Back to resultsStudy to Evaluate the Safety, Tolerability, and Efficacy of BGE-175 in Hospitalized Adults With Coronavirus Disease 2019 (COVID-19) That Are Not in Respiratory Failure
Primary Purpose
Covid19
Status
Terminated
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
BGE-175
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Covid19 focused on measuring COVID-19, BGE-175, BioAge, Respiratory failure
Eligibility 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 ≥ 50 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:
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)
- Hemodynamic compromise (defined by systolic blood pressure < 90 mm Hg, or diastolic blood pressure < 60 mm Hg) or requiring vasopressors
- 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
- Known positive test for influenza A or influenza B at the time of 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:
- Myocardial infarction (within the last month)
- Moderate or severe heart failure (New York Heart Association [NYHA] class III or IV)
- Acute stroke (within the last month)
- 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 of 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
- 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
Sites / Locations
- Banner Health
- Velocity Clinical Research, Chula Vista
- Long Beach Medical Center
- UCI Center for Clinical Research
- Sharp Memorial Hospital
- North Colorado Medical Center
- Stamford Hospital
- University of Florida - Health, Jacksonville
- Baptist Health, Lexington
- University of Maryland Medical System
- Jadestone Clinical Research, LLC
- Clinica Privada Independencia
- Sanatorio De La Trinidad Mitre
- Clinica Adventista Belgrano (CAB)
- Hospital Universitário Cassiano Antônio de Moraes
- Hospital Felicio Rocho (HFR)
- Centro de Pesquisa Hospital Ana Nery Santa Cruz do Sul
- Hospital Ernesto Dornelles
- Clínica Supera Oncologia
- Unidade de Pesquisa Clinica da Fundação Pio XII - Hospital de Amor de Barretos
- Hospital das Clínicas da Faculdade de Medicina de Botucatu UNESP (HC-FMB/UNESP)
- Pontificia Universidade Catolica de Campinas (PUC-CAMP) - Hospital e Maternidade Celso Pierro (HMCP) - Centro de Pesquisa São Lucas
- Clinica de Alergia Martti Antila
- Conjunto Hospitalar de Mandaqui
- Fundação Faculdade Regional de Medicina de São José do Rio Preto
- Instituto Nacional de Infectologia Evandro Chagas / Fundação Oswaldo Cruz (FIOCRUZ)
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
BGE-175
Placebo
Arm Description
BGE-175 tablet to be taken by mouth once a day for 14 days
Placebo tablet to be taken by mouth once a day for 14 days
Outcomes
Primary Outcome Measures
Proportion of Participants Who Have Died or Progressed to Respiratory Failure
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, noninvasive ventilation, mechanical ventilation, or extracorporeal membrane oxygenation (ECMO) at Day 28.
The proportion of participants is represented as a percentage.
Secondary Outcome Measures
Proportion of Participants Experiencing Treatment-emergent Adverse Events
Proportion of participants experiencing treatment-emergent adverse events as measured by the Common Terminology Criteria for Adverse Events (CTCAE) v 5.0.
The proportion of participants is represented as a percentage.
Survival
Proportion of participants surviving at Day 14, Day 28, and Day 57. The proportion of participants is represented as a percentage.
Proportion of Subjects Who Survive Without Progression to Respiratory Failure Through Day 28
Proportion of subjects who survive without progression to respiratory failure at Day 28.
The proportion of participants is represented as a percentage.
Time to Two Successive Negative Viral Titers in Nasopharyngeal Swabs
Kaplan-Meier Estimate of Time to Two Successive Negative Viral Titers in Nasopharyngeal Swab (median)
Time to Clinical Worsening From Baseline Value (Defined by Time to ≥ 1-point Worsening on WHO Ordinal Scale for COVID-19)
Kaplan-Meier Estimate of Time to Clinical Worsening from Baseline Value. Time to clinical worsening from baseline value (defined by time to ≥ 1-point worsening on World Health Organization (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. A higher score means a worse outcome.
