Adrecizumab (HAM8101) to Improve Prognosis and Outcomes in COVID-19 Trial
Status:
Not yet recruiting
Trial end date:
2023-06-01
Target enrollment:
Participant gender:
Summary
The clinical trial is designed as a prospective, multi-center, double-blind, randomised,
placebo-controlled, interventional trial to assess safety, tolerability and efficacy of
Adrecizumab (on top of SOC) in patients with COVID-19, and to evaluate if improvement of
vascular integrity with Adrecizumab on top of SOC is superior to placebo/ control substance
(NaCl 0.9%) on top of SOC in reduction of morbidity and mortality endpoints in patients with
COVID-19.
The main reason for admission to ICU and need for mechanical ventilation of these patients is
acute lung injury within a broad pneumonic spectrum, increased ventricular filling pressures
and resulting congestion. It is hypothesized, that Adrenomedullin (ADM) is a key player in
the (dys)-regulation of vascular integrity (Figure 2). Adrecizumab is the first-in-class
humanized monoclonal anti-Adrenomedullin antibody, and acts as a long-lasting plasma
Adrenomedullin enhancer stabilizing barrier function at a reasonable safety profile. The mode
of action for the anti-Adrenomedullin antibody Adrecizumab has been developed on the basis of
published data, own experimental data and theoretical considerations.