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BIO 300 Oral Suspension in Discharged COVID-19 Patients

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ClinicalTrials.gov Identifier: NCT04482595
Recruitment Status : Recruiting
First Posted : July 22, 2020
Last Update Posted : July 16, 2021
Sponsor:
Collaborators:
NYU Langone Health
National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by (Responsible Party):
Humanetics Corporation

Brief Summary:
Randomized, double-blinded, placebo-controlled, two-arm study to evaluate the effectiveness and safety of BIO 300 Oral Suspension (BIO 300) for the mitigation of impaired pulmonary function in 2019 Coronavirus Disease (COVID-19) patients recently discharged from the hospital. Patients will be randomized 1:1 to receive BIO 300 or placebo. All patients will receive the same background current standard of care.

Condition or disease Intervention/treatment Phase
Pulmonary Fibrosis Drug: BIO 300 Oral Suspension Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 66 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized, placebo-controlled
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 2 Study of BIO 300 Oral Suspension in Discharged COVID-19 Patients
Actual Study Start Date : November 11, 2020
Estimated Primary Completion Date : August 2021
Estimated Study Completion Date : May 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: BIO 300 Oral Suspension (genistein 1500 mg)
BIO 300 Oral Suspension (genistein 1500 mg) will be self-administered daily for 7 days each week for 12 weeks.
Drug: BIO 300 Oral Suspension
Suspension of genistein nanoparticles

Placebo Comparator: Placebo
BIO 300 Oral Suspension matched placebo will be self-administered daily for 7 days each week for 12 weeks.
Drug: Placebo
Matched placebo for BIO 300 Oral Suspension




Primary Outcome Measures :
  1. Change in DLCO [ Time Frame: 12 Weeks ]
    Diffusing capacity of the lungs for carbon monoxide (DLCO)

  2. Change in 6 Minute Walk Test [ Time Frame: 12 Weeks ]
    6 minute walk test (6MWT)


Secondary Outcome Measures :
  1. Change in FVC [ Time Frame: 12 Weeks, 6 Months and 12 Months ]
    Forced vital capacity (FVC)

  2. Change in St. George's Respiratory Questionnaire (SGRQ) Scores [ Time Frame: 12 Weeks, 6 Months and 12 Months ]
    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.

  3. Change in Pulmonary Fibrosis on HRCT Scan [ Time Frame: 12 Weeks, 6 Months and 12 Months ]
    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

  4. Incidence of Re-Hospitalization [ Time Frame: 12 Months ]
    Incidence of hospitalization after initial discharge and initiating treatment

  5. All-Cause Mortality [ Time Frame: 12 Months ]
    Mortality at 12 months after initiating treatment

  6. Change in FEV1 [ Time Frame: 12 Weeks, 6 Months and 12 Months ]
    Forced expiratory volume in one second (FEV1)

  7. Change in FEV1/FVC Ratio [ Time Frame: 12 Weeks, 6 Months and 12 Months ]
    Ratio of forced expiratory volume in one second (FEV1) to forced vital capacity (FVC)

  8. Change in 6 Minute Walk Test [ Time Frame: 6 Months and 12 Months ]
    6 minute walk test (6MWT)

  9. Change in Pulse Oximetry at Rest and During the 6MWT [ Time Frame: 12 Weeks, 6 Months and 12 Months ]
    Oxygen saturation (pulse oximetry) at rest and during the 6 minute walk test (6MWT)

  10. Change in DLCO [ Time Frame: 6 Months and 12 Months ]
    Diffusing capacity of the lungs for carbon monoxide (DLCO)

  11. Adverse Events Related to BIO 300 Oral Suspension [ Time Frame: 12 Months ]
    Evaluate the safety of BIO 300 Oral Suspension treatment

  12. Change in Clinical Laboratory Values [ Time Frame: 4 Weeks, 8 Weeks, 12 Weeks, 6 Months and 12 Months ]
    Monitoring of blood serum levels for bilirubin, C-reactive protein (CRP), creatinine, blood urea nitrogen (BUN), cholesterol and triglycerides (all reported as mg/dL)

