A Phase 2 Study of RTB101 as COVID-19 Post-Exposure Prophylaxis in Older Adults

Exclusion Criteria

• •1. Any subject who self-reports:
• •1. As a current smoker, or stopped smoking within the past 6 months.
• •2. As a previous smoker with a ≥10 pack year smoking history.
• •3. Has a household member who currently smokes in the house.
• •2. Subjects with a medical history of chronic obstructive pulmonary disease (COPD), emphysema or chronic bronchitis requiring active treatment with a prescription medication
• •3. The subject has already had symptoms consistent with COVID-19 at screening.
• •4. Subjects who require chronic supplemental oxygen therapy at screening.
• •5. Subjects with current evidence of an unstable medical disorder including an unstable respiratory disorder, gastrointestinal disorder (including Child-Pugh class B and C hepatic impairment), renal disorder or hematologic disorder (including active leukemia) for which they have had an exacerbation of symptoms within the past month, or are undergoing a change in treatment.
• •6. The following cardiac conditions:
• •1. Unstable angina pectoris
• •2. History of myocardial infarction (MI), coronary bypass surgery, or any percutaneous coronary intervention (PCI) within 6 months prior to Screening
• •3. Congestive heart failure requiring active treatment with a prescription medication
• •4. Unstable or life-threatening cardiac arrhythmia
• •a. Chronic stable atrial fibrillation is allowed
• •7. Subjects with a history of systemic autoimmune diseases (e.g., lupus, inflammatory bowel disease, rheumatoid arthritis, etc.).
• •a. Psoriasis confined to the skin and eczema are allowed
• •8. Subjects receiving immunosuppressive therapy including chronic use of supraphysiologic steroids such as prednisone \>10 mg daily (however, inhaled corticosteroids and acute use of higher doses of prednisone to treat conditions such as exacerbation of asthma or other acute conditions are allowed).
• •9. Subjects with an immunodeficiency disease, including a history of a positive human immunodeficiency virus (HIV) test result.
• •10. Subjects with a history of gastric bypass surgery.
• •11. Subjects who require treatment with strong CYP3A4 or CYP1A2 inhibitors or inducers, or subjects who require treatment with digoxin.
• •12. Use of any other investigational medication or participation in any other investigational study within 5 half-lives of the investigational medication, or within 30 days, whichever is longer; or longer if required by local regulations.