BGE-175-201

  • STATUS
    Recruiting
Updated on 19 July 2021

Summary

A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 2 Study to Investigate the Efficacy and Safety of Asapiprant in Hospitalized Patients Over Sixty Years of Age With COVID-19

Description

The purpose of this study is to evaluate the efficacy of asapiprant given by oral (PO) or nasogastric tube (NG) administration versus placebo on the clinical signs and symptoms of COVID-19 infection in hospitalized subjects ≥ 60 years of age.

Details
Condition COVID-19
Clinical Study IdentifierTX277861
Last Modified on19 July 2021

Eligibility

Yes No Not Sure

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 severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection
Laboratory (polymerase chain reaction [PCR]) confirmed infection with SARS-CoV-2
Age > 60 years
COVID-19 illness of any duration, and O2 saturation measurements ≤ 94% over 5 minutes on room air (Note: low flow O2 is permitted, but room air O2 saturation must be ≤ 94%)
Not with evidence of critical COVID-19 illness as defined by at least one of the following
a.) RF defined by requiring at least one of the following: 1.) Endotracheal intubation and mechanical ventilation; 2.) O2 delivered by high-flow nasal cannula at flow rates > 20 L/min with fraction of delivered O2 ≥ 0.5; 3.) Noninvasive positive pressure ventilation (NIPPV); 4.) Extracorporeal membrane oxygenation (ECMO); 5.) Clinical diagnosis of RF (i.e., clinical need for one of the preceding therapies, but preceding therapies are not able to be administered in setting of resource limitation)
b.) Hemodynamic compromise (defined by systolic blood pressure < 90 mm Hg, or diastolic blood pressure < 60 mm Hg) or requiring vasopressors
c.) Multi-organ dysfunction/failure
Female subjects of childbearing potential must have a negative pregnancy test at screening or pre-treatment on Day 1. Note: Female subjects of childbearing potential are defined as pre-menopausal, < 12 months of amenorrhea post-menopause, or no history of surgical sterilization (hysterectomy or oophorectomy) or tubal ligation
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
Positive test for influenza A or influenza B at the time of study entry
History of human immunodeficiency virus (HIV) infection that is not controlled with current treatment
History of Hepatitis B surface antigen, or Hepatitis C positive prior to 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)
Hepatic function impairment defined as a Child-Pugh score of 7 or greater
Stage 4 or higher 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 co-morbidity, including
a.) Myocardial infarction (within the last month)
b.) Moderate or severe heart failure (New York Heart Association [NYHA] class III or IV)
c.) Acute stroke (within the last month)
d.) 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 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
e.) 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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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