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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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The Impact of Donor COVID-19 Infection Status on the Recipient in Allogeneic Hematopoietic Stem Cell Transplantation.

Conditions
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COVID-19, Hematopoietic Stem Cell Transplantation

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: Hematological diseases, other than hematological malignancies.

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Donor infected with covid19<br>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<br>Including donors not yet infected with COVID19 at the time of hematopoietic stem cell collection. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hematopoietic reconstitution | To compare the differences in the time of hematopoietic reconstitution between the two groups after transplantation. | 1 month after enrollment of the last case | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Infection of COVID19 | To compare the rate of early COVID19 infection between the two groups as well as the rate of severe disease. | 1 month after enrollment of the last case | 
| Acute graft-versus-host disease | To compare the incidence and extent of aGVHD between the two groups. | 100 days after enrollment of the last case | 
| COVID19 related mortality | The percentage of HM patients with COVID-19 who died. | 100 days after enrollment of the last case |