A Phase II study to understand the safety and effects of inhaled SNG001, the study medication, in patients who are mechanically ventilated due to a respiratory viral infection in the lungs
| ISRCTN | ISRCTN30482473 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN30482473 |
| Integrated Research Application System (IRAS) | 1010122 |
| Central Portfolio Management System (CPMS) | 62305 |
| Protocol serial number | SG021 |
| Sponsor | Synairgen (United Kingdom) |
| Funder | Synairgen Research Ltd |
- Submission date
- 09/11/2024
- Registration date
- 29/01/2025
- Last edited
- 08/07/2026
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
Plain English summary of protocol
Background and study aims
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.
Who can participate?
Patients who require mechanical ventilation due to a virus infection in the lung
What does the study involve?
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. During the study participants will still receive standard of care including other treatments for viral pneumonia
What are the possible benefits and risks of participating?
The potential health benefit from participating in this study is that SNG001 may help patients recover from their lung infection, shorten their symptoms and/or shorten the length of time they will need to be on a ventilator. In addition, the results of this study will be used for future product development decisions to improve SNG001. Information learned from the study may help other people in the future.
SNG001 has been investigated in seven completed clinical studies, across various populations including asthmatics, COPD and COVID-19 patients. Of the 758 patients treated with SNG001, 342 patients with COVID-19 required hospitalisation and oxygen supplementation due to the severity of their disease. Treatment with SNG001 across the different studies was generally well tolerated, with no specific safety signals being observed, whether related to local tolerance or systemic effects. SNG001 has not been administered to patients with severe viral lung infections undergoing IMV hence the specific focus of Part 1 of the study on safety. A review of the safety data and potential risks supports the design of the proposed clinical trial (SG021) of SNG001. To minimize any potential risks Part 1 of the study will initially assess safety in patients receiving a lower dose of SNG001. The independent data review committee will provide ongoing oversight of safety throughout both parts of the study.
Where is the study run from?
Synairgen Research Ltd (UK)
When is the study starting and how long is it expected to run for?
November 2024 to March 2027
Who is funding the study?
Synairgen Research Ltd (UK)
Who is the main contact?
Sophie Hemmings, submissions@synairgen.com
Contact information
Scientific
Tremona Road
Southampton
SO16 6YD
United Kingdom
| Phone | +44 (0)23 80512 800 |
|---|---|
| submissions@synairgen.com |
Principal investigator
Tremona Road
Southampton
SO16 6YD
United Kingdom
| Phone | +44 (0)2380512800 |
|---|---|
| submissions@synairgen.com |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Double-blind randomized placebo-controlled parallel-group trial (Part 1 of the study is open-label, uncontrolled, to assess the safety of SNG001) |
| Secondary study design | Randomised controlled trial |
| Scientific title | A Phase II, 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 |
| Study objectives | The primary objective of Part 1 will be to evaluate the safety of SNG001 administration to participants with a confirmed respiratory virus infection undergoing IMV. The primary objective of Part 2 will be to evaluate the efficacy of SNG001, versus placebo, in participants with a confirmed respiratory virus infection undergoing IMV. Secondary objectives of part 2: 1. To evaluate the safety of SNG001 administration to participants with a confirmed respiratory virus infection undergoing IMV. 2. To evaluate antiviral and biomarker responses after administration of SNG001. |
| Ethics approval(s) |
Approved 19/09/2025, South Central - Hampshire B REC (2 Redman Place, Stratford, London, E20 1JQ, United Kingdom; -; hampshireb.rec@hra.nhs.uk), ref: 24/SC/0385 |
