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Study to Evaluate the Safety, Tolerability, and Efficacy of BGE-175 in Participants ≥ 60 Years of Age and Hospitalized With Coronavirus Disease 2019 (COVID-19) That Are Not in Respiratory Failure

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ClinicalTrials.gov Identifier: NCT04705597
Recruitment Status : Not yet recruiting
First Posted : January 12, 2021
Last Update Posted : January 12, 2021
Sponsor:
Information provided by (Responsible Party):
BioAge Labs, Inc.

Brief Summary:
The primary objectives of this study are to evaluate the safety, tolerability, and efficacy of BGE-175 in participants ≥ 60 years of age hospitalized with documented COVID-19.

Condition or disease Intervention/treatment Phase
Covid19 Drug: BGE-175 Other: Placebo Phase 2

Detailed Description:

This is a randomized, placebo-controlled, parallel-group, multicenter, double-blind study of BGE-175 administered PO or NG in participants ≥ 60 years of age and hospitalized with documented COVID-19 who are not yet in respiratory failure.

After signing informed consent, participants will be screened upon presentation at the hospital. Screening will include full physical examination, vital signs, safety laboratory evaluation, oxygen saturation, pre-diagnostics to measure prostaglandin D2 (PGD2) status, and baseline assessment of World Health Organization (WHO) Ordinal Scale for COVID-19. If confirmed that the participant qualifies for this protocol according to listed inclusion and exclusion criteria, participants will receive the first dose of study medication, PO. The participant will then receive study medication PO or NG (if intubated or unable to swallow medication) once daily, at approximately the same time each day for up to 13 additional days. Study medication will be administered in addition to standard of care deemed appropriate by the treating physician(s). Participants will be randomized to receive BGE-175 or placebo. Participants will be monitored daily for all relevant efficacy outcomes, oxygen saturation, and adverse events. Blood will be drawn periodically for safety laboratory measurements, plasma kinetics, lymphocyte subsets, C-reactive protein, and cytokines. Nasopharyngeal swabs will be collected to measure viral load. Participants will be monitored for 14 days after administration of the last dose (Day 28) and followed through Day 57.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 132 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Multicenter, Randomized, Double-blind, Placebo-controlled
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Double-blind
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 2 Study to Investigate the Efficacy and Safety of BGE-175 in Hospitalized Patients Over 60 Years of Age With COVID-19
Estimated Study Start Date : February 2021
Estimated Primary Completion Date : February 2022
Estimated Study Completion Date : April 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: BGE-175
BGE-175 tablet to be taken by mouth once a day for 14 days
Drug: BGE-175
Drug

Placebo Comparator: Placebo
Placebo tablet to be taken by mouth once a day for 14 days
Other: Placebo
Placebo




Primary Outcome Measures :
  1. Proportion of participants who have died or progressed to respiratory failure [ Time Frame: First dose date up to Day 28 ]
    Proportion of participants who have died or progressed to respiratory failure as defined by progressing to the need for high-flow nasal cannula O2 delivery (including venturi mask delivery, nonrebreather delivery, or low resistance nasal cannula delivery), noninvasive ventilation, mechanical ventilation, or extracorporeal membrane oxygenation (ECMO) at Day 28.


Secondary Outcome Measures :
  1. Proportion of participants experiencing treatment-emergent adverse events [ Time Frame: Day 57 ]
    Proportion of participants experiencing treatment-emergent adverse events as measured by the Common Terminology Criteria for Adverse Events (CTCAE) v 5.0

  2. Survival [ Time Frame: Day 14, Day 28, Day 57 ]
    Proportion of participants surviving at

  3. Viral load [ Time Frame: Day 28 ]
    Time to two successive negative viral titers in nasopharyngeal swab

  4. Clinical worsening on a 9-point ordinal scale [ Time Frame: First dose date up to Day 57 ]
    Time to clinical worsening from baseline value (defined by time to ≥ 1-point worsening on WHO Ordinal Scale for COVID-19). The ordinal scale is an assessment of the clinical status at a given day. Each day, the worst score from the previous day will be recorded. The scale is as follows: 0.) Uninfected 1.) Ambulatory with no limitation of activities 2.) Ambulatory with limitation of activities 3.) Hospitalized, mild disease with no oxygen therapy 4.) Hospitalized, mild disease with oxygen by mask or nasal prongs 5.) Hospitalized, severe disease with noninvasive ventilation or high-flow oxygen 6.) Hospitalized, severe disease with intubation and mechanical ventilation 7.) Hospitalized, severe disease with ventilation and additional organ support (pressors, renal retention therapy, extracorporeal membrane oxygenation) 8.) Death.

