Clinical trial NCT04794387: The Lymphoma and Leukemia Society Amended COVID-19 Registry
Official title: The Lymphoma and Leukemia Society Amended COVID-19 Registry
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Covid19
Keywords: COVID-19 Booster
Lead sponsor: Lymphoma and Leukemia Society
Sponsor class: OTHER
First posted: 2021-03-12
Enrollment: 1000
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: People with blood cancer who did not develop antibodies after a complete COVID-19 vaccination.

Brief summary: The LLS COVID-19 Registry is being amended to invite people who participated in the LLS COVID-19 Registry and did not develop antibodies after receiving a complete COVID-19 vaccination, as well as people with blood cancer who did not participate in the initial LLS COVID-19 Registry and also did not develop antibodies after receiving a complete COVID-19 vaccination, to participate in this amended LLS COVID-19 Registry.

Detailed description: The results of the Leukemia and Lymphoma Society (LLS) COVID-19 Registry indicate that about twenty-five percent (25%) of people with blood cancer and on immunosuppressants participating in the LLS COVID-19 Registry, who received a complete COVID-19 vaccination, did not develop antibodies.

The Food and Drug Administration has authorized third doses (boosters) of the Pfizer and Moderna Covid-19 vaccines for people with weakened immune systems, in a bid to bolster their protection against infection as the highly contagious Delta variant circulates. The agency will amend the emergency-use authorizations for the two vaccines to allow immunocompromised people to get an additional dose.

Therefore the LLS COVID-19 Registry is being amended to invite people who participated in the LLS COVID-19 Registry and did not develop antibodies as noted above, as well as people with blood cancer who did not participate in the initial LLS COVID-19 Registry and also did not develop antibodies after receiving a complete COVID-19 vaccination, to participate in this amended LLS COVID-19 Registry. Using the same design as the initial COVID-19 Registry (Protocol LLSC19-001), this amended LLS COVID-19 Registry will determine if people who have decided to receive a booster vaccination, who did not develop antibodies after receiving a complete COVID-19 vaccination will develop antibodies after a single dose booster of either the Pfizer or Moderna COVID-19 vaccination.

Eligibility criteria: Inclusion Criteria:

* People with blood cancer who did not develop antibodies after a complete COVID-19 vaccination.

Exclusion Criteria:

* People who receiived a complete COVID-19 vaccination and did develop antibodies.
* People unwilling or unable to receive COVID-19 booster.

Primary outcomes:
measure: A SARS antibody test will be paired with surveys to measure the response people with blood cancer, who did not develop antibodes after a complete COVID-19 vaccination, have to the COVID-19 booster.
timeFrame: 10 years
Secondary outcomes:
Other outcomes:
Locations:
city: Rye Brook
country: United States
facility: Lymphoma and Leukemia Society
state: New York
Study officials:
References: