The Impact of Donor COVID-19 Infection Status on the Recipient in Allo-HSCT

Chen Suning

Status: Enrolling

Conditions: COVID-19; Hematopoietic Stem Cell Transplantation

Study type: Observational

Funder types: Other

Identifiers

NCT05675826

COVID19-HSCT-1

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 16 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age between 16 and 65 years old.
2. History of hematological malignancies (acute leukemias, myelodysplastic syndromes, myeloproliferative neoplasms, lymphomas, myeloma).
3. Allogeneic hematopoietic stem cell transplantation perform during the COVID19 pandemic.

Exclusion criteria

Hematological diseases, other than hematological malignancies.

Trial design

40 participants in 2 patient groups

Donor infected with covid19

Description:

This includes donors who have been infected or are infected with COVID19 at the time of hematopoietic stem cell collection.

Donor not infected with covid

Description:

Including donors not yet infected with COVID19 at the time of hematopoietic stem cell collection.