The Impact of Donor COVID-19 Infection Status on the Recipient in Allogeneic Hematopoietic Stem Cell Transplantation.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Hematopoietic reconstitution
研究概览
简要总结
This study was conducted to observe whether COVID-19 can be transmitted through stem cell transplantation and whether COVID-19-positive donors have an effect on early hematopoietic reconstitution and immune reconstitution in the recipients.
详细描述
Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) induced COVID-19 infections are showing an explosive increase in China starting in late 2022. SARS-CoV-2 infections are characterized by an initial viral replication followed by an inflammatory phase with lymphocyte depletion in severe patients.
Past studies have shown that SARS-CoV -2 is detectable in the blood of 8%-15% of patients and that viremia occurs in the first 2-3 days after the onset of symptoms. EBMT, WMDA and other organizations have suggested that COVID-19 positive donors must be excluded or delayed from donation for safety reasons.
However, there have not been any reports of transmission from donor to recipient in blood product transfusion or cell therapy. In the only reported cases of allogeneic HSCT from SARS-CoV-2 positive donors, there was also no evidence of recipient infection from the graft.
In the current situation where the vast majority of people are infected with COVID-19 in the short term, many patients, such as those with leukemia, are in urgent need of transplantation due to the aggressive， hard-to-control，underlying disease. The investigators established this observational clinical trial to investigate whether COVID-19 is transmitted through stem cells and whether COVID-19 positive donors have an impact on early hematopoietic reconstitution and immune reconstitution in recipients.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 16 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 16 and 65 years old.
- •History of hematological malignancies (acute leukemias, myelodysplastic syndromes, myeloproliferative neoplasms, lymphomas, myeloma).
- •Allogeneic hematopoietic stem cell transplantation perform during the COVID19 pandemic.
排除标准
- •Hematological diseases, other than hematological malignancies.
结局指标
主要结局
Hematopoietic reconstitution
时间窗: 1 month after enrollment of the last case
To compare the differences in the time of hematopoietic reconstitution between the two groups after transplantation.
次要结局
- Infection of COVID19(1 month after enrollment of the last case)
- Acute graft-versus-host disease(100 days after enrollment of the last case)
- COVID19 related mortality(100 days after enrollment of the last case)
研究者
Chen Suning
Physician
The First Affiliated Hospital of Soochow University