Phase 2 Study to Determine if RTB101 Reduces the Severity of COVID-19 in Older Adults Residing in Nursing Homes

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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COVID19

Intervention / Treatment
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* Drug: RTB101
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 10 mg daily RTB101<br>TORC1 inhibitor | Drug: RTB101<br>* Oral RTB101 10 mg hard gelatin capsule once daily for 4 weeks<br>* Other names: BEZ235;|
| Placebo Comparator: Placebo<br>Placebo | Drug: Placebo<br>* Oral matching placebo once daily for 4 weeks<br>* Other names: Placebo capsule;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Mechanistic Target of Rapamycin (mTOR), Virus