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New treatment option for Viral Pneumonia
Official title Phase 2 Study of Inhaled SNG001 in Mechanically Ventilated Patients With Respiratory Viral Infection
ClinicalTrials.gov ID: NCT06999603
What this study is testing
What is SNG001?
SNG001 is an investigational medicine, given as an once-daily inhaled treatment, being studied as a potential treatment for viral pneumonia.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
You likely can't join if
- A participant must not be assigned by chance 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.
See the full eligibility criteria
Who can join
- 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...
- 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
What rules you out
- A participant must not be assigned by chance 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...
- 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...
- 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...
- 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...
- 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...
- 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 Exclusion Criteria: A participant must not be assigned by...
- 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:
- 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;pancytopenia;
- Established AIDS, defined as a CD4 count \<200 cells/microL, and/or the presence of any AIDS-defining condition.
- 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...
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Sacramento, California, United States
- Torrance, California, United States
- Naples, Florida, United States
- Atlanta, Georgia, United States
- Idaho Falls, Idaho, United States
- Chicago, Illinois, United States
- Detroit, Michigan, United States
- Royal Oak, Michigan, United States
- Rochester, Minnesota, United States
- St Louis, Missouri, United States
- Buffalo, New York, United States
- New York, New York, United States
- Chapel Hill, North Carolina, United States
- Cincinnati, Ohio, United States
- Cleveland, Ohio, United States
- Columbus, Ohio, United States
- Toledo, Ohio, United States
- Portland, Oregon, United States
- Anderson, South Carolina, United States
- Dallas, Texas, United States
+ 40 more site(s).
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
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, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Sacramento, California, United States; Torrance, California, United States; Naples, Florida, United States; Atlanta, Georgia, United States; Idaho Falls, Idaho, United States; Chicago, Illinois, United States and 54 more location(s). 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 ClinicalTrials.gov; the study team decides eligibility.