Clinical trial NCT04409327: Phase 2 Study to Determine if RTB101 Reduces the Severity of COVID-19 in Older Adults Residing in Nursing Homes
Official title: Randomized Double Blind Placebo-Controlled Study to Determine if Prophylaxis With RTB101 Compared to Placebo Reduces Severity of Lab Confirmed COVID19 in Adults ≥65 Years in a Nursing Home in Which ≥1 Person(s) Have Lab Confirmed COVID19
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: COVID19
Keywords: Mechanistic Target of Rapamycin (mTOR)
Virus
Lead sponsor: Restorbio Inc.
Sponsor class: INDUSTRY
First posted: 2020-06-01
Enrollment: 36
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: The percentage of subjects who develop laboratory-confirmed COVID-19: - with protocol-defined progressive symptoms OR - are hospitalized OR - die
timeFrame: Through Week 4
Secondary outcomes:
measure: The percentage of subjects who develop symptomatic laboratory-confirmed COVID-19 infection
timeFrame: Through Week 4
measure: Mortality rate in subjects who develop laboratory-confirmed COVID19
timeFrame: Through Week 8
measure: Percent of subjects who are hospitalized due to having one or more predefined COVID-19 symptoms and laboratory-confirmed SARS-CoV-2
timeFrame: Through Week 4
measure: Percent of subjects who require mechanical ventilation, noninvasive ventilation, high flow nasal canula oxygen delivery or ICU admission during the hospitalization for COVID19
timeFrame: Through Week 8
measure: Safety and tolerability will be assessed by report of AE/SAEs
timeFrame: Through Week 5 and 8
Other outcomes:
Locations:
city: Middletown
country: United States
facility: Nursing Home
state: Rhode Island
Study officials:
affiliation: Restorbio Inc.
name: Medical Director
role: STUDY_DIRECTOR
References: