Covid19AutoCOVID-19NCT04760184
Impact of COVID-19 After Autologous Hematopoietic Stem Cell Transplantation in Sweden
An observational study of Covid19 and Myeloma Multiple, run by Uppsala University at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Covid19, Myeloma Multiple, Malignant Lymphoma
- What is being tested?
- Autologous stem cell transplantation
- How many people
- 20 participants
- Where
- 1 siteSweden
- Study dates
- 1 Apr 2021to 31 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Age below 18 years and 0 months at the time of transplantation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of COVID-19 on Patients Treated With Autologous Hematopoietic Stem Cell Transplantation in Sweden - a Retrospective Cohort Study
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.
Read the 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.
- Conditions
- Covid19, Myeloma Multiple, Malignant Lymphoma, Hematologic Neoplasms, Stem Cell Transplant Complications
- Being tested
- Autologous stem cell transplantation
- Keywords
- Autologous stem cell transplantation, COVID-19
- Medical subject headings
- COVID-19, Multiple Myeloma, Lymphoma, Hematologic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autologous stem cell transplantationOther
The study will describe the implications of COVID-19 infection following autologous stem cell transplantation
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Autologous stem cell transplantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
Overall survival after infection with COVID-19
Measured: 30 days
Overall survival
Overall survival after infection with COVID-19
Measured: 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
Measured: within 6 months after infection
Secondary outcomes (31)
Time of COVID-19 infection
Time of SARS-CoV-2 infection in relation to autologous stem cell transplantation
Measured: Up to 15 months
Hospitalization
Duration of hospitalization
Measured: Up to 15 months
Oxygen treatment
Duration of oxygen treatment
Measured: Up to 15 months
High-flow oxygen therapy
Duration of high-flow oxygen therapy
Measured: Up to 15 months
Non-invasive ventilation
Duration of non-invasive ventilation (NIV)
Measured: Up to 15 months
Intensive care
Duration of care in intensive care unit
Measured: Up to 15 months
Invasive mechanical ventilation
Duration of Invasive mechanical ventilation
Measured: Up to 15 months
ECMO
Duration of extracorporeal membrane oxygenation (ECMO)
Measured: Up to 15 months
Occurence of ARDS
Diagnosis of Acute respiratory distress syndrome (ARDS)
Measured: Up to 15 months
Occurence of arterial thrombosis
Event of arterial thrombosis
Measured: Up to 15 months
Occurence of venous thrombosis
Event of venous thrombosis
Measured: Up to 15 months
Occurence of arrhythmias
Event of recorded arrhythmias
Measured: Up to 15 months
Occurence of acute cardiac injury
Event of acute cardiac injury
Measured: Up to 15 months
Occurence of secondary infection
Event of any secondary infection
Measured: Up to 15 months
Occurence of cytokine release syndrome
Event of cytokine release syndrome
Measured: Up to 15 months
Comorbidities
Description of comorbidities prior to autologous stem cell transplantation
Measured: Prior to autologous stem cell transplantation
Disease status
Description of disease status prior to autologous stem cell transplantation
Measured: Prior to autologous stem cell transplantation
Previous disease modifying treatment
Description of previous disease modifying treatment prior to autologous stem cell transplantation
Measured: Prior to autologous stem cell transplantation
Conditioning treatment
Description of conditioning treatment prior to autologous stem cell transplantation
Measured: At autologous stem cell transplantation
Time of infection
Time of COVID-19 in relation to autologous stem cell transplantation
Measured: At autologous stem cell transplantation or up to 15 months
Neutropenia
Event of neutropenia at diagnosis of COVID-19
Measured: At autologous stem cell transplantation or up to 15 months
Elevated CRP
