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Phase 2 study of inhaled SNG001 in mechanically ventilated patients with respiratory virus infection
EU CTIS ID: 2024-520375-27-00
What this study is testing
Part 1: To evaluate the safety of SNG001 administration to participants with a confirmed respiratory virus infection undergoing invasive mechanical ventilation (IMV). Part 2: To evaluate the efficacy of SNG001 versus placebo in participants with a confirmed respiratory virus infection undergoing IMV.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 1. Part 1: Informed consent or legal representative’s consent obtained.
- 10. Part 2: Time from intubation to administration of first dose of study medication ≤48 hours.
- 11. Part 2: Informed consent or legal representative’s consent obtained.
- 12. 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.
- 2. Part 1: Patients ≥50 years of age at the time of consent.
- 3. Part 1: Patient admitted to the ICU and requiring IMV due to a respiratory virus infection
You likely can't join if
- 1. Part 1: Expected termination of IMV within 24 hours from the time of randomisation.
- 18. Part 1: Females who are breast-feeding or lactating.
- 19. 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.
- 10. Part 1: Use of inhaled sedation.
- 20. Part 1: Severe chronic lung disease requiring home oxygen therapy, including chronic obstructive pulmonary disease, asthma, cystic fibrosis, or pulmonary fibrosis.
- 21. Part 2: Expected termination of IMV within 24 hours from the time of randomisation.
See the full eligibility criteria
Who can join
- 1. Part 1: Informed consent or legal representative’s consent obtained.
- 10. Part 2: Time from intubation to administration of first dose of study medication ≤48 hours.
- 11. Part 2: Informed consent or legal representative’s consent obtained.
- 12. 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.
- 2. Part 1: Patients ≥50 years of age at the time of consent.
- 3. Part 1: Patient admitted to the ICU and requiring IMV due to a respiratory virus infection
- 4. 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).
- 5. Part 1: Time from intubation to administration of first dose of study medication ≤48 hours.
- 6. 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.
- 7. 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).
- 8. Part 2: Patient admitted to the ICU and requiring IMV due to a respiratory virus infection.
- 9. 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).
What rules you out
- 1. Part 1: Expected termination of IMV within 24 hours from the time of randomisation.
- 18. Part 1: Females who are breast-feeding or lactating.
- 19. 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.
- 10. Part 1: Use of inhaled sedation.
- 20. Part 1: Severe chronic lung disease requiring home oxygen therapy, including chronic obstructive pulmonary disease, asthma, cystic fibrosis, or pulmonary fibrosis.
- 21. Part 2: Expected termination of IMV within 24 hours from the time of randomisation.
- 22. Part 2: Life expectancy <24 hours.
- 23. Part 2: Liver failure (Child-Pugh C).
- 24. Part 2: Severe congestive heart failure (NYHA IV).
- 25. Part 2: Receipt of lung transplant.
- 26. Part 2: Known or suspected active tuberculosis, or infection with other mycobacteria.
- 5. Part 1: Receipt of lung transplant.
- 27. Part 2: Known or suspected active systemic fungal infection.
- 28. 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.
- 29. Part 2: Anticipated transfer to another hospital, which would prevent the participant from continuing in the study and completing protocol assessments.
- 11. Part 1: Presence of tracheostomy or laryngectomy.
- 30. Part 2: Need for long-term mechanical ventilation prior to ICU admission.
- 12. Part 1: Requirement for airway pressure release ventilation mode.
- 13. Part 1: History of hypersensitivity to natural or recombinant IFNβ or to any of the excipients in the drug preparation.
- 14. 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.
- 2. Part 1: Life expectancy <24 hours.
- 3. Part 1: Liver failure (Child-Pugh C).
- 6. Part 1: Known or suspected active tuberculosis, or infection with other mycobacteria.
- 4. Part 1: Severe congestive heart failure (New York Heart Association [NYHA] IV)
- 31. Part 2: Use of inhaled sedation.
- 32. Part 2: Presence of tracheostomy or laryngectomy.
- 33. Part 2: History of hypersensitivity to natural or recombinant IFNβ or to any of the excipients in the drug preparation.
- 34. 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.
- 35. Part 2: Participation in previous clinical studies of SNG001.
- 36. 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.
- 37. Part 2: Known or suspected pregnancy.
- 38. Part 2: Females who are breast-feeding or lactating.
- 39. Part 2: Severe chronic lung disease requiring home oxygen therapy, including chronic obstructive pulmonary disease, asthma, cystic fibrosis, or pulmonary fibrosis.
- 7. Part 1: Known or suspected active systemic fungal infection.
- 8. Part 1: Anticipated transfer to another hospital, which would prevent the participant from continuing in the study and completing protocol assessments.
- 9. Part 1: Need for long-term mechanical ventilation prior to ICU admission.
- 15. Part 1: Participation in previous clinical studies of SNG001.
- 16. 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.
- 17. Part 1: Known or suspected pregnancy.
The study team makes the final eligibility decision.
Where it's taking place
- United States
- United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United States; United Kingdom. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.