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Nebulised interferon-β1a (SNG001) in hospitalised COVID-19: SPRINTER phase III study
Phillip D Monk1, Jody L Brookes1, Victoria J Tear1
1Synairgen Research Ltd, Southampton, UK.
ERJ Open Research
|March 30, 2023
Summary
SNG001, an inhaled interferon beta-1a treatment for hospitalized COVID-19 patients, did not significantly speed recovery or hospital discharge. However, it showed a favorable safety profile and a trend toward preventing disease progression.
Area of Science:
- Respiratory Medicine
- Virology
- Pharmacology
Background:
- Hospitalizations for COVID-19 persist despite available vaccines and therapies.
- Interferon (IFN)-β is a natural immune stimulant effective against viruses like SARS-CoV-2.
- SNG001 is an inhaled formulation of IFN-β1a designed for lung delivery.
Purpose of the Study:
- To assess the efficacy and safety of SNG001 in hospitalized COVID-19 adults requiring oxygen.
- To evaluate recovery metrics, including hospital discharge and return to normal activity.
- To examine secondary endpoints such as disease progression and mortality.
Main Methods:
- A double-blind, randomized controlled trial comparing SNG001 to placebo in hospitalized COVID-19 patients.
- Participants received SNG001 or placebo once daily for 14 days, alongside standard care.
- Primary outcomes measured time to hospital discharge and recovery; secondary outcomes included disease progression and death.
Main Results:
- Median time to hospital discharge was 7.0 days for SNG001 vs. 8.0 days for placebo (p=0.51).
- Median time to recovery was 25.0 days in both groups (p=0.89).
- A 25.7% relative risk reduction in progression to severe disease or death was observed with SNG001 (p=0.161), with a favorable safety profile.
Conclusions:
- The primary study objective of accelerating recovery was not met.
- SNG001 demonstrated a favorable safety profile in hospitalized COVID-19 patients.
- Analysis suggests SNG001 may offer a benefit in preventing severe disease progression.
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