Phase 2b 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 the drug in patients with respiratory failure due to COVID-19.
- Conditions
- COVID-19MedDRA version: 23.0Level: PTClassification code 10051905Term: Coronavirus infectionSystem Organ Class: 10021881 - Infections and infestationsTherapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
- Registration Number
- EUCTR2021-003246-20-ES
- Lead Sponsor
- Enlivex Therapeutics R&D, Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 152
1. Male or female >18 and <85 years of age.
2. Laboratory confirmation of SARS-CoV-2 infection by reverse transcription polymerase chain reaction from any diagnostic sampling source.
3. Patient hospitalized due to COVID-19 within 7 days prior to enrollment, meeting the criteria for severe or critical COVID-19
4. Patient with mild to moderate ARDS:
5. Signed written informed consent by the patient.
6. Women and men who are of childbearing potential, willing to use acceptable contraceptive measures during 4 weeks from enrollment.
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 62
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 90
1. Patient on IMV/ECMO.
2. Woman who is pregnant or breastfeeding.
3. Patient with weight <50 kg or >120 kg or BMI >40 kg/m2.
4. Patient with stage 4 or 5 chronic kidney disease or estimated glomerular filtration rate <30 mL/min.
5. Patient with an active malignant tumor (diagnosed or on active treatment for the past 6 months).
6. Patient who is participating in other concurrent interventional clinical trials or have been treated with any experimental agents within 30 days prior to enrollment.
7. Patient who based on their medical history and receipt of therapies that would suggest infection, has suspected serious, active bacterial (including a suspected clinical diagnosis of current active tuberculosis [TB] or, if known, latent TB treated for less than 4 weeks with appropriate anti-TB therapy per institutional guidelines), fungal, or viral (including, but not limited to, active HBV, HCV, or HIV/AIDS) infection.
8. Patient with known immunocompromised state or immunosuppressive medications taken for indications other than SARS-CoV-2 as follows:
a. Prednisone or equivalent to a dose >10 mg/day, methotrexate >15 mg/week, within the last 60 days; cyclophosphamide, cyclosporine A (unless as ophthalmic formulation), leflunomide/teriflunomide (unless as monotherapy), tacrolimus (unless as a topical formulation), everolimus, temsirolimus, or azathioprine, in the last 60 days;
b. Methylprednisolone, dexamethasone, cortisone, or betamethasone for more than 7 days within the last 28 days or within 5 half-lives, whichever is longer;
c. Chemotherapy in the last 3 months;
d. Mycophenolate mofetil or sirolimus for solid organ transplant or bone marrow transplant;
e. Thalidomide within the last 72 hours;
f. Anti-tumor necrosis factor (TNF) agents, interleukin (IL)-1 receptor antagonists, CTLA-4 fusion proteins, anti-CD20, anti-CD52, anti-IL-2, anti-IL-6R, anti-IL-12/23, anti-B-cell activation factor (BAFF) or integrin inhibitor agents within the last 8 weeks.
9. Patient with known New York Heart Association (NYHA) class III and IV heart failure or unstable angina, ventricular arrhythmias, ischemic heart disease, or myocardial infarction within 6 months prior to diagnosis of COVID-19.
10. Patient with known active upper gastrointestinal (GI) tract ulceration or hepatic dysfunction including but not limited to biopsy-proven cirrhosis; end-stage cirrhosis (Child Pugh Class C); portal hypertension; episodes of past upper GI bleeding attributed to portal hypertension; or prior episodes of hepatic failure, encephalopathy, or coma.
11. Patient with known idiopathic pulmonary fibrosis.
12. Patient with chronic respiratory disease requiring home oxygen therapy on a regular basis for more than 6 hours per day.
13. Patient with known chronic obstructive pulmonary disease GOLD 4 (forced expiratory volume in one second <30% predicted).
14. Patient with any medical, psychiatric or substance abuse condition, concurrent medical therapies, or abnormal laboratory values that in the opinion of the site Investigator may be of greater safety risk, influence response to study product, or interfere with the study assessments.
15. Patient with Glasgow Coma Scale <13 with verbal score <5.
16. Patient with hemoglobin <8 g/dL.
17. Patient with history of chronic liver disease, evidence of acute cholangitis or cholecystitis. Patients with at least one of the following:
• Alanine transaminase (ALT) or aspartate transaminase
(AST) >10×ULN (upper limit of normal)
• Bilirubin >5×
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method