Impact of COVID-19 After Autologous Hematopoietic Stem Cell Transplantation in Sweden

NCT04760184 | Completed

• 1 other identifier: 2020-03433
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

This retrospective observational cohort study aims to describe the impact of COVID-19 in patients treated with autologous stem cell transplantation (ASCT) for malignant disease in terms of risk factors, morbidity, need for supportive care and mortality. All patients treated with ASCT in Sweden from 1st January 2020 until 31st December 2020 are eligible for this study. Patients who also has tested positive for SARS-CoV-2 from start of conditioning or later will be identified through the national registry of the Public Health Agency of Sweden and a systematic analysis of their medical records will be performed.

Conditions

Covid19; Myeloma Multiple; Malignant Lymphoma; Hematologic Neoplasms; Stem Cell Transplant Complications

Keywords

Autologous stem cell transplantation; COVID-19

Outcome Measures

Primary Outcomes (3)

• Overall survival

  Overall survival after infection with COVID-19

  30 days

• Overall survival

  Overall survival after infection with COVID-19

  90 days

• COVID-19 related mortality

  As classified by the WHO; a death resulting from a clinically compatible illness in a confirmed COVID-19 case, unless there is a clear alternative cause of death that cannot be related to COVID disease (e.g., trauma). There should be no period of complete recovery between the illness and death

  within 6 months after infection

Secondary Outcomes (31)

• Time of COVID-19 infection

  Up to 15 months

• Hospitalization

  Up to 15 months

• Oxygen treatment

  Up to 15 months

• High-flow oxygen therapy

  Up to 15 months

• Non-invasive ventilation

  Up to 15 months

Study Arms (1)

COVID19 positives after autologous stem cell transplantation

All Swedish citizens treated with ASCT for malignant disease in Sweden from 1st January 2020 until 31st December 2020 who has tested positive for SARS-CoV-2 from start of conditioning until the end of the study period 31st March 2021.

Other: Autologous stem cell transplantation

Interventions

Autologous stem cell transplantation OTHER

The study will describe the implications of COVID-19 infection following autologous stem cell transplantation

COVID19 positives after autologous stem cell transplantation

Eligibility Criteria

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

Study Population

All Swedish citizens treated with ASCT for malignant disease in Sweden from 1st January 2020 until 31st December 2020 are eligible for this study. There will be a minimum follow-up time of one month for all patients.

You may qualify if:

• Diagnosis of hematological cancer (C81-C96 according to the International Classification of Diseases 10th revision (ICD-10).
• Autologous hematopoietic stem cell transplantation performed 1 January 2020 until 31st December 2020 at a Swedish transplantation center.
• Positive RT-PCR test for SARS-CoV-2 performed in Sweden

You may not qualify if:

• \- Age below 18 years and 0 months at the time of transplantation

Sponsors & Collaborators

• Uppsala University: lead
• Karolinska University Hospital: collaborator
• Sahlgrenska University Hospital: collaborator
• Lund University Hospital: collaborator
• University Hospital, Linkoeping: collaborator
• University Hospital, Umeå: collaborator
• Region Örebro County: collaborator
• Uppsala University Hospital: collaborator

Study Sites (1)

Uppsala Universitet

Uppsala, Sweden

Location

Related Publications (12)

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MeSH Terms

Conditions

COVID-19; Multiple Myeloma; Lymphoma; Hematologic Neoplasms

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; Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases; Lymphatic Diseases; Neoplasms by Site

Study Officials

• Honar Cherif, MD, Ass prof

  Department of Medical Sciences, Uppsala University

  PRINCIPAL INVESTIGATOR

• Thomas Silfverberg, MD

  Center for Clinical Research Dalarna and Department of Medical Sciences-Uppsala University

  STUDY CHAIR

• Kristina Carlson, MD, Ass Prof

  Department of Medical Sciences, Uppsala University

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 11, 2020
• First Posted: February 18, 2021
• Study Start: April 1, 2021
• Primary Completion: August 30, 2021
• Study Completion: December 31, 2021
• Last Updated: February 8, 2022

Record last verified: 2022-02

Locations

SE (1)