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

Running, not enrolling · Phase 2 · Has a placebo group

Conditions studied: Covid19

In brief

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.

Key facts

Study ID

NCT04584710

Run by

Restorbio Inc.

People needed

60

Starts

2020-10-13

Expected to finish

2021-02-01

Last updated by the study team

2021-02-09

Who can join

Age: 65 and older. Sex: any. Healthy volunteers: not accepted.

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.).
• a. Psoriasis confined to the skin and eczema are allowed
• 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).
• Subjects with an immunodeficiency disease, including a history of a positive human immunodeficiency virus (HIV) test result.
• Subjects with a history of gastric bypass surgery.
• Subjects who require treatment with strong CYP3A4 or CYP1A2 inhibitors or inducers, or subjects who require treatment with digoxin.
• 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.

Where it is running

• University of Connecticut, UConn Center on Aging — Farmington, Connecticut, United States
• Hebrew Senior Life, Marcus Institute for Aging Research — Roslindale, Massachusetts, United States

Full record on ClinicalTrials.gov

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