<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/NCT04482595</url>
  </required_header>
  <id_info>
    <org_study_id>CL0105-01</org_study_id>
    <secondary_id>272201800011C-P00005-9999-1</secondary_id>
    <nct_id>NCT04482595</nct_id>
  </id_info>
  <brief_title>BIO 300 Oral Suspension in Previously Hospitalized Long COVID Patients</brief_title>
  <official_title>A Phase 2 Study of BIO 300 Oral Suspension in Discharged COVID-19 Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Humanetics Corporation</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>NYU Langone Health</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>National Institute of Allergy and Infectious Diseases (NIAID)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Humanetics Corporation</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 randomized, double-blinded, placebo-controlled, two-arm study to evaluate the&#xD;
      safety and efficacy of BIO 300 Oral Suspension (BIO 300) as a therapy to improve lung&#xD;
      function in patients that were hospitalized for severe COVID-19-related illness and continue&#xD;
      to experience post-acute respiratory complications associated with Long-COVID after&#xD;
      discharge. Patients will be randomized 1:1 to receive BIO 300 or placebo.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">November 11, 2020</start_date>
  <completion_date type="Anticipated">March 31, 2024</completion_date>
  <primary_completion_date type="Anticipated">June 30, 2023</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>Randomized, placebo-controlled</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in DLCO</measure>
    <time_frame>12 Weeks</time_frame>
    <description>Diffusing capacity of the lungs for carbon monoxide (DLCO)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in 6 Minute Walk Test</measure>
    <time_frame>12 Weeks</time_frame>
    <description>6 minute walk test (6MWT)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in FVC</measure>
    <time_frame>12 Weeks, 6 Months and 12 Months</time_frame>
    <description>Forced vital capacity (FVC)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in St. George's Respiratory Questionnaire (SGRQ) Scores</measure>
    <time_frame>12 Weeks, 6 Months and 12 Months</time_frame>
    <description>Patient reported outcome to measure impact on overall health, daily life, and perceived well-being in patients with impaired pulmonary function. Scores range from 0-100 with higher scores indicating more limitations.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Pulmonary Fibrosis on HRCT Scan</measure>
    <time_frame>12 Weeks, 6 Months and 12 Months</time_frame>
    <description>Evidence of pulmonary fibrosis on high resolution computerized tomography (HRCT) scans of the lungs based on a 4-point Likert scale, where 0 is no evidence of fibrosis and 3 is severe fibrosis</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of Re-Hospitalization</measure>
    <time_frame>12 Months</time_frame>
    <description>Incidence of hospitalization after initial discharge and initiating treatment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>All-Cause Mortality</measure>
    <time_frame>12 Months</time_frame>
    <description>Mortality at 12 months after initiating treatment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in FEV1</measure>
    <time_frame>12 Weeks, 6 Months and 12 Months</time_frame>
    <description>Forced expiratory volume in one second (FEV1)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in FEV1/FVC Ratio</measure>
    <time_frame>12 Weeks, 6 Months and 12 Months</time_frame>
    <description>Ratio of forced expiratory volume in one second (FEV1) to forced vital capacity (FVC)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in 6 Minute Walk Test</measure>
    <time_frame>6 Months and 12 Months</time_frame>
    <description>6 minute walk test (6MWT)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Pulse Oximetry at Rest and During the 6MWT</measure>
    <time_frame>12 Weeks, 6 Months and 12 Months</time_frame>
    <description>Oxygen saturation (pulse oximetry) at rest and during the 6 minute walk test (6MWT)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in DLCO</measure>
    <time_frame>6 Months and 12 Months</time_frame>
    <description>Diffusing capacity of the lungs for carbon monoxide (DLCO)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adverse Events Related to BIO 300 Oral Suspension</measure>