  13. Change in Clinical Laboratory Values [ Time Frame: 4 Weeks, 8 Weeks, 12 Weeks, 6 Months and 12 Months ]
    Monitoring of blood serum levels for troponin T, d-dimer and ferritin (all reported as ng/mL)

  14. Change in Clinical Laboratory Values for Albumin [ Time Frame: 4 Weeks, 8 Weeks, 12 Weeks, 6 Months and 12 Months ]
    Monitoring of blood serum levels for albumin (g/dL)

  15. Change in Clinical Laboratory Values for Serum Enzymes [ Time Frame: 4 Weeks, 8 Weeks, 12 Weeks, 6 Months and 12 Months ]
    Monitoring of blood serum levels for alkaline phosphatase (ALP), alanine transaminase (ALT), aspartate aminotransferase (AST) and lactate dehydrogenase (LDH) (all reported as Units/L)

  16. Change in Complete Blood Counts with Differential [ Time Frame: 4 Weeks, 8 Weeks, 12 Weeks, 6 Months and 12 Months ]
    Monitoring of white blood cell, red blood cell and platelet counts


Other Outcome Measures:
  1. Change in Supplemental Oxygen Use [ Time Frame: 12 Weeks, 6 Months and 12 Months ]
    Prescribed supplemental oxygen flow rate at night, rest and exertion

  2. Change in Duration of Supplemental Oxygen Use [ Time Frame: 12 Weeks, 6 Months and 12 Months ]
    Duration of supplemental oxygen use

  3. Change in Serum Cytokine Expression [ Time Frame: 4 Weeks, 8 Weeks, 12 Weeks, 6 Months and 12 Months ]
    Expression levels of serum-derived cytokines (IL-1b, IL-6, IL-8, TNFa, and TGFb1)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age ≥ 18
  2. Patients hospitalized for COVID-19-related complications ready to be discharged and those within 56 days of discharge (even if the patient was referred to subacute or acute respiratory rehabilitation after discharge)
  3. Patients who had a clinical diagnosis of COVID-19-related acute respiratory distress syndrome (ARDS) when hospitalized
  4. Radiographic signs of lung injury after standard treatment of COVID-19 such as, ground glass opacity, consolidation, or fibrotic shadows
  5. Able to perform a PFT and have a DLCO <60% of predicted at discharge
  6. Able to perform a 6-minute walk test
  7. Blood routine, liver and kidney function test values are within the controllable range

    1. Adequate hepatic function as evidenced by ALT, AST and LDH < 2X ULN and bilirubin < 1.5X ULN for the reference lab
    2. Adequate renal function as evidenced by a serum creatinine ≤ 1.5 X ULN for the reference laboratory OR a calculated creatinine clearance of ≥ 60 mL/min by the Cockcroft-Gault Equation
    3. Adequate hematopoietic function as evidenced by white blood cells ≥ 3x10^9 / L and platelets ≥ 100x10^9 / L
  8. Female patients of childbearing potential must have a negative pregnancy test on Day 1 (screening visit) of protocol
  9. Female patients of childbearing potential and male participants with female sexual partners of childbearing potential must agree to use an effective method of non-estrogen-based contraception (e.g., condom and a diaphragm, condom and intrauterine device, condom and Depo-Provera, condom and Nexplanon, or condom and progesterone mini-pill) during the 12-week portion of the study that they are receiving study medication and for 30 days following the last dose of study medication, or to abstain from sexual intercourse during these time periods. Women who have been off estrogen contraceptives for a minimum 5 days are eligible. A woman not of childbearing potential is one who has undergone bilateral oophorectomies or who is post-menopausal, defined as no menstrual periods for 12 consecutive months
  10. Ability of the patient or the patient's legal representative to read and provide written informed consent

Exclusion Criteria:

