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

Phase 2TerminatedNCT04362189

Hope Biosciences Research Foundation48 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

COVID-19

Interventions

HB-adMSCBIOLOGICAL

Hope Biosciences allogeneic adipose-derived mesenchymal stem cells

PlaceboOTHER

Saline

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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.

Locations (2)

River Oaks Hospital and Clinics

Houston, Texas, United States

United Memorial Medical Center

Houston, Texas, United States

Outcomes

Primary Outcomes

Tumor Necrosis Factor-Alpha (TNF-alpha)

Change from baseline in Tumor Necrosis Factor-Alpha (TNF-alpha) in the blood (pg/mL)

Time frame: Day 0, 3, 7, and 10

Interleukin-10 (IL-10)

Change from baseline level of Interleukin-10 (IL-10) in the blood (pg/mL)

Time frame: Day 0, 3, 7, and 10

Interleukin-6 (IL-6)

Change from baseline in Interleukin-6 (IL-6) in the blood (pg/mL)

Time frame: Day 0, 3, 7, and 10

C-Reactive Protein (CRP)

Change from baseline in C-Reactive Protein (CRP) in the blood (mg/L)

Time frame: Day 0, 3, 7, and 10

Oxygenation

Change from baseline Oxygenation (%) in the blood

Time frame: Day 0, 3, 7, and 10

Return To Room Air (RTRA)

Number of participants who returned to room air

Time frame: Day 0, 3, 7, and 10

Secondary Outcomes

D-dimer

Change from baseline in D-dimer in the blood (mg/L)

Time frame: Day 0, 3, 7, and Day 10

Myoglobin

Clinical lab evaluation of level of Myoglobin in the blood (ng/mL)

Time frame: Day 0, 3 7, and 10

Troponin

Data from ClinicalTrials.gov

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Clinical lab evaluation of level of Troponin in the blood (ng/mL)

Time frame: Day 0, 3, 7, and 10

Creatinine Kinase MB (CK-MB)

Clinical lab evaluation of level of Creatinine Kinase (CK-MB) in the blood (ng/mL)

Time frame: Day 0, 3, 7, and 10

Serum Ferritin

Clinical lab evaluation of level of Serum Ferritin in the blood (ng/mL)

Time frame: Day 0, 3, 7, and 10

NK Cell Surface Antigen (CD3-CD56+)

Clinical lab evaluation of Percentage of Cells CD3-CD56+ in the blood (%)

Time frame: Day 0, 3, 7, and 10

CD4+/CD8+ Ratio

Clinical lab evaluation of Ratio of CD4+/CD8+ Cells in the blood

Time frame: Day 0, 3, 7, and 10

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.

Time frame: Day 0, 3, 7, 10, and 28 (End of Study)

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.

Time frame: Day 0 and Day 28

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.

Time frame: Day 0, Day 28

Glucose

Clinical lab evaluation of level of Glucose in the blood (mg/dL)