Efficacy and doses of Ulinastatin in treatment of Covid-19 a single centre study

Muralidhara TR, Nagesh R, Mohan, Hemanth Kamath, Kumara SS

Kauvery Hospital, Electronic-City, Bangalore, India

Background

Ulinastatin is a glycoprotein extracted from fresh human urine. It inhibits the activity of various proteolytic enzymes. Patients with severe covid-19 exhibit elevated serum levels of proinflammatory cytokines IL-6, Tumour necrosis factor, IL-I Beta, characterised as cytokine storm, which is believed to progress, leading to deterioration and death. Ulinastatin dampens inflammatory response. However, data on efficacy and the doses are limited. We evaluated the efficacy and doses of ulinastatin in-hospital all-cause mortality in patients with moderate to severe covid-19.

Methods

This retrospective study was conducted between April 1st and June 30, 2021, at the tertiary care centre. Covid-19 was confirmed with RT-PCR by naso pharyngeal swab. Patients with moderate to severe covid-19 (moderate SPO2 < 94%, severe SPO2 < 90%) on room air were included. This is the first study comparing the doses of ulinastatin in Covid-19.

Results

In total 145 patients, 75 patients with moderate to severe Covid-19 were treated with ulinastatin + other standard treatment. Seventy patients were treated only with a standard treatment regime. All course mortality was significantly lower in patients treatment with ulinastitin (15.3% VS 20.5%). In total of 75 patients treated with ulinastatin, 40 patients were given 200,000 units BD and 35 patients were given 200,000 units QID. There was not much difference in the all-cause mortality (15% VS 13%) between the two doses. No adverse effects were noted.

Conclusions

Our observational data showed a beneficial effect in moderate-severe Covid-19 patients and there was not much difference in beneficial effects with regular doses 200,000 q 12th hourly as compared higher doses of 200,000 q 6th hourly. This is the first observational study comparing the doses and having highest number of patients treated with ulinastatin.