NEWS score. The lower the NEWS score, the better the patient's clinical condition. Zero is the lowest possible score, whereas 7 or greater represents a high degree of clinical risk.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safety of Dual Therapy as Measured by Complete Blood Count</measure>
    <time_frame>6 months</time_frame>
    <description>Changes in blood parameters measured in a Complete Blood Count (CBC).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safety of Quadruple Therapy as Measured by Complete Blood Count</measure>
    <time_frame>6 months</time_frame>
    <description>Changes in blood parameters measured in a Complete Metabolic Panel.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safety of Dual Therapy as Measured by Metabolic Panel -Albumin</measure>
    <time_frame>6 months</time_frame>
    <description>Changes in serum albumin levels</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safety of Quadruple Therapy as Measured by Metabolic Panel - Albumin</measure>
    <time_frame>6 months</time_frame>
    <description>Changes in serum albumin levels</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safety of Quadruple Therapy as Measured by Metabolic Panel - A/G Ratio</measure>
    <time_frame>6 months</time_frame>
    <description>Changes in serum albumin/globulin ratio</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safety of Dual Therapy as Measured by Metabolic Panel A/G Ratio</measure>
    <time_frame>6 months</time_frame>
    <description>Changes in serum albumin/globulin ratio</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safety of Quadruple Therapy as Measured by Metabolic Panel - Alkaline Phosphatase</measure>
    <time_frame>6 months</time_frame>
    <description>Changes in serum alkaline phosphatase levels</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safety of Dual Therapy as Measured by Metabolic Panel Alkaline Phosphatase</measure>
    <time_frame>6 months</time_frame>
    <description>Changes in serum alkaline phosphatase levels</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safety of Dual Therapy as Measured by Metabolic Panel - AST</measure>
    <time_frame>6 months</time_frame>
    <description>Changes in serum AST levels</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safety of Quadruple Therapy as Measured by Metabolic Panel - AST</measure>
    <time_frame>6 months</time_frame>
    <description>Changes in serum AST levels</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safety of Quadruple Therapy as Measured by Metabolic Panel - ALT</measure>
    <time_frame>6 months</time_frame>
    <description>Changes in serum ALT levels</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safety of Dual Therapy as Measured by Metabolic Panel ALT</measure>
    <time_frame>6 months</time_frame>
    <description>Changes in serum ALT levels</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safety of Dual Therapy as Measured by Metabolic Panel BUN/Creatinine Ratio</measure>
    <time_frame>6 months</time_frame>
    <description>Changes in serum BUN/Creatinine Ratio</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safety of Quadruple Therapy as Measured by Metabolic Panel BUN/Creatinine Ratio</measure>
    <time_frame>6 months</time_frame>
    <description>Changes in serum BUN/Creatinine Ratio</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safety of Quadruple Therapy as Measured by Metabolic Panel - BUN</measure>
    <time_frame>6 months</time_frame>
    <description>Changes in serum Blood Urea Nitrogen levels</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safety of Dual Therapy as Measured by Metabolic Panel - BUN</measure>
    <time_frame>6 months</time_frame>
    <description>Changes in serum Blood Urea Nitrogen levels</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safety of Dual Therapy as Measured by Metabolic Panel - Calcium</measure>
    <time_frame>6 months</time_frame>
    <description>Changes in serum calcium levels</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safety of Quadruple Therapy as Measured by Metabolic Panel - Calcium</measure>
    <time_frame>6 months</time_frame>
    <description>Changes in serum calcium levels</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safety of Quadruple Therapy as Measured by Metabolic Panel - Carbon Dioxide</measure>
    <time_frame>6 months</time_frame>
    <description>Changes in serum carbon dioxide levels</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safety of Dual Therapy as Measured by Metabolic Panel - Carbon Dioxide</measure>
    <time_frame>6 months</time_frame>
    <description>Changes in serum carbon dioxide levels</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safety of Dual Therapy as Measured by Metabolic Panel - Chloride</measure>
    <time_frame>6 months</time_frame>
    <description>Changes in serum chloride levels</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safety of Quadruple Therapy as Measured by Metabolic Panel - Chloride</measure>
