A Phase 2 Study of RTB101 as COVID-19 Post-Exposure Prophylaxis in Older Adults

NCT04584710 | Active Not Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: RTB101-2113R01AG064802-02S1
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

Brief Summary

The proposed trial will obtain preliminary data on the feasibility of studying RTB101 as compared to placebo for COVID-19 post-exposure prophylaxis in adults age ≥ 65 years to inform the design of a subsequent pivotal trial.

Conditions

Covid19

Keywords

Mechanistic Target of Rapamycin (mTOR); Virus

Outcome Measures

Primary Outcomes (1)

• To determine the length of time from date of receipt of a positive SARS-CoV2 test result to date of first dose of study drug in asymptomatic adults age ≥ 65 years

  The number of days from the date of receipt of a positive SARS-CoV-2 swab test result to the date of first dose of study drug in asymptomatic subjects who: * have SARS-CoV-2 detected on a surveillance nasal or nasopharyngeal swab OR * live in the same house or apartment as someone who has laboratory-confirmed symptomatic COVID-19

  Beginning of randomization through Week 2

Secondary Outcomes (10)

• To determine the feasibility of using an eDiary to assess study drug compliance in the study drug population

  Beginning of randomization through Week 2

• To determine the feasibility of using an eDiary to assess study drug compliance in the study drug population

  Beginning of randomization through Week 2

• To determine the feasibility of using an eDiary to assess study drug compliance in the study drug population

  Beginning of randomization through Week 2

• To determine the feasibility of using an eDiary to assess COVID-19 symptoms in the study population

  From time of first dose through Week 3

• To determine the feasibility of using an eDiary to assess COVID-19 symptoms in the study population

  From time of first dose through Week 3

Study Arms (2)

10 mg daily RTB101

EXPERIMENTAL

RTB101 TORC1 inhibitor

Drug: RTB101

Placebo

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

RTB101 DRUG

Oral RTB101 10 mg hard gelatin capsule once daily for 2 weeks

Also known as: Dactolisib, BEZ235

10 mg daily RTB101

Placebo DRUG

Oral matching placebo once daily for 2 weeks

Also known as: Placebo capsule

Placebo

Eligibility Criteria

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

You may not qualify if:

• Any subject who self-reports:
• As a current smoker, or stopped smoking within the past 6 months.
• As a previous smoker with a ≥10 pack year smoking history.
• Has a household member who currently smokes in the house.
• Subjects with a medical history of chronic obstructive pulmonary disease (COPD), emphysema or chronic bronchitis requiring active treatment with a prescription medication
• The subject has already had symptoms consistent with COVID-19 at screening.
• Subjects who require chronic supplemental oxygen therapy at screening.
• 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 or hematologic disorder (including active leukemia) for which they have had an exacerbation of symptoms within the past month, or are undergoing a change in treatment.
• The following cardiac conditions:
• Unstable angina pectoris
• History of myocardial infarction (MI), coronary bypass surgery, or any percutaneous coronary intervention (PCI) within 6 months prior to Screening
• Congestive heart failure requiring active treatment with a prescription medication
• Unstable or life-threatening cardiac arrhythmia
• a. Chronic stable atrial fibrillation is allowed
• Subjects with a history of systemic autoimmune diseases (e.g., lupus, inflammatory bowel disease, rheumatoid arthritis, etc.).

Sponsors & Collaborators

• Restorbio Inc.: lead
• National Institute on Aging (NIA): collaborator

Study Sites (2)

University of Connecticut, UConn Center on Aging

Farmington, Connecticut, 06030, United States

Location

Hebrew Senior Life, Marcus Institute for Aging Research

Roslindale, Massachusetts, 02131, 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 Monitor

  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: October 8, 2020
• First Posted: October 14, 2020
• Study Start: October 13, 2020
• Primary Completion: February 1, 2021
• Study Completion: February 1, 2021
• Last Updated: February 9, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)