COmmunity patients at Risk of Viral Infections including SARS-CoV-2 [COVID-19]
Research type
Research Study
Full title
Community participants with COPD or bronchiectasis and at risk of Respiratory Viral Infections including SARS-CoV-2: An open-label, multicentre feasibility study of an inhaled nitric oxide generating solution (RESP301)
IRAS ID
290709
Contact name
Anu Kemppinen
Contact email
Sponsor organisation
Thirty Respiratory Limited
Eudract number
2020-004951-34
Duration of Study in the UK
1 years, 5 months, 30 days
Research summary
Is self-administered RESP301 treatment feasible and safe in community patients with COPD or bronchiectasis during an exacerbation?
Patients with a respiratory disease are at higher risk of poor outcomes due to worsening of symptoms caused by SARS-CoV-2 and other respiratory infections. New therapies are needed for treating high risk patients at early stages of an infection. This study will assess the feasibility and safety of using an inhaled nitric oxide generating solution, RESP301, as a self-administered treatment following flare-up of symptoms.
RESP301 is a liquid solution which produces nitric oxide in the lungs when inhaled using a nebuliser. The components of RESP301 are already used in clinical practice and inhaled nitric oxide is used as a treatment for newborns and patients with COPD. In a laboratory setting, RESP301 has been shown to be effective against respiratory viruses, including SARS-CoV-2.
This study aims to recruit approximately 150 adult patients with COPD or bronchiectasis in the UK. A minimum of 70 participants will receive a test dose of RESP301 during a screening visit. Response to the test dose will be monitored. Participants who tolerate the test dose will continue in the study and should contact the study team if they experience exacerbation symptoms in the next 52 weeks. Following a call with the site team to discuss symptoms, participants will receive RESP301 delivered to their home to self-administer for 7 days.
The study duration for each participant will be at most 57 weeks, including the study visit and monthly calls. Participants who start the course of study treatment, will receive daily calls during the treatment period and will also be followed up after they complete the treatment.
The study is funded by Thirty Respiratory Limited.
REC name
South Central - Oxford C Research Ethics Committee
REC reference
20/SC/0448
Date of REC Opinion
27 Nov 2020
REC opinion
Favourable Opinion