Event of elevated C-reactive protein (CRP) at diagnosis of COVID-19
Measured: At autologous stem cell transplantation or up to 15 months
Elevated leukocyte count
Event of elevated leukocyte count at diagnosis of COVID-19
Measured: At autologous stem cell transplantation or up to 15 months
Lymphocytopenia
Event of lymphocytopenia at diagnosis of COVID-19
Measured: At autologous stem cell transplantation or up to 15 months
Elevated liver enzymes
Event of elevated liver enzymes at diagnosis of COVID-19
Measured: At autologous stem cell transplantation or up to 15 months
Elevated lactate dehydrogenase
Event of elevated lactate dehydrogenase at diagnosis of COVID-19
Measured: At autologous stem cell transplantation or up to 15 months
Elevated ferritin
Event of elevated ferritin at diagnosis of COVID-19
Measured: At autologous stem cell transplantation or up to 15 months
Elevated d-dimer
Event of elevated d-dimer at diagnosis of COVID-19
Measured: At autologous stem cell transplantation or up to 15 months
Prolonged aPTT
Event of prolonged activated partial thromboplastin time (aPTT) at diagnosis of COVID-19
Measured: At autologous stem cell transplantation or up to 15 months
Elevated troponin
Event of elevated troponin at diagnosis of COVID-19
Measured: At autologous stem cell transplantation or up to 15 months
Elevated creatinine
Event of elevated creatinine at diagnosis of COVID-19
Measured: At autologous stem cell transplantation or up to 15 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2021
- Study start1 Apr 2021
- Primary completion30 Aug 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Covid19Studies of the same condition, open and under way.
- More trials run by Uppsala UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Uppsala University
- Sponsor type
- University, hospital or other
- Collaborators
- Karolinska University Hospital, Sahlgrenska University Hospital, Lund University Hospital, University Hospital, Linkoeping, University Hospital, Umeå, Region Örebro County, Uppsala University Hospital
- Responsible party
- Sponsor
- Investigators
- Honar Cherif, MD, Ass prof, Principal investigator, Department of Medical Sciences, Uppsala UniversityThomas Silfverberg, MD, Study chair, Center for Clinical Research Dalarna and Department of Medical Sciences-Uppsala UniversityKristina Carlson, MD, Ass Prof, Study chair, Department of Medical Sciences, Uppsala University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04760184
- Sponsor's protocol ID
- 2020-03433
- Acronym
- AutoCOVID-19
- Status last verified
- Feb 2022
- First submitted
- 11 Dec 2020
- Last updated
- 8 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Upon request the pseudonymized data sheet will be made available for other researchers depending on purpose of the request.
Publications
Phelan AL, Katz R, Gostin LO. The Novel Coronavirus Originating in Wuhan, China: Challenges for Global Health Governance. JAMA. 2020 Feb 25;323(8):709-710. doi: 10.1001/jama.2020.1097. No abstract available.
PubMed 31999307Mossad SB, Longworth DL, Goormastic M, Serkey JM, Keys TF, Bolwell BJ. Early infectious complications in autologous bone marrow transplantation: a review of 219 patients. Bone Marrow Transplant. 1996 Aug;18(2):265-71.
PubMed 8864433Ljungman P, Ward KN, Crooks BN, Parker A, Martino R, Shaw PJ, Brinch L, Brune M, De La Camara R, Dekker A, Pauksen K, Russell N, Schwarer AP, Cordonnier C. Respiratory virus infections after stem cell transplantation: a prospective study from the Infectious Diseases Working Party of the European Group for Blood and Marrow Transplantation. Bone Marrow Transplant. 2001 Sep;28(5):479-84. doi: 10.1038/sj.bmt.1703139.
PubMed 11593321Hutspardol S, Essa M, Richardson S, Schechter T, Ali M, Krueger J, Fujii H, Egeler RM, Gassas A. Significant Transplantation-Related Mortality from Respiratory Virus Infections within the First One Hundred Days in Children after Hematopoietic Stem Cell Transplantation. Biol Blood Marrow Transplant. 2015 Oct;21(10):1802-7. doi: 10.1016/j.bbmt.2015.06.015. Epub 2015 Jun 25.
