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
Overview
- Phase
- Phase 2
- Status
- Terminated
- Sponsor
- BioAge Labs, Inc.
- Enrollment
- 194
- Locations
- 26
- Primary Endpoint
- Proportion of Participants Who Have Died or Progressed to Respiratory Failure
Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description
Double-blind
Eligibility Criteria
- Ages
- 50 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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)
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)
Arms & Interventions
Placebo
Placebo tablet to be taken by mouth once a day for 14 days
Intervention: Placebo (Other)
BGE-175
BGE-175 tablet to be taken by mouth once a day for 14 days
Intervention: BGE-175 (Drug)
Outcomes
Primary Outcomes
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, noninvasive ventilation, mechanical ventilation, or extracorporeal membrane oxygenation (ECMO) at Day 28. The proportion of participants is represented as a percentage.
Secondary Outcomes
- Proportion of Patients Who Develop Critical COVID-19 Illness(First dose date up to Day 57)
- Duration of Noninvasive Ventilation by Nonrebreather Mask or High-flow Nasal Cannula(First dose date up to Day 57)
- Number of Patients Who Had Mechanical Ventilation.(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)(First dose date up to Day 57)
- Proportion of Participants Experiencing Treatment-emergent Adverse Events(First dose of treatment through study Day 57)
- Survival(Baseline through Day 57; at Day 14, Day 28 and Day 57)
- Time to Two Successive Negative Viral Titers in Nasopharyngeal Swabs(Baseline through Day 28)
- Number of Patients Who Had Intubation During the Study(First dose date up to Day 57)
- Duration of Supplemental Oxygen Administration(First dose date up to Day 57)
- Proportion of Subjects Who Survive Without Progression to Respiratory Failure Through Day 28(First dose of treatment through Day 14, Day 28)
- 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)(First dose date up to Day 28)
- Mean Change From Baseline in WHO Ordinal Scale for COVID-19 Score(Day 14/End of Treatment, Day 28, Day 57)
- Duration of Intubation(First dose date up to Day 57)
- Time to Discharge From Hospital Intensive Care Unit(First dose date up to Day 57)
- Proportion of Participants Requiring Intensive Care Unit Admission(First dose date up to Day 57)
- Number of Patients Who Had Supplemental Oxygen Administration(First dose date up to Day 57)
- Number of Patients Who Had Noninvasive Ventilation or High-flow Nasal Cannula O2 Administration(First dose date up to Day 57)
- Duration of Mechanical Ventilation(First dose date up to Day 57)
- Duration of Mechanical Ventilation Plus Additional Organ Support Using Vasopressors, and/or Renal Replacement Therapy and/or ECMO(First dose date up to Day 57)
- Daily Ratio of Oxygen Saturation (SpO2) to Fractional Inspired O2 (SpO2/FiO2)(First dose date up to Day 28)
- Number of Patients With Re-hospitalization(First dose date up to Day 57)
- Number of Patients Who Had Mechanical Ventilation Plus Additional Organ Support Using Vasopressors, and/or Renal Replacement Therapy and/or ECMO.(First dose date up to Day 57)
- Time to Discharge From the Hospital(First dose date up to Day 57)