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

NCT04705597 | Terminated Phase 2 Results DMC FDA Drug

• 1 other identifier: BGE-175-201
• Study Type: interventional
• Target: 194
• Locations: 3 countries
• Sites: 26

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.

Conditions

Covid19

Keywords

COVID-19; BGE-175; BioAge; Respiratory failure

Outcome Measures

Primary Outcomes (1)

• Proportion of Participants Who Have Died or Progressed to Respiratory Failure

  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.

  First dose date up to Day 28

Secondary Outcomes (23)

• 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

• Proportion of Subjects Who Survive Without Progression to Respiratory Failure Through Day 28

  First dose of treatment through Day 14, Day 28

• Time to Two Successive Negative Viral Titers in Nasopharyngeal Swabs

  Baseline through Day 28

• 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

Study Arms (2)

BGE-175

EXPERIMENTAL

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

Drug: BGE-175

Placebo

PLACEBO COMPARATOR

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

Other: Placebo

Interventions

BGE-175 DRUG

Drug

BGE-175

Placebo OTHER

Placebo

Placebo

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• BioAge Labs, Inc.: lead

Study Sites (26)

Banner Health

Mesa, Arizona, 85202, United States

Location

Velocity Clinical Research, Chula Vista

Chula Vista, California, 91911, United States

Location

Long Beach Medical Center

Long Beach, California, 90806, United States

Location

UCI Center for Clinical Research

Orange, California, 92868, United States

Location

Sharp Memorial Hospital

San Diego, California, 92123, United States

Location

North Colorado Medical Center

Greeley, Colorado, 80631, United States

Location

Stamford Hospital

Stamford, Connecticut, 06904, United States

Location

University of Florida - Health, Jacksonville

Jacksonville, Florida, 32209, United States

Location

Baptist Health, Lexington

Lexington, Kentucky, 40503, United States

Location

University of Maryland Medical System

Baltimore, Maryland, 21201, United States

Location

Jadestone Clinical Research, LLC

Silver Spring, Maryland, 20904, United States

Location

Clinica Privada Independencia

Ciudad Autonoma de Buenos Aires, Buenos Aires, C1426ABP, Argentina

Location

Sanatorio De La Trinidad Mitre

Buenos Aires, Buenos Aires F.D., C1039AAO, Argentina

Location

Clinica Adventista Belgrano (CAB)

Buenos Aires, Buenos Aires F.D., C1430EGF, Argentina

Location

Hospital Universitário Cassiano Antônio de Moraes

Vitória, Espiritu Santo, 29043-260, Brazil

Location

Hospital Felicio Rocho (HFR)

Belo Horizonte, Minas Gerais, 30180-080, Brazil

Location

Centro de Pesquisa Hospital Ana Nery Santa Cruz do Sul

Santa Cruz do Sul, Rio Grande Do Sol, 96835-090, Brazil

Location

Hospital Ernesto Dornelles

Porto Alegre, Rio Grande do Sul, 90160-093, Brazil

Location

Clínica Supera Oncologia

Chapecó, Santa Catarina, 89801-355, Brazil

Location

Unidade de Pesquisa Clinica da Fundação Pio XII - Hospital de Amor de Barretos

Barretos, São Paulo, 14784-400, Brazil

Location

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

Botucatu, São Paulo, 18618-687, Brazil

Location

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

Campinas, São Paulo, 13060-904, Brazil

Location

Fundação Faculdade Regional de Medicina de São José do Rio Preto

São José do Rio Preto, São Paulo, 15090-000, Brazil

Location

Conjunto Hospitalar de Mandaqui

São Paulo, São Paulo, 02432, Brazil

Location

Clinica de Alergia Martti Antila

Sorocaba, São Paulo, 18040-425, Brazil

Location

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

Rio de Janeiro, 21040-360, Brazil

Location

MeSH Terms

Conditions

COVID-19; Respiratory Insufficiency

Interventions

asapiprant

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Results Point of Contact

• Title: Patrick Martin, M.D.
• Organization: BioAge Labs, Inc.

patrick@bioagelabs.com

215-260-5134

Study Officials

• Richard G Wilkerson, MD

  University of Maryland, Baltimore

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double-blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Multicenter, Randomized, Double-blind, Placebo-controlled

Study Record Dates

• First Submitted: January 4, 2021
• First Posted: January 12, 2021
• Study Start: March 18, 2021
• Primary Completion: April 20, 2022
• Study Completion: May 19, 2022
• Last Updated: July 3, 2023
• Results First Posted: July 3, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

AR (3); US (11); BR (12)