A retrospective study published in the Journal of the Association of Physicians of India provides evidence that early administration of Ulinastatin (ULI) as an add-on to standard of care (SOC) may improve outcomes in COVID-19 patients not requiring intubation.
Ulinastatin is a protease inhibitor that has been shown to have anti-inflammatory and immunomodulatory effects, making it a potential candidate for COVID-19 treatment. This study by Yatin Mehta and peers aimed to evaluate the impact of ULI as an add-on to SOC on 30-day mortality in COVID-19 patients requiring ICU admission.
This multicentric, retrospective study collected data on clinical, laboratory, and outcome parameters in patients with COVID-19 admitted to the ICU. Patients were divided into two groups: those treated with SOC alone and those treated with ULI in addition to SOC.
The highlights of the study were:
A total of 94 patients were included in the study, with 47 in each group.
The 30-day mortality rate was significantly lower in the ULI plus SOC group compared to the SOC alone group (36.2% vs 51.1%, OR 0.54, 95% CI 0.30–0.97, p = 0.040).
The effect of ULI on mortality was more pronounced in patients who did not require intubation (10.9% vs 34.0%, OR 0.24, 95% CI 0.09–0.66, p = 0.006) and in those who received early administration of ULI (within 72 hours of admission) (30.7% vs 57.9%, OR 0.32, 95% CI 0.11–0.91, p = 0.032).
On multivariate analysis, intubation was the only predictor of mortality (adjusted OR 10.13, 95% CI 3.77–27.25, p < 0.0001), and the effect of ULI on survival was not significant (adjusted OR 0.58, 95% CI 0.22–1.52, p = 0.270).
The findings of this study suggest that ULI, as an add-on to SOC, may reduce 30-day mortality in COVID-19 patients requiring ICU admission. The effect of ULI was more pronounced in patients who did not require intubation and in those who received early administration of ULI. ULI could still be a beneficial add-on therapy in patients not requiring intubation. However, further studies, preferably randomized controlled trials, are required to validate these findings.
Mehta, Y., Zirpe, K., Dixit, S., Dubey, S., Kanade, R., Kulkarni, A., ... & Kumar, N. (2023). Ulinastatin Add-on to Standard of Care in Critically Ill COVID-19 Patients: A Multicenter, Retrospective Study. Journal of the Association of Physicians of India, 71(2), 25-29. https://doi.org/10.5005/japi-11001-0181