    <time_frame>12 Months</time_frame>
    <description>Evaluate the safety of BIO 300 Oral Suspension treatment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Clinical Laboratory Values</measure>
    <time_frame>4 Weeks, 8 Weeks, 12 Weeks, 6 Months and 12 Months</time_frame>
    <description>Monitoring of blood serum levels for bilirubin, C-reactive protein (CRP), creatinine, blood urea nitrogen (BUN), cholesterol and triglycerides (all reported as mg/dL)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Clinical Laboratory Values</measure>
    <time_frame>4 Weeks, 8 Weeks, 12 Weeks, 6 Months and 12 Months</time_frame>
    <description>Monitoring of blood serum levels for troponin T, d-dimer and ferritin (all reported as ng/mL)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Clinical Laboratory Values for Albumin</measure>
    <time_frame>4 Weeks, 8 Weeks, 12 Weeks, 6 Months and 12 Months</time_frame>
    <description>Monitoring of blood serum levels for albumin (g/dL)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Clinical Laboratory Values for Serum Enzymes</measure>
    <time_frame>4 Weeks, 8 Weeks, 12 Weeks, 6 Months and 12 Months</time_frame>
    <description>Monitoring of blood serum levels for alkaline phosphatase (ALP), alanine transaminase (ALT), aspartate aminotransferase (AST) and lactate dehydrogenase (LDH) (all reported as Units/L)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Complete Blood Counts with Differential</measure>
    <time_frame>4 Weeks, 8 Weeks, 12 Weeks, 6 Months and 12 Months</time_frame>
    <description>Monitoring of white blood cell, red blood cell and platelet counts</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Change in Supplemental Oxygen Use</measure>
    <time_frame>12 Weeks, 6 Months and 12 Months</time_frame>
    <description>Prescribed supplemental oxygen flow rate at night, rest and exertion</description>
  </other_outcome>
  <other_outcome>
    <measure>Change in Duration of Supplemental Oxygen Use</measure>
    <time_frame>12 Weeks, 6 Months and 12 Months</time_frame>
    <description>Duration of supplemental oxygen use</description>
  </other_outcome>
  <other_outcome>
    <measure>Change in Serum Cytokine Expression</measure>
    <time_frame>4 Weeks, 8 Weeks, 12 Weeks, 6 Months and 12 Months</time_frame>
    <description>Expression levels of serum-derived cytokines (IL-1b, IL-6, IL-8, TNFa, and TGFb1)</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">50</enrollment>
  <condition>COVID-19</condition>
  <condition>Long COVID</condition>
  <condition>Pulmonary Fibrosis</condition>
  <condition>Post-acute Respiratory Complications of COVID-19</condition>
  <arm_group>
    <arm_group_label>BIO 300 Oral Suspension (genistein 1500 mg)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>BIO 300 Oral Suspension (genistein 1500 mg) will be self-administered daily for 7 days each week for 12 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>BIO 300 Oral Suspension matched placebo will be self-administered daily for 7 days each week for 12 weeks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>BIO 300 Oral Suspension</intervention_name>
    <description>Suspension of genistein nanoparticles</description>
    <arm_group_label>BIO 300 Oral Suspension (genistein 1500 mg)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Matched placebo for BIO 300 Oral Suspension</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Age ≥ 18&#xD;
&#xD;
          2. Patients hospitalized for COVID-19-related complications ready to be discharged and&#xD;
             those within 365 days of discharge (even if the patient was referred to subacute or&#xD;
             acute respiratory rehabilitation after discharge)&#xD;
&#xD;
          3. Radiographic signs of lung injury after standard treatment of COVID-19 such as, ground&#xD;
             glass opacity, consolidation, or fibrotic shadows at screening&#xD;
&#xD;
          4. Able to perform a PFT and have a DLCO &lt;70% of predicted at screening&#xD;
&#xD;
          5. Able to perform a 6-minute walk test&#xD;
&#xD;
          6. Blood routine, liver and kidney function test values are within the controllable range&#xD;
&#xD;
               1. Adequate hepatic function as evidenced by ALT, AST and LDH &lt; 2X ULN and bilirubin&#xD;
                  &lt; 1.5X ULN for the reference lab&#xD;
