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

COVID19 Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04409327
• Other study ID #: RTB101-210
• Status: Terminated
• Phase: Phase 2
• Start date: July 11, 2020
• Est. completion date: January 24, 2021

Study information

• Verified date: February 2021
• Source: Restorbio Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 36
• Est. completion date: January 24, 2021
• Est. primary completion date: December 27, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID19

Intervention

Drug:
• RTB101
Oral RTB101 10 mg hard gelatin capsule once daily for 4 weeks
• Placebo
Oral matching placebo once daily for 4 weeks

Locations

Country	Name	City	State
United States	Nursing Home	Middletown	Rhode Island

Sponsors (1)

Lead Sponsor	Collaborator
Restorbio Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The percentage of subjects who develop laboratory-confirmed COVID-19: - with protocol-defined progressive symptoms OR - are hospitalized OR - die		Through Week 4
Secondary	The percentage of subjects who develop symptomatic laboratory-confirmed COVID-19 infection		Through Week 4
Secondary	Mortality rate in subjects who develop laboratory-confirmed COVID19		Through Week 8
Secondary	Percent of subjects who are hospitalized due to having one or more predefined COVID-19 symptoms and laboratory-confirmed SARS-CoV-2		Through Week 4
Secondary	Percent of subjects who require mechanical ventilation, noninvasive ventilation, high flow nasal canula oxygen delivery or ICU admission during the hospitalization for COVID19		Through Week 8
Secondary	Safety and tolerability will be assessed by report of AE/SAEs		Through Week 5 and 8