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

COVID-19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05675826
• Other study ID #: COVID19-HSCT-1
• Status: Recruiting
• Start date: December 26, 2022
• Est. completion date: April 30, 2023

Study information

• Verified date: January 2023
• Source: The First Affiliated Hospital of Soochow University
• Contact: Suning Chen, PHD
• Phone: +86-13814881746
• Email: chensuning[@]sina.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: April 30, 2023
• Est. primary completion date: January 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19
• Hematopoietic Stem Cell Transplantation

Locations

Country	Name	City	State
China	First Affiliated Hospital of Soochow University	Suzhou	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Chen Suning

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	COVID19 related mortality	The percentage of HM patients with COVID-19 who died.	100 days after enrollment of the last case