  5. Clinical improvement [ Time Frame: First dose date up to Day 57 ]
    Defined by time to ≥ 1-point worsening on WHO Ordinal Scale for COVID-19

  6. Clinical improvement [ Time Frame: Day 14/End of Treatment, Day 28, Day 57 ]
    Mean change in WHO Ordinal Scale for COVID-19 score

  7. Time to extubation [ Time Frame: First dose date up to Day 57 ]
    Time from dressing complete to the recorded time of endotracheal tube removal

  8. Time to discharge from hospital intensive care unit [ Time Frame: First dose date up to Day 57 ]
    Time from intensive care unit admission to the recorded time of intensive care unit discharge

  9. Incidence of supplemental oxygen administration [ Time Frame: First dose date up to Day 57 ]
    Incidence of participants receiving supplemental oxygen

  10. Duration of supplemental oxygen administration [ Time Frame: First dose date up to Day 57 ]
    Duration of participants receiving supplemental oxygen

  11. Duration of noninvasive ventilation by nonrebreather mask or high-flow nasal cannula [ Time Frame: First dose date up to Day 57 ]
    Duration of participants receiving noninvasive ventilation by nonrebreather mask or high-flow nasal cannula

  12. Incidence of noninvasive ventilation by nonrebreather mask or high-flow nasal cannula [ Time Frame: First dose date up to Day 57 ]
    Incidence of participants receiving noninvasive ventilation by nonrebreather mask or high-flow nasal cannula

  13. Duration of mechanical ventilation plus additional organ support using vasopressors, and/or renal replacement therapy and/or ECMO [ Time Frame: First dose date up to Day 57 ]
    Duration of participants receiving mechanical ventilation plus additional organ support using vasopressors, and/or renal replacement therapy and/or ECMO

  14. Incidence of mechanical ventilation plus additional organ support using vasopressors, and/or renal replacement therapy and/or ECMO [ Time Frame: First dose date up to Day 57 ]
    Incidence of participants receiving mechanical ventilation plus additional organ support using vasopressors, and/or renal replacement therapy and/or ECMO

  15. Daily ratio of oxygen saturation (SpO2) to fractional inspired O2 (SpO2/FiO2) [ Time Frame: First dose date up to Day 28 ]
    Daily ratio of participants' oxygen saturation (SpO2) to fractional inspired O2 (SpO2/FiO2)

  16. Time to discharge from the hospital [ Time Frame: First dose date up to Day 57 ]
    Length (in days) of the time of hospitalization until medical discharge

  17. Time to re-hospitalization [ Time Frame: First dose date up to Day 57 ]
    Length (in days) of the time from medical discharge from hospital to rehospitalization

  18. Proportion of participants requiring intensive care unit admission [ Time Frame: Day 57 ]
    Proportion of participants admitted to hospital intensive care unit


Other Outcome Measures:
  1. Measure of Inflammation Markers [ Time Frame: Day 28 ]
    Inflammation marker IL-6

  2. Measure of Inflammation Markers [ Time Frame: Day 28 ]
    Inflammation marker CRP

  3. Measure of Inflammation Markers [ Time Frame: Day 28 ]
    Inflammation marker IL-10

  4. Measure of Inflammation Markers [ Time Frame: Day 28 ]
    Inflammation marker TNF-α

  5. Measure of Inflammation Markers [ Time Frame: Day 28 ]
    Inflammation marker IFN-γ

  6. Measure of Inflammation Markers [ Time Frame: Day 28 ]
    Inflammation marker IFN-α

  7. Measure of Inflammation Markers [ Time Frame: Day 28 ]
    Inflammation marker IP-10

  8. Measure of Inflammation Markers [ Time Frame: Day 28 ]
    Inflammation marker MCP-1

  9. Measure of Inflammation Markers [ Time Frame: Day 28 ]
    Inflammation marker CD4+ T cells

  10. Measure of Inflammation Markers [ Time Frame: Day 28 ]
    Inflammation marker CD8+ T cells

  11. Measure of Inflammation Markers [ Time Frame: Day 28 ]
    Absolute lymphocyte count

  12. Concentration of BGE-175 [ Time Frame: Day 14 ]
    Assess peak and trough concentrations of BGE-175 at steady-state

  13. Activity of prostaglandin D2 [ Time Frame: Day 1 ]
    Assess prostaglandin D2 pre-diagnostic to assess correlation with response to treatment for COVID-19 based on change in the WHO Ordinal Scale for COVID-19 score

  14. Proportion of participants experiencing any treatment-emergent adverse events [ Time Frame: First dose date up to Day 57 ]
    Proportion of participants experiencing any treatment-emergent adverse events as measured by the Common Terminology Criteria for Adverse Events (CTCAE) v 5.0

  15. Proportion of participants experiencing any adverse events [ Time Frame: First dose date up to Day 57 ]
    Proportion of participants experiencing any adverse events as measured by the Common Terminology Criteria for Adverse Events (CTCAE) v 5.0

  16. Proportion of participants experiencing any treatment-emergent graded laboratory abnormalities [ Time Frame: First dose date up to Day 57 ]
    Proportion of participants experiencing any treatment-emergent graded laboratory abnormalities as defined by laboratory parameters/reference ranges



