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Asapiprant in Hospitalized Patients Over Sixty Years of Age With COVID-19

Alpesh Amin


A Study On:

  • Coronavirus Infection
  • Infection Disease

Status:

  • Open

Eligibility

50 Years and older (Adult, Older Adult)

Interested in joining this trial?

Official Title

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

Details

This is a randomized, placebo-controlled, parallel-group, multicenter, double-blind study of BGE-175 administered PO or NG in participants greater than or equal to 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.


Eligibility

You can join if...

Inclusion Criteria:

  1. Ability to voluntarily provide informed consent that is documented per local requirements
  2. An understanding, ability, and willingness to fully comply with study procedures and restrictions
  3. Hospitalized subjects with a confirmed SARS-CoV-2 infection
  4. Laboratory (polymerase chain reaction [PCR]) confirmed infection with SARS-CoV-2
  5. Age greater than or equal to 50 years
  6. COVID-19 illness of any duration, and oxygen saturation measurements less than or equal to 94% over 5 minutes on room air (Note: low flow oxygen is permitted, but room air oxygen saturation must be less than or equal to 94%)
  7. Not in respiratory failure
  8. Females subjects of childbearing potential must have a negative pregnancy test at screening or pre-treatment on Day 1
  9. 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:

  1. Participation in any other randomized, controlled clinical trial of an experimental treatment for COVID-19 (uncontrolled, compassionate use trials are allowed)
  2. In the opinion of the investigator, progression to death is imminent and inevitable within the next 24 hours, irrespective of the provision of treatments
  3. Currently participating in a vaccination trial for SARS-CoV-2
  4. Subject requires oxygen administration by high flow nasal cannula (> 20 L/min)
  5. Positive influenza test at screening
  6. Positive for human immunodeficiency virus (HIV) that is not controlled with current treatment
  7. Hepatitis B surface antigen, or Hepatitis C positive at the time of screening. Subjects who are positive for Hepatitis C 8. 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.
  8. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 5 × the upper limit of normal (ULN)
  9. 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
  10. Serious comorbidity
  11. History of severe allergic or anaphylactic reactions or hypersensitivity to the study drug
  12. Consideration by the investigator, for any reason, that the subject is an unsuitable candidate to receive study treatment

Get in touch with our study team