PubMed 26117558Huang C, Wang Y, Li X, Ren L, Zhao J, Hu Y, Zhang L, Fan G, Xu J, Gu X, Cheng Z, Yu T, Xia J, Wei Y, Wu W, Xie X, Yin W, Li H, Liu M, Xiao Y, Gao H, Guo L, Xie J, Wang G, Jiang R, Gao Z, Jin Q, Wang J, Cao B. Clinical features of patients infected with 2019 novel coronavirus in Wuhan, China. Lancet. 2020 Feb 15;395(10223):497-506. doi: 10.1016/S0140-6736(20)30183-5. Epub 2020 Jan 24.
PubMed 31986264Eichenberger EM, Soave R, Zappetti D, Small CB, Shore T, van Besien K, Douglass C, Westblade LF, Satlin MJ. Incidence, significance, and persistence of human coronavirus infection in hematopoietic stem cell transplant recipients. Bone Marrow Transplant. 2019 Jul;54(7):1058-1066. doi: 10.1038/s41409-018-0386-z. Epub 2018 Nov 1.
PubMed 30385869He W, Chen L, Chen L, Yuan G, Fang Y, Chen W, Wu D, Liang B, Lu X, Ma Y, Li L, Wang H, Chen Z, Li Q, Gale RP. COVID-19 in persons with haematological cancers. Leukemia. 2020 Jun;34(6):1637-1645. doi: 10.1038/s41375-020-0836-7. Epub 2020 Apr 24.
PubMed 32332856Ljungman P, Mikulska M, de la Camara R, Basak GW, Chabannon C, Corbacioglu S, Duarte R, Dolstra H, Lankester AC, Mohty M, Montoto S, Murray J, Peffault de Latour R, Snowden JA, Yakoub-Agha I, Verhoeven B, Kroger N, Styczynski J; European Society for Blood and Marrow Transplantation. The challenge of COVID-19 and hematopoietic cell transplantation; EBMT recommendations for management of hematopoietic cell transplant recipients, their donors, and patients undergoing CAR T-cell therapy. Bone Marrow Transplant. 2020 Nov;55(11):2071-2076. doi: 10.1038/s41409-020-0919-0. Epub 2020 May 13.
PubMed 32404975Terpos E, Engelhardt M, Cook G, Gay F, Mateos MV, Ntanasis-Stathopoulos I, van de Donk NWCJ, Avet-Loiseau H, Hajek R, Vangsted AJ, Ludwig H, Zweegman S, Moreau P, Einsele H, Boccadoro M, San Miguel J, Dimopoulos MA, Sonneveld P. Management of patients with multiple myeloma in the era of COVID-19 pandemic: a consensus paper from the European Myeloma Network (EMN). Leukemia. 2020 Aug;34(8):2000-2011. doi: 10.1038/s41375-020-0876-z. Epub 2020 May 22.
PubMed 32444866Dai M, Liu D, Liu M, Zhou F, Li G, Chen Z, Zhang Z, You H, Wu M, Zheng Q, Xiong Y, Xiong H, Wang C, Chen C, Xiong F, Zhang Y, Peng Y, Ge S, Zhen B, Yu T, Wang L, Wang H, Liu Y, Chen Y, Mei J, Gao X, Li Z, Gan L, He C, Li Z, Shi Y, Qi Y, Yang J, Tenen DG, Chai L, Mucci LA, Santillana M, Cai H. Patients with Cancer Appear More Vulnerable to SARS-CoV-2: A Multicenter Study during the COVID-19 Outbreak. Cancer Discov. 2020 Jun;10(6):783-791. doi: 10.1158/2159-8290.CD-20-0422. Epub 2020 Apr 28.
PubMed 32345594Pinana JL, Martino R, Garcia-Garcia I, Parody R, Morales MD, Benzo G, Gomez-Catalan I, Coll R, De La Fuente I, Luna A, Merchan B, Chinea A, de Miguel D, Serrano A, Perez C, Diaz C, Lopez JL, Saez AJ, Bailen R, Zudaire T, Martinez D, Jurado M, Calbacho M, Vazquez L, Garcia-Cadenas I, Fox L, Pimentel AI, Bautista G, Nieto A, Fernandez P, Vallejo JC, Solano C, Valero M, Espigado I, Saldana R, Sisinni L, Ribera JM, Jimenez MJ, Trabazo M, Gonzalez-Vicent M, Fernandez 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.
