A Study to Compare COVID-19 Nasal Testing to Gastric, Bile, or Intestinal Testing

Overview

About this study

The primary aim of this study is to determine if there is any evidence of viral shedding within the gastrointestinal or pulmonary system in patients with a prior recent negative nasopharyngeal PCR test. This will be of critical importance to the practice of endoscopy during this pandemic as it will help:  1) determine if a pre-endoscopy testing strategy is adequate to ramp-up access to semi-urgent and eventually elective procedures, while allowing the decreased utilization of limited or costly personal protective equipment (e.g., N95 respirators) while still keeping the GI endoscopy staff safe; and 2) realize the false negative rate of pre-procedural testing, which is vital to inform procedural practice policy and operations.  

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • Adults > 18 years of age regardless of medical condition.
  • SARS-CoV-2 nasopharyngeal PCR testing prior to gastrointestinal endoscopy as part of routine clinical care. 
  • Undergoing an upper gastrointestinal endoscopic procedure (e.g, EGD, EUS, ERCP, upper enteroscopy), lower endoscopy (colonoscopy, flexible sigmoidoscopy, lower EUS), or ERCP.
  • Ability to understand study procedures and to comply with them for the entire length of the study.

Exclusion Criteria:

  • Inability or unwillingness of individual or legal guardian/representative to give written informed consent.  

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Vinay Chandrasekhara, M.D.

Closed for enrollment

Contact information:

William Winter

(507) 422-5673

Winter.William@mayo.edu

More information

Publications

Publications are currently not available
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CLS-20509073

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