NCT04794387

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 9, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 12, 2021

Completed
6 months until next milestone

Study Start

First participant enrolled

August 27, 2021

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 13, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 13, 2022

Completed
Last Updated

March 2, 2023

Status Verified

August 1, 2021

Enrollment Period

1.3 years

First QC Date

March 9, 2021

Last Update Submit

March 1, 2023

Conditions

Covid19

Keywords

COVID-19 Booster

Outcome Measures

Primary Outcomes (1)

  • 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.

    Observational Study

    10 years

Interventions

Amended LLS COVID-19 RegistryBIOLOGICAL

Do people with blood cancer who did not develop antibodies after a complete COVID-19 vaccination, develop antoibodies after a COVID-19 booster?

Eligibility Criteria

Age21 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lymphoma and Leukemia Society

Rye Brook, New York, 10573, United States

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
10 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 9, 2021

First Posted

March 12, 2021

Study Start

August 27, 2021

Primary Completion

December 13, 2022

Study Completion

December 13, 2022

Last Updated

March 2, 2023

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will share

ONLY De-identified data will be made available to researchers approved by The Lymphoma and Leukemia Society.

Shared Documents
STUDY PROTOCOL
Time Frame
data will become available after it is de-identified and entered into a secure database. This data will be collected and made available over 10 years.

Locations

US(1)