A Phase 1b/2a Trial to Evaluate Invobenitug Also Known as Procizumab (PCZ; AK1967) in Critical Cardiovascular Care.

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• Signed informed consent
• Diagnosis of CS based on the following entry criteria:; Need for ongoing vasopressors and/or inotropes to maintain a MAP ≥ 65 mmHg or SBP ≥ 90 mmHg; Lactate ≥ 2.0 mmol/L; High DPP3 concentration ≥ 30 ng/mL
• Etiology of CS must be one of the following: ACS, septic (according to SEPSIS 3 criteria) or adHF origin

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• Patients who will be receiving vasopressors and/or inotropes for more than 16 hours prior to receiving the IMP
• Patients receiving Ang II and/or levosimendan
• Reduced life expectancy of less than 6 months due to comorbidities (prior to shock onset)
• Only for Part 1: Patients on cannula-based MCS (including VV and VA-ECMO, impella or left ventricular assist device of any type (excluding IABP)) or on renal replacement therapy. Patients who are treated by impella and/or ECMO but have no evidence of hemolysis during screening can be enrolled in the trial
• Sustained SBP > 120 mmHg during the hour prior to randomization
• Patients who have undergone any form of surgery in the last 7 days, except 1) minor surgeries such as cosmetic surgeries, skin surgery, dental surgery and impella implantation 2) surgery for peritonitis with adequate source control, which are allowed
• Patients who are currently enrolled in another clinical trial, or who have participated in such trials within one month prior to randomization
• Patients with known allergies or hypersensitivity to the IMP or its excipients or any related medication
• Stroke or transient ischemic attack within the last 3 months
• Very severe frailty, or moribund condition or presence of clinical circumstances indicating imminent death
• Primary hypertrophic or restrictive cardiomyopathy or congenital heart disease or systemic illness known to be associated with infiltrative heart disease
• Patients with valvular heart diseases as the primary cause of cardiogenic shock
• Other known causes of shock, namely; Hypovolemia; Hemorrhage; Anaphylaxis; Intoxication (e.g., drug-induced shock); Dynamic left ventricular outflow tract obstruction; isolated right heart failure, including cardiac tamponade and/or pulmonary embolism; Known mechanical complications due to myocardial infarction, including papillary muscle rupture, ventricular septal rupture, free wall rupture; Inappropriate pacing or shock resulting from ICD malfunction
• Known severe chronic liver disease (Model for End-Stage Liver Disease (MELD) Score >30), known severe chronic pulmonary disease (including COPD classification GOLD4 and/or chronic oxygen therapy and/or restrictive chronic pulmonary failure and/or severe interstitial lung disease), known severe thyroid disease, known CKD with eGFR <20 ml/min/1.73 m2 or chronic dialysis
• Patients who have severe immune suppression: recent (<3 months) chemotherapy and/or severe neutropenia (neutrophile count <500 cells/mm3) and/or chronic high glucocorticoid dose (≥0.5 mg/kg per day of prednisone equivalent) and/or recent (<3 months) organ transplantation
• Patients below the age of 18 or above 80 years
• Patients being longer than 24 hours in the ICU at the time of randomization
• SCAI Shock Stage E
• Patients exceeding a maximum body weight of 120 kg (EU, Armenia, Serbia) and 150 kg (US)
• CPR lasting more than 15 minutes and/or the patient is not conscious at randomization
• Pericardial constriction
• Patients with untreated sepsis
• Women who are pregnant or breastfeeding
• Any reason that the investigator anticipates that the patient will be unable to complete the protocol or its required procedures (US only)