A clinical study to test if a drug called PLX-PAD is both safe and can help in the treatment of COVID-19 patients

Phase 1

Conditions: Pneumonia or Acute Respiratory Distress Syndrome (ARDS) caused by severe COVID-19 disease
MedDRA version: 23.0Level: PTClassification code 10051905Term: Coronavirus infectionSystem Organ Class: 10021881 - Infections and infestations
Therapeutic area: Diseases [C] - Virus Diseases [C02]

Registration Number: EUCTR2020-001857-31-BG

Lead Sponsor: Pluristem Ltd.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 40

Inclusion Criteria

Subjects must meet all of the inclusion criteria listed below to be eligible for the study:
1. Willing and able to provide written informed consent, or with a legal representative (as defined by local regulation) who can provide informed consent.
2. Male or non-pregnant female 18 to 85 years of age at time of randomization.
3. Laboratory-confirmed SARS-CoV-2 infection as determined by PCR, in any specimen within up to 28 days prior to randomization.
4. Meets definition of ARDS according to Berlin criteria with oxygenation of PaO2/FIO2 = 200mm Hg (graded as Moderate or Severe).
5. By the time of expected treatment initiation on invasive mechanical ventilation for less than 72 hours.
6. Women of childbearing potential must have a negative serum pregnancy test at primary screening and must be willing to use at least one highly effective birth control method
throughout the study.
Any female subject who is surgically sterile, or with bilateral tubal occlusion, or whose partner is vasectomized, or who reliably applies sexual abstinence or who is postmenopausal (one year
without menses) will be considered not of childbearing potential.

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 20
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20

Exclusion Criteria

Subjects with any one of the exclusion criteria listed below will not be eligible for the study (based on medical record at current admission):
1. Mild ARDS as defined by Berlin criteria (200 mm Hg < PaO2/FIO2 = 300mmHg)
2. Body weight under 55 kg (121 lbs)
3. Stage 4 and above chronic kidney disease (clearly defined in patient’s medical history, eGFR <30 mL/min/1.73m2 [based on MDRD equation]) or patients that require renal replacement
therapy for any reason at time of primary screening.
4. Serum creatinine level of over 3 mg/dL at last test before randomization.
5. Total Bilirubin =3 mg/dL at last test before randomization.
6. Continuous administration of vasoactive agents required due to shock at time of randomization (either one): dopamine >15 (mcg/kg/min), vasopressin >0.04 (units/min), phenylephrine >1
(mcg/kg/min), epinephrine =0.3 (mcg/kg/min), or norepinephrine =0.3 (mcg/kg/min).
7. Known allergy to any of the following: dimethyl sulfoxide (DMSO), human serum albumin, bovine serum albumin.
8. Stroke or acute myocardial infarction within 3 months before current hospital.
9. Congestive heart failure (New York Heart Association [NYHA] class III-IV) at primary screening (stated in medical history) or investigator discretion as to presence of moderate to severe baseline congestive heart failure.
10. Chronic Obstructive Pulmonary disease GOLD stage above III (Stated in medical history or investigator discretion of severe COPD.
11. Other chronic pulmonary disease under chronic oxygen treatment.
12. Known medical history of Acquired immunodeficiency syndrome (AIDS) or HIV under chronic treatment.
13. Known medical history of Active acute or chronic HBV or HCV .
14. Known medical history of active tuberculosis or active tuberculosis including under treatment at time of primary screening .
15. Pre-existing significant coagulopathies that put the patient at an increased risk of major bleeding according to the Investigator’s judgment.
16. History of thromboembolism or known chronic hypercoagulopathic syndrome\state.
17. Subjects under acute or chronic anticoagulant therapy (warfarin with international normalized ratio (INR) >2 or Direct Oral Anticoagulants, or full dose subcutaneous or intravenous
treatment for atrial fibrillation and\or prosthetic heart valves, and or suspicion or proven thromboembolic events), unless this therapy is required and can be safely modified , according
to local clinical routines (e.g. PTT monitoring, timing of low molecular heparin injections), around the time of PLX-PAD injections based on the study Investigator’s/ treating physician’s discretion and patient’s risk of bleeding.
18. Subject is currently enrolled in another controlled clinical trial(s) with investigational drug, unless in long-term follow-up phase (in which there is no IP administration).
19. Exposure to allogeneic cell-based therapy in the past or exposure to autologous cell therapy in the last 12 months before screening.
20. History of solid organ transplantation.
21. Active malignancy or history of malignancy within 3 years prior to screening except for successfully resected skin basal cell carcinoma or skin squamous cell carcinoma.
22. Treatment with extracorporeal membrane oxygenation (ECMO) support (at time of randomization).
23. In the opinion of the Investigator, the subject is unsuitable for participating in the study.

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

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