Official Title
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
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.

Terminated
COVID19

Drug: RTB101

Oral RTB101 10 mg hard gelatin capsule once daily for 4 weeks
Other Name: Array

Drug: Placebo

Oral matching placebo once daily for 4 weeks
Other Name: Placebo capsule

Eligibility Criteria

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

Eligibility Gender
All
Eligibility Age
Minimum: 65 Years ~ Maximum: N/A
Countries
United States
Locations

Nursing Home
Middletown, Rhode Island, United States

Medical Director, Study Director
Restorbio Inc.

Restorbio Inc.
NCT Number
Keywords
Mechanistic Target of Rapamycin (mTOR)
Virus
MeSH Terms
COVID-19
Dactolisib