Status:
RECRUITING
Phase 2 Study of Inhaled SNG001 in Mechanically Ventilated Patients With Respiratory Viral Infection
Lead Sponsor:
Synairgen Research Ltd.
Conditions:
Viral Pneumonia
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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...
Eligibility Criteria
Inclusion
- Part 1
- 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.
- Part 1
Exclusion
- 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.
- Participation in previous clinical studies of SNG001.
- 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.
- Known or suspected pregnancy.
- Females who are breast-feeding or lactating.
- 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.
- Severe chronic lung disease requiring home oxygen therapy, including chronic obstructive pulmonary disease, asthma, cystic fibrosis, or pulmonary fibrosis.
- Part 2 Inclusion Criteria:
- To be eligible for randomisation into Part 2 of this study, each participant must fulfil the following criteria:
- 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).
- Patient admitted to the ICU and requiring IMV due to a respiratory virus infection.
- Presence of Flu A, Flu B, RSV, RV, adenovirus, parainfluenza, HMPV, or coronaviruses (including SARS-COV-2 and seasonal coronaviruses) in a Lower Respiratory Tract sample, confirmed by a positive virus test using a Sponsor approved rapid POC test (e.g., RT-PCR).
- Time from intubation to administration of first dose of study medication ≤48 hours.
- Informed consent or legal representative's consent obtained.
- 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
Key Trial Info
Start Date :
September 2 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2027
Estimated Enrollment :
550 Patients enrolled
Trial Details
Trial ID
NCT06999603
Start Date
September 2 2025
End Date
May 1 2027
Last Update
December 31 2025
Active Locations (67)
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1
University of California - Davis
Sacramento, California, United States, 95817
2
Lundquist Institute for Biomedical Innovation at Harbor UCLA Medical Center
Torrance, California, United States, 90502
3
NCH Pulmonary Critical Care
Naples, Florida, United States, 34102
4
Emory University
Atlanta, Georgia, United States, 30308