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Efficacy and Safety Study of Allogeneic HB-adMSCs 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: NCT04362189
Recruitment Status : Not yet recruiting
First Posted : April 24, 2020
Last Update Posted : May 22, 2020
Sponsor:
Collaborators:
Advanced Diagnostics Healthcare
Hope Biosciences Stem Cell Research Foundation
Information provided by (Responsible Party):
Hope Biosciences

Brief Summary:
Hope Biosciences is conducting a research study of an investigational product called allogeneic adipose-derived mesenchymal stem cells (abbreviated as HB-adMSCs) as treatment for patients suspected to have COVID-19. The study purpose is to evaluate the safety and efficacy of four IV infusions of either placebo or HB-adMSCs in subjects with COVID-19.

Condition or disease Intervention/treatment Phase
COVID-19 Drug: HB-adMSC Drug: Placebo Phase 2

Detailed Description:
This is a Phase II, Randomized, Placebo-Controlled, Double-Blinded, Clinical Trial to Assess Efficacy of HB-adMSCs to treat COVID-19 patients. 100 patients will be enrolled. Eligible participants are suspected to have COVID-19 and consent to participate. The primary endpoints of this study are to detect change from baseline in inflammatory markers, change from baseline in oxygenation, and decrease time to negative PCR test result. In addition, participants will be monitored for overall clinical status by standard clinical laboratories, change from baseline in IL-10, CD4:CD8 ratio, CD3-CD56+, VEGF, and clinical improvement according to 7-point ordinal scale, as well as incidence of adverse events.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Placebo-Controlled, Double-Blind, Single Center, Efficacy and Safety Study of Allogeneic HB-adMSCs for the Treatment of COVID-19
Estimated Study Start Date : May 15, 2020
Estimated Primary Completion Date : October 31, 2020
Estimated Study Completion Date : October 31, 2020

Arm Intervention/treatment
Experimental: HB-adMSCs
Subjects assigned to this arm will receive 4 intravenous infusions of HB-adMSCs at 100 million cells/dose. HB-adMSC infusions will occur at day 0, 3, 7, and 10.
Drug: HB-adMSC
Hope Biosciences allogeneic adipose-derived mesenchymal stem cells

Placebo Comparator: Placebo
Subjects assigned to this arm will receive 4 intravenous infusions of placebo (saline solution). Infusions will occur at day 0, 3, 7, and 10.
Drug: Placebo
Saline




Primary Outcome Measures :
  1. D-dimer [ Time Frame: screening, day 0, 7, 10 ]
    change from baseline in level of D-dimer (ng/mL)

  2. Interleukin-6 [ Time Frame: screening, day 0, 7, 10 ]
    change from baseline in interleukin-6

  3. C Reactive protein [ Time Frame: screening, day 0, 7, 10 ]
    Change from baseline in C Reactive protein

  4. Oxygenation [ Time Frame: screening, day 0, 7, 10 ]
    change from baseline oxygenation (%)

  5. PCR test SARS-CoV-2 [ Time Frame: Day 0, 3, 7, 10 ]
    time to achieve negative PCR test results


Secondary Outcome Measures :
  1. EKG qt interval [ Time Frame: screening, day 0, 3, 7, 10 ]
    Monitoring for changes in qt interval

  2. Leukocyte differential [ Time Frame: screening, day 0, 7, 10 ]
    change from baseline in leukocyte differential

  3. TNF alpha [ Time Frame: screening, day 0, 7, 10 ]
    change from baseline in TNF alpha

  4. Glucose [ Time Frame: screening, day 0, 7, 10 ]
    clinical lab evaluation of level of glucose in the blood (mg/dL)

  5. Calcium [ Time Frame: screening, day 0, 7, 10 ]
    clinical lab evaluation of level of calcium in the blood (mg/dL)

  6. Albumin [ Time Frame: screening, day 0, 7, 10 ]
    clinical lab evaluation of level of albumin in the blood (g/dL)

  7. Total protein [ Time Frame: screening, day 0, 7, 10 ]
    clinical lab evaluation of level of total protein in the blood (g/dL)

  8. Sodium [ Time Frame: screening, day 0, 7, 10 ]
    clinical lab evaluation of level of sodium in the blood (mol/L)

  9. Total carbon dioxide [ Time Frame: screening, day 0, 7, 10 ]
    clinical lab evaluation of level of total carbon dioxide in the blood (mmol/L)

