The Impact of Donor COVID-19 Infection Status on the Reci... | NCT05675826

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

NCT05675826

Sponsor

Chen Suning

Status

Unknown status

Last Update Posted

Jan 12, 2023Actual

Enrollment

40Estimated

Phase

Not provided

Conditions

COVID-19
Hematopoietic Stem Cell Transplantation

Interventions

Not provided

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 26, 2022Actual

Primary Completion Date

Jan 31, 2023Estimated

Completion Date

Apr 30, 2023Estimated

First Submitted Date

Jan 4, 2023

First Submission Date that Met QC Criteria

Jan 6, 2023

First Posted Date

Jan 9, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 10, 2023

Last Update Posted Date

Jan 12, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Chen Suning, Physician, The First Affiliated Hospital of Soochow UniversitySponsor-Investigator

Lead Sponsor

Chen SuningOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

40Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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.

Interventions

Not provided

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

16 Years

Maximum Age

65 Years

Standard Ages

ChildAdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Suning Chen, PHD	Contact	+86-13814881746		chensuning@sina.com
Jing Lu, Master	Contact	+86-13771836270		lujing@suda.edu.cn

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
First Affiliated Hospital of Soochow University	Recruiting	Suzhou	Jiangsu	215000	China

Condition Browse Module

MeSH Terms

ID	Term
D000086382	COVID-19

Ancestor Terms

ID	Term
D011024	Pneumonia, Viral
D011014	Pneumonia
D012141	Respiratory Tract Infections
D007239	Infections

Browse Leaves

Not provided

Browse Branches

Not provided