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Study of inhaled interferon beta-1a (SNG001) for treatment of patients with viral lower respiratory tract infections who require mechanical ventilation

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study focuses on treating patients with lower respiratory tract viral infections who require breathing support through a ventilator. The study will test a medication called SNG001, which contains interferon beta-1a and is given through inhalation using a nebulizer (a device that turns liquid medicine into a fine mist that can be breathed in). The study will include patients who have various respiratory viruses, including influenza, respiratory syncytial virus, rhinovirus, adenovirus, parainfluenza, human metapneumovirus, and coronaviruses.

The purpose of this research is to determine if SNG001 is safe and effective for treating patients on ventilators who have viral respiratory infections. The study is divided into two parts - the first part will look at the safety of the treatment, while the second part will compare SNG001 to placebo to see how well it works. Patients will receive either SNG001 or placebo through a nebulizer while they are on a ventilator.

During the study, doctors will monitor patients' recovery, including how long they need to stay in the intensive care unit, how long they need ventilator support, and whether the treatment helps them recover from their viral infection. The treatment period will last up to 14 days, and patients will be monitored for up to 28 days to assess their recovery.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial qualification

    The study consists of two parts targeting patients with respiratory virus infections who require mechanical ventilation.

    Part 1 accepts patients aged 50 and above. Part 2 includes patients aged 18 and above with specific health conditions, or patients 50 and above regardless of health conditions.

    A positive virus test must confirm the presence of specific respiratory viruses within 48 hours before being connected to a breathing machine.

  2. Step 2

    Treatment initiation

    Treatment must begin within 48 hours of being connected to the breathing machine.

    You will receive either SNG001 (a medication containing interferon beta-1a) or a placebo through inhalation.

    The medication is given as a nebulizer solution, which means it is turned into a fine mist that can be inhaled through the breathing machine.

  3. Step 3

    Monitoring period

    Medical staff will monitor your health status throughout your stay in the intensive care unit.

    They will track any changes in your condition using special assessment tools that measure organ function.

    Regular samples will be taken from your breathing tube to check for the presence of virus.

    The monitoring includes checking for any side effects or complications.

  4. Step 4

    Follow-up period

    Your health status will be monitored for 28 days after starting the treatment.

    The medical team will record how long you need breathing support, your time in intensive care, and total hospital stay.

    They will continue to monitor your recovery using a special scale that measures clinical improvement.

    A final health assessment will be conducted 28 days after your last dose of medication.

Who can join the trial?

14 criteria

  • You must provide informed consent (agreement to participate) or have a legal representative give consent on your behalf
  • For Part 1, you must be 50 years or older
  • You must be admitted to the Intensive Care Unit (ICU) and require mechanical ventilation (breathing support through a machine)
  • You must have a confirmed respiratory virus infection, which can include:
    • Influenza A or B
    • Respiratory syncytial virus (RSV)
    • Rhinovirus
    • Adenovirus
    • Parainfluenza
    • Human metapneumovirus
    • Coronaviruses (including SARS-COV-2)
    • The time between starting mechanical ventilation and receiving the first dose of study medication must be less than 48 hours
    • If you are a woman who can become pregnant (under 55 years old), you must have a negative pregnancy test
    • For Part 2, you must either be:
      • Between 18 and 50 years old with an immune system condition (such as cancer treatment, organ transplant, or taking certain medications that affect the immune system)
      • OR 50 years or older (with or without immune system conditions)

Who cannot join the trial?

15 criteria

  • Age below 18 years or above 65 years
  • Known allergies or hypersensitivity to the study medication (SNG001) or its components
  • Pregnant or breastfeeding women
  • History of severe respiratory conditions not related to viral infections
  • Currently participating in other clinical trials
  • Severe liver or kidney dysfunction
  • Active cancer or ongoing cancer treatment
  • Uncontrolled diabetes or heart conditions
  • Recent major surgery (within 3 months)
  • History of organ transplantation
  • Severe immunodeficiency (weakened immune system)
  • Current treatment with medications that could interact with the study drug
  • Unable to provide informed consent
  • History of substance abuse within the past year
  • Mental health conditions that could affect study participation
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Investigated drugs

SNG001 is an inhaled formulation of interferon beta, which is a naturally occurring protein that helps the body fight viral infections. It is delivered directly to the lungs through a nebulizer. This medication is designed to boost the body's natural antiviral defenses, particularly in patients who are on mechanical ventilation due to severe respiratory viral infections. The treatment aims to help reduce the severity of viral infections in the respiratory system and potentially improve outcomes for patients requiring breathing support through a ventilator.

What is already known about the treatment

SNG001 - An inhaled formulation of interferon beta-1a that is administered through mechanical ventilation systems for patients with severe respiratory viral infections. This investigational medication is currently undergoing Phase 2 clinical trials to evaluate its safety and effectiveness in treating lower respiratory tract viral infections in mechanically ventilated patients. SNG001 works by delivering the therapeutic protein directly to the lungs, where it helps boost the body's natural antiviral immune response at the molecular level by stimulating the production of antiviral proteins. As a biological response modifier, it belongs to the class of immunomodulatory drugs and represents a novel approach to treating severe viral respiratory conditions.

Investigated diseases

Lower Respiratory Tract Viral Infection - A condition where viruses infect the airways below the vocal cords, including the bronchi, bronchioles, and lungs. The infection causes inflammation of the lower airways, leading to symptoms such as coughing, wheezing, and difficulty breathing. The condition often begins with typical cold-like symptoms in the upper respiratory tract before progressing to the lower airways. Mucus production increases in the airways, and the surrounding tissues may become swollen and inflamed. The infection can affect people of all ages and typically develops over several days.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-520375-27-00Protocol codeSG021Estimated enrolment574 patientsSponsorSynairgen Research Limited

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