Proportion of Patients Who Develop Critical COVID-19 Illness
Proportion of patients who develop critical COVID-19 illness as defined by at least one of the following:
A. RF defined based on resource utilization requiring at least one of the following: Endotracheal intubation and mechanical ventilation, oxygen delivered by high-flow nasal cannula (heated, humidified, oxygen delivered via reinforced nasal cannula at flow rates > 20 L/min with fraction of delivered oxygen ≥ 0.5), noninvasive positive pressure ventilation, ECMO, clinical diagnosis respiratory failure (i.e., clinical need for one of the preceding therapies, but preceding therapies not able to be administered in setting of resource limitation) B. Hemodynamic compromise (defined by systolic blood pressure < 90 mm Hg, or diastolic blood pressure < 60 mm Hg or requiring vasopressors) C. Multi-organ dysfunction/failure
The proportion of participants is represented as a percentage.
Time to Clinical Improvement From Baseline Value (Defined by Time to ≥ 1-point Improvement on WHO Ordinal Scale for COVID-19 Score - Must be Maintained Through Day 28)
Kaplan-Meier Estimate of Time to Clinical Improvement from Baseline Value. Time to clinical improvement defined by time to ≥ 1-point improvement on World Health Organization (WHO) Ordinal Scale for COVID-19 - must be maintained through Day 28. 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. A higher score means a worse outcome.
Mean Change From Baseline in WHO Ordinal Scale for COVID-19 Score
Mean change from baseline in WHO Ordinal Scale for COVID-19 score
World Health Organization (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. A higher score means a worse outcome.
Number of Patients Who Had Intubation During the Study
Proportion of Patients who had Intubation during the study defined as proportion of patients who had any documented intubation during the study.
Duration of Intubation
Duration of Intubation (first post-dosing intubation)
Time to Discharge From Hospital Intensive Care Unit
Time from intensive care unit admission to the recorded time of intensive care unit discharge
Number of Patients Who Had Supplemental Oxygen Administration
Proportion of patients who had any documented post-dosing supplemental O2 administration during the study.
Duration of Supplemental Oxygen Administration
Duration of participants receiving supplemental oxygen
Number of Patients Who Had Noninvasive Ventilation or High-flow Nasal Cannula O2 Administration
Proportion of patients who had any documented post-dosing noninvasive ventilation or high-flow nasal cannula O2 administration.
Duration of Noninvasive Ventilation by Nonrebreather Mask or High-flow Nasal Cannula
Duration of participants receiving noninvasive ventilation by nonrebreather mask or high-flow nasal cannula
Number of Patients Who Had Mechanical Ventilation.
Proportion of patients who had any documented post-dosing mechanical ventilation.
Duration of Mechanical Ventilation
Duration of participants receiving mechanical ventilation
Number of Patients Who Had Mechanical Ventilation Plus Additional Organ Support Using Vasopressors, and/or Renal Replacement Therapy and/or ECMO.
Proportion of patients who had any documented post-dosing mechanical ventilation plus additional organ support using vasopressors, and/or renal replacement therapy and/or ECMO.
Duration of Mechanical Ventilation Plus Additional Organ Support Using Vasopressors, and/or Renal Replacement Therapy and/or ECMO
Duration of participants receiving mechanical ventilation plus additional organ support using vasopressors, and/or renal replacement therapy and/or ECMO
Daily Ratio of Oxygen Saturation (SpO2) to Fractional Inspired O2 (SpO2/FiO2)
Daily ratio of participants' oxygen saturation (SpO2) to fractional inspired O2 (SpO2/FiO2)
Time to Discharge From the Hospital
Length (in days) of the time of hospitalization until medical discharge
Number of Patients With Re-hospitalization
Proportion of patients who are hospitalized again after the discharge of first hospitalization.
Proportion of Participants Requiring Intensive Care Unit Admission
Proportion of participants admitted to hospital intensive care unit post randomization.
The proportion of participants is represented as a percentage.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04705597
Brief Title
Study to Evaluate the Safety, Tolerability, and Efficacy of BGE-175 in Hospitalized Adults With Coronavirus Disease 2019 (COVID-19) That Are Not in Respiratory Failure
Official Title
A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 2 Study to Investigate the Efficacy and Safety of BGE-175 in Hospitalized Adults With COVID-19
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Terminated
Why Stopped
The incidence of COVID-19 hospitalization cases decreased to a level that continued enrollment was no longer feasible
Study Start Date
March 18, 2021 (Actual)
Primary Completion Date
April 20, 2022 (Actual)
Study Completion Date
May 19, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
BioAge Labs, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The primary objectives of this study are to evaluate the safety, tolerability, and efficacy of BGE-175 in participants ≥ 50 years of age hospitalized with documented COVID-19.
