<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/NCT04504734</url>
  </required_header>
  <id_info>
    <org_study_id>RT-003</org_study_id>
    <nct_id>NCT04504734</nct_id>
  </id_info>
  <brief_title>Bucillamine in Treatment of Patients With COVID-19</brief_title>
  <official_title>Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study of Bucillamine in Patients With Mild-Moderate COVID-19</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Revive Therapeutics, Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Revive Therapeutics, Ltd.</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a Phase 3, multi-center, randomized, double blind, placebo controlled, clinical study&#xD;
      of bucillamine (2 dosage levels) in patients with mild-moderate COVID-19. Patients will be&#xD;
      randomized 1:1:1 to receive bucillamine 100 mg 3 times a day (TID), bucillamine 200 mg TID or&#xD;
      placebo TID for up to 14 days. After the first interim analysis when a single dose is&#xD;
      selected, patients will then be randomized 1:1 to the selected bucillamine dose or placebo.&#xD;
      This dose has now been chosen as 600 mg. The study will be overseen by an independent Data&#xD;
      and Safety Monitoring Board (DSMB). Up to 50 centers in the United States will conduct this&#xD;
      study. Up to 1000 patients will be enrolled in this study. Patients will participate in the&#xD;
      study approximately 45 days.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a Phase 3, multi-center, randomized, double blind, placebo controlled, clinical study&#xD;
      of bucillamine (2 dosage levels) in patients with mild-moderate COVID-19. Patients will be&#xD;
      randomized 1:1:1 to receive bucillamine 100 mg 3 times a day (TID), bucillamine 200 mg TID or&#xD;
      placebo TID for up to 14 days. After the first interim analysis when a single dose is&#xD;
      selected, patients will then be randomized 1:1 to the selected bucillamine dose or placebo.&#xD;
      This dose has now been chosen as 600 mg. The study will be overseen by an independent Data&#xD;
      and Safety Monitoring Board (DSMB). Up to 50 centers in the United States will conduct this&#xD;
      study.&#xD;
&#xD;
      Patients qualifying for study enrollment will initiate therapy as outpatients, under home&#xD;
      quarantine. Patients will receive continued standard care of therapy (per study site written&#xD;
      policies or guidelines) together with bucillamine and/ or matching placebo for up to 14 days.&#xD;
      Dosing should continue until the treatment course is completed or as medically indicated&#xD;
      (e.g., deterioration of clinical status and alternative therapy required). If the patient&#xD;
      requires hospitalization during the study period, treatment will be discontinued.&#xD;
&#xD;
      Following completion of the treatment course, follow up assessments will be performed by a&#xD;
      study nurse 14, 28, 42, and 60 days following the end of treatment.&#xD;
&#xD;
      Up to 1000 patients will be enrolled in this study. Patients will participate in the study&#xD;
      approximately 45 days.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Met definition of futility according to DSMB&#xD;
  </why_stopped>
  <start_date type="Actual">November 27, 2020</start_date>
  <completion_date type="Actual">June 12, 2023</completion_date>
  <primary_completion_date type="Actual">June 12, 2023</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>
    <masking_description>Double-blind, placebo controlled</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Efficacy: Frequency of hospitalization or death</measure>
    <time_frame>From time of first dose through Day 28 following randomization</time_frame>
    <description>Proportion of patients meeting a composite endpoint of hospitalization or death</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Safety: Changes in adverse events from baseline to end of study</measure>
    <time_frame>From time of first dose through Day 28 following randomization</time_frame>
    <description>Number of adverse events</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">713</enrollment>
  <condition>Covid19</condition>
  <arm_group>
    <arm_group_label>Bucillamine low dose</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Bucillamine 100 mg 3 times a day (TID)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Bucillamine high dose</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Bucillamine 200 mg 3 times a day (TID)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo, 3 times a day (TID)</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Bucillamine</intervention_name>
    <description>100mg tablets</description>
    <arm_group_label>Bucillamine low dose</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>100mg tablets</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Bucillamine</intervention_name>
    <description>200mg tablets</description>
    <arm_group_label>Bucillamine high dose</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Is within 72 hours from onset of symptoms consistent with COVID 19 at time of study&#xD;
             enrollment&#xD;
&#xD;
          -  Has at least 2 of the following: fever (oral temperature ≥38°C), cough, shortness of&#xD;
             breath, chest x ray changes consistent with COVID-19 at time of screening&#xD;
&#xD;
          -  Has peripheral capillary oxygen saturation (SpO2) ≥94 by pulse oximetry at time of&#xD;
             screening&#xD;
