Double-Blind, Multicenter, Study to Evaluate the Efficacy of PLX PAD for the Treatment of 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: NCT04389450 |
Recruitment Status :
Recruiting
First Posted : May 15, 2020
Last Update Posted : October 29, 2020
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
COVID ARDS | Biological: PLX-PAD Biological: Placebo | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 140 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Parallel-Group Phase II Study to Evaluate the Efficacy and Safety of Intramuscular Injections of PLX PAD for the Treatment of Severe COVID-19 |
Actual Study Start Date : | October 1, 2020 |
Estimated Primary Completion Date : | May 2021 |
Estimated Study Completion Date : | March 2022 |
Arm | Intervention/treatment |
---|---|
Experimental: PLX-PAD interval high dose
PLX-PAD will be administered via 15 IM injections (1 mL each). Each subject will be treated twice, with an interval of 1 week between treatments.
|
Biological: PLX-PAD
PLX-PAD, allogeneic ex vivo expanded placental mesenchymal-like adherent stromal cells |
Experimental: PLX-PAD low dose
PLX-PAD 300, single administration, second administration of placebo after 1 week.
|
Biological: PLX-PAD
PLX-PAD, allogeneic ex vivo expanded placental mesenchymal-like adherent stromal cells |
Placebo Comparator: Control Group A
Placebo, two administrations, 1 week apart
|
Biological: Placebo
Placebo solution for injection |
Experimental: PLX-PAD high dose
PLX-PAD, single administration
|
Biological: PLX-PAD
PLX-PAD, allogeneic ex vivo expanded placental mesenchymal-like adherent stromal cells |
Placebo Comparator: Control Group B
Placebo, single administration
|
Biological: Placebo
Placebo solution for injection |
- Number of ventilator free days [ Time Frame: 28 days ]
- All-cause mortality [ Time Frame: 28 days ]
- Duration of mechanical ventilation [ Time Frame: 8 weeks ]

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.
Ages Eligible for Study: | 40 Years to 80 Years (Adult, Older Adult) |
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 40-80 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.

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): NCT04389450
United States, California | |
University of California Irvine | Recruiting |
Irvine, California, United States, 92868 | |
Contact: Leonid Groysman, MD 562-826-5831 lgroysma@hs.uci.edu | |
University of Southern California (USC) - Keck School of Medicine (KSOM) | Not yet recruiting |
Los Angeles, California, United States, 90033 | |
Contact: Sivagini Ganesh, MD 323-409-7594 Sivagini.Ganesh@med.usc.edu | |
University Of California Davis,4860 Y Street | Not yet recruiting |
Sacramento, California, United States, 95817 | |
Contact: Christian E Sandrock, MD 916-734-3351 cesandrock@UCDAVIS.EDU | |
United States, Florida | |
Baptist Health Medical Center | Recruiting |
Jacksonville, Florida, United States, 32207 | |
Contact: Eddy J Gutierrez, Dr 904-202-3885 Eddy.Gutierrez@bmcjax.com | |
United States, Georgia | |
Medical College of Georgia at Augusta University | Not yet recruiting |
Augusta, Georgia, United States, 30907 | |
Contact: Rabih I Bechara,, MD 706-721-5636 rbechara@augusta.edu | |
Sarah Cannon Research Institute, LLC (Mercer University School of Medicine) | Recruiting |
Macon, Georgia, United States, 31217 | |
Contact: Jennifer C Hoffman,, MD 615-329-7635 hoffman_jc@mercer.edu | |
United States, Mississippi | |
University of Mississippi Medical Center | Not yet recruiting |
Jackson, Mississippi, United States, 39216 | |
Contact: Luis A Shimose Ciudad, MD 601-984-5560 lshimoseciudad@umc.edu | |
United States, New Jersey | |
Cooper Research Institute | Not yet recruiting |
Camden, New Jersey, United States, 08103 | |
Contact: Nitin Puri, MD 856-536-1030 puri-nitin@CooperHealth.edu | |
Holy Medical Center | Recruiting |
Teaneck, New Jersey, United States, 07666 | |
Contact: Suraj Saggar, Dr. 201-503-0660 surajsaggar@hotmail.com | |
United States, New York | |
Montefiore Medical Center | Not yet recruiting |
New York, New York, United States, 10467 | |
Contact: Harish Seethamraju, MD 718-920-6546 hseetham@montefiore.org | |
Maimonides Medical Center | Recruiting |
New York, New York, United States, 11219 | |
Contact: Paul Sanders, MD 718-283-7686 PaSaunders@maimonidesmed.org | |
Mercy Medical Center | Recruiting |
New York, New York, United States, 11570 | |
Contact: Maqsood Alam, MD 516-974-5177 MAQS687@yahoo.com | |
United States, Pennsylvania | |
Thomas Jefferson University | Not yet recruiting |
Philadelphia, Pennsylvania, United States, 19107 | |
Contact: George Gautam, Dr. 215-955-5161 Gautam.George@jefferson.edu |
Responsible Party: | Pluristem Ltd. |
ClinicalTrials.gov Identifier: | NCT04389450 |
Other Study ID Numbers: |
PLX-COV-01 |
First Posted: | May 15, 2020 Key Record Dates |
Last Update Posted: | October 29, 2020 |
Last Verified: | October 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |