Actively Recruiting
Phase 2 Study Testing Safety and Effectiveness of Inhaled SNG001 for Adults with Respiratory Virus Infection on Mechanical Ventilation
Led by Synairgen Research Ltd. · Updated on 2025-12-31
550
Participants Needed
67
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, antiviral response, and effectiveness of inhaled SNG001 in patients who require invasive mechanical ventilation due to respiratory virus infections like influenza, RSV, and coronaviruses. This Phase 2 study aims to determine if SNG001 can speed up virus clearance and reduce death rates compared to standard care. The study is sponsored by Synairgen Research Ltd. and involves two parts based on age and immune status. Participants will receive either SNG001 or a placebo inhaled once daily via the Solo nebuliser for up to 14 days while in the hospital. In Part 1, patients aged 50 and older will be given either SNG001 or placebo to assess safety. In Part 2, participants aged 18 to 50 with immunocompromising conditions, and those over 50 regardless of immune status, will receive SNG001 or placebo to evaluate its effectiveness. During the study, researchers will monitor adverse events, mortality within 28 days, and other health outcomes such as time to extubation, ventilator-free days, ICU and hospital stay duration, and virus clearance. Tests will include virus detection, biomarker levels, and organ support needs. Follow-up assessments will continue up to 42 days after randomization to ensure thorough safety and efficacy evaluations.
CONDITIONS
Brief Title
Phase 2 Study of Inhaled SNG001 in Mechanically Ventilated Patients With Respiratory Viral Infection
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Informed consent or legal representative's consent obtained
- For Part 1: Patients aged 50 years or older
- For Part 2: Patients aged 18 to under 50 years with an immunocompromising condition, or patients 50 years or older regardless of immune status
- Admitted to ICU and requiring invasive mechanical ventilation due to respiratory virus infection
- Confirmed presence of respiratory virus by approved rapid test
- Time from intubation to first dose of study drug 48 hours or less
- Women of childbearing potential must have a negative pregnancy test (women under 55 years)
You will not qualify if you...
- Expected termination of mechanical ventilation within 24 hours from randomization
- Life expectancy less than 24 hours
- Liver failure classified as Child-Pugh C
- Severe congestive heart failure (NYHA Class IV)
- History of lung transplant
- Known or suspected active tuberculosis or other mycobacterial infection
- Known or suspected active systemic fungal infection
- Anticipated transfer to another hospital preventing study completion
- Need for long-term mechanical ventilation prior to ICU admission
- Use of inhaled sedation
- Presence of tracheostomy or laryngectomy
- Requirement for airway pressure release ventilation mode
- History of hypersensitivity to interferon beta or drug excipients
- Participation in previous SNG001 studies or recent investigational drug use
- Known or suspected pregnancy or breastfeeding
- Severe chronic lung disease requiring home oxygen therapy
- For Part 1: Immunocompromising conditions including AIDS, hematological malignancy, bone marrow transplantation, or recent immunosuppressive therapy
- For Part 2: Recent hematological malignancy treatment, bone marrow or solid organ transplant, high-dose corticosteroids, certain immunotherapies, neutropenia, severe bone marrow suppression, or established AIDS
Research Team
S
Sophie Hemmings
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here