Phase 2 study, conducted in few medical centers, patients will be allocated randomly to receive active drug or placebo. The study will evaluate the efficacy and safety of different doses of the drug in patients with organ failure due to sepsis condition.

Phase 1

• Conditions: Sepsis; MedDRA version: 20.0Level: PTClassification code 10040047Term: SepsisSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

• Registration Number: EUCTR2021-003273-66-ES
• Lead Sponsor: Enlivex Therapeutics R&D Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-07-14
• Last Update Posted: 8 November 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 160

Inclusion Criteria

1. Suspected, presumed or documented community-acquired pneumonia by imaging.
2. Meets Sepsis 3 criteria: the presence of organ dysfunction as identified by a total SOFA score =2 points above pre-admission SOFA.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 67
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 93

Exclusion Criteria

1. Invasive ventilated patient and PaO2/FiO2 < 100 mmHg
2. SOFA score = 10 at screening (Day -1).
3. Patients with septic shock; requiring persisting hypotension treated with vasopressors to maintain MAP =65 mmHg AND having a serum lactate level >4 mmol/L (36 mg/dL) despite adequate volume resuscitation at screening and on Day 1 prior to IP administration
4. Known active severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) or chronic viral infections, such as, hepatitis B virus (HBV) or hepatitis C virus (HCV), human immunodeficiency virus (HIV) or other chronic infections.
5. Chronic respiratory disease requiring home oxygen therapy on a regular basis for > 6 h/day.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified