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.
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.
Drug: BGE-175
Drug
Other: Placebo
Placebo
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
Banner Health
Mesa, Arizona, United States
Velocity Clinical Research, Chula Vista
Chula Vista, California, United States
Long Beach Medical Center
Long Beach, California, United States
UCI Center for Clinical Research
Orange, California, United States
Sharp Memorial Hospital
San Diego, California, United States
North Colorado Medical Center
Greeley, Colorado, United States
Stamford Hospital
Stamford, Connecticut, United States
University of Florida - Health, Jacksonville
Jacksonville, Florida, United States
Baptist Health, Lexington
Lexington, Kentucky, United States
University of Maryland Medical System
Baltimore, Maryland, United States
Jadestone Clinical Research, LLC
Silver Spring, Maryland, United States
Clinica Privada Independencia
Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina
Sanatorio De La Trinidad Mitre
Buenos Aires, Ciudad Autonoma De Buenos Aires, Argentina
Clinica Adventista Belgrano (CAB)
Buenos Aires, Ciudad Autónoma De Buenos Aires, Argentina
Hospital Universitário Cassiano Antônio de Moraes
Vitória, Espiritu Santo, Brazil
Hospital Felicio Rocho (HFR)
Belo Horizonte, Minas Gerais, Brazil
Centro de Pesquisa Hospital Ana Nery Santa Cruz do Sul
Santa Cruz Do Sul, Rio Grande Do Sol, Brazil
Hospital Ernesto Dornelles
Porto Alegre, Rio Grande Do Sul, Brazil
Clínica Supera Oncologia
Chapecó, Santa Catarina, Brazil
Unidade de Pesquisa Clinica da Fundação Pio XII - Hospital de Amor de Barretos
Barretos, Sao Paulo, Brazil
Hospital das Clínicas da Faculdade de Medicina de Botucatu UNESP (HC-FMB/UNESP)
Botucatu, Sao Paulo, Brazil
Pontificia Universidade Catolica de Campinas (PUC-CAMP) - Hospital e Maternidade Celso Pierro (HMCP) - Centro de Pesquisa São Lucas
Campinas, Sao Paulo, Brazil
Clinica de Alergia Martti Antila
Sorocaba, Sao Paulo, Brazil
Conjunto Hospitalar de Mandaqui
São Paulo, Sao Paulo, Brazil
Fundação Faculdade Regional de Medicina de São José do Rio Preto
São José do Rio Preto, São Paulo, Brazil
Instituto Nacional de Infectologia Evandro Chagas / Fundação Oswaldo Cruz (FIOCRUZ)
Rio De Janeiro, Brazil
Richard G Wilkerson, MD, Principal Investigator
University of Maryland Medical Center