Efficacy and safety of asunercept, a CD95L-selective inhibitor, in hospitalised patients with moderate-to-severe COVID-19: ASUNCTIS, a multicentre, randomised, open-label, controlled, phase 2 trial
Abstract
Summary Background The phase 2 ASUNCTIS study assessed the efficacy and safety of asunercept, a fully human CD95 (Fas) ligand-binding protein, in hospitalised patients with moderate-to-severe coronavirus disease (COVID-19) to assess the clinical benefit of CD95 ligand inhibition in this viral disease. Methods In this open-label, multicentre, randomised, controlled, phase 2 trial, patients with COVID-19–induced pneumonia and respiratory deterioration were randomly assigned (1:1:1:1) in 12 Russian and Spanish hospitals using an interactive web-response system to receive standard of care (SOC) or SOC plus weekly asunercept 25 mg, 100 mg, or 400 mg, administered intravenously for up to 4 weeks, or until hospital discharge or death. The randomisation was stratified according to the respiratory support methods at the time of enrolment, corresponding to categories 4–6 of a clinical severity assessment scale comprising 9 levels that was recommended by the World Health Organization (WHO) at the time of the study. The main inclusion criterion was laboratory confirmed infection with SARS-CoV-2 OR typical radiological signs of SARS-CoV-2 infection. The primary endpoint was time from randomisation to clinical improvement on two consecutive days of at least one category on a WHO clinical severity assessment scale in the modified intent-to-treat population. All patients were subjected to regular safety analyses. This trial is registered with EudraCT (2020-001887-27) and ClinicalTrials.gov…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 145 participants or records.
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