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

resTORbio

Status and phase

Terminated

Phase 2

Conditions

COVID19

Treatments

Drug: Placebo

Drug: RTB101

Study type

Interventional

Funder types

Industry

Identifiers

NCT04409327

RTB101-210

Details and patient eligibility

About

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

Full 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.

Enrollment

36 patients

Sex

All

Ages

65+ years old

Volunteers

No Healthy Volunteers

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