PubMed 32864192Passamonti 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, Bertu 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.
PubMed 32798473
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of COVID-19 on Patients Treated With Autologous Hematopoietic Stem Cell Transplantation in Sweden - a Retrospective Cohort Study
- ClinicalTrials.gov ID
- NCT04760184
- Acronym / sponsor ID
- AutoCOVID-19 / 2020-03433
- Conditions
- Covid19, Myeloma Multiple, Malignant Lymphoma, Hematologic Neoplasms, Stem Cell Transplant Complications
- Keywords
- Autologous stem cell transplantation, COVID-19
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Uppsala UniversityUniversity, hospital or other
- Collaborators
- Karolinska University Hospital, Sahlgrenska University Hospital, Lund University Hospital, University Hospital, Linkoeping, University Hospital, Umeå, Region Örebro County, Uppsala University Hospital
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 30 Aug 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 18 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| COVID19 positives after autologous stem cell transplantation | – | Other: Autologous stem cell transplantationAll 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- Age below 18 years and 0 months at the time of transplantation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Autologous stem cell transplantationThe study will describe the implications of COVID-19 infection following autologous stem cell transplantation | Other | COVID19 positives after autologous stem cell transplantation |
Primary outcome
Overall survival
Time frame: 30 days
Overall survival after infection with COVID-19
Overall survival
Time frame: 90 days
Overall survival after infection with COVID-19
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
31 secondary outcomes
Time of COVID-19 infection
Time frame: Up to 15 months
Hospitalization
Time frame: Up to 15 months
Oxygen treatment
Time frame: Up to 15 months
High-flow oxygen therapy
Time frame: Up to 15 months
Non-invasive ventilation
Time frame: Up to 15 months
Intensive care
Time frame: Up to 15 months
Invasive mechanical ventilation
Time frame: Up to 15 months
ECMO
Time frame: Up to 15 months
Occurence of ARDS
Time frame: Up to 15 months
Occurence of arterial thrombosis
Time frame: Up to 15 months
Occurence of venous thrombosis
Time frame: Up to 15 months
Occurence of arrhythmias
Time frame: Up to 15 months
Occurence of acute cardiac injury
Time frame: Up to 15 months
Occurence of secondary infection
Time frame: Up to 15 months
Occurence of cytokine release syndrome
Time frame: Up to 15 months
Comorbidities
Time frame: Prior to autologous stem cell transplantation
Disease status
Time frame: Prior to autologous stem cell transplantation
Previous disease modifying treatment
Time frame: Prior to autologous stem cell transplantation
Conditioning treatment
Time frame: At autologous stem cell transplantation
Time of infection
Time frame: At autologous stem cell transplantation or up to 15 months
Neutropenia
Time frame: At autologous stem cell transplantation or up to 15 months
Elevated CRP
Time frame: At autologous stem cell transplantation or up to 15 months
Elevated leukocyte count
Time frame: At autologous stem cell transplantation or up to 15 months
Lymphocytopenia
Time frame: At autologous stem cell transplantation or up to 15 months
Elevated liver enzymes
Time frame: At autologous stem cell transplantation or up to 15 months
Elevated lactate dehydrogenase
Time frame: At autologous stem cell transplantation or up to 15 months
Elevated ferritin
Time frame: At autologous stem cell transplantation or up to 15 months
Elevated d-dimer
Time frame: At autologous stem cell transplantation or up to 15 months
Prolonged aPTT
Time frame: At autologous stem cell transplantation or up to 15 months
Elevated troponin
Time frame: At autologous stem cell transplantation or up to 15 months
Elevated creatinine
Time frame: At autologous stem cell transplantation or up to 15 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2022.
- Background: PubMed 31999307Phelan AL, Katz R, Gostin LO. The Novel Coronavirus Originating in Wuhan, China: Challenges for Global Health Governance. JAMA. 2020 Feb 25;323(8):709-710. doi: 10.1001/jama.2020.1097. No abstract available.
