Clinically Symptomatic Respiratory Illness Clinical Trial
Official title:
A Multicenter, Randomized, Double Blind, Placebo-Controlled, Phase 3 Study to Determine if RTB101 Prevents Clinically Symptomatic Respiratory Illness in the Elderly
| Verified date | November 2019 |
| Source | Restorbio Inc. |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
The purpose of this study is to determine if RTB101 prevents illness associated with respiratory tract infections in people ≥65 years of age.
| Status | Withdrawn |
| Enrollment | 0 |
| Est. completion date | November 15, 2019 |
| Est. primary completion date | November 15, 2019 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 65 Years and older |
| Eligibility |
Inclusion Criteria: - Subjects must be =65 years of age - Subjects should require no or minimal assistance with self-care and activities of daily living. Subjects in assisted-living or long-term care residential facilities that provide minimal assistance are eligible - Sexually active male subjects with a partner of child-bearing potential must be willing to wear a condom while on study drug and for 1 week after stopping study drug and should not father a child in this period Exclusion Criteria: - Subjects who are current smokers, stopped smoking = 1 year prior to screening, or have and a = 10 pack year smoking history - Subjects with a medical history of clinically significant lung diseases (including COPD) other than asthma - Subjects with current evidence of a serious and/or unstable medical disorder - Subjects with unstable cardiac conditions - Subjects with a history of systemic autoimmune diseases - Subjects with Type I diabetes mellitus - Subjects with a history of immunodeficiency diseases, including a positive human immunodeficiency virus (HIV) test result - Infection with Hepatitis B (HBV) or Hepatitis C (HCV) |
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Restorbio Inc. |
Mannick JB, Morris M, Hockey HP, Roma G, Beibel M, Kulmatycki K, Watkins M, Shavlakadze T, Zhou W, Quinn D, Glass DJ, Klickstein LB. TORC1 inhibition enhances immune function and reduces infections in the elderly. Sci Transl Med. 2018 Jul 11;10(449). pii: eaaq1564. doi: 10.1126/scitranslmed.aaq1564. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Percentage of subjects with clinically symptomatic respiratory illness | Through Week 16 | ||
| Secondary | Percentage of subjects with clinically symptomatic respiratory illness associated with =1 laboratory-confirmed pathogen(s) | Through Week 16 | ||
| Secondary | Rate of clinically symptomatic respiratory illness (with or without an associated laboratory-confirmed pathogen) | Through Week 16 | ||
| Secondary | Rate of clinically symptomatic respiratory illnesses associated with =1 laboratory-confirmed pathogen(s) | Through Week 16 | ||
| Secondary | Time to alleviation of moderate and severe respiratory illness symptoms due to clinically symptomatic respiratory illness | Through Week 16 | ||
| Secondary | Percentage of subjects with severe respiratory illness symptoms due to clinically symptomatic respiratory illnesses | Through Week 16 | ||
| Secondary | Number of participants with treatment-emergent adverse events as assessed by CTCAE v5.0 | Through Week 20 | ||
| Secondary | Rate of clinically symptomatic respiratory illnesses associated with specific laboratory-confirmed viruses | Descriptive statistics will be provided for the rate of clinically symptomatic respiratory illnesses associated with specific laboratory-confirmed viruses. No formal statistical tests will be conducted. | Through Week 16 |