Phase 2 Evaluation of Inhaled Interferon Beta-1a (SNG001) in Mechanically Ventilated Patients with Lower Respiratory Tract Viral Infections
- Trial ID
- 2024-520375-27-00
- Protocol
- SG021
- Sponsor
- Synairgen Research Limited
Trial statistics
Diseases & Conditions
Objectives
The primary objective is to assess the safety of inhaled SNG001 in patients receiving invasive mechanical ventilation with a confirmed lower respiratory tract viral infection, and to determine the efficacy of SNG001 compared with placebo in this population. Safety evaluation addresses the heightened risk profile of critically ill, ventilated patients, while efficacy assessment seeks evidence of therapeutic benefit that could improve clinical outcomes. Secondary objectives are to:
- evaluate the safety of SNG001 administration in the same patient cohort during the efficacy phase;
- characterize antiviral activity and biomarker responses following SNG001 treatment.
Participants
The trial enrolled 440 participants of both sexes who were admitted to intensive care units and required invasive mechanical ventilation due to a confirmed Lower respiratory tract viral infections. Eligible individuals were aged 18 years or older, including a cohort of patients 50 years of age and older, and encompassed both immunocompromised and non‑immunocompromised subjects. Selection was based on recent confirmation (≤48 hours before intubation) of a respiratory virus such as influenza A/B, RSV, rhinovirus, adenovirus, parainfluenza, human metapneumovirus, or coronaviruses by a sponsor‑approved rapid test or standard of care assay, and on an intubation‑to‑first‑dose interval of no more than 48 hours. Inclusion required informed consent from the patient or a legal representative, and for women of childbearing potential (defined as <55 years) a negative pregnancy test. The study population consisted of critically ill patients with acute respiratory failure, many of whom had underlying immunosuppressive conditions or were receiving high‑dose corticosteroids; lifestyle factors such as diet and physical activity were not applicable due to the severity of illness and mechanical ventilation status.
Plans and Procedures
The study is a phase 2, two‑part investigation in mechanically ventilated patients with confirmed lower respiratory tract viral infections. Part 1 evaluates safety of a single inhaled dose of SNG001 administered via nebuliser solution, while Part 2 is a randomized, double‑blind, placebo‑controlled comparison of SNG001 versus matching placebo to assess efficacy. Eligible participants must be intubated within 48 hours before the first dose and meet age and immunocompromising criteria; informed consent is obtained from the patient or legal representative. The protocol includes a screening visit to confirm viral status, acquire consent, and perform baseline assessments, followed by a baseline/randomisation visit on the day of first dosing. Participants receive daily inhalations during the intensive‑care stay and are evaluated at predefined intervals (days 7, 10, 14, and 28) for clinical outcomes, biomarker changes, and safety parameters. The end‑of‑study visit occurs at day 28 post‑randomisation or at hospital discharge, whichever occurs first. Overall participant involvement extends up to 28 days after the final dose. Early discontinuation may occur in the event of a serious adverse event, death, withdrawal of consent, or clinically significant deterioration requiring protocol‑specified withdrawal.
Treatment
The investigational product, interferon beta-1a, is provided as the nebuliser solution SNG001 for inhalation use. Each dose contains 15,600,000 IU per millilitre (equivalent to 12 MIU/mL). The solution is administered to participants via a calibrated nebuliser circuit directly into the respiratory tract. Dosing is performed in accordance with the study schedule, with each administration recorded in the dosing log.
The control arm receives a matching placebo formulated to mimic the SNG001 inhalation solution. The placebo contains no active substance and is supplied in an identical nebuliser solution container to preserve blinding. Administration follows the same inhalation route and schedule as the active investigational product.
All inhalation treatments are delivered while participants are undergoing invasive mechanical ventilation. Study staff document the time of each dose, verify nebuliser performance, and monitor adherence through electronic case report forms. Compliance checks include inspection of device logs and reconciliation of dispensed volumes against the prescribed dosing regimen.
