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

The RTB101-211 study is a Randomized, Double-Blind, Placebo-Controlled Phase 2a Study of RTB101 as COVID-19 Post-Exposure Prophylaxis in Asymptomatic Adults Age ≥65 Years who: have SARS-CoV-2 detected on a surveillance nasal or nasopharyngeal swab OR live in the same house or apartment as someone who has laboratory-confirmed symptomatic COVID-19. The study is designed to obtain study feasibility data for RTB101 in an unbiased fashion and will inform the design of a subsequent pivotal trial.

• Informed consent must be obtained from the subject before any assessment is performed.
• Adults (male and female) aged 65 years and over who are asymptomatic but:

• have SARS-CoV-2 detected during surveillance nasal or nasopharyngeal swab testing OR
• live in the same house or apartment as someone who has laboratory-confirmed symptomatic COVID-19 .
• Sexually active male subjects with a partner of child-bearing potential must be willing to wear a condom while on study drug and for 1 week after stopping study drug and should not father a child in this period. A condom is required to be used also by vasectomized men with a partner of child-bearing potential to prevent delivery of the drug via seminal fluid.
• Subject must be able to understand and comply with the requirements of the study including having internet access and an email account, willingness to answer an eDiary questionnaire on a personal electronic device each night, and willingness to answer the telephone questionnaires twice weekly

Exclusion criteria

• Any subject who self-reports:

• As a current smoker, or stopped smoking within the past 6 months.
• As a previous smoker with a ≥10 pack year smoking history.
• Has a household member who currently smokes in the house.
• Subjects with a medical history of chronic obstructive pulmonary disease (COPD), emphysema or chronic bronchitis requiring active treatment with a prescription medication
• The subject has already had symptoms consistent with COVID-19 at screening.
• Subjects who require chronic supplemental oxygen therapy at screening.
• 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.
• The following cardiac conditions:

• Unstable angina pectoris
• History of myocardial infarction (MI), coronary bypass surgery, or any percutaneous coronary intervention (PCI) within 6 months prior to Screening
• Congestive heart failure requiring active treatment with a prescription medication
• Unstable or life-threatening cardiac arrhythmia

a. Chronic stable atrial fibrillation is allowed

• 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

• 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).
• Subjects with an immunodeficiency disease, including a history of a positive human immunodeficiency virus (HIV) test result.
• Subjects with a history of gastric bypass surgery.
• Subjects who require treatment with strong CYP3A4 or CYP1A2 inhibitors or inducers, or subjects who require treatment with digoxin.
• 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.