PB0065 - Targeting the endothelium when treating convalescent COVID-19 patients, the effect on serum biomarkers, and post-COVID functional status. Midterm results of a randomized, placebo-controlled trial.

Background: Long-term care for COVID-19 survivors has become a global concern, and targeting the endothelium in the treatment or prevention of COVID-19 severity and complications is of great interest.

Aims: To evaluate the effect of Sulodexide (a glycosaminoglycan-heparin mixture) on serum biomarkers and post-COVID functional status when used in patients in a convalescent-phase from a severe clinical COVID-19 presentation.

Methods: This prospective, randomized, placebo-controlled trial, includes patients with chronic comorbidities, in a convalescent phase from a severe clinical COVID-19 presentation but within 40 days of the initial symptoms. Patients were allocated to either receive an oral 250LRU dose of sulodexide twice a day or a placebo for 8 weeks. Endothelium, inflammation, and thrombosis serum biomarkers were measured at baseline, week 4, and week 8, including Thrombomodulin, p-selectin, Von Willebrand factor, ICAM-1, VCAM-1, Interleukin-6, d-dimer, C reactive protein, and fibrinogen. A Post-COVID functional status (PCFS) scale was also recorded. Comparisons between treatment groups and subgroup analysis were made using the Chi-square test, student t-test, or ANCOVA on the post-baseline value.

Results: We are reporting the midterm results on 100 subjects. The mean age was 56 years, with 66% female. At recruitment, patients average 20 days from initial clinical symptoms. 80% of patients had received at least one dose of vaccination. Elevated serum biomarker levels were present in 78% of the study group vs 81% of the control group at baseline, 54% vs 69% at week 4, and 25% vs 40% (p=0.24) at week 8. The average PCFS scale in the study group was 1.39 vs 1.89 (p=0.02) at week 8. All symptomatic patients had elevated biomarkers serum levels.

Conclusion(s): After 8-week treatment, patients receiving sulodexide tended to lower biomarker serum levels than the control group and a better PCFS scale. Better conclusions can be achieved with a larger sample size at the end of the trial.