Detailed Description
This is a randomized, placebo-controlled, parallel-group, multicenter, double-blind study of BGE-175 administered PO or NG in participants ≥ 50 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19
Keywords
COVID-19, BGE-175, BioAge, Respiratory failure
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Multicenter, Randomized, Double-blind, Placebo-controlled
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Double-blind
Allocation
Randomized
Enrollment
194 (Actual)
8. Arms, Groups, and Interventions
Arm Title
BGE-175
Arm Type
Experimental
Arm Description
BGE-175 tablet to be taken by mouth once a day for 14 days
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo tablet to be taken by mouth once a day for 14 days
Intervention Type
Drug
Intervention Name(s)
BGE-175
Intervention Description
Drug
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
Proportion of Participants Who Have Died or Progressed to Respiratory Failure
Description
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, noninvasive ventilation, mechanical ventilation, or extracorporeal membrane oxygenation (ECMO) at Day 28.
The proportion of participants is represented as a percentage.
Time Frame
First dose date up to Day 28
Secondary Outcome Measure Information:
Title
Proportion of Participants Experiencing Treatment-emergent Adverse Events
Description
Proportion of participants experiencing treatment-emergent adverse events as measured by the Common Terminology Criteria for Adverse Events (CTCAE) v 5.0.
The proportion of participants is represented as a percentage.
Time Frame
First dose of treatment through study Day 57
Title
Survival
Description
Proportion of participants surviving at Day 14, Day 28, and Day 57. The proportion of participants is represented as a percentage.
Time Frame
Baseline through Day 57; at Day 14, Day 28 and Day 57
Title
Proportion of Subjects Who Survive Without Progression to Respiratory Failure Through Day 28
Description
Proportion of subjects who survive without progression to respiratory failure at Day 28.
The proportion of participants is represented as a percentage.
Time Frame
First dose of treatment through Day 14, Day 28
Title
Time to Two Successive Negative Viral Titers in Nasopharyngeal Swabs
Description
Kaplan-Meier Estimate of Time to Two Successive Negative Viral Titers in Nasopharyngeal Swab (median)
Time Frame
Baseline through Day 28
Title
Time to Clinical Worsening From Baseline Value (Defined by Time to ≥ 1-point Worsening on WHO Ordinal Scale for COVID-19)
Description
Kaplan-Meier Estimate of Time to Clinical Worsening from Baseline Value. Time to clinical worsening from baseline value (defined by time to ≥ 1-point worsening on World Health Organization (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. A higher score means a worse outcome.
Time Frame
First dose date up to Day 57
Title
Proportion of Patients Who Develop Critical COVID-19 Illness
Description
Proportion of patients who develop critical COVID-19 illness as defined by at least one of the following:
A. RF defined based on resource utilization requiring at least one of the following: Endotracheal intubation and mechanical ventilation, oxygen delivered by high-flow nasal cannula (heated, humidified, oxygen delivered via reinforced nasal cannula at flow rates > 20 L/min with fraction of delivered oxygen ≥ 0.5), noninvasive positive pressure ventilation, ECMO, clinical diagnosis respiratory failure (i.e., clinical need for one of the preceding therapies, but preceding therapies not able to be administered in setting of resource limitation) B. Hemodynamic compromise (defined by systolic blood pressure < 90 mm Hg, or diastolic blood pressure < 60 mm Hg or requiring vasopressors) C. Multi-organ dysfunction/failure
The proportion of participants is represented as a percentage.
Time Frame
First dose date up to Day 57
Title
Time to Clinical Improvement From Baseline Value (Defined by Time to ≥ 1-point Improvement on WHO Ordinal Scale for COVID-19 Score - Must be Maintained Through Day 28)
Description
Kaplan-Meier Estimate of Time to Clinical Improvement from Baseline Value. Time to clinical improvement defined by time to ≥ 1-point improvement on World Health Organization (WHO) Ordinal Scale for COVID-19 - must be maintained through Day 28. 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. A higher score means a worse outcome.
