SARS-CoV-2 Donor-Recipient Immunity Transfer (NCT04666025) | Clinical Trial Compass
CompletedNot Applicable
SARS-CoV-2 Donor-Recipient Immunity Transfer
United States26 participantsStarted 2020-09-23
Plain-language summary
This study investigates whether donors with previous exposure to COVID-19 can pass their immunity by hematopoietic (blood) stem cell transplant (HCT) donation to patients that have not been exposed. Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is the virus that causes the COVID19 infection. This study may provide critical information for medical decision-making and possible immunotherapy interventions in immunocompromised transplant recipients, who are at high risk for COVID19 severe illness.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* ALL COHORTS: Documented written informed consent of the participant
* ALL COHORTS: Recipients must have a planned allogeneic HCT procedure. MRD, MUD, and haplo HCT allowed. Usage of post-transplant cyclophosphamide (PTCy) permitted only in haplo setting
* ALL COHORTS: GCSF-mobilized peripheral blood stem cell (PBSC) only as graft source
* ALL COHORTS: Planned HCT with minimal to no-T cell depletion of graft for the treatment of the following hematologic malignancies:
* Lymphoma (Hodgkin and non-Hodgkin)
* Myelodysplastic syndrome
* Acute lymphoblastic leukemia in first or second remission (for acute lymphoblastic leukemia/lymphoblastic lymphoma, the disease status must be in hematologic remission by bone marrow and peripheral blood. Persistent lymphadenopathy on computed tomography \[CT\] or CT/positron emission tomography \[PET\] scan without progression is allowed)
* Acute myeloid leukemia in first or second remission
* Chronic myelogenous leukemia in first chronic or accelerated phase, or in second chronic phase
* Other hematologic malignancies including chronic lymphocytic leukemia, myeloproliferative disorders and myelofibrosis
* ALL COHORTS: Willingness to
* Provide blood samples and saliva specimens
* Permit medical record review
* ADDITIONAL CRITERIA FOR RECIPIENTS IN THE MAIN COHORT:
* Absence of documented COVID-19 history and active COVID-19 infection
* ADDITIONAL CRITERIA FOR RECIPIENTS IN THE REFERENCE COHORT: Active CO…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Severe acute respiratory syndrome (SARS)-Coronavirus 2 (CoV-2) Spike protein (S)-specific IgG concentration and T cell levels
Timeframe: Up to 180 days post-hematopoietic stem cell transplant (HCT)
2
SARS-CoV-2 nucleocapsid protein (N) -specific IgG concentration and T cell levels