&#xD;
               2. Adequate renal function as evidenced by a serum creatinine ≤ 1.5 X ULN for the&#xD;
                  reference laboratory OR a calculated creatinine clearance of ≥ 60 mL/min by the&#xD;
                  Cockcroft-Gault Equation&#xD;
&#xD;
               3. Adequate hematopoietic function as evidenced by white blood cells ≥ 3x10^9 / L&#xD;
                  and platelets ≥ 100x10^9 / L&#xD;
&#xD;
          7. Female patients of childbearing potential must have a negative pregnancy test at&#xD;
             screening&#xD;
&#xD;
          8. Female patients of childbearing potential and male participants with female sexual&#xD;
             partners of childbearing potential must agree to use an effective method of&#xD;
             non-estrogen-based contraception (e.g., condom and a diaphragm, condom and&#xD;
             intrauterine device, condom and Depo-Provera, condom and Nexplanon, or condom and&#xD;
             progesterone mini-pill) during the 12-week portion of the study that they are&#xD;
             receiving study medication and for 30 days following the last dose of study&#xD;
             medication, or to abstain from sexual intercourse during these time periods. Women who&#xD;
             have been off estrogen contraceptives for a minimum of 5 days prior to the first&#xD;
             scheduled day of study intervention dosing are eligible. A woman not of childbearing&#xD;
             potential is one who has undergone bilateral oophorectomies or who is post-menopausal,&#xD;
             defined as no menstrual periods for 12 consecutive months&#xD;
&#xD;
          9. Ability of the patient or the patient's legal representative to read and provide&#xD;
             written informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Severe background disease like severe cardiac or pulmonary insufficiency (WHO grade&#xD;
             III or IV), severe liver and kidney diseases, severe COPD, severe neurological&#xD;
             disease, or concurrent malignancy (other than non-melanoma skin cancer) which is&#xD;
             uncontrolled or actively being treated&#xD;
&#xD;
          2. Severe asthma on chronic therapy with biologics or steroids.&#xD;
&#xD;
          3. Prior malignancy in which any thoracic radiotherapy was administered except for&#xD;
             partial or tangent breast irradiation for early-stage (stages I or II) breast cancer&#xD;
&#xD;
          4. D-dimer levels of &gt;2,000 ng/mL at screening&#xD;
&#xD;
          5. Use of anti-pulmonary fibrosis drugs (e.g., imatinib, nintedanib, pirfenidone,&#xD;
             penicillamine, colchicine, tumor necrosis factor alpha blocker) within 5 days of the&#xD;
             first scheduled day of study intervention dosing&#xD;
&#xD;
          6. Use of anti-cytokine release syndrome drugs (e.g., anakinra, sarilumab, siltuximab,&#xD;
             tocilizumab and/or lenzilumab) within 5 days of the first scheduled day of study&#xD;
             intervention dosing&#xD;
&#xD;
          7. Use of systemic corticosteroids (e.g., prednisone, dexamethasone) within 5 days of the&#xD;
             first scheduled day of study intervention dosing&#xD;
&#xD;
          8. An active infection or infection with a fever ≥ 38.5°C within 3 days of the first&#xD;
             scheduled day of study intervention dosing&#xD;
&#xD;
          9. Poorly controlled intercurrent illnesses, such as interstitial lung disease,&#xD;
             uncontrolled hypertension; poorly controlled diabetes mellitus; unstable angina,&#xD;
             myocardial infarction, acute coronary syndrome or cerebrovascular event within 6&#xD;
             months of Screening; history of congestive heart failure (NYHA Class III or IV);&#xD;
             severe valvular heart disease; or poorly controlled cardiac arrhythmias not responding&#xD;
             to medical therapy or a pacemaker&#xD;
&#xD;
         10. QTc with Fridericia's correction that is unmeasurable, or ≥480 msec on screening ECG.&#xD;
             The average QTc from the screening ECG (completed in triplicate) must be &lt;480 msec for&#xD;
             the patient to be eligible for the study&#xD;
&#xD;
         11. Patients taking any concomitant medication that may cause QTc prolongation, induce&#xD;
             Torsades de Pointes (www.crediblemeds.org) are not eligible if QTc ≥460 msec&#xD;
&#xD;
