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

January 10, 2023 updated by: Chen Suning

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

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.

Study Overview

Status

Recruiting

Conditions

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 Type

Observational

Enrollment (Anticipated)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Jiangsu
      • Suzhou, Jiangsu, China, 215000
        • Recruiting
        • First Affiliated Hospital of Soochow University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 65 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The study population wil be patients who underwent allogeneic HSCT during the COVID19 epidemic.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Donor infected with covid19
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
Including donors not yet infected with COVID19 at the time of hematopoietic stem cell collection.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chen Suning

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 26, 2022

Primary Completion (Anticipated)

January 31, 2023

Study Completion (Anticipated)

April 30, 2023

Study Registration Dates

First Submitted

January 4, 2023

First Submitted That Met QC Criteria

January 6, 2023

First Posted (Actual)

January 9, 2023

Study Record Updates

Last Update Posted (Actual)

January 12, 2023

Last Update Submitted That Met QC Criteria

January 10, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • COVID19-HSCT-1

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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