Efficacy and Safety Study of Allogeneic HB-adMSCs for the Treatment of COVID-19

COVID-19 Clinical Trial

Official title:

A Randomized, Placebo-Controlled, Double-Blind, Efficacy and Safety Study of Allogeneic HB-adMSCs for the Treatment of COVID-19

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04362189
• Other study ID #: HBCOV03
• Status: Terminated
• Phase: Phase 2
• Start date: June 30, 2020
• Est. completion date: September 30, 2021

Study information

• Verified date: July 2023
• Source: Hope Biosciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 (IL-6, IL-10, TNF-alpha, C Reactive protein), improving oxygenation, and decreasing time to return to room air (RTRA). In addition, participants will be monitored for overall clinical status by standard clinical laboratories, change from baseline in exploratory markers (D-dimer, myoglobin, troponin, creatinine kinase MB, serum ferritin, CD4:CD8 ratio, CD3-CD56+), time to negative PCR results and clinical improvement according to 7-point ordinal scale, as well as incidence of adverse events.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 48
• Est. completion date: September 30, 2021
• Est. primary completion date: September 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

1. Men, and women, over 18 years of age inclusively.

2. Patient is suspected to have COVID-19 infection.

3. Provides consent or consent is given by their legally authorized representative (LAR).

4. Agrees to the collection of venous blood per protocol.

5. Women of childbearing potential (WOCBP) and men (if their sexual partners are WOCBP) must use at least 1 highly effective form of birth control throughout the study and for 6 months after the last dose of study treatment. Highly effective methods of birth control include true sexual abstinence (defined as refraining from heterosexual intercourse during the entire period of risk, in line with the preferred and usual lifestyle of the patient), surgery (bilateral tubal ligation or occlusion, vasectomized partner), progestogen-only or estrogen/progestogen hormonal contraceptive associated with inhibition of ovulation (oral, patch, injectable, implantable, or intravaginal), intrauterine device (IUD), or intrauterine hormone-releasing system (IUS).

Exclusion Criteria:

1. Pregnancy, lactation and those who are not pregnant but do not take effective contraceptive measures, in women of childbearing age. Absence of pregnancy will be confirmed through urine pregnancy test.

2. Patients who have participated or are participating in a clinical trial of an experimental vaccine for SARS-CoV-2 or coronavirus during the study or within 30 days.

3. Inability to provide informed consent or to comply with study requirements.

4. Patients with the following concomitant or past medical history:

• Both Hypertension and Diabetes Mellitus.

• Both Hypertension and Chronic Kidney Disease.

• Both Diabetes Mellitus and Chronic Kidney Disease.

5. History or evidence of alcohol abuse.

6. History or evidence of consumption of illicit drugs.

7. Patients requiring mechanical ventilation.

8. Patients who are determined by the Principal Investigator to be unsuitable for study enrollment for other reasons.

9. 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.

Related Conditions & MeSH terms

• COVID-19

Intervention

Biological:
• HB-adMSC
Hope Biosciences allogeneic adipose-derived mesenchymal stem cells

Other:
• Placebo
Saline

Locations

Country	Name	City	State
United States	River Oaks Hospital and Clinics	Houston	Texas
United States	United Memorial Medical Center	Houston	Texas

Sponsors (4)

