respiratory virus infection
Conditions
Interventions
Data regarding safety events will only be collected for this clinical investigation. Assessment of whether any safety events regarding trial participants have occurred will be conducted by investigato
Sponsors
Synairgen Research Ltd.
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Part I (applicable for US only)To be eligible for randomisation into Part 1 of the 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 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 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).**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.* Patients with confirmed respiratory virus infection and bacterial or fungal respiratory co-infection may be eligible for the study, providing that in the opinion of the Investigator, based on routine clinical, radiological, and microbiological assessments, the primary reason for the patient’s ICU admission and IMV is their viral infection.** The Sponsor will monitor the aetiology of viral infections during the conduct of the study and may decide to limit enrollment of patients with certain viral infections, to achieve a balanced mix of viruses. Part II (applicable for EU)To be eligible for randomisation into Part 2 of the 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.orb. 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 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).**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.* Patients with confirmed respiratory virus infection and bacterial or fungal respiratory co-infection may be eligible for the study, providing th
Exclusion criteria
Exclusion criteria: Part I (applicable for US only)A participant must not be randomised into Part 1 of the study if they meet any of the following criteria: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 active systemic fungal infection.8. Anticipated transfer to another hospital, which would prevent the participant from continuing in the study and completing protocol assessments.9. Need for long-term mechanical ventilation prior to ICU admission.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 IFNß 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 breast-feeding or lactating.19. Immunocompromising condition, including:a. 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;b. Haematological malignancy;c. Bone marrow transplantation; ord. 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.20. Severe chronic lung disease requiring home oxygen therapy, including chronic obstructive pulmonary disease, asthma, cystic fibrosis, or pulmonary fibrosis. Part II (applicable for EU)A participant must not be randomised into Part 2 of the study if they meet any of the following criteria: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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety during administration of the IMP whilst the SG021 participant is receiving IMV or NIV assessed by: Cumulative incidence of serious adverse events (SADEs);Cumulative incidence of ADEsSeverity of ADEs | — |
Countries
Belgium, France, Netherlands, Spain, United Kingdom, United States
Contacts
Public ContactS. Hemmings
Synairgen Research Ltd.
Outcome results
None listed