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

NCT04409327 | Terminated Phase 2 DMC FDA Drug

• 1 other identifier: RTB101-210
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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

Conditions

COVID19

Keywords

Mechanistic Target of Rapamycin (mTOR); Virus

Outcome Measures

Primary Outcomes (1)

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

  Through Week 4

Secondary Outcomes (5)

• 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

Study Arms (2)

10 mg daily RTB101

EXPERIMENTAL

TORC1 inhibitor

Drug: RTB101

Placebo

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

RTB101 DRUG

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

Also known as: Dactolisib, BEZ235

10 mg daily RTB101

Placebo DRUG

Oral matching placebo once daily for 4 weeks

Also known as: Placebo capsule

Placebo

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Restorbio Inc.: lead

Study Sites (1)

Nursing Home

Middletown, Rhode Island, 02842, United States

Location

MeSH Terms

Conditions

COVID-19; Hereditary Sensory and Autonomic Neuropathies; Virus Diseases

Interventions

dactolisib

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Nervous System Malformations; Nervous System Diseases; Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Polyneuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Genetic Diseases, Inborn

Study Officials

• Medical Director

  Restorbio Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 28, 2020
• First Posted: June 1, 2020
• Study Start: July 11, 2020
• Primary Completion: December 27, 2020
• Study Completion: January 24, 2021
• Last Updated: February 10, 2021

Record last verified: 2021-02

Locations

US (1)