- ElectroCore Inc ECOR has announced top-line results from the SAVIOR-1 study evaluating non-invasive vagus nerve stimulation (nVNS) using gammaCore Sapphire in hospitalized COVID-19 patients.
- The investigator-initiated trial conducted in Spain was designed to evaluate the safety and feasibility of nVNS in addition to the current standard of care.
- Patients' clinical and biochemical endpoints were measured over the first five days of therapy, and the adjusted means were compared.
- It was noted that the assessment of the severity of the condition resulted in a 3.5 to 1 bias with more severe patients in the treatment arm.
- Concerning the clinical endpoint of oxygen saturation, the nVNS treated group showed a modest but no significant improvement.
- Among the biomarkers evaluated, the adjusted mean decrease in C-Reactive Protein (CRP) from baseline was significantly greater in the nVNS treated group (-59.08 vs. -27.83).
- Trends toward significance were also observed for decreases in the treatment group for procalcitonin (-0.11 vs. -0.05) and d-dimer (-277.53 vs. 1264.37).
- Increased CRP levels, procalcitonin, and d-dimer have all been reported to be associated with more severe disease.
- Other biochemical measures also favored the treatment group but did not achieve significance.
- nVNS was well tolerated with no major device-related adverse events, and the therapy was administered three times daily on the majority of patients as outlined in the study protocol.
- Full data from the study, including cytokine levels pending final lab results, will be submitted to a peer-reviewed journal later this year.
- Price Action: ECOR shares are up 8.67% at $2.13 in the premarket trading on the last check Wednesday.
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