The purpose of this study is to determine if prophylaxis with RTB101 decreases the severity of laboratory-confirmed COVID-19 among adults ≥ 65 years who reside in a nursing homes in which one or more residents or staff have laboratory-confirmed COVID-19
RTB101-210 is Placebo-Controlled Study to Determine if Prophylaxis with RTB101 as Compared to
Placebo Reduces the Severity of Laboratory-Confirmed COVID-19 in Adults Age ≥65 Years who
Reside in a Nursing Home in which One or More Residents or Staff have Laboratory-Confirmed
COVID-19. This trial is being conducted in follow up to a Phase 3 trial, in which trends
toward a reduction in the severity of laboratory-confirmed RTIs including coronavirus RTIs
were again seen. Therefore, RTB101 is a potential pan antiviral immunotherapy that may
prevent or ameliorate viral RTIs, including COVID-19, in older adults.
Drug: RTB101
Oral RTB101 10 mg hard gelatin capsule once daily for 4 weeks
Other Name: Array
Drug: Placebo
Oral matching placebo once daily for 4 weeks
Other Name: Placebo capsule
Inclusion Criteria:
- Informed consent must be obtained from the subject or health care proxy before any
assessment is performed.
- Adults (male and female) aged 65 years and over.
- Residing in a nursing home in which one or more residents or staff has developed
laboratory-confirmed symptomatic COVID-19 infection at the time of randomization
Exclusion Criteria:
Subjects will not be eligible if they meet any of the following criteria:
- Any subject who is a current smoker or has a ≥ 10 pack year smoking history.
- Subjects with a medical history of chronic obstructive pulmonary disease (COPD).
- Subjects who are in hospice or receiving comfort care only.
- Subjects who have symptomatic laboratory-confirmed COVID-19 at the time of screening
or randomization.
- 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 (including subjects with an estimated glomerular
filtration rate (eGFR) ≤30 mL/min/1.73m2), or hematologic disorder (including active
leukemia).
- Subjects receiving immunosuppressive therapy including chronic use of 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 positive human immunodeficiency
virus (HIV) test result.
- Sexually active males with a partner of child-bearing potential
Nursing Home
Middletown, Rhode Island, United States
Medical Director, Study Director
Restorbio Inc.