Time Frame
First dose date up to Day 28
Title
Mean Change From Baseline in WHO Ordinal Scale for COVID-19 Score
Description
Mean change from baseline in WHO Ordinal Scale for COVID-19 score
World Health Organization (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. A higher score means a worse outcome.
Time Frame
Day 14/End of Treatment, Day 28, Day 57
Title
Number of Patients Who Had Intubation During the Study
Description
Proportion of Patients who had Intubation during the study defined as proportion of patients who had any documented intubation during the study.
Time Frame
First dose date up to Day 57
Title
Duration of Intubation
Description
Duration of Intubation (first post-dosing intubation)
Time Frame
First dose date up to Day 57
Title
Time to Discharge From Hospital Intensive Care Unit
Description
Time from intensive care unit admission to the recorded time of intensive care unit discharge
Time Frame
First dose date up to Day 57
Title
Number of Patients Who Had Supplemental Oxygen Administration
Description
Proportion of patients who had any documented post-dosing supplemental O2 administration during the study.
Time Frame
First dose date up to Day 57
Title
Duration of Supplemental Oxygen Administration
Description
Duration of participants receiving supplemental oxygen
Time Frame
First dose date up to Day 57
Title
Number of Patients Who Had Noninvasive Ventilation or High-flow Nasal Cannula O2 Administration
Description
Proportion of patients who had any documented post-dosing noninvasive ventilation or high-flow nasal cannula O2 administration.
Time Frame
First dose date up to Day 57
Title
Duration of Noninvasive Ventilation by Nonrebreather Mask or High-flow Nasal Cannula
Description
Duration of participants receiving noninvasive ventilation by nonrebreather mask or high-flow nasal cannula
Time Frame
First dose date up to Day 57
Title
Number of Patients Who Had Mechanical Ventilation.
Description
Proportion of patients who had any documented post-dosing mechanical ventilation.
Time Frame
First dose date up to Day 57
Title
Duration of Mechanical Ventilation
Description
Duration of participants receiving mechanical ventilation
Time Frame
First dose date up to Day 57
Title
Number of Patients Who Had Mechanical Ventilation Plus Additional Organ Support Using Vasopressors, and/or Renal Replacement Therapy and/or ECMO.
Description
Proportion of patients who had any documented post-dosing 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
Title
Duration of Mechanical Ventilation Plus Additional Organ Support Using Vasopressors, and/or Renal Replacement Therapy and/or ECMO
Description
Duration of participants receiving 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
Title
Daily Ratio of Oxygen Saturation (SpO2) to Fractional Inspired O2 (SpO2/FiO2)
Description
Daily ratio of participants' oxygen saturation (SpO2) to fractional inspired O2 (SpO2/FiO2)
Time Frame
First dose date up to Day 28
Title
Time to Discharge From the Hospital
Description
Length (in days) of the time of hospitalization until medical discharge
Time Frame
First dose date up to Day 57
Title
Number of Patients With Re-hospitalization
Description
Proportion of patients who are hospitalized again after the discharge of first hospitalization.
Time Frame
First dose date up to Day 57
Title
Proportion of Participants Requiring Intensive Care Unit Admission
Description
Proportion of participants admitted to hospital intensive care unit post randomization.
The proportion of participants is represented as a percentage.
