COmmunity Patients at Risk of Viral Infections Including SARS-CoV-2
Status:
Recruiting
Trial end date:
2022-12-01
Target enrollment:
Participant gender:
Summary
Patients with a respiratory disease are at higher risk of poor outcomes due to worsening of
symptoms caused by Severe Acute Respiratory Syndrome Coronavirus 2 (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 safety, tolerability and feasibility 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 Chronic Obstructive Pulmonary
Disease (COPD). In a laboratory setting, RESP301 has been shown to be effective against
respiratory viruses, including SARS-CoV-2.
This study will first determine the maximum tolerated dose of RESP301 in up to 48 adult
patients with COPD or bronchiectasis in the United Kingdom (UK) (Part 1; Dose Finding Phase).
After completion of Part 1, approximately 150 patients will be recruited into Part 2 of the
trial (Expansion Phase). A minimum of 50 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.