Status:
TERMINATED
Phase 2 Study to Determine if RTB101 Reduces the Severity of COVID-19 in Older Adults Residing in Nursing Homes
Lead Sponsor:
Restorbio Inc.
Conditions:
COVID19
Eligibility:
All Genders
65+ years
Phase:
PHASE2
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 ...
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 Nurs...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 11 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 24 2021
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT04409327
Start Date
July 11 2020
End Date
January 24 2021
Last Update
February 10 2021
Active Locations (1)
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1
Nursing Home
Middletown, Rhode Island, United States, 02842