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COVID-19 Updates

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 COVID-19 Updates

Reported Data
Data Collection
Published Study Results
Ongoing Studies
Communications
Additional Resources


COVID-19 Reported Data

As of 10/30/20

Number of COVID-19 Infections: 665

Number of Centers Reporting: 146 (119 US, 27 non-US)

 


SEE DATA BREAKDOWNS BY:

  • Patient sex
  • Type of cellular therapy
  • Age at infection
  • US region
  • Time from infusion

Data Collection

Quick Links:

The CIBMTR continues to collect data and reimburse centers. FormsNet3 and CIBMTR Center Support are fully operational.

COVID-19 (SARS-CoV-2) Pandemic Impact on Hematopoietic Cell Transplantation (HCT)

  • In an effort to determine the impact of the COVID-19 pandemic on autologous and allogeneic HCT practice, including outcomes, the CIBMTR is requesting supplemental data for each qualifying transplant registered.
  • These data are essential to understanding how changes to the original transplant plan affect recipient outcomes. Impacts include changes to the original HCT date, donor, product type, preparative regimen, GVHD prophylaxis, and the need to cryopreserve the product. 
  • These data are expected to be used in future studies and reports, including the annual Center-Specific Survival Analysis (CSA) for HCT. The supplemental data will be collected prospectively, as long as the pandemic impacts how HCTs are performed. We are committed to ending the supplemental data collection at that time. 
  • Accessing and Downloading COVID Impact HCT File, Providing Supplemental Data, & Uploading to CIBMTR Center Support
  • COVID Data Collection FAQ
  • More information: 8/18/20

New Form: Respiratory Virus Post-Infusion Data Form (2149)

  • Now available in FormsNet3.
  • Collects detailed data regarding the diagnosis, treatment, and outcomes of COVID-19 infections.
  • Centers will be reimbursed for completing this form.
  • Reinfection: If a patient tests positive again >21 days after resolution, please report a new COVID-19 infection.
  • More information: 4/1/204/10/204/21/20, 5/11/20, 7/14/20

New COVID-19 Diagnosis on Data Collection Forms

  • COVID-19 diagnosis can now be reported on the F2100 and F4100. More information: 3/26/20
  • F2400, F4000, F2450, and F2900 now include questions related to COVID-19 infections. More information: 4/10/20, 5/11/20

Continue to Consent Patients to the Research Database

  • Consent can be obtained by the clinician consenting the patient to HCT or other cellular therapy.
  • No evaluations or appointments are required that are not standard of care.
  • There is no additional risk to patients, clinicians, or study staff.
  • Position statement from the CIBMTR and ASTCT, urging continued consent and enrollment of patients in the CIBMTR's Database Protocol.

Prioritize Data Collection for:

  • Respiratory Virus Post-Infusion Data Form (2149)
  • Consecutive Transplant Audit
  • Recipients on studies, especially BMT CTN
  • More information: 3/20/20, 4/10/20, 5/1/20

CPI, Data Audits, and One Year Forms Due Requirement for Reimbursement

  • Continuous process improvement (CPI) requirements are reinstated for the trimester ending 12/31/20 for all product types via a "ramp up" plan. More information: 3/16/20, 5/1/20, 8/11/20
  • On-site CIBMTR data audits are evaluated 8 weeks prior to the scheduled date. If the on-site audit cannot be conducted, audits may be conducted remotely or rescheduled for a later date. More information: 3/20/20, 5/1/20
  • Requirement that forms be submitted within one year of their due date in order to be reimbursed is suspended for forms due 3/1/20 or later. More information: 4/1/20

COVID-19 Published Study Results

Frigault MJ, Nikiforow S, Mansour M, et al. Tocilizumab not associated with increased infection risk after CAR T - Implications for COVID-19? Blood. 2020 May 26. doi.org/10.1182/blood.20200062. [Epub ahead of print]

Eapen M, Zhang MJ, Tang XY, et al. Hematopoietic cell transplantation with cryopreserved grafts for severe aplastic anemia. Biology of Blood and Marrow Transplantation. 2020 May 8. doi:10.1016/j.bbmt.2020.04.027. [Epub ahead of print]

Hamadani M, Zhang M-J, Tang X-Y, et al. Graft cryopreservation does not impact overall survival after allogeneic HCT using post-transplant cyclophosphamide for GVHD prophylaxis. Biology of Blood and Marrow Transplantation. 2020 Apr 10.
doi:10.1016/j.bbmt.2020.04.001. [Epub ahead of print]

  • Conclusion: Graft cryopreservation does not significantly delay hematopoietic recovery, increase acute GVHD risk or non-relapse mortality, or decrease overall survival after allogeneic HCT using posttransplant cyclophosphamide.
  • Plain language summary: Freezing cells for blood and marrow transplant saves lives


Ongoing Studies

Working Committee Studies Continue

  • If you are a study PI, let your statistician know if you are unable to maintain your previous study timeline.
  • Studies requiring supplemental data collection will likely be delayed.
  • More information: 3/27/20

RCI BMT and BMT CTN Trials Affected

  • Accrual is temporarily suspended for some trials, and accrual is restricted for others.
  • On-site monitoring is suspended.
  • More information: BMT CTN SharePoint website (password required)

Communications

COVID-19
​August 18, 2020

​COVID-19 (SARS-CoV-2) Pandemic Impact on Hematopoietic Cell Transplantation (HCT) (PDF)

​August 11, 2020
​Reinstating CPI (PDF)
​July 14, 2020
Reporting COVID-19 Reinfection (PDF)
​June 23, 2020
​Reporting Cause of Death for Recipients with COVID-19 (PDF)
​May 11, 2020Respiratory Virus Post-Infusion Form (2149) Released in FormsNet3; Additional Form Modifications (PDF)
​May 1, 2020

​Continuous Process Improvement (CPI), Consecutive Transplant Audit (CTA), and Clinical Data Validation (Audit) (PDF)

​April 21, 2020

​Updates to the Fillable PDF Respiratory Virus Post-Infusion Form (2149) (PDF)

​April 15, 2020

Email to Medical Directors: 
Continuing to Register Patients with CIBMTR (PDF)

Position Statement: Reporting to the CIBMTR during the COVID-19 Pandemic (PDF)

​April 10, 2020

​Form 2149 FAQ, FormsNet Spring Released Delayed & Reporting Priorities (PDF)

​April 1, 2020

Reimbursement for Forms Submitted One Year After Due Date & Respiratory Virus Post-Infusion Form (2149) (PDF)

​March 27, 2020

Working Committees and the CIBMTR

March 26, 2020

​Collecting Data on the Impact of the COVID-19 Pandemic on our Transplant and Cell Therapy Recipients (PDF)

​March 24, 2020

​COVID-19 Impact to CIBMTR International Centers (PDF) 

​March 20, 2020

​COVID-19 Impact to CIBMTR Network Centers in the US (PDF)

​March 16, 2020

COVID-19 and CPI Standards (PDF)


Additional Resources

ASTCT's COVID-19 Resource Community

Be The Match's COVID-19 FAQs




Last Updated: 10/30/2020 8:26 AM
CIBMTR