Phase 2 Study of Inhaled SNG001 in Mechanically Ventilated Patients With Respiratory Viral Infection

NCT06999603 | Recruiting Phase 2 DMC FDA Drug

• 4 other identifiers: SG0212024-520375-27-00U1111-1317-0525ISRCTN30482473
• Study Type: interventional
• Target: 550
• Locations: 6 countries
• Sites: 67

Brief Summary

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

Viral Pneumonia

Keywords

Influenza; Respiratory Syncytial Virus; Rhinovirus; Adenovirus; Human Metapneumovirus; Coronavirus; Intubated; Mechanically ventilated; Interferon; Intensive care; SARS-CoV-2; Parainfluenza

Outcome Measures

Primary Outcomes (2)

• Part 1: AE and SAE Severity

  The occurrence and severity of AEs and serious adverse events (SAEs), including pre-specified respiratory and cardiovascular deteriorations.

  Up to 28 days from randomisation

• Part 2: All-cause mortality

  All deaths recorded on study

  Within 28 days from randomisation

Secondary Outcomes (11)

• Part 2: AE and SAE severity

  Up to 42 days from randomisation

• Part 2: Change in mSOFA from baseline

  Up to 14 days

• Part 2: Time to Extubation

  Up to 28 days from randomisation

• Part 2: Number of ventilator free days

  Up to 28 days from randomisation

• Part 2: Duration of stay in ICU

  Up to 28 days from randomisation

Study Arms (4)

Part 1 Safety Evaluation of SNG001

EXPERIMENTAL

Participants will inhale a dose of SNG001 via the Solo nebuliser, once a day for up to 14 days. A first, single syringe, low-dose cohort may be followed by an optional second cohort utilising a two-syringe dose.

Drug: SNG001

Part 1 Safety Evaluation of SNG001 (Placebo)

PLACEBO COMPARATOR

Participants will inhale a dose of placebo matched to SNG001 (only excipients of the SNG001 solution) via the Solo nebuliser, once a day for up to 14 days.

Drug: Placebo

Part 2 Efficacy Evaluation of SNG001

EXPERIMENTAL

Participants will inhale the higher (two-syringe) dose of SNG001 via the Solo nebuliser, once a day for up to 14 days.

Drug: SNG001

Part 2 Efficacy evaluation of SNG001 (Placebo)

PLACEBO COMPARATOR

Participants will inhale a dose of placebo matched to SNG001 (only excipients of the SNG001 solution) via the Solo nebuliser, once a day for up to 14 days

Drug: Placebo

Interventions

SNG001 DRUG

SNG001 nebuliser solution is presented as a ready-to-use aqueous solution (neutral pH) in glass syringes containing 0.65 mL of drug product solution containing 12 MIU/mL of IFNβ 1a.

Part 1 Safety Evaluation of SNG001; Part 2 Efficacy Evaluation of SNG001

Placebo DRUG

The placebo nebuliser solution is presented in glass syringes containing 0.65 mL of solution containing the same formulation as the study medication but without IFNβ 1a (i.e., only the excipients of the SNG001 solution).

Part 1 Safety Evaluation of SNG001 (Placebo); Part 2 Efficacy evaluation of SNG001 (Placebo)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• To be eligible for randomisation into Part 1 of this study, each participant must fulfil the following criteria:
• Informed consent or legal representative's consent obtained.
• Patients ≥50 years of age at the time of consent.
• Patient admitted to the ICU and requiring invasive mechanical ventilation (IMV) due to a respiratory virus infection.
• Presence of Influenza A (Flu A), Influenza B (Flu B), respiratory syncytial virus (RSV), rhinovirus (RV), adenovirus, parainfluenza, human metapneumovirus (HMPV), or coronaviruses (including SARS-COV-2 and seasonal coronaviruses) in a nose swab sample, confirmed by a positive virus test using a Sponsor approved rapid POC test (e.g., reverse transcription polymerase chain reaction \[RT-PCR\]).
• Time from intubation to administration of first dose of study medication ≤48 hours.
• Women of childbearing potential must have a negative pregnancy test. For this study, women of childbearing potential are defined as women \<55 years old.

