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

NCT ID: NCT04705597

Last Updated: 2023-07-03

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 194 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-18
• Study Completion Date: 2022-05-19

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.

Conditions

Covid19

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

BGE-175

BGE-175 tablet to be taken by mouth once a day for 14 days

Group Type: EXPERIMENTAL

BGE-175

Intervention Type: DRUG

Drug

Placebo

Placebo tablet to be taken by mouth once a day for 14 days

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

Placebo

Interventions

BGE-175

Drug

Intervention Type: DRUG

Placebo

Placebo

Intervention Type: OTHER

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

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

BioAge Labs, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Richard G Wilkerson, MD

Role: PRINCIPAL_INVESTIGATOR

University of Maryland, Baltimore

Locations

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, Buenos Aires F.D., Argentina

Clinica Adventista Belgrano (CAB)

Buenos Aires, Buenos Aires F.D., 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, São Paulo, Brazil

Hospital das Clínicas da Faculdade de Medicina de Botucatu UNESP (HC-FMB/UNESP)

Botucatu, São Paulo, Brazil

Pontificia Universidade Catolica de Campinas (PUC-CAMP) - Hospital e Maternidade Celso Pierro (HMCP) - Centro de Pesquisa São Lucas

Campinas, São Paulo, Brazil

Fundação Faculdade Regional de Medicina de São José do Rio Preto

São José do Rio Preto, São Paulo, Brazil

Conjunto Hospitalar de Mandaqui

São Paulo, São Paulo, Brazil

Clinica de Alergia Martti Antila

Sorocaba, São Paulo, Brazil

Instituto Nacional de Infectologia Evandro Chagas / Fundação Oswaldo Cruz (FIOCRUZ)

Rio de Janeiro, , Brazil

Countries

United States; Argentina; Brazil

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

BGE-175-201

Identifier Type: -

Identifier Source: org_study_id