Adaptive Open-label Study Evaluating the Safety and Efficacy of Autologous Non- Hematopoietic Peripheral Blood Stem Cells Therapy in COVID-19 Outbreak in Abu Dhabi, 2020 (SENTAD-COVID Study)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 146
- 试验地点
- 1
- 主要终点
- Rate of mortality within 28-days.
研究概览
简要总结
SENTAD-COVID Study is an adaptive, prospective, multicentric, open-label, and randomized controlled clinical trial involving hospitalized adult patients with confirmed coronavirus disease 2019 (COVID-19) infection during the outbreak in Abu Dhabi, 2020. The patients were randomly allocated in a parallel assignment involving two groups of participants: Group A (Experimental arm): autologous non-hematopoietic peripheral blood stem cells (NHPBSC) therapy as add-on COVID-19 standard care, or Group B (No investigational intervention arm): COVID-19 standard care. Standard care is defined as per the "UAE National Guidelines for Clinical Management and Treatment of COVID-19". SENTAD-COVID Study was conducted in the Sheikh Khalifa Medical City (SKMC) of Abu Dhabi, as Primary Care Clinical Trial Unit, while the cell processing and investigational product formulation were completed by Abu Dhabi Stem Cells Center (ADSCC), according to Good Laboratory Practices (GLPs) and Good Manufacturing Practices (GMPs).
详细描述
Group A patients received autologous NHPBSC therapy through jet nebulization, in addition to the standard care, while Group B (No investigational intervention arm) received only the UAE approved standard care. The primary endpoints were the safety and efficacy assessment, measured as Adverse Reactions (ARs) incidence [according to World Health Organization - Uppsala Monitoring Centre (WHO-UMC) causality assessment system], rate of mortality within 28-days, and the time to clinical improvement of 2 points on a seven-category ordinal scale or discharge from the Hospital, whichever came first. Immune response profile, acute-phase serum markers, and coagulation testing profile were evaluated as well, before treatment (baseline - Day 0), at Day 14, and Day 21 (in patients with early response, defined as 2 points of difference in the clinical critical treatment index within 7 days of treatment, the assessment will be performed at Day 7). The trial was approved by the institutional ADSCC Research Ethics Committees (REC), and the Emirates Institutional Review Board (IRB) for COVID-19 Research and the written informed consent was obtained from all patients or from the patient's legal representative if the patient was too unwell to provide consent. SENTAD-COVID Study was conducted in accordance with the principles of the Declaration of Helsinki and the Good Clinical Practice (GCP) Guidelines of the International Conference on Harmonization (ICH). The authors were responsible for designing the trial and for compiling and analyzing the data.
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
- None
盲法说明
None (open-label)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •RT-PCR Laboratory confirmation of COVID-
- •Male or female aged ≥ 18 years.
- •Interstitial lung change ≥ 3 judged by "Lungs Lobar based scoring" according to computed tomography (CT) scans.
- •Hospitalized and symptomatic patients, referring one or more of the following symptoms (fever, cough, or shortness of breath), in association with (at least one): tiredness, runny nose, headache, sore throat, chills, muscle pain, or new loss of taste or smell).
- •Ability to comply with test requirements and peripheral blood stem cells collection.
- •The patient or legal representative agrees to participate in the study, and signs the SENTAD-COVID Study informed consent form.
排除标准
- •Pediatric patients (aged < 18 years).
- •Diagnosis of any kind of shock.
- •Organ transplants in the past 3 months.
- •Patients receiving immunosuppressive therapy.
- •Diagnostic of Hepatitis B Virus (HBV) infection.
- •Diagnostic of Human Immunodeficiency Virus (HIV) infection or Acquired Immunodeficiency Syndrome (AIDS).
- •Current diagnosis of cancer.
- •History of malignancies in the past 5 years.
- •Pregnant or lactating women.
- •Have participated in other clinical trials in the past 3 months.
- •Inability to comply with test requirements and peripheral blood stem cells collection.
- •Inability to provide informed consent.
研究组 & 干预措施
Group A
Autologous Non-Hematopoietic Peripheral Blood Stem Cells (NHPBSC) therapy as add-on COVID-19 standard care.
干预措施: Autologous Non-Hematopoietic Peripheral Blood Stem Cells (NHPBSC) (Biological)
Group B
COVID-19 Standard care.
干预措施: COVID-19 standard care (Drug)
结局指标
主要结局
Rate of mortality within 28-days.
时间窗: Day 0 - 28
Incidence of deaths within 28-days in enrolled patients.
Time to clinical improvement on a seven-category ordinal scale.
时间窗: Day 0 - 28
Days from administration of the Investigational Product to improvement of seven-category ordinal scale by at least 2 points.
Adverse reactions incidence.
时间窗: Day 0 - 28
Proportion of participants with treatment-related Adverse Event as assessed by CTCAE v5.0.
次要结局
- Assessment of the immune response profile.(Days 0, 14, and 28)
- Assessment of acute-phase serum markers.(Days 0, 14, and 28)