         12. Patients who have undergone thoracotomy within 4 weeks of Day 1 of protocol therapy&#xD;
&#xD;
         13. Patients that have a known allergy to any of the placebo components&#xD;
&#xD;
         14. Psychiatric conditions, social situations or substance abuse that precludes the&#xD;
             ability of the study participant to cooperate with the requirements of the trial and&#xD;
             protocol therapy&#xD;
&#xD;
         15. Pregnancy or currently on estrogen-based contraceptives&#xD;
&#xD;
         16. Women who are breastfeeding&#xD;
&#xD;
         17. Past or current medical problems or findings from physical examination or laboratory&#xD;
             testing that are not listed above, which, in the opinion of the investigator, may pose&#xD;
             additional risks from participation in the study, may interfere with the participant's&#xD;
             ability to comply with study requirements or that may impact the quality or&#xD;
             interpretation of the data obtained from the study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Michael D Kaytor, Ph.D.</last_name>
    <phone>952-400-0405</phone>
    <email>mkaytor@humaneticscorp.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>University of Colorado Anschutz Medical Campus</name>
      <address>
        <city>Aurora</city>
        <state>Colorado</state>
        <zip>80045</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>NYU Langone Health</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10016</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Julia Cirillo</last_name>
      <phone>929-455-5970</phone>
      <email>BIO300@nyulangone.org</email>
    </contact>
    <investigator>
      <last_name>Rany Condos, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>University of Texas Health Science Center at Houston</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>MaryJane Keller, NP</last_name>
      <phone>713-486-2012</phone>
      <email>MaryJane.Keller@uth.tmc.edu</email>
    </contact>
    <investigator>
      <last_name>Isabel Mira-Avendano, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Rodeo Abrencillo, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Bela Patel, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Houston Methodist Research Institute</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77210</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2023</verification_date>
  <study_first_submitted>July 17, 2020</study_first_submitted>
  <study_first_submitted_qc>July 21, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 22, 2020</study_first_posted>
  <last_update_submitted>January 20, 2023</last_update_submitted>
  <last_update_submitted_qc>January 20, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">January 25, 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>
    <mesh_term>Post-Acute COVID-19 Syndrome</mesh_term>
    <mesh_term>Pulmonary Fibrosis</mesh_term>
  </condition_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/NCT04482595
org study id: CL0105-01
secondary id: 272201800011C-P00005-9999-1
nct id: NCT04482595
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
This is a randomized, double-blinded, placebo-controlled, two-arm study to evaluate the
      safety and efficacy of BIO 300 Oral Suspension (BIO 300) as a therapy to improve lung
      function in patients that were hospitalized for severe COVID-19-related illness and continue
      to experience post-acute respiratory complications associated with Long-COVID after
      discharge. Patients will be randomized 1:1 to receive BIO 300 or placebo.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Randomized, placebo-controlled
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Change in DLCO
time frame: 12 Weeks
description: Diffusing capacity of the lungs for carbon monoxide (DLCO)
measure: Change in 6 Minute Walk Test
time frame: 12 Weeks
description: 6 minute walk test (6MWT)
measure: Change in FVC
time frame: 12 Weeks, 6 Months and 12 Months
description: Forced vital capacity (FVC)
measure: Change in St. George's Respiratory Questionnaire (SGRQ) Scores
time frame: 12 Weeks, 6 Months and 12 Months
description: Patient reported outcome to measure impact on overall health, daily life, and perceived well-being in patients with impaired pulmonary function. Scores range from 0-100 with higher scores indicating more limitations.
