Phase 2 study of inhaled SNG001 in mechanically ventilated patients with respiratory virus infection
Research type
Research Study
Full title
A phase 2, two-part study to assess the safety, antiviral biomarker responses, and efficacy of inhaled SNG001 for the treatment of patients with a confirmed respiratory virus infection undergoing invasive mechanical ventilation
IRAS ID
1010122
Contact name
Sophie Hemmings
Contact email
Sponsor organisation
Synairgen Research Ltd
ISRCTN Number
ISRCTN30482473
Research summary
The purpose of this study is to assess if the medicine (SNG001) could potentially be a treatment for patients who have severe viral lung infections (‘pneumonia’) such as those caused by flu or COVID-19.
SNG001 contains interferon-β, a protein that occurs naturally in humans, which helps the body’s immune system fight off viruses. Clinical trials have shown that SNG001 has anti-viral activity and potential beneficial effects on clinical outcomes in patients with viral infections in the lung. In critically ill patients who require mechanical ventilation due to severe viral pneumonia, SNG001 could help clear the infection and thereby improve outcomes and recovery. SNG001 is delivered by inhalation using a nebuliser to target the virus in the lungs. SNG001 has been extensively evaluated in other patient groups including those with COVID-19, COPD and asthma.
Patients who require mechanical ventilation due to a virus infection in the lung will be included in this study. Patients who can consent will be approached for the study. Consent from Legal representatives will be sought for patients unable to give consent. Once the participant has recovered, they will be asked to consent to continue in the study.
This study has two parts. Part 1 will assess the safety of SNG001. A small group of participants will receive a low dose. Based on recommendations from an independent safety committee, a second group may receive a higher dose. The dose for Part 2 will be determined by the results from Part 1. Part 2 will evaluate how effective SNG001 is compared to placebo in up to 450 participants who will be randomly allocated to receive either SNG001 or placebo. They will be dosed for 14 days or until hospital discharge whichever happens first. When participants are no longer on a ventilator, dosing will continue through a mouthpiece attached to the nebuliser. During the study Participants will still receive standard of care including other treatments for viral pneumonia.REC name
South Central - Hampshire B Research Ethics Committee
REC reference
24/SC/0385
Date of REC Opinion
28 Jan 2025
REC opinion
Further Information Favourable Opinion