Respiratory viral infections Infections and Infestations
Conditions
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 IFNß-1
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 recomme
Sponsors
Synairgen (United Kingdom)
Eligibility
Sex/Gender
All
Inclusion criteria
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 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
Exclusion criteria
Exclusion criteria: Part 1: 1. Expected termination of IMV within 24 hours from the time of randomisation 2. Life expectancy 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 IFNß 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 Part 2: All-cause mortality within 28 days from randomisation measured using the proportion of patients who died between randomisation and day 28 in each study arm | — |
Secondary
| Measure | Time frame |
|---|---|
| Part 1: None Part 2: 1. The occurrence and severity of AEs and SAEs, including pre-specified respiratory and cardiovascular deteriorations, assessed by site staff using recognised assessment tools and/or patients’ clinical condition, up to Day 42 2. Organ failure assessed using the modified Sequential Organ Failure Assessment (mSOFA) score (5-point scores for the different organ systems) daily during ICU stay up to day 15 3. Time to extubation, defined as the date free from all tubes (endotracheal tube and tracheostomy tube), which was sustained for a minimum of 48 hours, up to 28 days from randomisation 4. Ventilator-free days over 28 days from randomisation measured using the mean number of days between randomisation and day 28 in each study arm when patients were not receiving mechanical ventilation 5. Duration of ICU stay up to 28 days from randomisation measured using the mean number of days between randomisation and day 28 in each study arm when patients were staying in the ICU 6. Duration of hospital stay up to 28 days from randomisation measured using the mean number of days between randomisation and day 28 in each study arm when patients were staying in the hospital 7. Clinical improvement assessed using the Ordinal Scale for Clinical Improvement (OSCI) score (8-point scale) from baseline to 7, 10, 14 and 28 days post-randomisation 8. Time to first negative virus test in tracheal aspirates assessed daily up to Day 7 by reverse transcription polymerase chain reaction (RT-PCR) test 9. Levels of IFNß-dependent biomarkers in tracheal aspirates measured using PCR daily up to Day 7 | — |
Countries
United Kingdom
Outcome results
None listed