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

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ClinicalTrials.gov Identifier: NCT04760184
Recruitment Status : Recruiting
First Posted : February 18, 2021
Last Update Posted : May 7, 2021
Sponsor:
Collaborators:
Karolinska University Hospital
Sahlgrenska University Hospital, Sweden
Lund University Hospital
University Hospital, Linkoeping
University Hospital, Umeå
Region Örebro County
Uppsala University Hospital
Information provided by (Responsible Party):
Uppsala University

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.

Condition or disease Intervention/treatment
Covid19 Myeloma Multiple Malignant Lymphoma Hematologic Neoplasms Stem Cell Transplant Complications Other: Autologous stem cell transplantation

Detailed Description:

Research question How does infection with SARS-CoV-2 affect patients with hematological malignancies who are treated with autologous hematopoietic stem cell transplantation?

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.

Data collection and storage Patients will be identified using local ASCT registers at the seven university hospitals, as there is no national register for ASCT-patients in Sweden. These seven university hospitals are the only sights to perform ASCT in Sweden. The Public Health Agency of Sweden (Folkhälsomyndigheten - FHM) has the national responsibility to surveil and control communicable disease. The FHM uses several different surveillance systems to monitor the spread of COVID-19. Since COVID-19 is subject to mandatory reporting under the Communicable Diseases Act, physicians and laboratories continuously supply data to be analyzed daily by the FHM. The coverage of this database is estimated to be very high, close to 100%. For this study the investigators will link the patients identified through the ASCT-centers with the register of SARS-Cov-2 positive patients (SmiNet) held by the FHM. Patients who has tested positive for SARS-CoV-2 on the day of start of conditioning or at any given time thereafter will be included in the study. Inclusion of positive SARS-CoV-2 tests will start from 1st January 2020 until 31st March 2021 to allow for 3 months of follow-up after transplantation. For every ASCT-patient that has tested positive for COVID-19 after ASCT a systematic analysis of their medical records will be performed to describe the circumstances, impact and outcome of the COVID-19.

All data collected will be stored in a deidentified data set on a secure server held by Dalarna Country Council where name and social security number have been erased and given a coded study number. Each patient will only be identified using a separately stored code key. All storage, correspondence and analysis with the code key and pseudonymized data set will adhere to current European General Data Protection Regulation (GDPR) guidelines. The code key will be destroyed as soon as data collection is completed, data quality is secured and the final report is published. The data set will be stored for 10 years and then be destroyed.

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Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Impact of COVID-19 on Patients Treated With Autologous Hematopoietic Stem Cell Transplantation in Sweden - a Retrospective Cohort Study
Actual Study Start Date : April 1, 2021
Estimated Primary Completion Date : June 30, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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
The study will describe the implications of COVID-19 infection following autologous stem cell transplantation




Primary Outcome Measures :
  1. Overall survival [ Time Frame: 30 days ]
    Overall survival after infection with COVID-19

  2. Overall survival [ Time Frame: 90 days ]
    Overall survival after infection with COVID-19

  3. COVID-19 related mortality [ Time Frame: within 6 months after infection ]
    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


Secondary Outcome Measures :
  1. Time of COVID-19 infection [ Time Frame: Up to 15 months ]
    Time of SARS-CoV-2 infection in relation to autologous stem cell transplantation

  2. Hospitalization [ Time Frame: Up to 15 months ]
    Duration of hospitalization

  3. Oxygen treatment [ Time Frame: Up to 15 months ]
    Duration of oxygen treatment

  4. High-flow oxygen therapy [ Time Frame: Up to 15 months ]
    Duration of high-flow oxygen therapy

  5. Non-invasive ventilation [ Time Frame: Up to 15 months ]
    Duration of non-invasive ventilation (NIV)

  6. Intensive care [ Time Frame: Up to 15 months ]
    Duration of care in intensive care unit

  7. Invasive mechanical ventilation [ Time Frame: Up to 15 months ]
    Duration of Invasive mechanical ventilation

  8. ECMO [ Time Frame: Up to 15 months ]
    Duration of extracorporeal membrane oxygenation (ECMO)

  9. Occurence of ARDS [ Time Frame: Up to 15 months ]
    Diagnosis of Acute respiratory distress syndrome (ARDS)

  10. Occurence of arterial thrombosis [ Time Frame: Up to 15 months ]
    Event of arterial thrombosis

  11. Occurence of venous thrombosis [ Time Frame: Up to 15 months ]
    Event of venous thrombosis

  12. Occurence of arrhythmias [ Time Frame: Up to 15 months ]
    Event of recorded arrhythmias

  13. Occurence of acute cardiac injury [ Time Frame: Up to 15 months ]
    Event of acute cardiac injury

  14. Occurence of secondary infection [ Time Frame: Up to 15 months ]
    Event of any secondary infection

  15. Occurence of cytokine release syndrome [ Time Frame: Up to 15 months ]
    Event of cytokine release syndrome

  16. Comorbidities [ Time Frame: Prior to autologous stem cell transplantation ]
    Description of comorbidities prior to autologous stem cell transplantation

  17. Disease status [ Time Frame: Prior to autologous stem cell transplantation ]
    Description of disease status prior to autologous stem cell transplantation

  18. Previous disease modifying treatment [ Time Frame: Prior to autologous stem cell transplantation ]
    Description of previous disease modifying treatment prior to autologous stem cell transplantation

  19. Conditioning treatment [ Time Frame: At autologous stem cell transplantation ]
    Description of conditioning treatment prior to autologous stem cell transplantation

  20. Time of infection [ Time Frame: At autologous stem cell transplantation or up to 15 months ]
    Time of COVID-19 in relation to autologous stem cell transplantation

