Actively Recruiting
Phase 2 Study of Inhaled SNG001 in Mechanically Ventilated Patients With Respiratory Viral Infection
Led by Synairgen Research Ltd. · Updated on 2025-12-31
550
Participants Needed
67
Research Sites
86 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The goal of this Phase 2 study is to assess about the safety, antiviral biomarker responses and efficacy of SNG001 when given to patients requiring invasive mechanical ventilation due to a respiratory virus infection. Its ability to speed up virus clearance and reduce mortality, compared with standard of care, will be studied. The study is split into two parts. All participants will receive standard of care in addition to SNG001 or placebo. In Part 1, the safety of SNG001 will be assessed. Participants of 50 years and older will receive study drug or placebo once a day for up to 14 days, whilst in hospital. In Part 2, the primary objective will be the efficacy of SNG001. Participants between 18 and 50 years with an immunocompromising condition and patients over 50 years (with or without an immunocompromising condition) will receive study drug once a day for up to 14 days, whilst in hospital.
CONDITIONS
Official 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
- Patient is 50 years or older (Part 1) or 18 to under 50 years with immunocompromising condition, or 50 years and older (Part 2)
- Admitted to ICU and requiring invasive mechanical ventilation due to respiratory virus infection
- Confirmed presence of specific respiratory viruses by approved rapid test
- Time from intubation to first dose of study medication is 48 hours or less
- Women of childbearing potential (under 55 years) must have a negative pregnancy test
You will not qualify if you...
- Expected to stop invasive mechanical ventilation within 24 hours from randomization
- Life expectancy less than 24 hours
- Liver failure (Child-Pugh C)
- Severe congestive heart failure (NYHA IV)
- Receipt of lung transplant
- Known or suspected active tuberculosis or other mycobacterial infection
- Known or suspected active systemic fungal infection
- Anticipated hospital transfer 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 IFN beta or any excipients
- Any condition that poses risk or interferes with study objectives
- Prior participation in SNG001 clinical studies
- Recent participation in other clinical studies with investigational drugs as specified
- Known or suspected pregnancy
- Females who are breastfeeding or lactating
- Immunocompromising conditions as defined, including recent cancer therapy, bone marrow transplantation, or high-dose corticosteroids
- Severe chronic lung disease requiring home oxygen therapy, including COPD, asthma, cystic fibrosis, or pulmonary fibrosis
AI-Screening
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Trial Site Locations
Total: 67 locations
1
University of California - Davis
Sacramento, California, United States, 95817
Not Yet Recruiting
2
Lundquist Institute for Biomedical Innovation at Harbor UCLA Medical Center
Torrance, California, United States, 90502
Actively Recruiting
3
NCH Pulmonary Critical Care
Naples, Florida, United States, 34102
Not Yet Recruiting
4
Emory University
Atlanta, Georgia, United States, 30308
Actively Recruiting
5
Snake River Research, PLLC
Idaho Falls, Idaho, United States, 83404
Actively Recruiting
6
Northwestern University
Chicago, Illinois, United States, 60611
Actively Recruiting
7
Sinai-Grace Hospital
Detroit, Michigan, United States, 48235
Actively Recruiting
8
William Beaumont Hospital
Royal Oak, Michigan, United States, 48073
Actively Recruiting
9
Mayo Clinic - Rochester
Rochester, Minnesota, United States, 55905
Actively Recruiting
10
Washington University in St. Louis
St Louis, Missouri, United States, 63108
Actively Recruiting
11
VA Western New York Healthcare system
Buffalo, New York, United States, 14215
Not Yet Recruiting
12
NYU Langone Tisch Hospital
New York, New York, United States, 10016
Not Yet Recruiting
13
University of North Carolina (UNC)
Chapel Hill, North Carolina, United States, 27599
Actively Recruiting
14
University of Cincinnati Medical Center (UCMC)
Cincinnati, Ohio, United States, 45219
Actively Recruiting
15
The Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
Not Yet Recruiting
16
The Ohio State University (OSU)
Columbus, Ohio, United States, 43210
Actively Recruiting
