SNG001 for Viral Pneumonia
(INVENT Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment called SNG001 (an experimental drug) for individuals with viral pneumonia who require mechanical breathing support. The trial aims to determine if SNG001 can safely expedite virus clearance and reduce the risk of death compared to standard treatments. In the first part, researchers test the safety of SNG001 on individuals aged 50 and older. The second part examines the drug's effectiveness, involving participants aged 18 to 50 with weakened immune systems or anyone over 50. Individuals currently hospitalized with a respiratory virus and needing breathing support might be suitable candidates for this trial. As a Phase 2 trial, this research focuses on assessing the treatment's effectiveness in an initial, smaller group of participants.
Do I need to stop my current medications to join the trial?
The trial information does not specify if you need to stop taking your current medications. However, if you are on certain immunosuppressive therapies or have participated in other clinical studies recently, you may not be eligible. It's best to discuss your specific medications with the trial team.
Is there any evidence suggesting that SNG001 is likely to be safe for humans?
Research has shown that SNG001 is generally safe for people. In earlier studies, the most common side effect was a headache, occurring in about 15% of those using SNG001. Additionally, the treatment did not increase hospital visits for COVID-19 pneumonia, suggesting it is fairly safe. Although SNG001 remains under investigation, these results provide some reassurance about its safety for humans.12345
Why do researchers think this study treatment might be promising?
Researchers are excited about SNG001 for viral pneumonia because it offers a unique approach compared to existing treatments. Unlike typical antivirals or antibiotics that target the virus or bacteria directly, SNG001 is an inhaled formulation of interferon-beta, which boosts the body’s immune response to fight off viral infections more effectively. This new delivery method via nebulizer allows the treatment to be administered directly to the lungs, potentially leading to faster and more targeted therapeutic effects. Additionally, by enhancing the immune system rather than directly attacking pathogens, SNG001 may reduce the risk of resistance that can occur with conventional treatments.
What evidence suggests that SNG001 might be an effective treatment for viral pneumonia?
Research has shown that SNG001, an inhaled treatment, looks promising for treating viral infections. In earlier studies, SNG001 reduced the risk of severe illness or death by 79% and boosted the body's ability to fight lung infections. This trial includes evaluations of both the safety and efficacy of SNG001. Clinical trials suggest it can improve health outcomes for people with viral infections. However, one study found it did not significantly reduce hospital stays for COVID-19. Overall, SNG001 appears safe and has shown positive effects on viral infections.12345
Are You a Good Fit for This Trial?
This trial is for patients aged 50 or older who are in the ICU on a ventilator due to respiratory viral infections like flu or COVID-19. They must have tested positive for a virus and can start treatment within 48 hours of intubation. Women under 55 must test negative for pregnancy.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment Part 1
Safety evaluation of SNG001 or placebo in participants 50 years and older, administered once daily for up to 14 days while in hospital
Treatment Part 2
Efficacy evaluation of SNG001 or placebo in participants 18-50 years with immunocompromising conditions and those over 50 years, administered once daily for up to 14 days while in hospital
Follow-up
Participants are monitored for safety and effectiveness after treatment, including assessments of OSCI score, virus test, and organ support status
What Are the Treatments Tested in This Trial?
Interventions
- SNG001
Trial Overview
The study tests SNG001, an inhaled drug, against a placebo in two parts: first assessing safety in people over 50, then efficacy in those between 18-50 with weak immune systems and all over 50s. It's given daily up to two weeks along with standard care.
How Is the Trial Designed?
4
Treatment groups
Experimental Treatment
Placebo Group
Participants will inhale the higher (two-syringe) dose of SNG001 via the Solo nebuliser, once a day for up to 14 days.
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.
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.
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
Find a Clinic Near You
Who Is Running the Clinical Trial?
Synairgen Research Ltd.
Lead Sponsor
Citations
Safety and efficacy of inhaled nebulised interferon beta-1a ...
SNG001 reduced the odds of developing severe disease or dying by 79% (OR 0·21 [95% CI 0·04–0·97]; p=0·046) in the prespecified logistic ...
Safety and efficacy of inhaled interferon-β1a (SNG001) in ...
In this trial, SNG001 was safe and associated with a non-statistically significant decrease in hospitalization for COVID-19 pneumonia. Funding.
ISRCTN30482473: A Phase II study to understand the ...
Clinical trials have shown that SNG001 has anti-viral activity and potential beneficial effects on clinical outcomes in patients with viral infections in the ...
Trial of Inhaled Anti-viral (SNG001) for SARS-CoV-2 ...
These trials have shown that SNG001 has: been well tolerated during virus infections. enhanced antiviral activity in the lungs (measured in sputum and blood ...
Results for the year ended 31 December 2022
An interim analysis of the data was reported in September 2020 which demonstrated that SNG001 boosted lung antiviral responses as assessed using ...
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