Randomized Double Blind Placebo-Controlled Study to Determine if Prophylaxis With RTB101 Compared to Placebo Reduces Severity of Lab Confirmed COVID19 in Adults ≥65 Years in a Nursing Home in Which ≥1 Person(s) Have Lab Confirmed COVID19
Trial Snapshot
- Phase
- Phase 2
- Status
- Terminated
- Sponsor
- Restorbio Inc.
- Enrollment
- 36
- Locations
- 1
- Primary Endpoint
- The percentage of subjects who develop laboratory-confirmed COVID-19: - with protocol-defined progressive symptoms OR - are hospitalized OR - die
Study Overview
Brief Summary
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
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 65 Years to — (Older Adult)
- Sex
- 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
Arms & Interventions
10 mg daily RTB101
TORC1 inhibitor
Intervention: RTB101 (Drug)
Placebo
Placebo
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
The percentage of subjects who develop laboratory-confirmed COVID-19: - with protocol-defined progressive symptoms OR - are hospitalized OR - die
Time Frame: Through Week 4
Secondary Outcomes
- Percent of subjects who require mechanical ventilation, noninvasive ventilation, high flow nasal canula oxygen delivery or ICU admission during the hospitalization for COVID19(Through Week 8)
- Safety and tolerability will be assessed by report of AE/SAEs(Through Week 5 and 8)
- Mortality rate in subjects who develop laboratory-confirmed COVID19(Through Week 8)
- Percent of subjects who are hospitalized due to having one or more predefined COVID-19 symptoms and laboratory-confirmed SARS-CoV-2(Through Week 4)
- The percentage of subjects who develop symptomatic laboratory-confirmed COVID-19 infection(Through Week 4)