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

NCT05675826 | Unknown

• 1 other identifier: COVID19-HSCT-1
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

COVID-19; Hematopoietic Stem Cell Transplantation

Outcome Measures

Primary Outcomes (1)

• 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 (3)

• Infection of COVID19

  1 month after enrollment of the last case

• Acute graft-versus-host disease

  100 days after enrollment of the last case

• COVID19 related mortality

  100 days after enrollment of the last case

Study Arms (2)

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.

Eligibility Criteria

• Age: 16 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• Hematological diseases, other than hematological malignancies.

Sponsors & Collaborators

• Chen Suning: lead

Study Sites (1)

First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, 215000, China

RECRUITING

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

Suning Chen, PHD

CONTACT

+86-13814881746; chensuning@sina.com

Jing Lu, Master

CONTACT

+86-13771836270; lujing@suda.edu.cn

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Physician

Study Record Dates

• First Submitted: January 4, 2023
• First Posted: January 9, 2023
• Study Start: December 26, 2022
• Primary Completion: January 31, 2023
• Study Completion: April 30, 2023
• Last Updated: January 12, 2023

Record last verified: 2023-01

Locations

CN (1)