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NCT06999603

Phase 2 Study of Inhaled SNG001 in Mechanically Ventilated Patients With Respiratory Viral Infection

Last Updated: 2025-12-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

550 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-09-02

Study Completion Date

2027-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Viral Pneumonia

Keywords

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Influenza Respiratory Syncytial Virus Rhinovirus Adenovirus Human Metapneumovirus Coronavirus Intubated Mechanically ventilated Interferon Intensive care SARS-CoV-2 Parainfluenza

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Part 1 of this study will include a low-dose (one syringe) first cohort, followed by an optional second cohort utilising a two-syringe dose. Part 2 will commence following the conclusion of Part 1 and will utilise the two-syringe dose. Both Part 1 and Part 2 of the study will be randomised, double-blind and placebo-controlled.

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Part 1 Safety Evaluation of SNG001

Participants will inhale a dose of SNG001 via the Solo nebuliser, once a day for up to 14 days. A first, single syringe, low-dose cohort may be followed by an optional second cohort utilising a two-syringe dose.

Group Type EXPERIMENTAL

SNG001

Intervention Type DRUG

SNG001 nebuliser solution is presented as a ready-to-use aqueous solution (neutral pH) in glass syringes containing 0.65 mL of drug product solution containing 12 MIU/mL of IFNβ 1a.

Part 1 Safety Evaluation of SNG001 (Placebo)

Participants will inhale a dose of placebo matched to SNG001 (only excipients of the SNG001 solution) via the Solo nebuliser, once a day for up to 14 days.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

The placebo nebuliser solution is presented in glass syringes containing 0.65 mL of solution containing the same formulation as the study medication but without IFNβ 1a (i.e., only the excipients of the SNG001 solution).

Part 2 Efficacy Evaluation of SNG001

Participants will inhale the higher (two-syringe) dose of SNG001 via the Solo nebuliser, once a day for up to 14 days.

Group Type EXPERIMENTAL

SNG001

Intervention Type DRUG

SNG001 nebuliser solution is presented as a ready-to-use aqueous solution (neutral pH) in glass syringes containing 0.65 mL of drug product solution containing 12 MIU/mL of IFNβ 1a.

Part 2 Efficacy evaluation of SNG001 (Placebo)

Participants will inhale a dose of placebo matched to SNG001 (only excipients of the SNG001 solution) via the Solo nebuliser, once a day for up to 14 days

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Interventions

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SNG001

SNG001 nebuliser solution is presented as a ready-to-use aqueous solution (neutral pH) in glass syringes containing 0.65 mL of drug product solution containing 12 MIU/mL of IFNβ 1a.

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

To be eligible for randomisation into Part 1 of this study, each participant must fulfil the following criteria:

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 invasive mechanical ventilation (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 a nose swab sample, confirmed by a positive virus test using a Sponsor approved rapid POC test (e.g., reverse transcription polymerase chain reaction \[RT-PCR\]).
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 \<55 years old.

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

1. b Patients ≥50 years of age at the time of consent, with or without an immunocompromising condition (as defined above).
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 a Lower Respiratory Tract sample, confirmed by a positive virus test using a Sponsor approved rapid POC test (e.g., RT-PCR).
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

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 IFNβ 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:

* 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.
20. Severe chronic lung disease requiring home oxygen therapy, including chronic obstructive pulmonary disease, asthma, cystic fibrosis, or pulmonary fibrosis.

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 systemic fungal infection.
8. 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.
9. Anticipated transfer to another hospital which would prevent the participant from continuing in the study and completing protocol assessments.
10. Need for long-term mechanical ventilation prior to ICU admission.
11. Use of inhaled sedation.
12. Presence of tracheostomy or laryngectomy
13. History of hypersensitivity to natural or recombinant IFNβ 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 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. Severe chronic lung disease requiring home oxygen therapy, including chronic obstructive pulmonary disease, asthma, cystic fibrosis, or pulmonary fibrosis

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

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2024-520375-27-00

Identifier Type: CTIS

Identifier Source: secondary_id

U1111-1317-0525

Identifier Type: OTHER

Identifier Source: secondary_id

ISRCTN30482473

Identifier Type: OTHER

Identifier Source: secondary_id

SG021

Identifier Type: -

Identifier Source: org_study_id

Phase 2 Study of Inhaled SNG001 in Mechanically Ventilated Patients With Respiratory Viral Infection

Study Results

Basic Information

Brief Summary

Detailed Description

Conditions

Keywords

Study Design

Study Groups

Part 1 Safety Evaluation of SNG001

SNG001

Part 1 Safety Evaluation of SNG001 (Placebo)

Placebo

Part 2 Efficacy Evaluation of SNG001

SNG001

Part 2 Efficacy evaluation of SNG001 (Placebo)

Placebo

Interventions

SNG001

Placebo

Eligibility Criteria

Inclusion Criteria

Exclusion Criteria

Sponsors

Synairgen Research Ltd.

Responsible Party

Locations

University of California - Davis

Lundquist Institute for Biomedical Innovation at Harbor UCLA Medical Center

NCH Pulmonary Critical Care

Emory University

Snake River Research, PLLC

Northwestern University

Sinai-Grace Hospital

William Beaumont Hospital

Mayo Clinic - Rochester

Washington University in St. Louis

VA Western New York Healthcare system

NYU Langone Tisch Hospital

University of North Carolina (UNC)

University of Cincinnati Medical Center (UCMC)

The Cleveland Clinic Foundation

The Ohio State University (OSU)

Mercy St. Vincent Medical Center

Oregon Health & Science University (OHSU)

AnMed Health Pulmonary and Sleep Medicine

Baylor University Medical Center

The University of Texas Health Science Center at Houston

Medical College of Wisconsin

Universitair Ziekenhuis Brussel

Ziekenhuis Oost-Limburg - Campus Sint-Jan

Centre Hospitalier Régional de la Citadelle

Centre Hospitalier Universitaire (CHU) de Liege

Centre Hospitalier d'Argenteuil

Centre Hospitalier de Bourg-en-Bresse

CHD Vendee

CH Le Mans

CHU de Lille

CHU de Limoges - Hopital Dupuytren 1

CHU de Nantes - Hotel-Dieu

HCL Centre Hospitalier Lyon Sud

CHU de Rouen - Hopital Charles-Nicolle

CHU St Etienne - Hopital Nord

CHRU de Strasbourg

CHRU de Tours - Hopital Bretonneau

Ziekenhuis Gelderse Vallei

Canisius-Wilhelmina Ziekenhuis (CWZ)

Ikazia Ziekenhuis

Universitair Medisch Centrum Utrecht

Hospital Universitario Vall d'Hebron

Hospital Clinic Barcelona

Hospital Universitari Mutua Terrassa

Hospital Universitari de Bellvitge

Hospital Universitario 12 de Octubre

Torbay Hospital

Aberdeen Royal Infirmary

Queen Elizabeth Hospital Birmingham

Bradford Royal Infirmary

Royal Sussex County Hospital

Cardiff and Vale Hospital