Lead Sponsor	Collaborator
Hope Biosciences Stem Cell Research Foundation	Hope Biosciences, River Oaks Hospital and Clinics, United Memorial Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tumor Necrosis Factor-Alpha (TNF-alpha)	Change from baseline in Tumor Necrosis Factor-Alpha (TNF-alpha) in the blood (pg/mL)	Day 0, 3, 7, and 10
Primary	Interleukin-10 (IL-10)	Change from baseline level of Interleukin-10 (IL-10) in the blood (pg/mL)	Day 0, 3, 7, and 10
Primary	Interleukin-6 (IL-6)	Change from baseline in Interleukin-6 (IL-6) in the blood (pg/mL)	Day 0, 3, 7, and 10
Primary	C-Reactive Protein (CRP)	Change from baseline in C-Reactive Protein (CRP) in the blood (mg/L)	Day 0, 3, 7, and 10
Primary	Oxygenation	Change from baseline Oxygenation (%) in the blood	Day 0, 3, 7, and 10
Primary	Return To Room Air (RTRA)	Number of participants who returned to room air	Day 0, 3, 7, and 10
Secondary	D-dimer	Change from baseline in D-dimer in the blood (mg/L)	Day 0, 3, 7, and Day 10
Secondary	Myoglobin	Clinical lab evaluation of level of Myoglobin in the blood (ng/mL)	Day 0, 3 7, and 10
Secondary	Troponin	Clinical lab evaluation of level of Troponin in the blood (ng/mL)	Day 0, 3, 7, and 10
Secondary	Creatinine Kinase MB (CK-MB)	Clinical lab evaluation of level of Creatinine Kinase (CK-MB) in the blood (ng/mL)	Day 0, 3, 7, and 10
Secondary	Serum Ferritin	Clinical lab evaluation of level of Serum Ferritin in the blood (ng/mL)	Day 0, 3, 7, and 10
Secondary	NK Cell Surface Antigen (CD3-CD56+)	Clinical lab evaluation of Percentage of Cells CD3-CD56+ in the blood (%)	Day 0, 3, 7, and 10
Secondary	CD4+/CD8+ Ratio	Clinical lab evaluation of Ratio of CD4+/CD8+ Cells in the blood	Day 0, 3, 7, and 10
Secondary	7-Point Ordinal Scale	Change from baseline in Ordinal scale score. Scale of 1-7. A score of 1 indicates Death and 7 indicates Subject is not Hospitalized and has no Limitations on activities.	Day 0, 3, 7, 10, and 28 (End of Study)
Secondary	Computed Tomography (CT) Score	Change from baseline Computed Tomography (CT) Scan Score. A semi-quantitative CT severity scoring was calculated per each of the 5 lobes considering the extent of anatomic involvement: 0, no involvement; 1, < 5% involvement; 2, 5-25% involvement; 3, 26-50% involvement; 4, 51-75% involvement; and 5, > 75% involvement. The resulting global CT score was the sum of each individual lobar score and (0 - no involvement to 25 - maximum involvement). Lower score is better.	Day 0 and Day 28
Secondary	Chest X-Ray Score	Change from baseline in Chest X-Ray Score. Scoring was calculated per each of the 5 lobes considering the extent of anatomic involvement: 0, no involvement; 1, < 5% involvement; 2, 5-25% involvement; 3, 26-50% involvement; 4, 51-75% involvement; and 5, > 75% involvement. The resulting score was the sum of each individual lobar score and (0 - no involvement to 25 - maximum involvement). Lower score is better.	Day 0, Day 28
Secondary	Glucose	Clinical lab evaluation of level of Glucose in the blood (mg/dL)	Screening, Day 0, 3, 7, and 10
Secondary	Blood Urea Nitrogen (BUN)	Clinical lab evaluation of level of Blood Urea Nitrogen (BUN) (mg/dL)	Screening, Day 0, 3, 7, and 10
Secondary	Estimated Glomerular Filtration Rate (eGFR) if Non-African American	Clinical lab evaluation of level of Estimated glomerular filtration rate (eGFR) if Non-African American in the blood (mL/min/1.73)	Screening, Day 0, 3, 7, and 10
Secondary	Estimated Glomerular Filtration Rate (eGFR) if African American	Clinical lab evaluation of level of Estimated glomerular filtration rate (eGFR) If African American in the blood (mL/min/1.73)	Screening, Day 0, 3, 7, and 10
Secondary	BUN/Creatinine Ratio	Clinical lab evaluation of BUN/Creatinine Ratio in the blood	Screening, Day 0, 3, 7, and 10
Secondary	Sodium	Clinical lab evaluation of level of Sodium in the blood (mmol/L)	Screening, Day 0, 3, 7, and 10
Secondary	Potassium	Clinical lab evaluation of level of Potassium in the blood (mmol/L)	Screening, Day 0, 3, 7, and 10
Secondary	Chloride	Clinical lab evaluation of level of Chloride in the blood (mmol/L)	Screening, Day 0, 3, 7, and 10
Secondary	Carbon Dioxide Total	Clinical lab evaluation of total level of Carbon Dioxide in the blood (mmol/L)	Screening, Day 0, 3, 7, and 10
Secondary	Calcium	Clinical lab evaluation of level of Calcium in the blood (mg/dL)	Screening, Day 0, 3, 7, and 10