You may not qualify if:

• A participant must not be randomised into Part 1 of the study if they meet any of the following criteria:
• Expected termination of IMV within 24 hours from the time of randomisation
• Life expectancy \<24 hours.
• Liver failure (Child-Pugh C).
• Severe congestive heart failure (New York Heart Association \[NYHA\] IV).
• Receipt of lung transplant.
• Known or suspected active tuberculosis, or infection with other mycobacteria
• Known or suspected active systemic fungal infection.
• Anticipated transfer to another hospital which would prevent the participant from continuing in the study and completing protocol assessments.
• 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 natural or recombinant IFNβ or to any of the excipients in the drug preparation.
• Any condition, including findings in the patient's medical history or in the pre-randomisation study assessments that in the opinion of the Investigator, constitute a risk or a contraindication for participation in the study or that could interfere with the study objectives, conduct, or evaluation.

Sponsors & Collaborators

• Synairgen Research Ltd.: lead

Study Sites (67)

University of California - Davis

Sacramento, California, 95817, United States

NOT YET RECRUITING

Lundquist Institute for Biomedical Innovation at Harbor UCLA Medical Center

Torrance, California, 90502, United States

RECRUITING

NCH Pulmonary Critical Care

Naples, Florida, 34102, United States

NOT YET RECRUITING

Emory University

Atlanta, Georgia, 30308, United States

RECRUITING

Snake River Research, PLLC

Idaho Falls, Idaho, 83404, United States

RECRUITING

Northwestern University

Chicago, Illinois, 60611, United States

RECRUITING

Sinai-Grace Hospital

Detroit, Michigan, 48235, United States

RECRUITING

William Beaumont Hospital

Royal Oak, Michigan, 48073, United States

RECRUITING

Mayo Clinic - Rochester

Rochester, Minnesota, 55905, United States

RECRUITING

Washington University in St. Louis

St Louis, Missouri, 63108, United States

RECRUITING

VA Western New York Healthcare system

Buffalo, New York, 14215, United States

NOT YET RECRUITING

NYU Langone Tisch Hospital

New York, New York, 10016, United States

NOT YET RECRUITING

University of North Carolina (UNC)

Chapel Hill, North Carolina, 27599, United States

RECRUITING

University of Cincinnati Medical Center (UCMC)

Cincinnati, Ohio, 45219, United States

RECRUITING

The Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

NOT YET RECRUITING

The Ohio State University (OSU)

Columbus, Ohio, 43210, United States

RECRUITING

Mercy St. Vincent Medical Center

Toledo, Ohio, 43608, United States

RECRUITING

Oregon Health & Science University (OHSU)

Portland, Oregon, 97239-3098, United States

RECRUITING

AnMed Health Pulmonary and Sleep Medicine

Anderson, South Carolina, 29621, United States

RECRUITING

Baylor University Medical Center

Dallas, Texas, 75246, United States

RECRUITING

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

NOT YET RECRUITING

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

NOT YET RECRUITING

Universitair Ziekenhuis Brussel

Brussels, 1090, Belgium

NOT YET RECRUITING

Ziekenhuis Oost-Limburg - Campus Sint-Jan

Genk, 3600, Belgium

NOT YET RECRUITING

Centre Hospitalier Régional de la Citadelle

Liège, 4000, Belgium

NOT YET RECRUITING

Centre Hospitalier Universitaire (CHU) de Liege

Liège, 4000, Belgium

NOT YET RECRUITING

Centre Hospitalier d'Argenteuil

Argenteuil, 95107, France

NOT YET RECRUITING

Centre Hospitalier de Bourg-en-Bresse

Bourg-en-Bresse, 01012, France

NOT YET RECRUITING

CHD Vendee

La Roche-sur-Yon, 85925, France

NOT YET RECRUITING

CH Le Mans

Le Mans, 72037, France

NOT YET RECRUITING

CHU de Lille

Lille, 59037, France

NOT YET RECRUITING

CHU de Limoges - Hopital Dupuytren 1

Limoges, 87042, France

NOT YET RECRUITING

CHU de Nantes - Hotel-Dieu

Nantes, 44093, France

NOT YET RECRUITING

HCL Centre Hospitalier Lyon Sud

Pierre-Bénite, 69495, France

NOT YET RECRUITING

CHU de Rouen - Hopital Charles-Nicolle

Rouen, 76000, France

NOT YET RECRUITING

CHU St Etienne - Hopital Nord

Saint-Priest-en-Jarez, 42270, France

NOT YET RECRUITING

CHRU de Strasbourg

Strasbourg, 67200, France

NOT YET RECRUITING

CHRU de Tours - Hopital Bretonneau

Tours, 37044, France

NOT YET RECRUITING

Ziekenhuis Gelderse Vallei

Ede, 6716 RP, Netherlands

NOT YET RECRUITING

Canisius-Wilhelmina Ziekenhuis (CWZ)