Efficacy
Efficacy will be evaluated primarily by all-cause mortality within 28 days from randomisation. Secondary efficacy parameters include the incidence and severity of adverse events, the change from baseline in the modified Sequential Organ Failure Assessment (mSOFA) score during the intensive‑care stay, time to extubation, the number of ventilator‑free days within 28 days, duration of intensive‑care unit stay, duration of hospital stay, mortality assessed 28 days after the final dose, the proportion of participants alive and free of organ support at 28 days from randomisation and at 28 days post‑final dose, change in the Ordinal Scale for Clinical Improvement (OSCI) score from baseline to days 7, 10, 14 and 28, time to first negative viral test in tracheal aspirates, and change from baseline in interferon‑β‑dependent biomarker levels in tracheal aspirates.
Assessments will be performed using validated clinical instruments: the mSOFA and OSCI scores will be recorded by investigators at specified timepoints, laboratory analyses of tracheal aspirates will determine viral clearance and biomarker concentrations, and clinical records will capture extubation timing, ventilator‑free days, and lengths of ICU and hospital stay. Data will be collected throughout the ICU admission and analysed according to the predefined schedule of visits and the 28‑day follow‑up period.
Inclusion and Exclusion Criteria
Inclusion Criteria
- Part 1: Informed consent or legal representative’s consent obtained.
- Part 1: Patients ≥50 years of age at the time of consent.
- Part 1: Patient admitted to the ICU and requiring IMV due to a respiratory virus infection
- Part 1: 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 point of care (POC) test (e.g., reverse transcription polymerase chain reaction [RT-PCR]) or SOC test via any sample type (SOC sample collected not more than 48 hours prior to intubation).
- Part 1: Time from intubation to administration of first dose of study medication ≤48 hours.
- Part 1: Women of childbearing potential must have a negative pregnancy test. For this study, women of childbearing potential are defined as women <55 years old.
- Part 2: a. Patients ≥18 and <50 years of age at the time of consent, with an immunocompromising condition, including: • Solid tumour malignancy undergoing cancer therapy (e.g. chemo-, radio-, immuno-, hormone or other types of therapy); • Haematological malignancy in remission, with or without maintenance therapy; • Immunosuppressive therapy for autoimmune disease; • Therapy for prevention of organ transplant rejection; • Corticosteroids >20 mg of prednisone or equivalent per day, administered continuously for >14 days prior to randomisation. or b. Patients ≥50 years of age at the time of consent, with or without an immunocompromising condition (as defined above).
- Part 2: Patient admitted to the ICU and requiring IMV due to a respiratory virus infection.
- Part 2: Presence of Flu A, Flu B, RSV, RV, adenovirus, parainfluenza, 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., RT-PCR) or SOC test via any sample type (SOC sample collected not more than 48 hours prior to intubation).
- Part 2: Time from intubation to administration of first dose of study medication ≤48 hours.
- Part 2: Informed consent or legal representative’s consent obtained.
- Part 2: Women of childbearing potential must have a negative pregnancy test. For this study, women of childbearing potential are defined as women <55 years old.
Exclusion Criteria
- Part 1: Expected termination of IMV within 24 hours from the time of randomisation.
- Part 1: Receipt of lung transplant.
- Part 1: Known or suspected active tuberculosis, or infection with other mycobacteria.
- Part 1: Known or suspected active systemic fungal infection.
- Part 1: Anticipated transfer to another hospital, which would prevent the participant from continuing in the study and completing protocol assessments.
- Part 1: Need for long-term mechanical ventilation prior to ICU admission.
- Part 1: Participation in previous clinical studies of SNG001.
- Part 1: Current or previous participation in another clinical study where the participant has received a dose of an Investigational Medicinal Product (IMP) containing small molecules within 30 days or 5 half-lives (whichever is longer) prior to entry into this study or containing biologicals within 3 months prior to entry into this study.
- Part 1: Known or suspected pregnancy.
- Part 1: Females who are breast-feeding or lactating.
- Part 1: Immunocompromising condition, including: • Established acquired immune deficiency syndrome (AIDS) defined as a cluster of differentiation 4 (CD4) count <200 cells/microL, and/or the presence of any AIDS-defining condition; • Haematological malignancy; • Bone marrow transplantation; or • Immunosuppressive therapy including: *Cancer therapy (e.g. chemo-, radio-, immuno-, hormone or other types of therapy), immune-cell depleting therapy, immunosuppressive therapy for autoimmune disorders, medications for prevention of organ transplantation rejection, administered within 6 months prior to randomisation; or *Corticosteroids >20 mg of prednisone or equivalent per day administered continuously for >14 days prior to randomisation.