    <time_frame>6 months</time_frame>
    <description>Changes in serum chloride levels</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safety of Quadruple Therapy as Measured by Metabolic Panel - Creatinine</measure>
    <time_frame>6 months</time_frame>
    <description>Changes in serum creatinine levels</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safety of Dual Therapy as Measured by Metabolic Panel - Creatinine</measure>
    <time_frame>6 months</time_frame>
    <description>Changes in serum creatinine levels</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safety of Dual Therapy as Measured by Metabolic Panel - Globulin</measure>
    <time_frame>6 months</time_frame>
    <description>Changes in serum globulin levels</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safety of Quadruple Therapy as Measured by Metabolic Panel - Globulin</measure>
    <time_frame>6 months</time_frame>
    <description>Changes in serum globulin levels</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safety of Quadruple Therapy as Measured by Metabolic Panel - Glucose</measure>
    <time_frame>6 months</time_frame>
    <description>Changes in blood glucose levels</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safety of Dual Therapy as Measured by Metabolic Panel - Glucose</measure>
    <time_frame>6 months</time_frame>
    <description>Changes in blood glucose levels</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safety of Dual Therapy as Measured by Metabolic Panel - Potassium</measure>
    <time_frame>6 months</time_frame>
    <description>Changes in blood potassium levels</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safety of Quadruple Therapy as Measured by Metabolic Panel - Potassium</measure>
    <time_frame>6 months</time_frame>
    <description>Changes in blood potassium levels</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safety of Quadruple Therapy as Measured by Metabolic Panel - Total Bilirubin</measure>
    <time_frame>6 months</time_frame>
    <description>Changes in serum total bilirubin levels</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safety of Dual Therapy as Measured by Metabolic Panel - Total Bilirubin</measure>
    <time_frame>6 months</time_frame>
    <description>Changes in serum total bilirubin levels</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safety of Dual Therapy as Measured by Metabolic Panel - Total Protein</measure>
    <time_frame>6 months</time_frame>
    <description>Changes in serum total protein levels</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safety of Quadruple Therapy as Measured by Metabolic Panel - Total Protein</measure>
    <time_frame>6 months</time_frame>
    <description>Changes in serum total protein levels</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safety of Dual Therapy as Measured by Treatment Related SAE</measure>
    <time_frame>6 months</time_frame>
    <description>Presence or absence of treatment related serious adverse events Grade III or higher</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safety of Quadruple Therapy as Measured by Treatment Related SAE</measure>
    <time_frame>6 months</time_frame>
    <description>Presence or absence of treatment related serious adverse events Grade III or higher</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>COVID</condition>
  <condition>COVID-19</condition>
  <condition>Corona Virus Infection</condition>
  <condition>Coronavirus Infection</condition>
  <condition>Coronavirus Sars-Associated as Cause of Disease Classified Elsewhere</condition>
  <condition>Coronavirus-19</condition>
  <condition>SARS-CoV 2</condition>
  <condition>SARS Pneumonia</condition>
  <arm_group>
    <arm_group_label>Dual Therapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Dual Therapy utilizing hydroxychloroquine and azithromycin.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Quadruple Therapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Quadruple therapy utilizing hydroxychloroquine, lopinavir, ritonavir, and azithromycin</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>hydroxychloroquine</intervention_name>
    <description>Treatment with the drug hydroxychloroquine</description>
    <arm_group_label>Dual Therapy</arm_group_label>
    <arm_group_label>Quadruple Therapy</arm_group_label>
    <other_name>Plaquenil</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Azithromycin</intervention_name>
    <description>Treatment with the drug azithromycin</description>
    <arm_group_label>Dual Therapy</arm_group_label>
    <arm_group_label>Quadruple Therapy</arm_group_label>
    <other_name>Zithromax</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ritonavir</intervention_name>
    <description>Treatment with the drug ritonavir</description>
    <arm_group_label>Quadruple Therapy</arm_group_label>
