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

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

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

Study Overview

• Status: Terminated
• Conditions: COVID19
• Intervention / Treatment: Drug: RTB101; Drug: Placebo

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: Interventional
• Enrollment (Actual): 36
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Rhode Island
    • Middletown, Rhode Island, United States, 02842
      • Nursing Home

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; Oral matching placebo once daily for 4 weeks; Other Names: Placebo capsule
Experimental: 10 mg daily RTB101; TORC1 inhibitor	Drug: RTB101; Oral RTB101 10 mg hard gelatin capsule once daily for 4 weeks; Other Names: Dactolisib; BEZ235

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The percentage of subjects who develop laboratory-confirmed COVID-19: - with protocol-defined progressive symptoms OR - are hospitalized OR - die	Through Week 4

Secondary Outcome Measures

Outcome Measure	Time Frame
The percentage of subjects who develop symptomatic laboratory-confirmed COVID-19 infection	Through Week 4
Mortality rate in subjects who develop laboratory-confirmed COVID19	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	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	Through Week 8
Safety and tolerability will be assessed by report of AE/SAEs	Through Week 5 and 8

Collaborators and Investigators

• Sponsor: Restorbio Inc.
• Investigators: Study Director: Medical Director, Restorbio Inc.

Study record dates

Study Major Dates

• Study Start (Actual): July 11, 2020
• Primary Completion (Actual): December 27, 2020
• Study Completion (Actual): January 24, 2021

Study Registration Dates

• First Submitted: May 28, 2020
• First Submitted That Met QC Criteria: May 28, 2020
• First Posted (Actual): June 1, 2020

Study Record Updates

• Last Update Posted (Actual): February 10, 2021
• Last Update Submitted That Met QC Criteria: February 5, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: Virus; Mechanistic Target of Rapamycin (mTOR)
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19; Antineoplastic Agents; Dactolisib
• Other Study ID Numbers: RTB101-210

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No