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

Stopped early · Phase 2 · Has a placebo group

Conditions studied: COVID19

In brief

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

Key facts

Study ID

NCT04409327

Run by

Restorbio Inc.

People needed

36

Starts

2020-07-11

Expected to finish

2021-01-24

Last updated by the study team

2021-02-10

Who can join

Age: 65 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Nursing Home — Middletown, Rhode Island, United States

Full record on ClinicalTrials.gov

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