    <other_name>norvir</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Lopinavir</intervention_name>
    <description>Treatment with the drug lopinavir</description>
    <arm_group_label>Quadruple Therapy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Signed informed consent, demonstrating that the subject understands the procedures&#xD;
             required for the study and the purpose of the study&#xD;
&#xD;
          2. Healthy, ambulant male or female subjects 18 years of age to 65 years of age&#xD;
&#xD;
          3. Positive test for COVID-19 by RT-PCR at screening&#xD;
&#xD;
          4. Subjects must agree to practice at least one highly effective method of birth control&#xD;
             for the duration of the study. This includes condoms with spermicide, oral birth&#xD;
             control pills, contraceptive implants, intra-uterine devices, or diaphragms. Subjects&#xD;
             not of reproductive potential will be exempt (e.g. post-menopausal, surgically&#xD;
             sterilized)&#xD;
&#xD;
          5. Subjects must agree they will do their best to attend the treatment facility daily for&#xD;
             10 days&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Refusal to sign informed consent form&#xD;
&#xD;
          2. Negative test for COVID-19 by RT-PCR at screening&#xD;
&#xD;
          3. Severe disease symptomatically including pneumonia, respiratory distress, tachypnea,&#xD;
             shortness of breath, temperature &gt; 38 degrees; pleuritic pain, or frequent cough.&#xD;
&#xD;
          4. Known drug allergy to any of the investigational medications&#xD;
&#xD;
          5. Currently taking medication with known drug interactions with investigational&#xD;
             medications (listed in appendix)&#xD;
&#xD;
          6. Prescription or other antiviral medications&#xD;
&#xD;
          7. Any comorbidities which constitute health risk for the subject&#xD;
&#xD;
          8. Pregnant or lactating females;&#xD;
&#xD;
          9. weight &lt; 110lb;&#xD;
&#xD;
         10. porphyria&#xD;
&#xD;
         11. established retinal disease&#xD;
&#xD;
         12. Inability to attend daily for 10 days&#xD;
&#xD;
         13. Any contraindications for treatment with hydroxychloroquine&#xD;
&#xD;
               1. Hypoglycemia&#xD;
&#xD;
               2. Known G6PD deficiency&#xD;
&#xD;
               3. Porphyria&#xD;
&#xD;
               4. Anemia&#xD;
&#xD;
               5. Neutropenia&#xD;
&#xD;
               6. Alcoholism&#xD;
&#xD;
               7. Myasthenia gravis&#xD;
&#xD;
               8. Skeletal muscle disorders&#xD;
&#xD;
               9. Maculopathy&#xD;
&#xD;
              10. Changes in visual field&#xD;
&#xD;
              11. Liver disease&#xD;
&#xD;
              12. Psoriasis&#xD;
&#xD;
              13. History of QT &gt;500msec&#xD;
&#xD;
              14. History of torsades de pointes&#xD;
&#xD;
         14. Anemia from pyruvate kinase and G6PD deficiencies&#xD;
&#xD;
         15. Abnormal EKG with QT prolongation acquired or from birth&#xD;
&#xD;
         16. History of jaundice or high fevers prior to developing COVID-19&#xD;
&#xD;
         17. Treatment with any of the medications listed in Appendix II&#xD;
&#xD;
         18. Treatment with any anti-epileptic medication&#xD;
&#xD;
         19. Treatment with any other drug not listed that affects the QT interval&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sabine Hazan, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>ProgenaBiome</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Thomas Borody, MD, PhD,</last_name>
    <role>Principal Investigator</role>
    <affiliation>Big Corona Ltd.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>ProgenaBiome</name>
      <address>
        <city>Ventura</city>
        <state>California</state>
        <zip>93003</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2021</verification_date>
  <study_first_submitted>June 25, 2020</study_first_submitted>
  <study_first_submitted_qc>July 4, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 7, 2020</study_first_posted>
  <last_update_submitted>April 6, 2021</last_update_submitted>
  <last_update_submitted_qc>April 6, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">April 8, 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>Infections</mesh_term>
    <mesh_term>Communicable Diseases</mesh_term>
    <mesh_term>COVID-19</mesh_term>
    <mesh_term>Coronavirus Infections</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ritonavir</mesh_term>
    <mesh_term>Lopinavir</mesh_term>
    <mesh_term>Azithromycin</mesh_term>
    <mesh_term>Hydroxychloroquine</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/NCT04459702
org study id: PRG-043
nct id: NCT04459702
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
is us export: No
This study seeks to determine whether dual or quadruple therapy is more effective in treating
      COVID-19.