- Part 1: Use of inhaled sedation.
- Part 1: Severe chronic lung disease requiring home oxygen therapy, including chronic obstructive pulmonary disease, asthma, cystic fibrosis, or pulmonary fibrosis.
- Part 2: Expected termination of IMV within 24 hours from the time of randomisation.
- Part 2: Life expectancy <24 hours.
- Part 2: Liver failure (Child-Pugh C).
- Part 2: Severe congestive heart failure (NYHA IV).
- Part 2: Receipt of lung transplant.
- Part 2: Known or suspected active tuberculosis, or infection with other mycobacteria.
- Part 2: Known or suspected active systemic fungal infection.
- Part 2: Immunocompromising condition, including: • Haematological malignancy requiring induction or consolidation therapy within 3 months prior to randomisation; • Bone marrow transplant within 6 months prior to randomisation; • Solid organ transplant within 6 months prior to randomisation; • Corticosteroids >75 mg of prednisone or equivalent per day, administered continuously for >7 days prior to randomisation; • Methotrexate therapy at randomisation, if the indication is chemotherapy for cancer; • Chimeric antigen receptor (CAR)-T cell therapy, administered within 3 months prior to randomisation; • Ibrutinib or alemtuzumab, administered within 3 months prior to randomisation; • Neutropenia < 500/mm3 not due to sepsis; • Clinical presentation consistent with severe bone marrow suppression or pancytopenia; • Established AIDS, defined as a CD4 count <200 cells/microL, and/or the presence of any AIDS-defining condition.
- Part 2: Anticipated transfer to another hospital, which would prevent the participant from continuing in the study and completing protocol assessments.
- Part 1: Presence of tracheostomy or laryngectomy.
- Part 2: Need for long-term mechanical ventilation prior to ICU admission.
- Part 1: Requirement for airway pressure release ventilation mode.
- Part 1: History of hypersensitivity to natural or recombinant IFNβ or to any of the excipients in the drug preparation.
- Part 1: 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.
- Part 1: Life expectancy <24 hours.
- Part 1: Liver failure (Child-Pugh C).
- Part 1: Severe congestive heart failure (New York Heart Association [NYHA] IV)
- Part 2: Use of inhaled sedation.
- Part 2: Presence of tracheostomy or laryngectomy.
- Part 2: History of hypersensitivity to natural or recombinant IFNβ or to any of the excipients in the drug preparation.
- Part 2: 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.
- Part 2: Participation in previous clinical studies of SNG001.
- Part 2: Current or previous participation in another clinical study where the participant has received a dose of an IMP containing small molecules within 30 days or 5 half-lives (whichever is longer) prior to entry into this study or containing biologicals within 3 months prior to entry into this study.
- Part 2: Known or suspected pregnancy.
- Part 2: Females who are breast-feeding or lactating.
- Part 2: Severe chronic lung disease requiring home oxygen therapy, including chronic obstructive pulmonary disease, asthma, cystic fibrosis, or pulmonary fibrosis.
Trial Status by Country
| Country | Status | Start of Recruitment | Planned Patients |
|---|---|---|---|
 Belgium | Not Recruiting | 12 Nov 2025 | 25 |
 France | Not Recruiting | 12 Nov 2025 | 58 |
 The Netherlands | Not Recruiting | 12 Nov 2025 | — |
 Spain | Not Recruiting | 12 Nov 2025 | 26 |
| Netherlands | — | — | 25 |
Sites & Investigators
Investigational Products
Details about the medicinal products being studied in this clinical trial.
| Product Name | Role in Trial | Formulation | Administration | Max Daily Dose | Treatment Duration | EU MP Number |
|---|---|---|---|---|---|---|
SNG001 | Test | NEBULISER SOLUTION | INHALATION USE | 15600000 | 14 | PRD12173654 |
Placebo to match SNG001Interferon beta-1a 12MIU/mL solution for inhalation | Placebo | N/A | — | — | — | N/A |