- Background: PubMed 8864433Mossad SB, Longworth DL, Goormastic M, Serkey JM, Keys TF, Bolwell BJ. Early infectious complications in autologous bone marrow transplantation: a review of 219 patients. Bone Marrow Transplant. 1996 Aug;18(2):265-71.
- Background: PubMed 11593321Ljungman P, Ward KN, Crooks BN, Parker A, Martino R, Shaw PJ, Brinch L, Brune M, De La Camara R, Dekker A, Pauksen K, Russell N, Schwarer AP, Cordonnier C. Respiratory virus infections after stem cell transplantation: a prospective study from the Infectious Diseases Working Party of the European Group for Blood and Marrow Transplantation. Bone Marrow Transplant. 2001 Sep;28(5):479-84. doi: 10.1038/sj.bmt.1703139.
- Background: PubMed 26117558Hutspardol S, Essa M, Richardson S, Schechter T, Ali M, Krueger J, Fujii H, Egeler RM, Gassas A. Significant Transplantation-Related Mortality from Respiratory Virus Infections within the First One Hundred Days in Children after Hematopoietic Stem Cell Transplantation. Biol Blood Marrow Transplant. 2015 Oct;21(10):1802-7. doi: 10.1016/j.bbmt.2015.06.015. Epub 2015 Jun 25.
- Background: PubMed 31986264Huang C, Wang Y, Li X, Ren L, Zhao J, Hu Y, Zhang L, Fan G, Xu J, Gu X, Cheng Z, Yu T, Xia J, Wei Y, Wu W, Xie X, Yin W, Li H, Liu M, Xiao Y, Gao H, Guo L, Xie J, Wang G, Jiang R, Gao Z, Jin Q, Wang J, Cao B. Clinical features of patients infected with 2019 novel coronavirus in Wuhan, China. Lancet. 2020 Feb 15;395(10223):497-506. doi: 10.1016/S0140-6736(20)30183-5. Epub 2020 Jan 24.
- Background: PubMed 30385869Eichenberger EM, Soave R, Zappetti D, Small CB, Shore T, van Besien K, Douglass C, Westblade LF, Satlin MJ. Incidence, significance, and persistence of human coronavirus infection in hematopoietic stem cell transplant recipients. Bone Marrow Transplant. 2019 Jul;54(7):1058-1066. doi: 10.1038/s41409-018-0386-z. Epub 2018 Nov 1.
- Background: PubMed 32332856He W, Chen L, Chen L, Yuan G, Fang Y, Chen W, Wu D, Liang B, Lu X, Ma Y, Li L, Wang H, Chen Z, Li Q, Gale RP. COVID-19 in persons with haematological cancers. Leukemia. 2020 Jun;34(6):1637-1645. doi: 10.1038/s41375-020-0836-7. Epub 2020 Apr 24.
- Background: PubMed 32404975Ljungman P, Mikulska M, de la Camara R, Basak GW, Chabannon C, Corbacioglu S, Duarte R, Dolstra H, Lankester AC, Mohty M, Montoto S, Murray J, Peffault de Latour R, Snowden JA, Yakoub-Agha I, Verhoeven B, Kroger N, Styczynski J; European Society for Blood and Marrow Transplantation. The challenge of COVID-19 and hematopoietic cell transplantation; EBMT recommendations for management of hematopoietic cell transplant recipients, their donors, and patients undergoing CAR T-cell therapy. Bone Marrow Transplant. 2020 Nov;55(11):2071-2076. doi: 10.1038/s41409-020-0919-0. Epub 2020 May 13.
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- Individual participant dataSharing planned: Undecided. Upon request the pseudonymized data sheet will be made available for other researchers depending on purpose of the request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Honar Cherif, MD, Ass prof principal investigator
Department of Medical Sciences, Uppsala University
Thomas Silfverberg, MD study chair
Center for Clinical Research Dalarna and Department of Medical Sciences-Uppsala University
Kristina Carlson, MD, Ass Prof study chair
Department of Medical Sciences, Uppsala University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Covid19 and Myeloma Multiple, run by Uppsala University at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (time frame: 30 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04760184, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2022.