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

About this Study

The objective of the study is to evaluate the efficacy and safety of intramuscular administration of PLX-PAD (mesenchymal stem cells) for the treatment of severe COVID-19 (hospitalized, mechanicaly ventilated, adult patients diagnosed with severe COVID-19 and ARDS).

Sponsor Protocol ID:PLX-COV-01
IRB Number:2020V0180
Actively Enrolling
Interventional
Phase 2
September 08, 2020
Eligibility Criteria
40 years old
80 years old
Both Male and Female
No
No
No

Inclusion Criteria
1. Male or non-pregnant female adult 40-80 years of age at time of enrollment.
2. Laboratory-confirmed SARS-CoV-2 infection as determined by PCR, in any specimen up to 21 days prior to randomization.
3. Meets definition of ARDS according to Berlin criteria.
4. On invasive mechanical ventilation, initiated in the last 24 hours before randomization, and up to 36 hours before first treatment initiation.

Exclusion Criteria
1. Mild ARDS as defined by Berlin criteria (PaO2/FIO2- 200-300 mmHg)
2. Body weight under 55 kg (121 lbs)
3. Stage 3b and above chronic kidney disease
4. Known allergy to any of the following: dimethyl sulfoxide (DMSO), human serum albumin, bovine serum albumin, anti-histamine.
5. Stroke or acute myocardial
6. Congestive heart failure
7. Chronic Obstructive Pulmonary disease GOLD stage above III
8. Patients with ALL risk factors as described:
a. Hypertension under chronic treatment of at least 2 anti-hypertensive drugs
b. Diabetes mellitus (either type) under chronic treatment with at least 2 anti-diabetic drug (or insulin as a single treatment).
c. Stage 2 obesity and above (BMI>35)
9. Acquired immunodeficiency syndrome (AIDS) or HIV under chronic treatment.
10. Active acute or chronic HBV or HCV (recovered patients are allowed).
11. Known history or active tuberculosis (latent TB is acceptable).
12. Pre-existing significant coagulopathies that put the patient at an increased risk of major bleeding according to the Investigator’s judgment.
13. History of thromboembolism or known hypercoagulopathic syndrome\state.
14. Subjects under acute or chronic anticoagulant therapy
15. Subject is currently enrolled in, or has not yet completed a period of at least 30 days since ending another controlled clinical trial(s) with investigational drug for immunomodulation, unless in long-term follow-up phase (in which there is no IP administration).
16. Exposure to allogeneic cell-based therapy in the past or exposure to autologous cell therapy in the last 12 months before screening.
17. History of solid organ transplantation.
18. 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.

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COVID-19 (Coronavirus)
Participating Locations
University Hospital
Contact Information
Contact Name: Luis Shimose
Phone Number: 601-496-9600
Email: lshimoseciudad@umc.edu
Principal Investigator:Shimose Ciudad, Luis A, M.D.
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