Trial reportJournal of biomedical science2026
Safety and antiviral activity of inhaled siRNA SNS812 for treatment of mild-to-moderate COVID-19: a phase 2 randomized trial.
Trial report in Journal of biomedical science, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05941793 (A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, Tolerability and Pharmacokinetics of SNS812 in Participants With Mild to Moderate COVID-19), which is not on this map. Not yet cited in PubMed.
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A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, Tolerability and Pharmacokinetics of SNS812 in Participants With Mild to Moderate COVID-19
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20 authors.
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Abstract
backgroundSARS-CoV-2 remains a global health threat because ongoing viral evolution and immune evasion reduce the effectiveness of existing therapies. SNS812 is an inhaled small interfering RNA targeting a highly conserved region of the viral RNA-dependent RNA polymerase gene, representing a strategy that may enable broader antiviral activity against emerging variants.
methodsIn this phase 2, double-blind, randomised, placebo-controlled trial, adults with mild-to-moderate COVID-19 within 3 days of symptom onset were randomly assigned (1:1:1) to receive placebo or inhaled SNS812 (100 mg or 200 mg) once daily for 7 days (ClinicalTrials.gov identifier: NCT05941793). Safety was the primary endpoint. Secondary endpoints included the time to sustained alleviation (TTSA) and resolution (TTSR) for prespecified composite target symptoms and individual symptoms. Virological outcomes were exploratory.
resultsA total of 135 participants were enrolled, with more than 90% infected with immune-evasive SARS-CoV-2 variants. No treatment-related adverse events or serious adverse events were reported. In exploratory analyses, the 200 mg SNS812 group showed a shorter median time to SARS-CoV-2 antigen negativity (2.9 vs 3.6 days; p = 0.007) and a faster viral load reduction rate (- 0.755 vs - 0.652; p = 0.040), demonstrating dose-dependent virological effects. In the modified intention-to-treat population, exploratory symptom analyses showed shorter TTSA and TTSR for prespecified target symptoms with SNS812 200 mg compared with placebo (median TTSR 6.1 vs 8.1 days; adjusted hazard ratio 2.07, 95% CI 1.30-3.29; median TTSA 3.6 vs 6.5 days; adjusted hazard ratio 1.81, 95% CI 1.14-2.88).
conclusionInhaled SNS812 was safe and well tolerated and showed dose-dependent antiviral activity, with exploratory signals of symptomatic improvement in adults with mild-to-moderate COVID-19 infected with immune-evasive variants. These findings support further evaluation in larger, adequately powered trials, including older and higher-risk populations.
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