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

• Status: Terminated
• Trial end date: 2021-01-24
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Restorbio Inc.
• Treatments: Dactolisib

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