COVID19
Conditions
Keywords
Mechanistic Target of Rapamycin (mTOR), Virus
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.
Interventions
DRUGRTB101
Oral RTB101 10 mg hard gelatin capsule once daily for 4 weeks
DRUGPlacebo
Oral matching placebo once daily for 4 weeks
Sponsors
Restorbio Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The percentage of subjects who develop laboratory-confirmed COVID-19: - with protocol-defined progressive symptoms OR - are hospitalized OR - die | Through Week 4 |
Secondary
| Measure | Time frame |
|---|---|
| The percentage of subjects who develop symptomatic laboratory-confirmed COVID-19 infection | Through Week 4 |
| 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 |
| 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 |
Countries
United States
Outcome results
None listed