The University of Maryland, Baltimore created an umbrella protocol to provide a single point of storage and oversight for the dissemination of biospecimens for COVID-19 research. The protocol has two arms, the Serology Arm, for health care workers and other non-patients who underwent serologic testing and the Patient Arm for patients admitted to the hospital with a positive COVID diagnosis. The study was designed to reduce the burden on clinical personnel and promote a coordinated and efficient method for obtaining, storing, and distributing specimens. This has facilitated a broad scope of research, across disciplines, with investigators being able to access biospecimens for their IRB approved studies.

This umbrella study has the following goals:

1. Centralize, coordinate and streamline COVID-19 biospecimen collection;
2. Store biospecimens in accordance with CDC guidance regarding COVID-19 specimens;
3. Minimize blood and other biologic sampling of patients;
4. Minimize the burden on patients and families from multiple contacts for providing biospecimens for research;
5. Minimize study team contact with infected or potentially infected patients;
6. Reduce health care worker (HCW) exposure to infected or potentially infected patients by limiting biospecimen collection to times of regularly scheduled blood or specimen collection as part of usual, routine, clinical care;
7. Establish a fair process to allocate limited biospecimen availability; and
8. Allow for biospecimen collection from health care workers and other non-patients undergoing COVID-19 testing (serologic, COVID-19 diagnostic tests) for clinical indications as determined by their employer.

Over the past two years we have collected more than 14,000 samples from the more than eight thousand patients we have enrolled, in total, for both the Serology and Patient arms of the study.

The Principal Investigator of this umbrella protocol is responsible for but not limited to ensuring the integrity of the protocol, ensuring patient consent is performed consistent with the protocol, compliance with IRB regulations, maintaining an inventory (database) of samples, insuring the confidentiality of patient identifiers, and, along with an Advisory Committee, of allocating samples to IRB approved protocols.

*Please email the team at C19BBiorepository@som.umaryland.edu for sample requests and or questions