Evaluating COVID-19 Convalescent Plasma for Preventing COVID-19 in Stem Cell Transplant Recipients
Institute of Hematology & Blood Diseases Hospital
This study tests if giving COVID-19 convalescent plasma to adults who have had a stem cell transplant can help prevent them from getting COVID-19.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 72 (estimated) |
| Ages | 16 Years and up |
| Sex | All |
| Sponsor | Institute of Hematology & Blood Diseases Hospital, China Academic / other |
| Locations | 1 site (Tianjin, None Selected) |
| Trial ID | NCT05904067 on ClinicalTrials.gov |
What this trial studies
This study evaluates the safety and efficacy of COVID-19 convalescent plasma (CCP) transfusion in preventing COVID-19 in adult patients who have undergone hematopoietic stem cell transplantation. A total of 72 patients will be randomly assigned to receive either CCP or a control treatment of oral ursodeoxycholic acid. The CCP group will receive 200 ml of plasma at specified intervals following transplantation, while the control group will receive standard care. The primary goal is to assess the safety of CCP and the incidence of COVID-19 infection within 28 days after the last infusion.
Who should consider this trial
Good fit: Ideal candidates are adults aged 16 and older who are receiving hematopoietic stem cell transplantation.
Not a fit: Patients who have had a prior COVID-19 infection or those with certain medical conditions that disqualify them from the study may not benefit.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the incidence of COVID-19 in vulnerable patients following stem cell transplantation.
How similar studies have performed: While the use of convalescent plasma has been explored in various contexts, this specific application in stem cell transplant recipients is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. receive hematopoietic stem cell transplantation 2. Be ≥ 16 years of age on the day of enrollment. 3. Understand the study procedures, alternative treatment available, and risks involved with the study, and voluntarily agree to participate by giving written informed consent. Exclusion Criteria: 1. Positive serological response to known HIV or active hepatitis C virus. 2. Patients with mental illness or other conditions that do not meet the requirements of research treatment and monitoring. 3. Unable or unwilling to sign consent form. 4. Patients with other special conditions assessed as unqualified by the researchers. 5. Patients suffered COVID-19 infection between day 0 and infusion of CCP after transplantation. Drop-out and Withdrawal Criteria 1. Failure of engraftment within 30 days of transplantation; 2. Patients who are not compliant with the requirements of the study and fail to follow the study plan. 3. Patients receiving prophylaxis for COVID-19 infection by methods other than this protocol during the trial. 4. A patient may withdraw from the study if he/she does not wish to continue participating in the study, and the date and reason for withdrawal shall be recorded. The investigator may also decide to discontinue a patient from the clinical study if there is an unacceptable risk.
Where this trial is running
Tianjin, None Selected
- Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences — Tianjin, None Selected, China (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.