Status:
TERMINATED
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
Lead Sponsor:
BioAge Labs, Inc.
Conditions:
Covid19
Eligibility:
All Genders
50+ years
Phase:
PHASE2
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 w...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 18 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 19 2022
Estimated Enrollment :
194 Patients enrolled
Trial Details
Trial ID
NCT04705597
Start Date
March 18 2021
End Date
May 19 2022
Last Update
July 3 2023
Active Locations (26)
Enter a location and click search to find clinical trials sorted by distance.
1
Banner Health
Mesa, Arizona, United States, 85202
2
Velocity Clinical Research, Chula Vista
Chula Vista, California, United States, 91911
3
Long Beach Medical Center
Long Beach, California, United States, 90806
4
UCI Center for Clinical Research
Orange, California, United States, 92868