A Randomized, Placebo-Controlled, Double-Blind, Efficacy and Safety Study of Allogeneic HB-adMSCs for the Treatment of COVID-19
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 48
- 试验地点
- 2
- 主要终点
- Interleukin-6 (IL-6)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men, and women, over 18 years of age inclusively.
- •Patient is suspected to have COVID-19 infection.
- •Provides consent or consent is given by their legally authorized representative (LAR).
- •Agrees to the collection of venous blood per protocol.
- •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).
排除标准
- •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.
- •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.
- •Inability to provide informed consent or to comply with study requirements.
- •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.
- •History or evidence of alcohol abuse.
- •History or evidence of consumption of illicit drugs.
- •Patients requiring mechanical ventilation.
- •Patients who are determined by the Principal Investigator to be unsuitable for study enrollment for other reasons.
- •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.
研究组 & 干预措施
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.
干预措施: HB-adMSC (Biological)
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.
干预措施: Placebo (Other)
结局指标
主要结局
Interleukin-6 (IL-6)
时间窗: Day 0, 3, 7, and 10
Change from baseline in Interleukin-6 (IL-6) in the blood (pg/mL)
Oxygenation
时间窗: Day 0, 3, 7, and 10
Change from baseline Oxygenation (%) in the blood
Interleukin-10 (IL-10)
时间窗: Day 0, 3, 7, and 10
Change from baseline level of Interleukin-10 (IL-10) in the blood (pg/mL)
C-Reactive Protein (CRP)
时间窗: Day 0, 3, 7, and 10
Change from baseline in C-Reactive Protein (CRP) in the blood (mg/L)
Tumor Necrosis Factor-Alpha (TNF-alpha)
时间窗: Day 0, 3, 7, and 10
Change from baseline in Tumor Necrosis Factor-Alpha (TNF-alpha) in the blood (pg/mL)
Return To Room Air (RTRA)
时间窗: Day 0, 3, 7, and 10
Number of participants who returned to room air
次要结局
- Sodium(Screening, Day 0, 3, 7, and 10)
- Potassium(Screening, Day 0, 3, 7, and 10)
- CD4+/CD8+ Ratio(Day 0, 3, 7, and 10)
- 7-Point Ordinal Scale(Day 0, 3, 7, 10, and 28 (End of Study))
- Serum Ferritin(Day 0, 3, 7, and 10)
- Calcium(Screening, Day 0, 3, 7, and 10)
- Red Blood Cell (RBC) Count(Screening, Day 0, 3, 7, and 10)
- Hemoglobin(Screening, Day 0, 3, 7, and 10)
- Mean Corpuscular Volume (MCV)(Screening, Day 0, 3, 7, and 10)
- Platelets(Screening, Day 0, 3, 7, and 10)
- Eosinophils(Screening, Day 0, 3, 7, and 10)
- Absolute Neutrophils(Screening, Day 0, 3, 7, and 10)
- Absolute Monocytes(Screening, Day 0, 3, 7, and 10)
- Blood Urea Nitrogen (BUN)(Screening, Day 0, 3, 7, and 10)
- Chloride(Screening, Day 0, 3, 7, and 10)
- Protein Total(Screening, Day 0, 3, 7, and 10)
- Albumin(Screening, Day 0, 3, 7, and 10)
- Albumin/Globulin (A/G) Ratio(Screening, Day 0, 3, 7, and 10)
- Prothrombin Time (PT)(Screening, Day 0, 3, 7, and 10)
- D-dimer(Day 0, 3, 7, and Day 10)
- Myoglobin(Day 0, 3 7, and 10)
- Troponin(Day 0, 3, 7, and 10)
- Computed Tomography (CT) Score(Day 0 and Day 28)
- Glucose(Screening, Day 0, 3, 7, and 10)
- BUN/Creatinine Ratio(Screening, Day 0, 3, 7, and 10)
- Creatinine Kinase MB (CK-MB)(Day 0, 3, 7, and 10)
- NK Cell Surface Antigen (CD3-CD56+)(Day 0, 3, 7, and 10)
- Chest X-Ray Score(Day 0, Day 28)
- Estimated Glomerular Filtration Rate (eGFR) if African American(Screening, Day 0, 3, 7, and 10)
- Carbon Dioxide Total(Screening, Day 0, 3, 7, and 10)
- Bilirubin Total(Screening, Day 0, 3, 7, and 10)
- Hematocrit(Screening, Day 0, 3, 7, and 10)
- Mean Corpuscular Hemoglobin Concentration (MCHC)(Screening, Day 0, 3, 7, and 10)
- Red Cell Distribution Width (RDW)(Screening, Day 0, 3, 7, and 10)
- Lymphocytes(Screening, Day 0, 3, 7, and 10)
- Absolute Basophils(Screening, Day 0, 3, 7, and 10)
- Estimated Glomerular Filtration Rate (eGFR) if Non-African American(Screening, Day 0, 3, 7, and 10)
- Globulin Total(Screening, Day 0, 3, 7, and 10)
- Alkaline Phosphatase(Screening, Day 0, 3, 7, and 10)
- Alanine Aminotransferase (SGPT)(Screening, Day 0, 3, 7, and 10)
- White Blood Count (WBC)(Screening, Day 0, 3, 7, and 10)
- Mean Corpuscular Hemoglobin (MCH)(Screening, Day 0, 3, 7, and 10)
- Neutrophils(Screening, Day 0, 3, 7, and 10)
- Aspartate Aminotransferase (SGOT)(Screening, Day 0, 3, 7, and 10)
- Monocytes(Screening, Day 0, 3, 7, and 10)
- Basophils(Screening, Day 0, 3, 7 and 10)
- Absolute Lymphocytes(Screening, Day 0, 3, 7, and 10)
- Absolute Eosinophils(Screening, Day 0, 3, 7, and 10)
- Immature Granulocytes(Screening, Day 0, 3, 7, and 10)
- Absolute Immature Granulocytes(Screening, Day 0, 3, 7, and 10)
- International Normalized Ratio (INR)(Screening, Day 0, 3, 7, and 10)
- Partial Thromboplastin Time (PTT)(Screening, Day 0, 3, 7, and 10)