A Phase 2 Study of BIO 300 in Patients with COVID-19

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions:
  • Age: Between 18 Year(s) - 100 Year(s)
  • Gender: Male or Female
  • Other Inclusion Criteria:
    1. Participants are 18 years old or older
    2. Those hospitalized for COVID-19-related complications ready to be discharged and those within 365 days of discharge
    3. Radiographic signs of lung injury after standard treatment of COVID-19
    4. Able to perform a Pulmonary Function Test (PFT) at screening
    5. Able to perform a 6-minute walk test
    6. Participant with blood routine, liver and kidney function test values as per the protocol
    7. Participants of childbearing potential with a negative pregnancy test at screening
    8. Patients of childbearing potential and participants with sexual partners of childbearing potential must agree to use an effective method of non-estrogen-based contraception during the 12- week portion of the study that they are receiving study medication and for 30 days following the last dose of study medication, or to abstain from sexual intercourse during these time periods
    9. Participants who are able to provide signed informed consent

You may not be eligible for this study if the following are true:

    1. Severe background disease like severe cardiac or pulmonary insufficiency, severe liver and kidney diseases, COPD, neurological disease, and/or cancer
    2. Severe asthma on chronic therapy with biologics or steroids
    3. Prior malignancy
    4. D-dimer levels of >2,000 ng/mL at screening
    5. Use of anti-pulmonary fibrosis drugs in the past 5 days
    6. Use of anti-cytokine release syndrome drugs in the past 5 days
    7. Use of systemic corticosteroids (e.g., prednisone, dexamethasone) in the past 5 days
    8. An active infection
    9. Poorly controlled intercurrent illnesses
    10. Patients who have undergone thoracotomy within 4 weeks
    11. Patients that have a known allergy to any of the placebo components
    12. Psychiatric conditions, social situations or substance abuse that precludes the ability of the study participant to cooperate with the requirements of the trial and protocol therapy
    13. Pregnant or breastfeeding

If you are registered as a volunteer, please log in to contact the study team/express interest in this study.