Nijmegen, 6532 SZ, Netherlands

NOT YET RECRUITING

Ikazia Ziekenhuis

Rotterdam, 3083 AN, Netherlands

NOT YET RECRUITING

Universitair Medisch Centrum Utrecht

Utrecht, 3584CX, Netherlands

NOT YET RECRUITING

Hospital Universitario Vall d'Hebron

Barcelona, 08035, Spain

NOT YET RECRUITING

Hospital Clinic Barcelona

Barcelona, 08036, Spain

NOT YET RECRUITING

Hospital Universitari Mutua Terrassa

Barcelona, 08221, Spain

NOT YET RECRUITING

Hospital Universitari de Bellvitge

Barcelona, 08907, Spain

NOT YET RECRUITING

Hospital Universitario 12 de Octubre

Madrid, 28041, Spain

NOT YET RECRUITING

Torbay Hospital

Paignton, Devon, TQ2 7AA, United Kingdom

RECRUITING

Aberdeen Royal Infirmary

Aberdeen, AB25 2ZN, United Kingdom

RECRUITING

Queen Elizabeth Hospital Birmingham

Birmingham, B15 2TH, United Kingdom

RECRUITING

Bradford Royal Infirmary

Bradford, BD9 6RJ, United Kingdom

RECRUITING

Royal Sussex County Hospital

Brighton, BN2 5BE, United Kingdom

RECRUITING

Cardiff and Vale Hospital

Cardiff, CF14 4XW, United Kingdom

RECRUITING

Glasgow Royal Infirmary

Glasgow, G4 0SF, United Kingdom

RECRUITING

Queen Elizabeth University Hospital

Glasgow, G51 4TF, United Kingdom

NOT YET RECRUITING

Hull Royal Infirmary

Hull, HU3 2JZ, United Kingdom

RECRUITING

Leicester Royal Infirmary

Leicester, LE1 5WW, United Kingdom

RECRUITING

University College London Hospital

London, NW1 2PG, United Kingdom

RECRUITING

Royal Free Hospital

London, NW3 2QG, United Kingdom

RECRUITING

St George's Hospital

London, SW17 0QT, United Kingdom

RECRUITING

Manchester Royal Infirmary

Manchester, M13 9WL, United Kingdom

NOT YET RECRUITING

The James Cook University Hospital

Middlesbrough, TS4 3 BW, United Kingdom

NOT YET RECRUITING

Freeman Hospital

Newcastle upon Tyne, NE7 7DN, United Kingdom

RECRUITING

Queens Medical Centre (QMC)

Nottingham, NG7 2UH, United Kingdom

NOT YET RECRUITING

Derriford Hospital

Plymouth, PL6 8DH, United Kingdom

NOT YET RECRUITING

Queen Alexandra Hospital

Portsmouth, PO6 3LY, United Kingdom

NOT YET RECRUITING

Southampton General Hospital

Southampton, SO16 6YD, United Kingdom

RECRUITING

MeSH Terms

Conditions

Pneumonia, Viral; Influenza, Human; Adenoviridae Infections; Coronavirus Infections; Paramyxoviridae Infections

Condition Hierarchy (Ancestors)

Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Lung Diseases; Respiratory Tract Diseases; Orthomyxoviridae Infections; RNA Virus Infections; DNA Virus Infections; Coronaviridae Infections; Nidovirales Infections; Mononegavirales Infections

Central Study Contacts

Sophie Hemmings

CONTACT

+442380512800; submissions@synairgen.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Part 1 of this study will include a low-dose (one syringe) first cohort, followed by an optional second cohort utilising a two-syringe dose. Part 2 will commence following the conclusion of Part 1 and will utilise the two-syringe dose. Both Part 1 and Part 2 of the study will be randomised, double-blind and placebo-controlled.

Study Record Dates

• First Submitted: May 22, 2025
• First Posted: May 31, 2025
• Study Start: September 2, 2025
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: December 31, 2025

Record last verified: 2025-12

Locations

BE (4); GB (20); NL (4); FR (12); US (22); ES (5)