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
Condition: Covid19
MeSH terms: COVID-19
Intervention: BGE-175; Placebo
Intervention description: Drug; Placebo
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
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
Enrollment: 194.0
Sex: All
Minimum age: 50 Years
Healthy volunteers: No
Keywords: COVID-19; BGE-175; BioAge; Respiratory failure

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.
    

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:

               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

          -  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:

               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 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

               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