Adrecizumab (HAM8101) to Improve Prognosis and Outcomes in COVID-19 Trial

• Status: Not yet recruiting
• Trial end date: 2023-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Universitätsklinikum Hamburg-Eppendorf

Criteria

Inclusion Criteria:

• Hospitalization for moderate to severe COVID-19, defined as ful-filling at a minimum the following clinical status category on the WHO 8-point ordinal scale: (i) "score 4" [oxygen via mask or nasal]

• Bio-ADM ≥50 pg/mL or ≥30% increase until the end of the next day (with a minimum of 35 pg/mL at all)

• DPP3 ≤50 ng/mL

• Age ≥18 years at time of screening

• Body weight ≤ 150 kg at time of screening

Exclusion Criteria:

• Life expectancy less than 3 months before COVID-19 at the discretion of the Investigator

• Invasive mechanical ventilation ≥ 72 hours at time-point of randomization

• History of severe asthma, atopic allergy, severe immune or chronic inflammatory conditions (e.g. systemic lupus erythematosus)

• Resuscitation > 45 minutes

• Hypersensitivity to the active substance, to Adrecizumab or any of its excipients, or known serious hypersensitivity to other monoclonal antibodies

• Currently receiving systemic chemotherapy and/or radiotherapy

• Pre-existing severe chronic liver disease (i.e. Child-Pugh C) before COVID-19 hospitalization

• Pre-existing dialysis therapy before COVID-19 hospitalization