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

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ClinicalTrials.gov Identifier: NCT04409327
Recruitment Status : Terminated (Insufficient accrual rate)
First Posted : June 1, 2020
Last Update Posted : February 10, 2021
Sponsor:
Information provided by (Responsible Party):
Restorbio Inc.

Tracking Information
First Submitted Date  ICMJE May 28, 2020
First Posted Date  ICMJE June 1, 2020
Last Update Posted Date February 10, 2021
Actual Study Start Date  ICMJE July 11, 2020
Actual Primary Completion Date December 27, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 28, 2020)
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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 28, 2020)
  • The Percentage of Subjects Who Develop Symptomatic Laboratory-confirmed COVID-19 Infection [ Time Frame: Through Week 4 ]
  • Mortality Rate in Subjects Who Develop Laboratory-confirmed COVID19 [ Time Frame: Through Week 8 ]
  • 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 ]
  • 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 ]
  • Safety and Tolerability Will be Assessed by Report of AE/SAEs [ Time Frame: Through Week 5 and 8 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Phase 2 Study to Determine if RTB101 Reduces the Severity of COVID-19 in Older Adults Residing in Nursing Homes
Official Title  ICMJE 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
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE COVID19
Intervention  ICMJE
  • Drug: RTB101
    Oral RTB101 10 mg hard gelatin capsule once daily for 4 weeks
    Other Names:
    • Dactolisib
    • BEZ235
  • Drug: Placebo
    Oral matching placebo once daily for 4 weeks
    Other Name: Placebo capsule
Study Arms  ICMJE
  • Experimental: 10 mg daily RTB101
    TORC1 inhibitor
    Intervention: Drug: RTB101
  • Placebo Comparator: Placebo
    Placebo
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: December 8, 2020)
36
Original Estimated Enrollment  ICMJE
 (submitted: May 28, 2020)
550
Actual Study Completion Date  ICMJE January 24, 2021
Actual Primary Completion Date December 27, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 65 Years and older   (Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04409327
Other Study ID Numbers  ICMJE RTB101-210
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Restorbio Inc.
Study Sponsor  ICMJE Restorbio Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Medical Director Restorbio Inc.
PRS Account Restorbio Inc.
Verification Date February 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP