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

NCT ID: NCT04409327

Last Updated: 2021-02-10

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-07-11
• Study Completion Date: 2021-01-24

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.

Conditions

COVID19

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

10 mg daily RTB101

TORC1 inhibitor

Group Type: EXPERIMENTAL

RTB101

Intervention Type: DRUG

Oral RTB101 10 mg hard gelatin capsule once daily for 4 weeks

Placebo

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Oral matching placebo once daily for 4 weeks

Interventions

RTB101

Oral RTB101 10 mg hard gelatin capsule once daily for 4 weeks

Intervention Type: DRUG

Placebo

Oral matching placebo once daily for 4 weeks

Intervention Type: DRUG

Other Intervention Names

Dactolisib; BEZ235; 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

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Restorbio Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director

Role: STUDY_DIRECTOR

Restorbio Inc.

Locations

Nursing Home

Middletown, Rhode Island, United States

Countries

United States

Other Identifiers

RTB101-210

Identifier Type: -

Identifier Source: org_study_id