In this study, patients will be administered either dual or quadruple therapy and have PCR
      tests run daily to determine efficacy as indicated by time to non-infectivity
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Efficacy of Treatment by Reduced Symptoms NEWS (National Early Warning System) scores
time frame: 6 months
description: Time to reduced symptoms in each treatment group as indicated by NEWS scores, which rate patient status based on a zero to three scale for 8 parameters. These values are added up to create the NEWS score. The lower the NEWS score, the better the patient's clinical condition. Zero is the lowest possible score, whereas 7 or greater represents a high degree of clinical risk.
measure: Efficacy of Treatment by Time to Non-Infectivity
time frame: 10 days
description: Time to non-infectivity as measured by PCR testing
measure: Safety of Dual Therapy as Measured by Symptoms rated on the NEWS (National Early Warning System) sores
time frame: 6 months
description: Patient symptoms will be recorded using the NEWS system, which rates patient status based on a zero to three scale for 8 parameters. These values are added up to create the NEWS score. The lower the NEWS score, the better the patient's clinical condition. Zero is the lowest possible score, whereas 7 or greater represents a high degree of clinical risk.
measure: Safety of Quadruple Therapy as Measured by Symptoms rated on the NEWS (National Early Warning System) scores.
time frame: 6 months
description: Patient symptoms will be recorded using the NEWS system, which rates patient status based on a zero to three scale for 8 parameters. These values are added up to create the NEWS score. The lower the NEWS score, the better the patient's clinical condition. Zero is the lowest possible score, whereas 7 or greater represents a high degree of clinical risk.
measure: Safety of Dual Therapy as Measured by Complete Blood Count
time frame: 6 months
description: Changes in blood parameters measured in a Complete Blood Count (CBC).
measure: Safety of Quadruple Therapy as Measured by Complete Blood Count
time frame: 6 months
description: Changes in blood parameters measured in a Complete Metabolic Panel.
measure: Safety of Dual Therapy as Measured by Metabolic Panel -Albumin
time frame: 6 months
description: Changes in serum albumin levels
measure: Safety of Quadruple Therapy as Measured by Metabolic Panel - Albumin
time frame: 6 months
description: Changes in serum albumin levels
measure: Safety of Quadruple Therapy as Measured by Metabolic Panel - A/G Ratio
time frame: 6 months
description: Changes in serum albumin/globulin ratio
measure: Safety of Dual Therapy as Measured by Metabolic Panel A/G Ratio
time frame: 6 months
description: Changes in serum albumin/globulin ratio
measure: Safety of Quadruple Therapy as Measured by Metabolic Panel - Alkaline Phosphatase
time frame: 6 months
description: Changes in serum alkaline phosphatase levels
measure: Safety of Dual Therapy as Measured by Metabolic Panel Alkaline Phosphatase
time frame: 6 months
description: Changes in serum alkaline phosphatase levels
measure: Safety of Dual Therapy as Measured by Metabolic Panel - AST
time frame: 6 months
description: Changes in serum AST levels
measure: Safety of Quadruple Therapy as Measured by Metabolic Panel - AST
time frame: 6 months
description: Changes in serum AST levels
measure: Safety of Quadruple Therapy as Measured by Metabolic Panel - ALT
time frame: 6 months
description: Changes in serum ALT levels
measure: Safety of Dual Therapy as Measured by Metabolic Panel ALT
time frame: 6 months
description: Changes in serum ALT levels
measure: Safety of Dual Therapy as Measured by Metabolic Panel BUN/Creatinine Ratio
time frame: 6 months
description: Changes in serum BUN/Creatinine Ratio
measure: Safety of Quadruple Therapy as Measured by Metabolic Panel BUN/Creatinine Ratio
time frame: 6 months
description: Changes in serum BUN/Creatinine Ratio
measure: Safety of Quadruple Therapy as Measured by Metabolic Panel - BUN
time frame: 6 months
description: Changes in serum Blood Urea Nitrogen levels
measure: Safety of Dual Therapy as Measured by Metabolic Panel - BUN
time frame: 6 months
description: Changes in serum Blood Urea Nitrogen levels
measure: Safety of Dual Therapy as Measured by Metabolic Panel - Calcium
time frame: 6 months
description: Changes in serum calcium levels
