Phase 2 Study to Determine if RTB101 Reduces the Severity of COVID-19 in Older Adults Residing in Nursing Homes
Purpose
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
Condition
- COVID19
Eligibility
- Eligible Ages
- Over 65 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
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
Study Design
- Phase
- Phase 2
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Prevention
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Arm Groups
Arm | Description | Assigned Intervention |
---|---|---|
Experimental 10 mg daily RTB101 |
TORC1 inhibitor |
|
Placebo Comparator Placebo |
Placebo |
|
Recruiting Locations
More Details
- NCT ID
- NCT04409327
- Status
- Terminated
- Sponsor
- Restorbio Inc.
Detailed Description
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.