Time Frame
First dose date up to Day 57
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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 ≥ 50 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:
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)
Hemodynamic compromise (defined by systolic blood pressure < 90 mm Hg, or diastolic blood pressure < 60 mm Hg) or requiring vasopressors
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
Known positive test for influenza A or influenza B at the time of 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:
Myocardial infarction (within the last month)
Moderate or severe heart failure (New York Heart Association [NYHA] class III or IV)
Acute stroke (within the last month)
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 of 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
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard G Wilkerson, MD
Organizational Affiliation
University of Maryland Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Banner Health
City
Mesa
State/Province
Arizona
ZIP/Postal Code
85202
Country
United States
Facility Name
Velocity Clinical Research, Chula Vista
City
Chula Vista
State/Province
California
ZIP/Postal Code
91911
Country
United States
Facility Name
Long Beach Medical Center
City
Long Beach
State/Province
California
ZIP/Postal Code
90806
Country
United States
Facility Name
UCI Center for Clinical Research
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
Sharp Memorial Hospital
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
North Colorado Medical Center
City
Greeley
State/Province
Colorado
ZIP/Postal Code
80631
Country
United States
Facility Name
Stamford Hospital
City
Stamford
State/Province
Connecticut
ZIP/Postal Code
06904
Country
United States
Facility Name
University of Florida - Health, Jacksonville
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32209
Country
United States
Facility Name
Baptist Health, Lexington
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40503
Country
United States
Facility Name
University of Maryland Medical System
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
Jadestone Clinical Research, LLC
City
Silver Spring
State/Province
Maryland
ZIP/Postal Code
20904
Country
United States
Facility Name
Clinica Privada Independencia
City
Ciudad Autonoma de Buenos Aires
State/Province
Buenos Aires
ZIP/Postal Code
C1426ABP
Country
Argentina
Facility Name
Sanatorio De La Trinidad Mitre
City
Buenos Aires
State/Province
Ciudad Autonoma De Buenos Aires
ZIP/Postal Code
C1039AAO
Country
Argentina
Facility Name
Clinica Adventista Belgrano (CAB)
City
Buenos Aires
State/Province
Ciudad Autónoma De Buenos Aires
ZIP/Postal Code
C1430EGF
Country
Argentina
Facility Name
Hospital Universitário Cassiano Antônio de Moraes
City
Vitória
State/Province
Espiritu Santo
ZIP/Postal Code
29043-260
Country
Brazil
Facility Name
Hospital Felicio Rocho (HFR)
City
Belo Horizonte
State/Province
Minas Gerais
ZIP/Postal Code
30180-080
Country
Brazil
Facility Name
Centro de Pesquisa Hospital Ana Nery Santa Cruz do Sul
City
Santa Cruz Do Sul
State/Province
Rio Grande Do Sol
ZIP/Postal Code
96835-090
Country
Brazil
Facility Name
Hospital Ernesto Dornelles
City
Porto Alegre
State/Province
Rio Grande Do Sul
ZIP/Postal Code
90160-093
Country
Brazil
Facility Name
Clínica Supera Oncologia
City
Chapecó
State/Province
Santa Catarina
ZIP/Postal Code
89801-355
Country
Brazil
Facility Name
Unidade de Pesquisa Clinica da Fundação Pio XII - Hospital de Amor de Barretos
City
Barretos
State/Province
Sao Paulo
ZIP/Postal Code
14784-400
Country
Brazil
Facility Name
Hospital das Clínicas da Faculdade de Medicina de Botucatu UNESP (HC-FMB/UNESP)
City
Botucatu
State/Province
Sao Paulo
ZIP/Postal Code
18618-687
Country
Brazil
Facility Name
Pontificia Universidade Catolica de Campinas (PUC-CAMP) - Hospital e Maternidade Celso Pierro (HMCP) - Centro de Pesquisa São Lucas
City
Campinas
State/Province
Sao Paulo
ZIP/Postal Code
13060-904
Country
Brazil
Facility Name
Clinica de Alergia Martti Antila
City
Sorocaba
State/Province
Sao Paulo
ZIP/Postal Code
18040-425
Country
Brazil
Facility Name
Conjunto Hospitalar de Mandaqui
City
São Paulo
State/Province
Sao Paulo
ZIP/Postal Code
02432
Country
Brazil
Facility Name
Fundação Faculdade Regional de Medicina de São José do Rio Preto
City
São José do Rio Preto
State/Province
São Paulo
ZIP/Postal Code
15090-000
Country
Brazil
Facility Name
Instituto Nacional de Infectologia Evandro Chagas / Fundação Oswaldo Cruz (FIOCRUZ)
City
Rio De Janeiro
ZIP/Postal Code
21040-360
Country
Brazil
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Study to Evaluate the Safety, Tolerability, and Efficacy of BGE-175 in Hospitalized Adults With Coronavirus Disease 2019 (COVID-19) That Are Not in Respiratory Failure
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