NCT04666025

SARS-CoV-2 Donor-Recipient Immunity Transfer

Observational Study of SARS-CoV-2 Donor-Recipient Immunity Transfer

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 26 (actual)
• Sponsor: City of Hope Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

PRIMARY OBJECTIVE: I. To establish the possibility of anti-SARS-CoV-2 adaptive immunity transfer from matched related (MRD) or unrelated (MUD) HCT donor to HCT recipient. SECONDARY OBJECTIVES: I. To explore anti-SARS-CoV-2 adaptive immunity transfer in the haploidentical (haplo) HCT setting. II. To assess the prevalence and change over time of SARS-CoV-2 seropositive donors among all consented donors. OUTLINE: DONORS: Prior to HCT, sibling donors (MRD and haplo) undergo a nasopharyngeal swab per standard of care for SARS-Cov-2 testing. For MUD donors, initial testing may consist of a questionnaire. All donors undergo collection of blood and saliva at the time of granulocyte-colony stimulating factor (G-CSF). Donors' medical charts are also reviewed. RECIPIENTS: Patients undergo a nasopharyngeal swab for SARS-Cov-2 testing at 30, 60, 90, 120 days post-HCT, and afterwards as deemed necessary by the treating physician. Patients also undergo the collection of blood and saliva specimens at days 30, 60, 90, 120, 150, and 180 post-HCT. Recipients' medical charts are also reviewed.

Conditions

• Accelerated Phase CML, BCR-ABL1 Positive
• Acute Lymphoblastic Leukemia
• Acute Myeloid Leukemia
• Chronic Lymphocytic Leukemia
• Chronic Phase CML, BCR-ABL1 Positive
• COVID-19 Infection
• Hematopoietic and Lymphoid Cell Neoplasm
• Hodgkin Lymphoma
• Lymphoblastic Lymphoma
• Myelodysplastic Syndrome
• Myelofibrosis
• Myeloproliferative Neoplasm
• Non-Hodgkin Lymphoma

Interventions

Type	Name	Description
PROCEDURE	Biospecimen Collection	Undergo collection of nasopharyngeal swabs, blood, and saliva samples
OTHER	Diagnostic Laboratory Biomarker Analysis	Correlative studies
OTHER	Electronic Health Record Review	Medical charts are reviewed
OTHER	Questionnaire Administration	Complete questionnaire

Timeline

• Start date: 2020-09-23
• Primary completion: 2023-05-05
• Completion: 2023-05-05
• First posted: 2020-12-14
• Last updated: 2024-04-08

Locations

1 site across 1 country: United States