measure: Safety of Quadruple Therapy as Measured by Metabolic Panel - Calcium
time frame: 6 months
description: Changes in serum calcium levels
measure: Safety of Quadruple Therapy as Measured by Metabolic Panel - Carbon Dioxide
time frame: 6 months
description: Changes in serum carbon dioxide levels
measure: Safety of Dual Therapy as Measured by Metabolic Panel - Carbon Dioxide
time frame: 6 months
description: Changes in serum carbon dioxide levels
measure: Safety of Dual Therapy as Measured by Metabolic Panel - Chloride
time frame: 6 months
description: Changes in serum chloride levels
measure: Safety of Quadruple Therapy as Measured by Metabolic Panel - Chloride
time frame: 6 months
description: Changes in serum chloride levels
measure: Safety of Quadruple Therapy as Measured by Metabolic Panel - Creatinine
time frame: 6 months
description: Changes in serum creatinine levels
measure: Safety of Dual Therapy as Measured by Metabolic Panel - Creatinine
time frame: 6 months
description: Changes in serum creatinine levels
measure: Safety of Dual Therapy as Measured by Metabolic Panel - Globulin
time frame: 6 months
description: Changes in serum globulin levels
measure: Safety of Quadruple Therapy as Measured by Metabolic Panel - Globulin
time frame: 6 months
description: Changes in serum globulin levels
measure: Safety of Quadruple Therapy as Measured by Metabolic Panel - Glucose
time frame: 6 months
description: Changes in blood glucose levels
measure: Safety of Dual Therapy as Measured by Metabolic Panel - Glucose
time frame: 6 months
description: Changes in blood glucose levels
measure: Safety of Dual Therapy as Measured by Metabolic Panel - Potassium
time frame: 6 months
description: Changes in blood potassium levels
measure: Safety of Quadruple Therapy as Measured by Metabolic Panel - Potassium
time frame: 6 months
description: Changes in blood potassium levels
measure: Safety of Quadruple Therapy as Measured by Metabolic Panel - Total Bilirubin
time frame: 6 months
description: Changes in serum total bilirubin levels
measure: Safety of Dual Therapy as Measured by Metabolic Panel - Total Bilirubin
time frame: 6 months
description: Changes in serum total bilirubin levels
measure: Safety of Dual Therapy as Measured by Metabolic Panel - Total Protein
time frame: 6 months
description: Changes in serum total protein levels
measure: Safety of Quadruple Therapy as Measured by Metabolic Panel - Total Protein
time frame: 6 months
description: Changes in serum total protein levels
measure: Safety of Dual Therapy as Measured by Treatment Related SAE
time frame: 6 months
description: Presence or absence of treatment related serious adverse events Grade III or higher
measure: Safety of Quadruple Therapy as Measured by Treatment Related SAE
time frame: 6 months
description: Presence or absence of treatment related serious adverse events Grade III or higher
arm group label: Dual Therapy
arm group type: Experimental
description: Dual Therapy utilizing hydroxychloroquine and azithromycin.
arm group label: Quadruple Therapy
arm group type: Experimental
description: Quadruple therapy utilizing hydroxychloroquine, lopinavir, ritonavir, and azithromycin
intervention type: Drug
intervention name: hydroxychloroquine
description: Treatment with the drug hydroxychloroquine
arm group label: Dual Therapy
arm group label: Quadruple Therapy
other name: Plaquenil
intervention type: Drug
intervention name: Azithromycin
description: Treatment with the drug azithromycin
arm group label: Dual Therapy
arm group label: Quadruple Therapy
other name: Zithromax
intervention type: Drug
intervention name: Ritonavir
description: Treatment with the drug ritonavir
arm group label: Quadruple Therapy
other name: norvir
intervention type: Drug
intervention name: Lopinavir
description: Treatment with the drug lopinavir
arm group label: Quadruple Therapy
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Sabine Hazan, MD
role: Principal Investigator
affiliation: ProgenaBiome
last name: Thomas Borody, MD, PhD,
role: Principal Investigator
affiliation: Big Corona Ltd.
facility: 
country: United States
responsible party type: Sponsor
mesh term: Infections
mesh term: Communicable Diseases
mesh term: COVID-19
mesh term: Coronavirus Infections
mesh term: Ritonavir
mesh term: Lopinavir
mesh term: Azithromycin
mesh term: Hydroxychloroquine
sharing ipd: No