| Health condition(s) or problem(s) studied | Respiratory viral infections |
| Intervention | Current interventions as of 07/07/2026: Part 1 (Randomized; double-blind; placebo-controlled): Participants who meet study entry criteria will receive the following intervention: Experimental Arm: Cohort 1, SNG001 (0.65 ml of nebuliser solution containing 12 MIU/ml of IFNβ-1a) given by inhalation using a nebuliser, once a day for a maximum of 14 days or until hospital discharge, whichever occurs earlier, in addition to Standard of Care (SOC). Cohort 1, Placebo Comparator Arm: Placebo to match the experimental arm of nebuliser solution (identical to the experimental arm but without IFNβ-1a) given by inhalation using a nebuliser, once a day for a maximum of 14 days or until hospital discharge whichever occurs earlier, in addition to SOC. Cohort 2 (Optional), SNG001 (two syringes) given by inhalation using a nebuliser, once a day for a maximum of 14 days or until hospital discharge whichever occurs earlier, in addition to SOC. Cohort 2 (Optional), Placebo Comparator Arm: Placebo to match the experimental arm of nebuliser solution (identical to the experimental arm but without IFNβ-1a) given by inhalation using a nebuliser, once a day for a maximum of 14 days or until hospital discharge whichever occurs earlier, in addition to SOC. Part 2 (Randomized; double-blind; placebo-controlled): Participants who meet study entry criteria will be randomised (using an online tool) to receive either of the following interventions: Experimental Arm: SNG001 (two syringes) of nebuliser solution containing 12 MIU/ml of IFNβ-1a) given by inhalation using a nebuliser, once a day for a maximum of 14 days or until hospital discharge whichever occurs earlier, in addition to SOC. Placebo Comparator Arm: SNG001 placebo (two syringes) of nebuliser solution identical to the experimental arm but without IFNβ-1a given by inhalation using a nebuliser, once a day for a maximum of 14 days or until hospital discharge, whichever occurs earlier, in addition to SOC. Previous interventions: Part 1 (Open-label; non-comparative): Participants who meet study entry criteria will receive the following intervention: Experimental Arm: Cohort 1, SNG001 (0.65 ml of nebuliser solution containing 12 MIU/ml of IFNβ-1a) given by inhalation using a nebuliser, once a day for a maximum of 14 days or until hospital discharge whichever occurs earlier, in addition to Standard of Care (SOC). Cohort 2 (Optional), SNG001 (at a dose recommended by the IDMC) given by inhalation using a nebuliser, once a day for a maximum of 14 days or until hospital discharge whichever occurs earlier, in addition to SOC. Part 2 (Randomized; double-blind; placebo-controlled): Participants who meet study entry criteria will be randomised (using an online tool) to receive either of the following interventions: Experimental Arm: SNG001 (at a dose recommended by the IDMC, (based on results of Part 1) of nebuliser solution containing 12 MIU/ml of IFNβ-1a) given by inhalation using a nebuliser, once a day for a maximum of 14 days or until hospital discharge whichever occurs earlier, in addition to SOC. Placebo Comparator Arm: SNG001 placebo to match experimental arm (based on results of Part 1) of nebuliser solution identical to the experimental arm but without IFNβ-1a) given by inhalation using a nebuliser, once a day for a maximum of 14 days or until hospital discharge whichever occurs earlier, in addition to SOC. |
| Intervention type | Drug |
| Phase | Phase II |
| Drug / device / biological / vaccine name(s) | Interferon beta-1a (IFN-β1a)/Aerogen Clinical Controller System |
| Primary outcome measure(s) |
Part 1: The occurrence and severity of adverse events (AEs) and serious adverse events (SAEs), including prespecified respiratory and cardiovascular deteriorations, assessed by site staff using recognised assessment tools and/or patients’ clinical condition, up to 28 days from randomisation |
| Key secondary outcome measure(s) |
Current secondary outcomes as of 07/07/2026; |
| Completion date | 13/03/2026 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Mixed |
| Lower age limit | 18 Years |
| Upper age limit | 100 Years |
| Sex | All |
