Purpose

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

Condition

Eligibility

Eligible Ages
Over 65 Years
Eligible Genders
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

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Prevention
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
10 mg daily RTB101
TORC1 inhibitor
  • Drug: RTB101
    Oral RTB101 10 mg hard gelatin capsule once daily for 4 weeks
    Other names:
    • Dactolisib
    • BEZ235
Placebo Comparator
Placebo
Placebo
  • Drug: Placebo
    Oral matching placebo once daily for 4 weeks
    Other names:
    • Placebo capsule

Recruiting Locations

More Details

NCT ID
NCT04409327
Status
Terminated
Sponsor
Restorbio Inc.

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.