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 study about?

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.

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 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 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 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 Study?

  • 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 Study?

  • 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

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Bellvitge University Hospital L'hospitalet De Llobregat Spain

Other Sites

Site Name City Country Status
Ziekenhuis Gelderse Vallei Stichting Ede The Netherlands
Centre Hospitalier Departemental Vendee La Roche sur Yon France
Centre Hospitalier Victor Dupouy Argenteuil France
Centre Hospitalier Universitaire Rouen Rouen France
Universitair Medisch Centrum Utrecht Utrecht The Netherlands
Hospital Clinic De Barcelona Barcelona Spain
Centre Hospitalier Le Mans Le Mans France
Centre Hospitalier Universitaire De Nantes Nantes France
Fundacio Assistencial De Mutua De Terrassa Fpc Terrassa Spain
Centre Hospitalier De Bourg-En-Bresse Bourg En Bresse France
Ziekenhuis Oost Limburg Genk Belgium
Centre hospitalier universitaire de Liege Liege Belgium
Centre Hospitalier Lyon Sud Pierre Benite France
Centre Hospitalier Regional De La Citadelle Liege Belgium
Hospital Universitario 12 De Octubre Madrid Spain
Vrije Universiteit Brussel Jette Belgium
Canisius Wilhelmina Ziekenhuis Nijmegen The Netherlands
Ikazia Ziekenhuis Rotterdam The Netherlands
Iipjzspn dp Cafehkrwlhga Hamovrfamis Uftoxdlpjdvpv dw Sialy Eetrzua (qmyguox Saint Priest En Jarez France
Hynfsxwl Vypm dmzpayse Barcelona Spain
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Clmzoo Hunpckoonnm Rbicghgh Ugavsbnfwvgvq Du Tsllq Tours France
Hxeezqkx Umqdwwrtzlivot Sejnrrzjda &rgeafw Heuilev dk Hquznbpkgud STRASBOURG, Alsace France

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Belgium Belgium
Not recruiting
12.11.2025
France France
Not recruiting
12.11.2025
Spain Spain
Not recruiting
12.11.2025
The Netherlands The Netherlands
Not recruiting
12.11.2025

Trial locations

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.

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 ID:
2024-520375-27-00
Protocol code:
SG021
NCT ID:
NCT06999603
Trial Phase:
Therapeutic exploratory (Phase II)

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