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

Primary Purpose

COVID19

Status

Terminated

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

RTB101

Placebo

About this trial

This is an interventional prevention trial for COVID19 focused on measuring Mechanistic Target of Rapamycin (mTOR), Virus

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept 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

Sites / Locations

Nursing Home

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

10 mg daily RTB101

Placebo

Arm Description

TORC1 inhibitor

Placebo

Outcomes

Primary Outcome Measures

The percentage of subjects who develop laboratory-confirmed COVID-19: - with protocol-defined progressive symptoms OR - are hospitalized OR - die

Secondary Outcome Measures

The percentage of subjects who develop symptomatic laboratory-confirmed COVID-19 infection

Mortality rate in subjects who develop laboratory-confirmed COVID19

Percent of subjects who are hospitalized due to having one or more predefined COVID-19 symptoms and laboratory-confirmed SARS-CoV-2

Percent of subjects who require mechanical ventilation, noninvasive ventilation, high flow nasal canula oxygen delivery or ICU admission during the hospitalization for COVID19

Safety and tolerability will be assessed by report of AE/SAEs

Full Information

NCT ID

NCT04409327

First Posted

May 28, 2020

Last Updated

February 5, 2021

Sponsor

Restorbio Inc.

1. Study Identification

Unique Protocol Identification Number

NCT04409327

Brief Title

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

2. Study Status

Record Verification Date

February 2021

Overall Recruitment Status

Terminated

Why Stopped

Insufficient accrual rate

Study Start Date

July 11, 2020 (Actual)

Primary Completion Date

December 27, 2020 (Actual)

Study Completion Date

January 24, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Restorbio Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

COVID19

Keywords

Mechanistic Target of Rapamycin (mTOR), Virus

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

36 (Actual)

8. Arms, Groups, and Interventions

Arm Title

10 mg daily RTB101

Arm Type

Experimental

Arm Description

TORC1 inhibitor

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Placebo

Intervention Type

Drug

Intervention Name(s)

RTB101

Other Intervention Name(s)

Dactolisib, BEZ235

Intervention Description

Oral RTB101 10 mg hard gelatin capsule once daily for 4 weeks

Intervention Type

Drug

Intervention Name(s)

Placebo

Other Intervention Name(s)

Placebo capsule

Intervention Description

Oral matching placebo once daily for 4 weeks

Primary Outcome Measure Information:

Title

The percentage of subjects who develop laboratory-confirmed COVID-19: - with protocol-defined progressive symptoms OR - are hospitalized OR - die

Time Frame

Through Week 4

Secondary Outcome Measure Information:

Title

The percentage of subjects who develop symptomatic laboratory-confirmed COVID-19 infection

Time Frame

Through Week 4

Title

Mortality rate in subjects who develop laboratory-confirmed COVID19

Time Frame

Through Week 8

Title

Percent of subjects who are hospitalized due to having one or more predefined COVID-19 symptoms and laboratory-confirmed SARS-CoV-2

Time Frame

Through Week 4

Title

Percent of subjects who require mechanical ventilation, noninvasive ventilation, high flow nasal canula oxygen delivery or ICU admission during the hospitalization for COVID19

Time Frame

Through Week 8

Title

Safety and tolerability will be assessed by report of AE/SAEs

Time Frame

Through Week 5 and 8

10. Eligibility

Sex

All

Minimum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Medical Director

Organizational Affiliation

Restorbio Inc.

Official's Role

Study Director

Facility Information:

Facility Name

Nursing Home

City

Middletown

State/Province

Rhode Island

ZIP/Postal Code

02842

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

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