&#xD;
          -  Has either a laboratory-confirmed SARS-CoV-2 infection as determined by FDA-approved&#xD;
             rapid diagnostic (e.g., PCR) assay&#xD;
&#xD;
          -  Has a score of ≤ 2 on the 8-category NIAID ordinal scale at time of screening&#xD;
&#xD;
          -  Agrees to the collection of blood and urine samples, nasopharyngeal (NP) swabs, and&#xD;
             non-invasive oxygen monitoring (via pulse oximeter) per protocol&#xD;
&#xD;
          -  Patient (or their legally authorized representative) is willing and able to provide&#xD;
             written informed consent prior to performing study procedures&#xD;
&#xD;
          -  Understands and agrees to comply with planned study procedures&#xD;
&#xD;
          -  Women of childbearing potential must agree to either abstinence or use at least 1&#xD;
             primary form of contraception not including hormonal contraception from the time of&#xD;
             screening through Day 29 following randomization. All subjects of childbearing&#xD;
             potential, including males with partners of childbearing potential, must use highly&#xD;
             effective methods of birth control defined as those, alone or in combination, that&#xD;
             result in a low failure rate (i.e., less than 1 percent per year) when used&#xD;
             consistently and correctly. Abstinence is NOT an acceptable method of contraception&#xD;
             UNLESS it is the subject's normal practice.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Prior history of, or considered to be at risk for, agranulocytosis, nephropathy, liver&#xD;
             disease, or interstitial pneumonia&#xD;
&#xD;
          -  Serious hepatic disorder (Child-Pugh scores B or C) or alanine transaminase (ALT) or&#xD;
             aspartate transaminase (AST) &gt; 5 times the upper limit of normal (ULN) at screening&#xD;
&#xD;
          -  Chronic kidney disease (CKD) National Kidney Foundation (NKF) stages 3B - 5 chronic&#xD;
             renal dysfunction (estimated glomerular filtration rate [eGFR] &lt;45 mL/min/1.73m2&#xD;
             according to Cockcroft Gault formula)&#xD;
&#xD;
          -  Proteinuria ≥ 1+ or ≥ 30 mg on dipstick urinalysis that is confirmed on repeat&#xD;
             assessment within 24 hours&#xD;
&#xD;
          -  Serum BUN ≥ 2 × ULN or Cr ≥ 2 × ULN&#xD;
&#xD;
          -  Leukopenia with absolute granulocyte count &lt; 1500/µL&#xD;
&#xD;
          -  History of positive Human Immunodeficiency virus (HIV) test or organ transplant&#xD;
&#xD;
          -  Receipt of cancer chemotherapy or immunomodulatory drugs including (but not limited&#xD;
             to) biologics such as anti-CD20, anti-TNF, anti-IL6; alkylating agents (e.g.,&#xD;
             cyclophosphamide); antimetabolites (e.g., azathioprine); or chronic corticosteroid use&#xD;
             equivalent to prednisone &gt;10 gm/day, during preceding 2 months&#xD;
&#xD;
          -  Confirmed positive for influenza at screening&#xD;
&#xD;
          -  Confirmed positive for respiratory syncytial virus (RSV) at screening&#xD;
&#xD;
          -  Pregnant or breastfeeding&#xD;
&#xD;
          -  Current use of, or known allergy to bucillamine or penicillamine (e.g., for Wilson's&#xD;
             disease, rheumatoid arthritis)&#xD;
&#xD;
          -  Current participation in any other clinical trial of an experimental treatment&#xD;
&#xD;
          -  Receipt of any experimental treatment for COVID-19 (herbal/homeopathic, off-label,&#xD;
             compassionate use, or trial related) within the 30 days prior to screening&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Cullman Clinical Trials</name>
      <address>
        <city>Cullman</city>
        <state>Alabama</state>
        <zip>35055</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Avant Research Associates, LLC</name>
      <address>
        <city>Huntsville</city>
        <state>Alabama</state>
        <zip>35802</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>West Valley Research Clinic</name>
      <address>
        <city>Phoenix</city>
        <state>Arizona</state>
        <zip>85031</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>HealthStar Research LLC</name>
      <address>
        <city>Hot Springs</city>
        <state>Arkansas</state>
        <zip>71913</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ASCADA Research</name>
      <address>
        <city>Huntington Beach</city>
        <state>California</state>
        <zip>92648</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Samuel Ross MD Inc.</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90035</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Amicis Research Center</name>
      <address>
        <city>Northridge</city>
        <state>California</state>
        <zip>91324</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Optimus Medical Group</name>
      <address>
        <city>San Francisco</city>
        <state>California</state>
        <zip>94102</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>C &amp; R Research Services USA</name>
      <address>
        <city>Coral Gables</city>
        <state>Florida</state>
        <zip>33134</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sweet Hope Research Specialty Inc</name>
      <address>
        <city>Hialeah</city>
        <state>Florida</state>
        <zip>33016</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Encore Medical Research</name>
      <address>
