The Impact of Donor COVID-19 Infection Status on the Recipient in Allo-HSCT
NCT ID: NCT05675826
Last Updated: 2023-01-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
40 participants
OBSERVATIONAL
2022-12-26
2023-04-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Donor infected with covid19
This includes donors who have been infected or are infected with COVID19 at the time of hematopoietic stem cell collection.
No interventions assigned to this group
Donor not infected with covid
Including donors not yet infected with COVID19 at the time of hematopoietic stem cell collection.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
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
16 Years
65 Years
ALL
No
Sponsors
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Chen Suning
OTHER
Responsible Party
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Chen Suning
Physician
Locations
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First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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COVID19-HSCT-1
Identifier Type: -
Identifier Source: org_study_id
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