measure: Change in Pulmonary Fibrosis on HRCT Scan
time frame: 12 Weeks, 6 Months and 12 Months
description: Evidence of pulmonary fibrosis on high resolution computerized tomography (HRCT) scans of the lungs based on a 4-point Likert scale, where 0 is no evidence of fibrosis and 3 is severe fibrosis
measure: Incidence of Re-Hospitalization
time frame: 12 Months
description: Incidence of hospitalization after initial discharge and initiating treatment
measure: All-Cause Mortality
time frame: 12 Months
description: Mortality at 12 months after initiating treatment
measure: Change in FEV1
time frame: 12 Weeks, 6 Months and 12 Months
description: Forced expiratory volume in one second (FEV1)
measure: Change in FEV1/FVC Ratio
time frame: 12 Weeks, 6 Months and 12 Months
description: Ratio of forced expiratory volume in one second (FEV1) to forced vital capacity (FVC)
measure: Change in 6 Minute Walk Test
time frame: 6 Months and 12 Months
description: 6 minute walk test (6MWT)
measure: Change in Pulse Oximetry at Rest and During the 6MWT
time frame: 12 Weeks, 6 Months and 12 Months
description: Oxygen saturation (pulse oximetry) at rest and during the 6 minute walk test (6MWT)
measure: Change in DLCO
time frame: 6 Months and 12 Months
description: Diffusing capacity of the lungs for carbon monoxide (DLCO)
measure: Adverse Events Related to BIO 300 Oral Suspension
time frame: 12 Months
description: Evaluate the safety of BIO 300 Oral Suspension treatment
measure: Change in Clinical Laboratory Values
time frame: 4 Weeks, 8 Weeks, 12 Weeks, 6 Months and 12 Months
description: Monitoring of blood serum levels for bilirubin, C-reactive protein (CRP), creatinine, blood urea nitrogen (BUN), cholesterol and triglycerides (all reported as mg/dL)
measure: Change in Clinical Laboratory Values
time frame: 4 Weeks, 8 Weeks, 12 Weeks, 6 Months and 12 Months
description: Monitoring of blood serum levels for troponin T, d-dimer and ferritin (all reported as ng/mL)
measure: Change in Clinical Laboratory Values for Albumin
time frame: 4 Weeks, 8 Weeks, 12 Weeks, 6 Months and 12 Months
description: Monitoring of blood serum levels for albumin (g/dL)
measure: Change in Clinical Laboratory Values for Serum Enzymes
time frame: 4 Weeks, 8 Weeks, 12 Weeks, 6 Months and 12 Months
description: Monitoring of blood serum levels for alkaline phosphatase (ALP), alanine transaminase (ALT), aspartate aminotransferase (AST) and lactate dehydrogenase (LDH) (all reported as Units/L)
measure: Change in Complete Blood Counts with Differential
time frame: 4 Weeks, 8 Weeks, 12 Weeks, 6 Months and 12 Months
description: Monitoring of white blood cell, red blood cell and platelet counts
measure: Change in Supplemental Oxygen Use
time frame: 12 Weeks, 6 Months and 12 Months
description: Prescribed supplemental oxygen flow rate at night, rest and exertion
measure: Change in Duration of Supplemental Oxygen Use
time frame: 12 Weeks, 6 Months and 12 Months
description: Duration of supplemental oxygen use
measure: Change in Serum Cytokine Expression
time frame: 4 Weeks, 8 Weeks, 12 Weeks, 6 Months and 12 Months
description: Expression levels of serum-derived cytokines (IL-1b, IL-6, IL-8, TNFa, and TGFb1)
arm group label: BIO 300 Oral Suspension (genistein 1500 mg)
arm group type: Experimental
description: BIO 300 Oral Suspension (genistein 1500 mg) will be self-administered daily for 7 days each week for 12 weeks.
arm group label: Placebo
arm group type: Placebo Comparator
description: BIO 300 Oral Suspension matched placebo will be self-administered daily for 7 days each week for 12 weeks.
intervention type: Drug
intervention name: BIO 300 Oral Suspension
description: Suspension of genistein nanoparticles
arm group label: BIO 300 Oral Suspension (genistein 1500 mg)
intervention type: Drug
intervention name: Placebo
description: Matched placebo for BIO 300 Oral Suspension
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Michael D Kaytor, Ph.D.
phone: 952-400-0405
email: mkaytor@humaneticscorp.com
facility: 
status: Completed
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
investigator: 
facility: 
status: Active, not recruiting
country: United States
responsible party type: Sponsor
mesh term: COVID-19
mesh term: Post-Acute COVID-19 Syndrome
mesh term: Pulmonary Fibrosis
sharing ipd: No