        <city>Hollywood</city>
        <state>Florida</state>
        <zip>33021</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Entrust Clinical Research</name>
      <address>
        <city>Kendall</city>
        <state>Florida</state>
        <zip>33156</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Columbus Clinical Services</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33125</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Verus Clinical Research</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33125</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nuren Medical &amp; Research Center</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33144</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Advance Medical Research Services Corp</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33165</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Amavita Clinical Research</name>
      <address>
        <city>North Miami Beach</city>
        <state>Florida</state>
        <zip>33169</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>C &amp; R Research Services USA</name>
      <address>
        <city>Tampa</city>
        <state>Florida</state>
        <zip>33614</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Encore Medical Research of Weston LLC</name>
      <address>
        <city>Weston</city>
        <state>Florida</state>
        <zip>33321</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinical Site Partners LLC</name>
      <address>
        <city>Winter Park</city>
        <state>Florida</state>
        <zip>32789</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>American Clinical Trials LLC</name>
      <address>
        <city>Acworth</city>
        <state>Georgia</state>
        <zip>30101</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Quad Clinical Research LLC</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60643</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Koch Family Medicine</name>
      <address>
        <city>Morton</city>
        <state>Illinois</state>
        <zip>61550</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Revive Research Institute Inc.</name>
      <address>
        <city>Farmington Hills</city>
        <state>Michigan</state>
        <zip>48334</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SRI International</name>
      <address>
        <city>Plymouth</city>
        <state>Michigan</state>
        <zip>48170</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Great Lakes Research Institute</name>
      <address>
        <city>Southfield</city>
        <state>Michigan</state>
        <zip>48075</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Revival Research Institute LLC</name>
      <address>
        <city>Sterling</city>
        <state>Michigan</state>
        <zip>48312</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Machuca Family Medicine</name>
      <address>
        <city>Las Vegas</city>
        <state>Nevada</state>
        <zip>89104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Prime Global Research</name>
      <address>
        <city>Bronx</city>
        <state>New York</state>
        <zip>10456</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>OnSite Clinical Solutions</name>
      <address>
        <city>Charlotte</city>
        <state>North Carolina</state>
        <zip>28208</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>OnSite Clinical Solutions, LLC</name>
      <address>
        <city>Charlotte</city>
        <state>North Carolina</state>
        <zip>28277</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Monroe Biomedical Research</name>
      <address>
        <city>Monroe</city>
        <state>North Carolina</state>
        <zip>28112</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Superior Clinical Research</name>
      <address>
        <city>Smithfield</city>
        <state>North Carolina</state>
        <zip>27577</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Superior Clinical Research</name>
      <address>
        <city>Yanceyville</city>
        <state>North Carolina</state>
        <zip>27379</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dayton Clinical Research</name>
      <address>
        <city>Dayton</city>
        <state>Ohio</state>
        <zip>45406</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pharmacorp Clinical Trials Inc.</name>
      <address>
        <city>Charleston</city>
        <state>South Carolina</state>
        <zip>29412</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novaceut Clinical Research</name>
      <address>
        <city>Clarksville</city>
        <state>Tennessee</state>
        <zip>37043</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Physicians Quality Care</name>
      <address>
        <city>Jackson</city>
        <state>Tennessee</state>
        <zip>38305</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Inquest Clinical Research</name>
      <address>
        <city>Baytown</city>
        <state>Texas</state>
        <zip>77521</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>C &amp; R Research Services USA</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77022</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Encore Imaging and Medical Research</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77065</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>R &amp; H Clinical Research Inc.</name>
      <address>
        <city>Katy</city>
        <state>Texas</state>