  1. Severe background disease like severe cardiac or pulmonary insufficiency (WHO grade III or IV), severe liver and kidney diseases, severe COPD, severe neurological disease, or concurrent malignancy (other than non-melanoma skin cancer) which is uncontrolled or actively being treated
  2. Severe asthma on chronic therapy with biologics or steroids.
  3. Prior malignancy in which any thoracic radiotherapy was administered except for partial or tangent breast irradiation for early-stage (stages I or II) breast cancer
  4. D-dimer levels of >2,000 ng/mL at screening
  5. Use of anti-pulmonary fibrosis drugs in the past 5 days, (e.g., imatinib, nintedanib, pirfenidone, penicillamine, colchicine, tumor necrosis factor alpha blocker)
  6. Use of anti-cytokine release syndrome drugs in the past 5 days (e.g., anakinra, sarilumab, siltuximab, tocilizumab and/or lenzilumab)
  7. Use of systemic corticosteroids (e.g., prednisone, dexamethasone) in the past 5 days
  8. An active infection or infection with a fever ≥ 38.5°C within 3 days of the first scheduled day of dosing
  9. Poorly controlled intercurrent illnesses, such as interstitial lung disease, uncontrolled hypertension; poorly controlled diabetes mellitus; unstable angina, myocardial infarction, acute coronary syndrome or cerebrovascular event within 6 months of Screening; history of congestive heart failure (NYHA Class III or IV); severe valvular heart disease; or poorly controlled cardiac arrhythmias not responding to medical therapy or a pacemaker
  10. QTc with Fridericia's correction that is unmeasurable, or ≥480 msec on screening ECG. The average QTc from the screening ECG (completed in triplicate) must be <480 msec for the patient to be eligible for the study
  11. Patients taking any concomitant medication that may cause QTc prolongation, induce Torsades de Pointes (www.crediblemeds.org) are not eligible if QTc ≥460 msec
  12. Patients who have undergone thoracotomy within 4 weeks of Day 1 of protocol therapy
  13. Patients that have a known allergy to any of the placebo components
  14. Psychiatric conditions, social situations or substance abuse that precludes the ability of the study participant to cooperate with the requirements of the trial and protocol therapy
  15. Pregnancy or currently on estrogen-based contraceptives
  16. Women who are breastfeeding
  17. Past or current medical problems or findings from physical examination or laboratory testing that are not listed above, which, in the opinion of the investigator, may pose additional risks from participation in the study, may interfere with the participant's ability to comply with study requirements or that may impact the quality or interpretation of the data obtained from the study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04482595


Contacts
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Contact: Michael D Kaytor, Ph.D. 952-400-0406 mkaytor@humaneticscorp.com

Locations
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United States, Colorado
University of Colorado Anschutz Medical Campus Recruiting
Aurora, Colorado, United States, 80045
Contact: Jeff McKeehan    303-724-6080    jeffrey.mckeehan@cuanschutz.edu   
Principal Investigator: Ellen L. Burnham, MD, MSc         
Sub-Investigator: Sarah Jolley, MD, MSc         
United States, New York
NYU Langone Health Recruiting
New York, New York, United States, 10016
Contact: Raveena Vakil    212-263-8119    raveena.vakil@nyulangone.org   
Principal Investigator: Rany Condos, MD         
United States, Texas
Houston Methodist Research Institute Not yet recruiting
Houston, Texas, United States, 77210
Sponsors and Collaborators
Humanetics Corporation
NYU Langone Health
National Institute of Allergy and Infectious Diseases (NIAID)
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Responsible Party: Humanetics Corporation
ClinicalTrials.gov Identifier: NCT04482595    
Other Study ID Numbers: CL0105-01
272201800011C-P00005-9999-1 ( U.S. NIH Grant/Contract )
First Posted: July 22, 2020    Key Record Dates
Last Update Posted: July 16, 2021
Last Verified: July 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pulmonary Fibrosis
Lung Diseases
Respiratory Tract Diseases