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Ability to voluntarily provide informed consent that is documented per local requirements
  • An understanding, ability, and willingness to fully comply with study procedures and restrictions
  • Hospitalized subjects with a confirmed SARS-CoV-2 infection
  • Laboratory (polymerase chain reaction [PCR]) confirmed infection with SARS-CoV-2
  • Age ≥ 60 years
  • COVID-19 illness of any duration, and oxygen saturation measurements ≤ 94% over 5 minutes on room air (Note: low flow oxygen is permitted, but room air oxygen saturation must be ≤ 94%)
  • Not in respiratory failure as defined by at least one of the following:

    1. Respiratory failure defined by requiring at least one of the following:

      • Endotracheal intubation and mechanical ventilation
      • Oxygen delivered by high-flow nasal cannula at flow rates > 20 L/min with fraction of delivered oxygen ≥ 0.5)
      • NIPPV
      • ECMO
      • Clinical diagnosis of respiratory failure (i.e., need for one of the preceding therapies, but preceding therapies are not being administered because it is unavailable in the current setting)
    2. Hemodynamic compromise (defined by systolic blood pressure < 90 mm Hg, or diastolic blood pressure < 60 mm Hg) or requiring vasopressors
    3. Multi-organ dysfunction/failure
  • Females subjects of childbearing potential must have a negative pregnancy test at screening or pre-treatment on Day 1
  • Male and female subjects of childbearing potential must agree to use methods of contraception that are consistent with local regulations for those participating in clinical studies

Exclusion Criteria:

  • Participation in any other randomized, controlled clinical trial of an experimental treatment for COVID-19 (uncontrolled, compassionate use trials are allowed)
  • In the opinion of the investigator, progression to death is imminent and inevitable within the next 24 hours, irrespective of the provision of treatments
  • Currently participating in a vaccination trial for SARS-CoV-2
  • Subject requires oxygen administration by high flow nasal cannula (> 20 L/min)
  • Positive influenza test at screening
  • Positive for human immunodeficiency virus (HIV) that is not controlled with current treatment
  • Hepatitis B surface antigen, or Hepatitis C positive at the time of screening. Subjects who are positive for Hepatitis C but have Hepatitis C virus (HCV) RNA below the limit of quantitation may be enrolled. Subjects with Hepatitis B, but with undetectable viral load, may be enrolled.
  • Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 5 × the upper limit of normal (ULN)
  • Stage 4 severe chronic kidney disease (i.e., estimated glomerular filtration rate [eGFR] < 30 mL/min) or acute renal failure resulting in eGFR < 30 mL/min
  • Serious comorbidity, including:

    1. Myocardial infarction (within the last month)
    2. Moderate or severe heart failure (New York Heart Association [NYHA] class III or IV)
    3. Acute stroke (within the last month)
    4. Uncontrolled malignancy. Uncontrolled malignancy would include cancers that are not considered in remission, or solid tumor or hematological malignancies with evidence of disease progression in the past 3 months (i.e., there is evidence disease progression by Response Evaluation Criteria in Solid Tumours [RECIST] or equivalent relevant criterion for the type of malignancy), and are not considered effectively managed with ongoing treatment as determined by the investigator
    5. Recent severe thromboembolic disease or evidence of severe thromboembolic disease defined as a current large vessel thromboembolic event or a thromboembolic event within the past 3 months (e.g., deep vein thrombosis [DVT], pulmonary embolism, ischemic stroke, transient ischemic attack) requiring interventional treatment. This exclusion does not prohibit prophylaxis for thromboembolic events, including those considered possible with concurrent SARS-CoV-2 infection.
  • History of severe allergic or anaphylactic reactions or hypersensitivity to the study drug
  • Consideration by the investigator, for any reason, that the subject is an unsuitable candidate to receive study treatment

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): NCT04705597


Contacts
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Contact: Patrick Martin, MD 215-260-5134 patrick@bioagelabs.com

Locations
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United States, Maryland
University of Maryland Medical System
Baltimore, Maryland, United States, 21201
Contact: Dana Beach, RN, BSN, CCRC    410-328-7635    dbeach3@som.umaryland.edu   
Sponsors and Collaborators
BioAge Labs, Inc.
Investigators
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Principal Investigator: Richard G Wilkerson, MD University of Maryland, College Park
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Responsible Party: BioAge Labs, Inc.
ClinicalTrials.gov Identifier: NCT04705597    
Other Study ID Numbers: BGE-175-201
First Posted: January 12, 2021    Key Record Dates
Last Update Posted: January 12, 2021
Last Verified: January 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
Keywords provided by BioAge Labs, Inc.:
COVID-19
BGE-175
BioAge
Respiratory failure
Additional relevant MeSH terms:
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Respiratory Insufficiency
Respiration Disorders
Respiratory Tract Diseases