Phase 2 Study to Determine if RTB101 Reduces the Severity of COVID-19 in Older Adults Residing in Nursing Homes
- Registration Number
- NCT04409327
- Lead Sponsor
- Restorbio Inc.
- 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 36
- 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
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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Placebo 10 mg daily RTB101 RTB101 TORC1 inhibitor
- Primary Outcome Measures
Name Time Method The percentage of subjects who develop laboratory-confirmed COVID-19: - with protocol-defined progressive symptoms OR - are hospitalized OR - die Through Week 4
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
Nursing Home
🇺🇸Middletown, Rhode Island, United States