drugset / Trial / NCT06999603

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

NCT06999603

Phase 2 Recruiting 550 enrolled Synairgen Research Ltd.
RandomizedSequentialDouble-blindTreatment

Summary

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.

Timeline

Start
2025-09-02
Primary completion
2027-04
Completion
2027-05

Drugs

EvaluationDrugModalityDoseRoute
Subject Interferon beta-1a Protein / enzyme biologic 0.65 ml Inhaled
Subject Interferon beta-1a Protein / enzyme biologic 1.3 ml Inhaled

Indications