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

Recruiting

• Conditions: COVID-19; Hematopoietic Stem Cell Transplantation

• Registration Number: NCT05675826
• Lead Sponsor: Chen Suning

Brief Summary

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

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.

Study Timeline

• Study Start: 2022-12-26
• Status Verified: 2023-01
• Study First Submitted: 2023-01-04
• Study First Submitted QC: 2023-01-06
• Study First Posted: 2023-01-09
• Last Update Submitted: 2023-01-10
• Last Update Posted: 2023-01-12
• Primary Completion: 2023-01-31
• Study Completion: 2023-04-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Hematopoietic reconstitution	1 month after enrollment of the last case	To compare the differences in the time of hematopoietic reconstitution between the two groups after transplantation.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

First Affiliated Hospital of Soochow University; 🇨🇳 Suzhou, Jiangsu, China