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About
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.
Enrollment
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Inclusion and exclusion criteria
Part 1 Inclusion Criteria:
To be eligible for randomisation into Part 1 of this study, each participant must fulfil the following criteria:
Part 1 Exclusion Criteria:
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:
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:
1.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
Part 2 Exclusion Criteria:
A participant must not be randomised into Part 2 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 (NYHA IV).
Receipt of lung transplant.
Known or suspected active tuberculosis, or infection with other mycobacteria.
Known or suspected systemic fungal infection.
Immunocompromising condition, including:
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
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 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.
Severe chronic lung disease requiring home oxygen therapy, including chronic obstructive pulmonary disease, asthma, cystic fibrosis, or pulmonary fibrosis
Primary purpose
Allocation
Interventional model
Masking
550 participants in 4 patient groups, including a placebo group
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Central trial contact
Sophie Hemmings
Data sourced from clinicaltrials.gov
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