Secondary	Protein Total	Clinical lab evaluation of total level of Protein in the blood (g/dL)	Screening, Day 0, 3, 7, and 10
Secondary	Albumin	Clinical lab evaluation of level of Albumin in the blood (g/dL)	Screening, Day 0, 3, 7, and 10
Secondary	Globulin Total	Clinical lab evaluation of the total level of Globulin in the blood (g/dL)	Screening, Day 0, 3, 7, and 10
Secondary	Albumin/Globulin (A/G) Ratio	Clinical lab evaluation of Albumin/Globulin (A/G) Ratio in the blood	Screening, Day 0, 3, 7, and 10
Secondary	Bilirubin Total	Clinical lab evaluation of the total level of Bilirubin in the blood (mg/dL)	Screening, Day 0, 3, 7, and 10
Secondary	Alkaline Phosphatase	Clinical lab evaluation of level of Alkaline Phosphatase in the blood (IU/L)	Screening, Day 0, 3, 7, and 10
Secondary	Aspartate Aminotransferase (SGOT)	Clinical lab evaluation of level of Aspartate aminotransferase (SGOT) in the blood (IU/L)	Screening, Day 0, 3, 7, and 10
Secondary	Alanine Aminotransferase (SGPT)	Clinical lab evaluation of level of Alanine aminotransferase (SGPT) in the blood (IU/L)	Screening, Day 0, 3, 7, and 10
Secondary	White Blood Count (WBC)	Clinical lab evaluation of count of White Blood Cells (WBCs) in the blood (x10^3/uL)	Screening, Day 0, 3, 7, and 10
Secondary	Red Blood Cell (RBC) Count	Clinical lab evaluation of Red Blood Cell (RBC) Count in the blood (cells x 10^3/uL)	Screening, Day 0, 3, 7, and 10
Secondary	Hemoglobin	Clinical lab evaluation of level of Hemoglobin in the blood (g/dL)	Screening, Day 0, 3, 7, and 10
Secondary	Hematocrit	Clinical lab evaluation of level of Hematocrit in the blood (%)	Screening, Day 0, 3, 7, and 10
Secondary	Mean Corpuscular Volume (MCV)	Clinical lab evaluation of level of Mean Corpuscular Volume (MCV) in the blood (fL)	Screening, Day 0, 3, 7, and 10
Secondary	Mean Corpuscular Hemoglobin (MCH)	Clinical lab evaluation of level of Mean Corpuscular Hemoglobin (MCH) in the blood (pg)	Screening, Day 0, 3, 7, and 10
Secondary	Mean Corpuscular Hemoglobin Concentration (MCHC)	Clinical lab evaluation of Mean Corpuscular Hemoglobin Concentration (MCHC) in the blood (g/dL)	Screening, Day 0, 3, 7, and 10
Secondary	Red Cell Distribution Width (RDW)	Clinical lab evaluation of Red Cell Distribution Width (RDW) in the blood (%)	Screening, Day 0, 3, 7, and 10
Secondary	Platelets	Clinical lab evaluation of level of Platelets in the blood (cells x10^3/uL)	Screening, Day 0, 3, 7, and 10
Secondary	Neutrophils	Clinical lab evaluation of level of Neutrophils in the blood (%)	Screening, Day 0, 3, 7, and 10
Secondary	Lymphocytes	Clinical lab evaluation of level of Lymphocytes in the blood (%)	Screening, Day 0, 3, 7, and 10
Secondary	Monocytes	Clinical lab evaluation of level of Monocytes in the blood (%)	Screening, Day 0, 3, 7, and 10
Secondary	Eosinophils	Clinical lab evaluation of level of Eosinophils n the blood (%)	Screening, Day 0, 3, 7, and 10
Secondary	Basophils	Clinical lab evaluation of level of Basophils in the blood (%)	Screening, Day 0, 3, 7 and 10
Secondary	Absolute Neutrophils	Clinical lab evaluation of level of Absolute Neutrophils in the blood (cells x10^3/uL)	Screening, Day 0, 3, 7, and 10
Secondary	Absolute Lymphocytes	Clinical lab evaluation of level of Absolute Lymphocytes in the blood (cells x10^3/uL)	Screening, Day 0, 3, 7, and 10
Secondary	Absolute Monocytes	Clinical lab evaluation of level of Absolute Monocytes in the blood (cells x10^3/uL)	Screening, Day 0, 3, 7, and 10
Secondary	Absolute Eosinophils	Clinical lab evaluation of level of Absolute Eosinophils in the blood (cells x10^3/uL)	Screening, Day 0, 3, 7, and 10
Secondary	Absolute Basophils	Clinical lab evaluation of level of Absolute Basophils in the blood (cells x10^3/uL)	Screening, Day 0, 3, 7, and 10
Secondary	Immature Granulocytes	Clinical lab evaluation of level of Immature Granulocytes in the blood (%)	Screening, Day 0, 3, 7, and 10
Secondary	Absolute Immature Granulocytes	Clinical lab evaluation of level of Absolute Immature Granulocytes in the blood (cells x10^3/uL)	Screening, Day 0, 3, 7, and 10
Secondary	International Normalized Ratio (INR)	Clinical lab evaluation of International Normalized Ratio (INR)	Screening, Day 0, 3, 7, and 10
Secondary	Prothrombin Time (PT)	Clinical lab evaluation of Prothrombin Time (seconds)	Screening, Day 0, 3, 7, and 10
Secondary	Partial Thromboplastin Time (PTT)	Clinical lab evaluation of Partial Thromboplastin Time (PTT) (seconds)	Screening, Day 0, 3, 7, and 10