| Target sample size at registration | 450 |
| Total final enrolment | 11 |
| Key inclusion criteria | Current inclusion criteria as of 07/07/2026: 1. Informed consent or legal representative’s consent obtained 2. Patients ≥35 (UK only) to 50 years of age at the time of consent 3. Patient admitted to the ICU and requiring IMV due to a respiratory virus infection* 4. 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 an LRT sample, confirmed by a positive virus test using a Sponsor approved rapid POC test (e.g., reverse transcription polymerase chain reaction [RT-PCR]), with a reported cycle threshold (Ct) value that meets the criteria as specified for each virus in Appendix A** 5. Time from intubation to administration of first dose of study medication ≤48 hours 6. 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: 1.1. Patients ≥18 and <50 years of age at the time of consent, with an immunocompromising condition, including: 1.1.1. Haematological malignancy; 1.1.2. Bone marrow transplantation; or 1.1.3. Immunosuppressive therapy, including cancer chemotherapy, immune-cell depleting therapy, immunosuppressive therapy for autoimmune disorders, medications for prevention of organ transplantation rejection, or the administration of corticosteroids >20 mg of prednisone or equivalent per day administered continuously for >14 days prior to randomisation or 1.2. Patients ≥50 years of age at the time of consent, with or without an immunocompromising condition 2. Patient admitted to the ICU and requiring IMV due to a respiratory virus infection* 3. Presence of Flu A, Flu B, RSV, RV, adenovirus, parainfluenza, HMPV, or coronaviruses (including SARS-COV-2 and seasonal coronaviruses) in an LRT sample, confirmed by a positive virus test using a Sponsor approved rapid POC test (e.g., RT PCR), with a reported Ct value that meets the criteria as specified for each virus in Appendix A** 4. Time from intubation to administration of first dose of study medication ≤48 hours 5. Informed consent or legal representative’s consent obtained 6. Women of childbearing potential must have a negative pregnancy test. For this study, women of childbearing potential are defined as women <55 years old Previous inclusion criteria: Part 1: 1. Informed consent or legal representative’s consent obtained 2. Patients ≥50 years of age at the time of consent 3. Patient admitted to the ICU and requiring IMV due to a respiratory virus infection* 4. 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 an LRT sample, confirmed by a positive virus test using a Sponsor approved rapid POC test (e.g., reverse transcription polymerase chain reaction [RT-PCR]), with a reported cycle threshold (Ct) value that meets the criteria as specified for each virus in Appendix A** 5. Time from intubation to administration of first dose of study medication ≤48 hours 6. 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: 1.1. Patients ≥18 and <50 years of age at the time of consent, with an immunocompromising condition, including: 1.1.1. Haematological malignancy; 1.1.2. Bone marrow transplantation; or 1.1.3. Immunosuppressive therapy, including cancer chemotherapy, immune-cell depleting therapy, immunosuppressive therapy for autoimmune disorders, medications for prevention of organ transplantation rejection, or the administration of corticosteroids >20 mg of prednisone or equivalent per day administered continuously for >14 days prior to randomisation or 1.2. Patients ≥50 years of age at the time of consent, with or without an immunocompromising condition 2. Patient admitted to the ICU and requiring IMV due to a respiratory virus infection* 3. Presence of Flu A, Flu B, RSV, RV, adenovirus, parainfluenza, HMPV, or coronaviruses (including SARS-COV-2 and seasonal coronaviruses) in an LRT sample, confirmed by a positive virus test using a Sponsor approved rapid POC test (e.g., RT PCR), with a reported Ct value that meets the criteria as specified for each virus in Appendix A** 4. Time from intubation to administration of first dose of study medication ≤48 hours 5. Informed consent or legal representative’s consent obtained 6. Women of childbearing potential must have a negative pregnancy test. For this study, women of childbearing potential are defined as women <55 years old |
