Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Study Evaluating Safety, Tolerability and Efficacy of Allocetra-OTS in Patients With COVID-19

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04659304
Recruitment Status : Not yet recruiting
First Posted : December 9, 2020
Last Update Posted : December 10, 2020
Sponsor:
Information provided by (Responsible Party):
Enlivex Therapeutics Ltd.

Brief Summary:
Phase 1b, multi-center, single-blinded, randomized, placebo-controlled study, evaluating safety, tolerability and efficacy of different doses and regimens of Allocetra-OTS, in up to 50 adult patients with critical COVID-19.

Condition or disease Intervention/treatment Phase
Covid19 Drug: Allocetra-OTS Other: Ringer's lactate Phase 1

Detailed Description:

Potential patients, who will be identified as suffering from critical COVID-19 (NIH classification), will be recruited.

After the patient has signed the Informed Consent Form (ICF), and after confirmation that the patient meets all eligibility criteria, the patient will be randomized to one of the 4 treatment groups: Placebo, Single Intravenous (IV) dose of Allocetra-OTS with 5x10^9 cells, Single Intravenous (IV) dose of Allocetra-OTS with 10x10^9 cells, Two IV doses of Allocetra-OTS with10x10^9 cells each dose (separated by 72 hours).

50 patients will be randomized in a 2:1:1:1 ratio between the 4 cohorts. Investigational Product (IP) administration will occur on Day 1 within 24±6 hours from the time of eligibility.

Following IP administration (Day 1), patients will be followed for safety and efficacy assessments through 28 days.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: parallel randomization in a 2:1:1:1 ratio between the 4 cohorts (20 patients in the placebo and 10 patients in each of the other cohorts)
Masking: Single (Participant)
Masking Description: The patients will be blinded to the assigned study intervention throughout the course of the study. In order to maintain the single blind, study intervention infusion bag and infusion line will be covered. study personal will be unblinded.
Primary Purpose: Treatment
Official Title: A Multi-Center Study, Placebo-Controlled, Evaluating Safety, Tolerability and Efficacy of Different Doses and Regimens of Allocetra-OTS in Patients With COVID-19
Estimated Study Start Date : March 2021
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : March 2022

Arm Intervention/treatment
Placebo Comparator: Cohort 1
Ringer's lactate solution
Other: Ringer's lactate
solution
Other Name: Placebo

Active Comparator: Cohort 2
Single Intravenous (IV) dose of Allocetra-OTS with 5x10^9 cells
Drug: Allocetra-OTS
Cell-based therapy comprised of allogeneic non-HLA matched peripheral blood mononuclear cells induced to an early apoptotic state.

Active Comparator: Cohort 3
Single Intravenous (IV) dose of Allocetra-OTS with 10x10^9 cells
Drug: Allocetra-OTS
Cell-based therapy comprised of allogeneic non-HLA matched peripheral blood mononuclear cells induced to an early apoptotic state.

Active Comparator: Cohort 4
Two IV doses of Allocetra-OTS with 10x10^9 cells in each dose
Drug: Allocetra-OTS
Cell-based therapy comprised of allogeneic non-HLA matched peripheral blood mononuclear cells induced to an early apoptotic state.




Primary Outcome Measures :
  1. Safety - Adverse Events [ Time Frame: 28 days ]
    Number and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs).


Secondary Outcome Measures :
  1. Efficacy - PaO2 or SO2/FiO2 Ratio [ Time Frame: 28 days ]
    Change in PaO2 or SO2/FiO2 Ratio

  2. Efficacy - SOFA score [ Time Frame: 7 days ]
    Change from baseline in Sequential Organ Failure Assessment (SOFA) score

  3. Efficacy - mortality [ Time Frame: 28 days ]
    All-cause mortality

  4. Efficacy - organ function / support measurements [ Time Frame: 28 days ]
    Oxygen free days, vasopressors free days, cumulative days in ICU or IMU



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male and female > 18 and < 80 years of age.
  2. Laboratory confirmation of SARS-CoV-2 infection by RT-PCR from any diagnostic sampling source.
  3. Patients classified according to NIH severity classification as:

    Critical illness: Individuals who have respiratory failure, and/or septic shock, and/or multiple organ dysfunction

  4. Signed written informed consent by the patient.
  5. Women and men who are of childbearing potential, willing to use acceptable contraceptive measures for the entire study duration.

Exclusion Criteria:

  1. Women who are pregnant or breast feeding.
  2. Stage 4 severe chronic kidney disease, i.e., eGFR < 30 ml/min (including patients receiving hemodialysis or hemofiltration)
  3. Patients with active malignant tumor, and/or other serious systemic diseases.
  4. Patients who are participating in other concurrent investigational clinical trials or have been treated with any experimental agents within 30 days prior to enrollment.
  5. Co-infection of HIV, tuberculosis.
  6. Known immunocompromised state or medications known to be immunosuppressive (i.e., immune suppressing agents including chronic corticosteroids > 10 mg/day, azathioprine, cyclosporine, cyclophosphamide)
  7. Patients with PaO2/FiO2 (P/F) or SpO2/FiO2 (S/F) ratio of <150
  8. Patients on mechanical ventilation.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04659304


Contacts
Layout table for location contacts
Contact: Odelia Ben Shitrit, MBA 972-548887609 odelia@enlivexpharm.com
Contact: Lior Binder 972-548054899 lior@enlivexpharm.com

Sponsors and Collaborators
Enlivex Therapeutics Ltd.
Investigators
Layout table for investigator information
Study Director: Oren Hershkovitz, PhD Enlivex Therapeutics R&D
Layout table for additonal information
Responsible Party: Enlivex Therapeutics Ltd.
ClinicalTrials.gov Identifier: NCT04659304    
Other Study ID Numbers: ENX-CL-03-001
First Posted: December 9, 2020    Key Record Dates
Last Update Posted: December 10, 2020
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Patient data will not contain any information which would make the patient identifiable. Data will be processes and shared using patient study number only.

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Enlivex Therapeutics Ltd.:
Cell therapy
Allocetra-OTS