Phase 3 study to determine if RTB101 prevents respiratory illness
Research type
Research Study
Full title
A Multicenter, Randomized, Double Blind, Placebo-Controlled, Phase 3 Study to Determine if RTB101 Prevents Clinically Symptomatic Respiratory Illness in the Elderly
IRAS ID
268796
Contact name
Sebastian Johnston
Contact email
Sponsor organisation
resTORbio Inc.
Eudract number
2019-002014-39
Duration of Study in the UK
0 years, 7 months, 21 days
Research summary
This is a research study of an experimental drug called RTB101 (dactolisib). The study is intended to find out if RTB101 is safe and whether it prevents clinically symptomatic respiratory illness that is either confirmed by laboratory test or not in people 65 years of age and older. RTB101 may prevent clinically symptomatic respiratory illnesses by improving the function of blood cells that fight infections. Improving the ability to fight infections is important in people age 65 and older because aging is associated with an increased risk of getting seriously sick from clinically symptomatic respiratory illnesses. In some very severe cases, clinically symptomatic respiratory illnesses can lead to death.
In addition, the purpose of this study is to determine if RTB101 helps decrease the percentage and rate of clinically symptomatic respiratory illness associated with one of more laboratory-confirmed pathogens, such as respiratory viruses. The study will also find out whether it decreases the duration of moderate and severe symptoms due to all respiratory illnesses that are confirmed with a laboratory test.
The study will also determine whether RTB101 has any important benefit in the participants’ use of various age-related health care resources (e.g., number of trips to the Emergency Room [ER]) as well as their overall quality of life.
This global study will involve approximately 1500 enrolled participants. The study will last up to 24 weeks (about 6 months, not including 28 day screening period) with a safety follow-up phone call at Week 48. At the end of the study treatment period at Week 16, there will be no further distribution of study drug (RTB101 or Placebo).
REC name
East of Scotland Research Ethics Service REC 2
REC reference
19/ES/0095
Date of REC Opinion
29 Aug 2019
REC opinion
Further Information Favourable Opinion