17
Mercy St. Vincent Medical Center
Toledo, Ohio, United States, 43608
Actively Recruiting
18
Oregon Health & Science University (OHSU)
Portland, Oregon, United States, 97239-3098
Actively Recruiting
19
AnMed Health Pulmonary and Sleep Medicine
Anderson, South Carolina, United States, 29621
Actively Recruiting
20
Baylor University Medical Center
Dallas, Texas, United States, 75246
Actively Recruiting
21
The University of Texas Health Science Center at Houston
Houston, Texas, United States, 77030
Not Yet Recruiting
22
Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Not Yet Recruiting
23
Universitair Ziekenhuis Brussel
Brussels, Belgium, 1090
Not Yet Recruiting
24
Ziekenhuis Oost-Limburg - Campus Sint-Jan
Genk, Belgium, 3600
Not Yet Recruiting
25
Centre Hospitalier Régional de la Citadelle
Liège, Belgium, 4000
Not Yet Recruiting
26
Centre Hospitalier Universitaire (CHU) de Liege
Liège, Belgium, 4000
Not Yet Recruiting
27
Centre Hospitalier d'Argenteuil
Argenteuil, France, 95107
Not Yet Recruiting
28
Centre Hospitalier de Bourg-en-Bresse
Bourg-en-Bresse, France, 01012
Not Yet Recruiting
29
CHD Vendee
La Roche-sur-Yon, France, 85925
Not Yet Recruiting
30
CH Le Mans
Le Mans, France, 72037
Not Yet Recruiting
31
CHU de Lille
Lille, France, 59037
Not Yet Recruiting
32
CHU de Limoges - Hopital Dupuytren 1
Limoges, France, 87042
Not Yet Recruiting
33
CHU de Nantes - Hotel-Dieu
Nantes, France, 44093
Not Yet Recruiting
34
HCL Centre Hospitalier Lyon Sud
Pierre-Bénite, France, 69495
Not Yet Recruiting
35
CHU de Rouen - Hopital Charles-Nicolle
Rouen, France, 76000
Not Yet Recruiting
36
CHU St Etienne - Hopital Nord
Saint-Priest-en-Jarez, France, 42270
Not Yet Recruiting
37
CHRU de Strasbourg
Strasbourg, France, 67200
Not Yet Recruiting
38
CHRU de Tours - Hopital Bretonneau
Tours, France, 37044
Not Yet Recruiting
39
Ziekenhuis Gelderse Vallei
Ede, Netherlands, 6716 RP
Not Yet Recruiting
40
Canisius-Wilhelmina Ziekenhuis (CWZ)
Nijmegen, Netherlands, 6532 SZ
Not Yet Recruiting
41
Ikazia Ziekenhuis
Rotterdam, Netherlands, 3083 AN
Not Yet Recruiting
42
Universitair Medisch Centrum Utrecht
Utrecht, Netherlands, 3584CX
Not Yet Recruiting
43
Hospital Universitario Vall d'Hebron
Barcelona, Spain, 08035
Not Yet Recruiting
44
Hospital Clinic Barcelona
Barcelona, Spain, 08036
Not Yet Recruiting
45
Hospital Universitari Mutua Terrassa
Barcelona, Spain, 08221
Not Yet Recruiting
46
Hospital Universitari de Bellvitge
Barcelona, Spain, 08907
Not Yet Recruiting
47
Hospital Universitario 12 de Octubre
Madrid, Spain, 28041
Not Yet Recruiting
48
Torbay Hospital
Paignton, Devon, United Kingdom, TQ2 7AA
Actively Recruiting
49
Aberdeen Royal Infirmary
Aberdeen, United Kingdom, AB25 2ZN
Actively Recruiting
50
Queen Elizabeth Hospital Birmingham
Birmingham, United Kingdom, B15 2TH
Actively Recruiting
51
Bradford Royal Infirmary
Bradford, United Kingdom, BD9 6RJ
Actively Recruiting
52
Royal Sussex County Hospital
Brighton, United Kingdom, BN2 5BE
Actively Recruiting
53
Cardiff and Vale Hospital
Cardiff, United Kingdom, CF14 4XW
Actively Recruiting
54
Glasgow Royal Infirmary
Glasgow, United Kingdom, G4 0SF
Actively Recruiting
55
Queen Elizabeth University Hospital
Glasgow, United Kingdom, G51 4TF
Not Yet Recruiting
56
Hull Royal Infirmary
Hull, United Kingdom, HU3 2JZ
Actively Recruiting
57
Leicester Royal Infirmary
Leicester, United Kingdom, LE1 5WW
Actively Recruiting
58
University College London Hospital
London, United Kingdom, NW1 2PG
Actively Recruiting
59
Royal Free Hospital
London, United Kingdom, NW3 2QG
Actively Recruiting
60
St George's Hospital
London, United Kingdom, SW17 0QT
Actively Recruiting
61
Manchester Royal Infirmary
Manchester, United Kingdom, M13 9WL
Not Yet Recruiting
62
The James Cook University Hospital
Middlesbrough, United Kingdom, TS4 3 BW
Not Yet Recruiting
63
Freeman Hospital
Newcastle upon Tyne, United Kingdom, NE7 7DN
Actively Recruiting
64
Queens Medical Centre (QMC)
Nottingham, United Kingdom, NG7 2UH
Not Yet Recruiting
65
Derriford Hospital
Plymouth, United Kingdom, PL6 8DH
Not Yet Recruiting
66
Queen Alexandra Hospital
Portsmouth, United Kingdom, PO6 3LY
Not Yet Recruiting
67
Southampton General Hospital
Southampton, United Kingdom, SO16 6YD
Actively Recruiting
Research Team
S
Sophie Hemmings
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
4
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