Phase 2 Study of Inhaled SNG001 in Mechanically Ventilated Patients With Respiratory Viral Infection
Trial Parameters
Brief 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.
Eligibility Criteria
Part 1 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 w