Q50 – 56: Infection

*Diagnosis of COVID-19 after the start of the preparative regimen: Any COVID-19 infections diagnosed after the start of the preparative regimen should be reported in questions 50 – 51 on the Post-TED (2450) form. An associated Respiratory Virus Post-Infusion Data (2149) form will be generated.

Questions 50 – 51: Did the recipient develop COVID-19 (SARS-CoV-2) since the date of last report?

SARS-CoV-2 is a novel virus belonging to the coronavirus (CoV) family that emerged in December 2019. The disease caused by this new CoV is known as COVID-19 (coronavirus disease 2019). The new virus is highly contagious and was officially declared a pandemic in March 2020. Transmission is believed to be from person to person through respiratory droplets from coughing and sneezing . Testing for COVID-19 is generally performed on specimens collected from a nasal swab or sputum sample .

As a result of the global COVID-19 pandemic, the U.S. Food and Drug Administration granted Sherlock Biosciences an emergency use of authorization (EUA) for its COVID-19 diagnostic assay, CRISPR. Although still in its infancy in real-life application, positive results by this method should be reported, even if tandem testing by other method(s) (i.e., PCR) indicate a negative result. If the CRISPR results are unclear, seek physician clarification.

Indicate whether or not the recipient has ever had a known COVID-19 (SARS-CoV-2) infection, based on a positive test result, at any during the current reporting period.

If the recipient has had a documented COVID-19 (SARS-CoV-2) infection, report Yes and then specify the first date of the pathological diagnosis.

If the recipient has not had a documented COVID-19 (SARS-CoV-2) infection, report No and continue with question 52.

Question 52: Was a vaccine for COVID-19 (SARS-CoV-2) received?

Indicate if the recipient received a vaccine for COVID-19 (one dose without a planned second dose, first dose with planned second dose, second dose, third dose, and / or booster dose) within the current reporting period.

If the recipient did not receive a vaccine for COVID-19 or it is not known if the recipient received a vaccine, select No or Unknown, respectively, and continue with question 57.

*COVID-19 Vaccine Doses
FormsNet3^SM application: Complete questions 53 – 56 to report all COVID-19 vaccine doses received in the current reporting period by adding an additional instance in the FormsNet3SM application. A separate instance should be added for each dose.
Paper form submission: Copy questions 53 – 56 and complete report all COVID-19 vaccine doses received in the current reporting period. A separate instance should be completed for each dose

Questions 53 – 54: Specify vaccine brand

For the reported dose, specify the vaccine brand the recipient received. If the vaccine brand is not listed, select Other type and specify.

Questions 55 – 56: Select dose(s) received

For the reported dose, specify the vaccine dose the recipient in the current reporting period and specify the date when the dose was received. If the exact date is not known, use the process described in the General Instructions, Guidelines for Completing Forms and select Date estimated.

Section Updates:

Question Number	Date of Change	Add/Remove/Modify	Description	Reasoning (If applicable)
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CIBMTR®(Center for International Blood and Marrow Transplant Research®) is a research collaboration between the National Marrow Donor Program®/Be The Match® and the Medical College of Wisconsin