| Key exclusion criteria | Current exclusion criteria as of 07/07/2026: Part 1: 1. Expected termination of IMV within 24 hours from the time of randomisation 2. Life expectancy <24 hours 3. Liver failure (Child-Pugh C) 4. Severe congestive heart failure (New York Heart Association [NYHA] IV) 5. Receipt of lung transplant 6. Known or suspected active tuberculosis, or infection with other mycobacteria 7. Known or suspected systemic fungal infection 8. Anticipated transfer to another hospital 9. Current need for long-term mechanical ventilation 10. Use of inhaled sedation 11. Presence of tracheostomy or laryngectomy 12. Requirement for airway pressure release ventilation mode 13. History of hypersensitivity to natural or recombinant IFNβ or to any of the excipients in the drug preparation 14. 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. 15. Participation in previous clinical studies of SNG001 16. 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 17. Known or suspected pregnancy 18. Females who are breastfeeding or lactating 19. Immunocompromising condition, including: 19.1. 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; 19.2. Haematological malignancy; 19.3. Bone marrow transplantation; or 19.4. Immunosuppressive therapy including cancer chemotherapy, immune-cell depleting therapy, immunosuppressive therapy for autoimmune disorders, medications for prevention of organ transplantation rejection, or the administration of corticosteroids >20 mg of prednisone or equivalent per day administered continuously for >14 days prior to randomisation 20. Severe chronic lung disease requiring home oxygen therapy, including chronic obstructive pulmonary disease, asthma, cystic fibrosis, or pulmonary fibrosis Part 2: 1. Expected termination of IMV within 24 hours from the time of randomisation 2. Life expectancy <24 hours 3. Liver failure (Child-Pugh C) 4. Severe congestive heart failure (NYHA IV) 5. Receipt of lung transplant 6. Known or suspected active tuberculosis, or infection with other mycobacteria 7. Known or suspected active systemic fungal infection 8. Immunocompromising condition, including: 8.1. Haematological malignancy requiring induction or consolidation therapy within 3 months prior to randomisation 8.2. Bone marrow transplant within 6 months prior to randomisation 8.3. Solid organ transplant within 6 months prior to randomisation 8.4. Corticosteroids >75 mg of prednisone or equivalent per day, administered continuously for >7 days prior to randomisation 8.5. Methotrexate therapy at randomisation, if the indication is chemotherapy for cancer 8.6. Chimeric antigen receptor (CAR)-T cell therapy, administered within 3 months prior to randomisation 8.7. Ibrutinib or alemtuzumab, administered within 3 months prior to randomisation 8.8. Neutropenia <500/mm3 not due to sepsis 8.9. Clinical presentation consistent with severe bone marrow suppression or pancytopenia 8.10. Established AIDS, defined as a CD4 count <200 cells/microL, and/or the presence of any AIDS-defining condition 9. Anticipated transfer to another hospital, which would prevent the participant from continuing in the study and completing protocol assessments. 10. Need for long-term mechanical ventilation prior to ICU admission. 11. Use of inhaled sedation. 12. Presence of tracheostomy or laryngectomy. 13. History of hypersensitivity to natural or recombinant IFNβ or to any of the excipients in the drug preparation. 14. 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. 15. Participation in previous clinical studies of SNG001. 16. 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. 17. Known or suspected pregnancy. 18. Females who are breastfeeding or lactating. 19. Severe chronic lung disease requiring home oxygen therapy, including chronic obstructive pulmonary disease, asthma, cystic fibrosis, or pulmonary fibrosis Previous exclusion criteria: Part 1: 1. Expected termination of IMV within 24 hours from the time of randomisation 2. Life expectancy <24 hours 3. Liver failure (Child-Pugh C) 4. Severe congestive heart failure (New York Heart Association [NYHA] IV) 5. Receipt of lung transplant 6. Known or suspected active tuberculosis, or infection with other mycobacteria 7. Known or suspected systemic fungal infection 8. Anticipated transfer to another hospital 9. Current need for long-term mechanical ventilation 10. Use of inhaled sedation 11. Requirement for airway pressure release ventilation mode 12. History of hypersensitivity to natural or recombinant IFNβ or to any of the excipients in the drug preparation 13. 