  21. Neutropenia [ Time Frame: At autologous stem cell transplantation or up to 15 months ]
    Event of neutropenia at diagnosis of COVID-19

  22. Elevated CRP [ Time Frame: At autologous stem cell transplantation or up to 15 months ]
    Event of elevated C-reactive protein (CRP) at diagnosis of COVID-19

  23. Elevated leukocyte count [ Time Frame: At autologous stem cell transplantation or up to 15 months ]
    Event of elevated leukocyte count at diagnosis of COVID-19

  24. Lymphocytopenia [ Time Frame: At autologous stem cell transplantation or up to 15 months ]
    Event of lymphocytopenia at diagnosis of COVID-19

  25. Elevated liver enzymes [ Time Frame: At autologous stem cell transplantation or up to 15 months ]
    Event of elevated liver enzymes at diagnosis of COVID-19

  26. Elevated lactate dehydrogenase [ Time Frame: At autologous stem cell transplantation or up to 15 months ]
    Event of elevated lactate dehydrogenase at diagnosis of COVID-19

  27. Elevated ferritin [ Time Frame: At autologous stem cell transplantation or up to 15 months ]
    Event of elevated ferritin at diagnosis of COVID-19

  28. Elevated d-dimer [ Time Frame: At autologous stem cell transplantation or up to 15 months ]
    Event of elevated d-dimer at diagnosis of COVID-19

  29. Prolonged aPTT [ Time Frame: At autologous stem cell transplantation or up to 15 months ]
    Event of prolonged activated partial thromboplastin time (aPTT) at diagnosis of COVID-19

  30. Elevated troponin [ Time Frame: At autologous stem cell transplantation or up to 15 months ]
    Event of elevated troponin at diagnosis of COVID-19

  31. Elevated creatinine [ Time Frame: At autologous stem cell transplantation or up to 15 months ]
    Event of elevated creatinine at diagnosis of COVID-19



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04760184


Contacts
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Contact: Thomas Silfverberg, MD +4623492000 thomas.silfverberg@regiondalarna.se

Locations
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Sweden
Uppsala Universitet Recruiting
Uppsala, Sweden
Contact: Thomas Silfverberg         
Sponsors and Collaborators
Uppsala University
Karolinska University Hospital
Sahlgrenska University Hospital, Sweden
Lund University Hospital
University Hospital, Linkoeping
University Hospital, Umeå
Region Örebro County
Uppsala University Hospital
Investigators
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Principal Investigator: Honar Cherif, MD, Ass prof Department of Medical Sciences, Uppsala University
Study Chair: 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
Publications:
Piñana JL, Martino R, García-García I, Parody R, Morales MD, Benzo G, Gómez-Catalan I, Coll R, De La Fuente I, Luna A, Merchán B, Chinea A, de Miguel D, Serrano A, Pérez C, Diaz C, Lopez JL, Saez AJ, Bailen R, Zudaire T, Martínez D, Jurado M, Calbacho M, Vázquez L, Garcia-Cadenas I, Fox L, Pimentel AI, Bautista G, Nieto A, Fernandez P, Vallejo JC, Solano C, Valero M, Espigado I, Saldaña R, Sisinni L, Ribera JM, Jimenez MJ, Trabazo M, Gonzalez-Vicent M, Fernández N, Talarn C, Montoya MC, Cedillo A, Sureda A; Infectious Complications Subcommittee of the Spanish Hematopoietic Stem Cell Transplantation and Cell Therapy Group (GETH). Risk factors and outcome of COVID-19 in patients with hematological malignancies. Exp Hematol Oncol. 2020 Aug 25;9:21. doi: 10.1186/s40164-020-00177-z. eCollection 2020.
Passamonti F, Cattaneo C, Arcaini L, Bruna R, Cavo M, Merli F, Angelucci E, Krampera M, Cairoli R, Della Porta MG, Fracchiolla N, Ladetto M, Gambacorti Passerini C, Salvini M, Marchetti M, Lemoli R, Molteni A, Busca A, Cuneo A, Romano A, Giuliani N, Galimberti S, Corso A, Morotti A, Falini B, Billio A, Gherlinzoni F, Visani G, Tisi MC, Tafuri A, Tosi P, Lanza F, Massaia M, Turrini M, Ferrara F, Gurrieri C, Vallisa D, Martelli M, Derenzini E, Guarini A, Conconi A, Cuccaro A, Cudillo L, Russo D, Ciambelli F, Scattolin AM, Luppi M, Selleri C, Ortu La Barbera E, Ferrandina C, Di Renzo N, Olivieri A, Bocchia M, Gentile M, Marchesi F, Musto P, Federici AB, Candoni A, Venditti A, Fava C, Pinto A, Galieni P, Rigacci L, Armiento D, Pane F, Oberti M, Zappasodi P, Visco C, Franchi M, Grossi PA, Bertù L, Corrao G, Pagano L, Corradini P; ITA-HEMA-COV Investigators. Clinical characteristics and risk factors associated with COVID-19 severity in patients with haematological malignancies in Italy: a retrospective, multicentre, cohort study. Lancet Haematol. 2020 Oct;7(10):e737-e745. doi: 10.1016/S2352-3026(20)30251-9. Epub 2020 Aug 13.

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Responsible Party: Uppsala University
ClinicalTrials.gov Identifier: NCT04760184    
Other Study ID Numbers: 2020-03433
First Posted: February 18, 2021    Key Record Dates
Last Update Posted: May 7, 2021
Last Verified: May 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Upon request the pseudonymized data sheet will be made available for other researchers depending on purpose of the request.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Uppsala University:
Autologous stem cell transplantation
COVID-19
Additional relevant MeSH terms:
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Hematologic Neoplasms
Lymphoma
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Site
Neoplasms
Hematologic Diseases
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hemorrhagic Disorders