Chimerix is currently enrolling a randomized, double blind, placebo-controlled Phase 2/3 study to evaluate the safety and efficacy of dociparstat sodium (DSTAT) in patients with ALI due to COVID-19. This study is designed to determine if DSTAT can accelerate recovery and prevent progression to mechanical ventilation in patients severely affected by COVID-19.
About DSTAT for COVID-19
COVID-19 is caused by a newly discovered coronavirus (SARS-CoV-2) that typically presents as a respiratory illness, similar to the flu, with symptoms such as a cough, fever, and in more severe cases, difficulty breathing. DSTAT has potential to improve outcomes in COVID-19 by dampening the excessive inflammation, aberrant immune cell responses, and coagulation disorders observed in severe disease.
The study is a 1:1 randomized, double-blind, placebo-controlled, Phase 2/3 trial to determine the safety and efficacy of DSTAT in adults with severe COVID-19 who are at high risk of respiratory failure. Eligible subjects will be those with confirmed COVID-19 who require hospitalization and supplemental oxygen therapy. The primary endpoint of the study is the proportion of subjects who survive and do not require mechanical ventilation through day 28. Additional endpoints include time to improvement as assessed by the National Institute of Allergy and Infectious Disease ordinal scale, time to hospital discharge, time to resolution of fever, number of ventilator-free days, all-cause mortality, and changes in key biomarkers (e.g. interleukin-6 (IL-6), tumor necrosis factor-α (TNF-α), high mobility group box 1 (HMGB1), C-reactive protein and d-dimer).
The Phase 2 portion of the study will enroll 24 subjects to confirm the maximum safe dose and will then expand by an additional 50 patients (74 total) at the selected dose. A formal analysis of all endpoints, including supportive biomarkers will be performed at the conclusion of the Phase 2 portion of the study. Contingent upon positive results, the Phase 3 portion of the study will enroll approximately 450 subjects.
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Visit the study page on clinicaltrials.gov.