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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-13

Study Completion Date

2021-02-28

Brief Summary

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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.

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Detailed Description

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The RTB101-211 study is a Randomized, Double-Blind, Placebo-Controlled Phase 2a Study of RTB101 as COVID-19 Post-Exposure Prophylaxis in Asymptomatic Adults Age ≥65 Years 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. The study is designed to obtain study feasibility data for RTB101 in an unbiased fashion and will inform the design of a subsequent pivotal trial.

Conditions

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Covid19

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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10 mg daily RTB101

RTB101

TORC1 inhibitor

Group Type EXPERIMENTAL

RTB101

Intervention Type DRUG

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

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Oral matching placebo once daily for 2 weeks

Interventions

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RTB101

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

Intervention Type DRUG

Placebo

Oral matching placebo once daily for 2 weeks

Intervention Type DRUG

Other Intervention Names

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Dactolisib BEZ235 Placebo capsule

Eligibility Criteria

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Exclusion Criteria

1. Any subject who self-reports:

1. As a current smoker, or stopped smoking within the past 6 months.
2. As a previous smoker with a ≥10 pack year smoking history.
3. Has a household member who currently smokes in the house.
2. Subjects with a medical history of chronic obstructive pulmonary disease (COPD), emphysema or chronic bronchitis requiring active treatment with a prescription medication
3. The subject has already had symptoms consistent with COVID-19 at screening.
4. Subjects who require chronic supplemental oxygen therapy at screening.
5. 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.
6. The following cardiac conditions:

1. Unstable angina pectoris
2. History of myocardial infarction (MI), coronary bypass surgery, or any percutaneous coronary intervention (PCI) within 6 months prior to Screening
3. Congestive heart failure requiring active treatment with a prescription medication
4. Unstable or life-threatening cardiac arrhythmia

a. Chronic stable atrial fibrillation is allowed
7. Subjects with a history of systemic autoimmune diseases (e.g., lupus, inflammatory bowel disease, rheumatoid arthritis, etc.).

a. Psoriasis confined to the skin and eczema are allowed
8. Subjects receiving immunosuppressive therapy including chronic use of supraphysiologic steroids such as 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).
9. Subjects with an immunodeficiency disease, including a history of a positive human immunodeficiency virus (HIV) test result.
10. Subjects with a history of gastric bypass surgery.
11. Subjects who require treatment with strong CYP3A4 or CYP1A2 inhibitors or inducers, or subjects who require treatment with digoxin.
12. Use of any other investigational medication or participation in any other investigational study within 5 half-lives of the investigational medication, or within 30 days, whichever is longer; or longer if required by local regulations.

Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No