  10. Potassium [ Time Frame: screening, day 0, 7, 10 ]
    clinical lab evaluation of level of potassium in the blood (mmol/L)

  11. Chloride [ Time Frame: screening, day 0, 7, 10 ]
    clinical lab evaluation of level of chloride in the blood (mmol/L)

  12. BUN [ Time Frame: screening, day 0, 7, 10 ]
    clinical lab evaluation of level of BUN in the blood (mg/dL)

  13. Creatinine [ Time Frame: screening, day 0, 7, 10 ]
    clinical lab evaluation of level of creatinine in the blood (mg/dL)

  14. Alkaline phosphatase [ Time Frame: screening, day 0, 7, 10 ]
    clinical lab evaluation of level of alkaline phosphatase in the blood (IU/L)

  15. Alanine aminotransferase [ Time Frame: screening, day 0, 7, 10 ]
    clinical lab evaluation of level of alanine aminotransferase in the blood (IU/L)

  16. Total bilirubin [ Time Frame: screening, day 0, 7, 10 ]
    clinical lab evaluation of level of total bilirubin in the blood (mg/dL)

  17. White blood cells [ Time Frame: screening, day 0, 7, 10 ]
    clinical lab evaluation of level of white blood cells in the blood (x10^3/uL)

  18. Red blood cells [ Time Frame: screening, day 0, 7, 10 ]
    clinical lab evaluation of level of red blood cells in the blood (x10^6/uL)

  19. Hemoglobin [ Time Frame: screening, day 0, 7, 10 ]
    clinical lab evaluation of level of hemoglobin in the blood (g/dL)

  20. Hematocrit [ Time Frame: screening, day 0, 7, 10 ]
    clinical lab evaluation of level of hematocrit in the blood (%)

  21. Mean corpuscular volume [ Time Frame: screening, day 0, 7, 10 ]
    clinical lab evaluation of level of mean corpuscular volume in the blood (fL)

  22. Mean corpuscular hemoglobin [ Time Frame: screening, day 0, 7, 10 ]
    clinical lab evaluation of level of mean corpuscular hemoglobin in the blood (pg)

  23. Mean corpuscular hemoglobin concentration [ Time Frame: screening, day 0, 7, 10 ]
    clinical lab evaluation of level of mean corpuscular hemoglobin concentration in the blood (g/dL)

  24. Red cell distribution width [ Time Frame: screening, day 0, 7, 10 ]
    clinical lab evaluation of level of red cell distribution width in the blood (%)

  25. Neutrophils [ Time Frame: screening, day 0, 7, 10 ]
    clinical lab evaluation of level of neutrophils in the blood (%)

  26. Lymphs [ Time Frame: screening, day 0, 7, 10 ]
    clinical lab evaluation of level of lymphocytes in the blood (%)

  27. Monocytes [ Time Frame: screening, day 0, 7, 10 ]
    clinical lab evaluation of level of monocytes in the blood (%)

  28. Eosinophils [ Time Frame: screening, day 0, 7, 10 ]
    clinical lab evaluation of level of eosinophils in the blood (%)

  29. Basophils [ Time Frame: screening, day 0, 7, 10 ]
    clinical lab evaluation of level of basophils in the blood (%)

  30. Absolute neutrophils [ Time Frame: screening, day 0, 7, 10 ]
    clinical lab evaluation of level of absolute neutrophils in the blood (x10^3/uL)

  31. Absolute lymphs [ Time Frame: screening, day 0, 7, 10 ]
    clinical lab evaluation of level of absolute lymphocytes in the blood (x10^3/uL)

  32. Absolute monocytes [ Time Frame: screening, day 0, 7, 10 ]
    clinical lab evaluation of level of absolute monocytes in the blood (x10^3/uL)

  33. Absolute eosinophils [ Time Frame: screening, day 0, 7, 10 ]
    clinical lab evaluation of level of absolute eosinophils in the blood (x10^3/uL)

  34. Absolute basophils [ Time Frame: screening, day 0, 7, 10 ]
    clinical lab evaluation of level of absolute basophils in the blood (x10^3/uL)

  35. Immature granulocytes [ Time Frame: screening, day 0, 7, 10 ]
    clinical lab evaluation of level of immature granulocytes in the blood (x10^3/uL)