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. 14. Participation in previous clinical studies of SNG001 15. 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 16. Known or suspected pregnancy 17. Females who are breastfeeding or lactating 18. Immunocompromising condition, including: 18.1. 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; 18.2. Haematological malignancy; 18.3. Bone marrow transplantation; or 18.4. Immunosuppressive therapy including cancer chemotherapy, immune-cell depleting therapy, immunosuppressive therapy for autoimmune disorders, medications for prevention of organ transplantation rejection, or the administration of corticosteroids >20 mg of prednisone or equivalent per day administered continuously for >14 days prior to randomisation 19. Severe chronic lung disease requiring home oxygen therapy, including chronic obstructive pulmonary disease, asthma, cystic fibrosis, or pulmonary fibrosis Part 2: 1. Expected termination of IMV within 24 hours from the time of randomisation 2. Life expectancy <24 hours 3. Liver failure (Child-Pugh C) 4. Severe congestive heart failure (NYHA IV) 5. Receipt of lung transplant 6. Known or suspected active tuberculosis, or infection with other mycobacteria 7. Known or suspected systemic fungal infection 8. Established AIDS, defined as a CD4 count <200 cells/microL, and/or the presence of any AIDS-defining condition 9. Anticipated transfer to another hospital 10. Current need for long-term mechanical ventilation 11. Use of inhaled sedation 12. History of hypersensitivity to natural or recombinant IFNβ or to any of the excipients in the drug preparation 13. 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 14. Participation in previous clinical studies of SNG001 15. 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 16. Known or suspected pregnancy 17. Females who are breastfeeding or lactating |
| Date of first enrolment | 04/12/2025 |
| Date of final enrolment | 02/02/2026 |
Locations
Countries of recruitment
- United Kingdom
- England
- Scotland
- Wales
- Belgium
- France
- Netherlands
- Spain
- United States of America
Study participating centres
Aberdeen
AB25 2ZN
Scotland
Mindelsohn Way
Edgbaston
Birmingham
B15 2GW
England
Duckworth Lane
Bradford
BD9 6RJ
England
Brighton
BN2 5BE
England
Cowbridge Road East
Cardiff
CF11 9XB
Wales
Glasgow
G4 0SF
Scotland
Anlaby Road
Hull
HU3 2JZ
England
Leicester
LE1 5WW
England
London
NW1 2PG
England
Pond Street
London
NW3 2QG
England
London
SW17 0QT
England
Middlesbrough
TS4 3BW
England
Freeman Road
High Heaton
Newcastle upon Tyne
NE7 7DN
England
Tremona Road
Southampton
SO16 6YD
England
Newton Road
Torquay
TQ2 7AA
England
Newcastle upon Tyne
NE1 4LP
England
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Basic results | 07/07/2026 | 07/07/2026 | No | No |
Additional files
- ISRCTN30482473_BasicResults_07Jul2026.pdf
- Basic results
Editorial Notes
08/07/2026: IPD confirmed as not expected to be made available.
07/07/2026: The following changes were made to the study record:
1. Basic results uploaded.
2. Ethics approval details and final enrolment number added.
3. The date of first enrolment was changed from 31/03/2025 to 04/12/2025.
4. The date of final enrolment was changed from 31/03/2027 to 02/02/2026.
5. The completion date was changed from 31/03/2027 to 13/03/2026.
6. The interventions, secondary outcomes, inclusion and exclusion criteria, and study participating centres were updated.
7. Belgium, France, Netherlands, Spain and United States of America were added to the countries of recruitment.
8. Aerogen Clinical Controller System was added to the drug/device/biological/vaccine name(s).
12/02/2025: Internal review.
29/01/2025: ISRCTN received notification of combined HRA/MHRA approval for this trial on 29/01/2025.
11/11/2024: Study's existence confirmed by the HRA.
