Prior to a pivotal trial, we performed a pilot study of upamostat, a serine protease inhibitor, in outpatients with symptomatic COVID-19. Methods: : SARS-CoV-2 patients with ≥2 moderate-severe symptoms onset within 5 days were randomized to oral upamostat 200 or 400 mg or placebo daily x14. Patients completed COVID-19 symptom questionnaires daily x28, then thrice weekly for 4 weeks, and underwent physical and laboratory examinations periodically. Results: : 61 patients enrolled: 20 each received placebo or upamostat 200 mg daily; 21 received upamostat 400 mg daily. Treatment was well tolerated; only one patient (upamostat 400) reported a drug-related adverse event, mild skin rash; no patient discontinued due to a drug-related adverse event. Median time to sustained recovery from severe symptoms was 8, 4 and 3 days for the 3 treatment groups, respectively. New severe symptoms developed in 20% in the placebo group versus 2.4% in the combined upamostat groups, (p=0.036). Three placebo patients (15%) versus no upamostat patients were hospitalized for worsening COVID (p=0.03). Mean D-dimer level remained constant in placebo patients but decreased by 38% and 48% in upamostat 200 and 400 patients, respectively. Conclusions: Upamostat was well tolerated, shortened recovery time, and decreased new severe symptoms and hospitalization.
Fuente: International Journal of Infectious Diseases
Available online 19 December 2022