        <zip>77494</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>FMC Science</name>
      <address>
        <city>Lampasas</city>
        <state>Texas</state>
        <zip>76550</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Family Practice Center</name>
      <address>
        <city>McAllen</city>
        <state>Texas</state>
        <zip>78501</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>R &amp; H Clinical Research Inc.</name>
      <address>
        <city>Stafford</city>
        <state>Texas</state>
        <zip>77477</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Renovatio Clinical</name>
      <address>
        <city>The Woodlands</city>
        <state>Texas</state>
        <zip>77380</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dr. Orvil Martínez-Rivera</name>
      <address>
        <city>San Juan</city>
        <zip>00926</zip>
        <country>Puerto Rico</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Puerto Rico</country>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2023</verification_date>
  <study_first_submitted>August 4, 2020</study_first_submitted>
  <study_first_submitted_qc>August 6, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 7, 2020</study_first_posted>
  <last_update_submitted>July 5, 2023</last_update_submitted>
  <last_update_submitted_qc>July 5, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">July 7, 2023</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>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Bucillamine</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/NCT04504734
org study id: RT-003
nct id: NCT04504734
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
This is a Phase 3, multi-center, randomized, double blind, placebo controlled, clinical study
      of bucillamine (2 dosage levels) in patients with mild-moderate COVID-19. Patients will be
      randomized 1:1:1 to receive bucillamine 100 mg 3 times a day (TID), bucillamine 200 mg TID or
      placebo TID for up to 14 days. After the first interim analysis when a single dose is
      selected, patients will then be randomized 1:1 to the selected bucillamine dose or placebo.
      This dose has now been chosen as 600 mg. The study will be overseen by an independent Data
      and Safety Monitoring Board (DSMB). Up to 50 centers in the United States will conduct this
      study. Up to 1000 patients will be enrolled in this study. Patients will participate in the
      study approximately 45 days.
This is a Phase 3, multi-center, randomized, double blind, placebo controlled, clinical study
      of bucillamine (2 dosage levels) in patients with mild-moderate COVID-19. Patients will be
      randomized 1:1:1 to receive bucillamine 100 mg 3 times a day (TID), bucillamine 200 mg TID or
      placebo TID for up to 14 days. After the first interim analysis when a single dose is
      selected, patients will then be randomized 1:1 to the selected bucillamine dose or placebo.
      This dose has now been chosen as 600 mg. The study will be overseen by an independent Data
      and Safety Monitoring Board (DSMB). Up to 50 centers in the United States will conduct this
      study.

      Patients qualifying for study enrollment will initiate therapy as outpatients, under home
      quarantine. Patients will receive continued standard care of therapy (per study site written
      policies or guidelines) together with bucillamine and/ or matching placebo for up to 14 days.
      Dosing should continue until the treatment course is completed or as medically indicated
      (e.g., deterioration of clinical status and alternative therapy required). If the patient
      requires hospitalization during the study period, treatment will be discontinued.

      Following completion of the treatment course, follow up assessments will be performed by a
      study nurse 14, 28, 42, and 60 days following the end of treatment.

      Up to 1000 patients will be enrolled in this study. Patients will participate in the study
      approximately 45 days.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
masking description: Double-blind, placebo controlled
measure: Efficacy: Frequency of hospitalization or death
time frame: From time of first dose through Day 28 following randomization
description: Proportion of patients meeting a composite endpoint of hospitalization or death
measure: Safety: Changes in adverse events from baseline to end of study
time frame: From time of first dose through Day 28 following randomization
description: Number of adverse events
arm group label: Bucillamine low dose
arm group type: Active Comparator
description: Bucillamine 100 mg 3 times a day (TID)
arm group label: Bucillamine high dose
arm group type: Active Comparator
description: Bucillamine 200 mg 3 times a day (TID)
arm group label: Placebo
arm group type: Placebo Comparator
description: Placebo, 3 times a day (TID)
intervention type: Drug
intervention name: Bucillamine
description: 100mg tablets
arm group label: Bucillamine low dose
intervention type: Drug
intervention name: Placebo
description: 100mg tablets
arm group label: Placebo
intervention type: Drug
intervention name: Bucillamine
description: 200mg tablets
arm group label: Bucillamine high dose
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
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country: Puerto Rico
country: United States
responsible party type: Sponsor
mesh term: COVID-19
mesh term: Bucillamine
sharing ipd: Undecided