  36. Platelets [ Time Frame: screening, day 0, 7, 10 ]
    clinical lab evaluation of level of platelets in the blood (x10^3/uL)

  37. Prothrombin time [ Time Frame: screening, day 0, 7, 10 ]
    clinical lab evaluation of time for blood to coagulate (seconds)

  38. INR [ Time Frame: screening, day 0, 7, 10 ]
    clinical lab evaluation of international normalized ratio of blood coagulation (no unit)

  39. NK cell surface antigen (CD3-CD54+) [ Time Frame: screening, day 0, 7, 10 ]
    clinical lab evaluation of percentage of cells CD3- and CD54+ (%)

  40. CD4+/CD8+ ratio [ Time Frame: screening, day 0, 7, 10 ]
    clinical lab evaluation of ratio of CD4+ cells to CD8+ cells (no unit)

  41. IL-10 [ Time Frame: screening, day 0, 7, 10 ]
    clinical lab evaluation of level of IL-10 in the blood (pg/mL)

  42. VEGF [ Time Frame: screening, day 0, 7, 10 ]
    clinical lab evaluation of level of VEGF in the blood (pg/mL)

  43. Myoglobin [ Time Frame: screening, day 0, 7, 10 ]
    clinical lab evaluation of level of myoglobin in the blood (ng/mL)

  44. Troponin [ Time Frame: screening, day 0, 7, 10 ]
    clinical lab evaluation of level of myoglobin in the blood (ng/mL)

  45. Creatinine kinase [ Time Frame: screening, day 0, 7, 10 ]
    clinical lab evaluation of level of creatinine kinase in the blood (U/L)

  46. Serum ferritin [ Time Frame: screening, day 0, 7, 10 ]
    clinical lab evaluation of level of serum ferritin in the blood (ng/mL)

  47. Adverse events [ Time Frame: screening through day 28 ]
    incidence of adverse events

  48. 7-point ordinal scale [ Time Frame: screening, day 0, 3, 7, 10, 28 ]
    change from baseline in ordinal scale score



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.


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Men, and women, over 18 years of age inclusively
  • Patient is hospitalized due to suspected COVID-19 infection
  • Agrees to the collection of venous blood per protocol

Exclusion Criteria:

  • Pregnancy, lactation and those who are not pregnant but do not take effective contraceptive measures.
  • Patients who are participating in other clinical trials or have intake of investigational drug within the previous 30 days.
  • Inability to provide informed consent or to comply with test requirements.
  • Acute intercurrent infections such as Hepatitis C Virus (HCV), Hepatitis B Virus (HBV), Human Immunodeficiency Virus (HIV) or Syphilis.
  • Any medical disease or condition that, in the opinion of the site Principal Investigator or sub-investigator, precludes study participation. Including acute, subacute, intermittent or chronic medical disease or condition that would place the subject at an unacceptable risk of injury, render the subject unable to meet the requirements of the protocol, or may interfere with the evaluation of responses or the subject's successful completion of this trial.
  • Receipt of any other SARS-CoV-2 or other experimental coronavirus vaccine at any time prior to or during the study.

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): NCT04362189


Contacts
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Contact: Katherine Ruppert, PhD 8329758840 katie@hopebio.org
Contact: Sherry Diers, RN 8329758840 sherry@hopebio.org

Locations
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United States, Texas
River Oaks Hospital and Clinics
Houston, Texas, United States, 77027
Contact: Mariann England    281-755-4141    mengland@adhealthcare.com   
Principal Investigator: Rajiv Thakur, MD         
Sub-Investigator: Joseph Gathe, MD, FACP         
Sub-Investigator: Thinh Vo, MD         
Sponsors and Collaborators
Hope Biosciences
Advanced Diagnostics Healthcare
Hope Biosciences Stem Cell Research Foundation
Investigators
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Principal Investigator: Rajiv Thakur, MD Advanced Diagnostics Healthcare
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Responsible Party: Hope Biosciences
ClinicalTrials.gov Identifier: NCT04362189    
Other Study ID Numbers: Allogeneic Treatment COVID-19
First Posted: April 24, 2020    Key Record Dates
Last Update Posted: May 22, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hope Biosciences:
Coronavirus
Stem cells
Mesenchymal stem cells
Adipose-derived mesenchymal stem cells