Clincosm LogoSign in Get a demo

Open-label Multicenter Study to Evaluate the Efficacy of PLX-PAD for the Treatment of COVID-19

Sponsor
Pluristem Ltd. (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT04614025
Collaborator
(none)
23
Enrollment
9
Locations
2
Arms
22.4
Anticipated Duration (Months)
2.6
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This clinical trial will examine if a new treatment of Mesenchymal-like Adherent stromal Cells (called PLX-PAD) can help patients intubated and mechanically ventilated due to COVID-19 to recover more quickly with less complications.

Condition or Disease Intervention/Treatment Phase
  • Biological: PLX-PAD
 Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
23 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Randomized, Controlled, Multicenter, Parallel-Group Phase IIa Study to Evaluate the Efficacy and Safety of Intramuscular Injections of PLX-PAD for the Treatment of Severe COVID-19
Actual Study Start Date :
Oct 19, 2020
Actual Primary Completion Date :
Aug 4, 2021
Anticipated Study Completion Date :
Sep 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: PLX-PAD Treatment

PLX-PAD 300 million cells (20 million/mL) administered via 15 IM injections (1 mL each). Single administration in addition to best standard medical care.

Biological: PLX-PAD
PLX-PAD - allogeneic ex-vivo expanded placental mesenchymal-like adherent stromal cells
No Intervention: Control Group

Best standard medical care

Outcome Measures

Primary Outcome Measures

  1. Number of ventilator-free days [28 days]

Secondary Outcome Measures

  1. All-cause mortality [28 and 60 days]

  2. Duration of mechanical ventilation [28 and 60 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 85 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Key Inclusion Criteria:

  • Willing and able to provide written informed consent, or with a legal representative who can provide informed consent.

  • Male or non-pregnant female adult 18-85 years of age at time of enrollment.

  • Laboratory-confirmed SARS-CoV-2 infection as determined by PCR, in any specimen up to 21 days prior to randomization.

  • Meets definition of ARDS according to Berlin criteria.

Key Exclusion Criteria:

  • Body weight under 55 kg (121 lbs)

  • Serum creatinine level of over 1.5 mg/dL at time of randomization.

  • Total Bilirubin ≥2 mg/dL at time of randomization.

  • Known allergy to any of the following: dimethyl sulfoxide (DMSO), human serum albumin, bovine serum albumin.

  • Stroke or acute myocardial infarction/unstable angina within 3 months prior to randomization.

  • Chronic Obstructive Pulmonary disease GOLD stage above II.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Charite Campus Virchow Berlin Germany 10117
2 Campus Benjamin Franklin - CBF Charité - Universitätsmedizin Berlin Germany 12203
3 University of hospital Bonn Bonn Germany 53127
4 Hospital Cologne-Merheim Köln Germany 51109
5 Emek Medical Center Afula Israel 1834111
6 Bnai Zion Medical Center Haifa Israel 31048
7 Rambam Health Care Campus Haifa Israel 3109601
8 Galilee Medical Center Nahariya Israel 22100
9 Baruch Padeh Medical Center, Poriya Tiberias Israel 15208

Sponsors and Collaborators

  • Pluristem Ltd.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Pluristem Ltd.
ClinicalTrials.gov Identifier:
NCT04614025
Other Study ID Numbers:
  • PLX-COV-03
First Posted:
Nov 3, 2020
Last Update Posted:
Aug 10, 2021
Last Verified:
Aug 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
No

Study Results

No Results Posted as of Aug 10, 2021