Clinical Trials

The primary purpose of this study is to evaluate the ability of patients, who are not healthcare workers (HCWs) and have no prior training in swab collection, to collect, package, and ship their own self-collected MT swab specimens (both commercial and Mayo Clinic 3-D printed versions) by following written instructions.

The purpose of this study is to to evaluate the analytical performance of the Cue Health rapid (25 minute) molecular test for SARS-CoV-2 RNA using the proprietary nasal sample wand, disposable cartridge, and reader being developed by Cue Health Inc.

The purpose of this study is to collect saliva specimens from individuals who tested positive for SARS-CoV-2 RNA in respiratory tract specimens to validate this specimen type for the SARS-Co-V-2 RNA Detection and Quantification digital droplet PCR-based assay, and to evaluate the use of SARS-CoV-2 viral load measured in saliva for correlation with levels in other specimen types, disease course, and/or response to therapy.

The purpose of this study is to validate the BinaxNOW™ COVID-19 Ag Card in the asymptomatic COVID-19 screening population.

The BinaxNOW™ COVID-19 Ag Card is a useful tool for the rapid detection of SARS-CoV-2 and screening for COVID-19 in both symptomatic and asymptomatic patient populations.

The purpose of this study is to develop algorithms that will enable earlier identification and testing triggers for COVID-19 in otherwise asymptomatic patients, and to identify baseline characteristics from patients that ultimately test positive for COVID-19 that may predict clinical trajectory during the evolution of disease.

The purpose of this study is to compare the concordance of nasopharyngeal and saliva samples using molecular polymerase chain reaction (PCR) testing (copying DNA smples).

This study will evaluate the efficacy of merimepodib (MMPD) administered orally every eight hours (q8h) for 10 days in adult patients with advanced COVID-19.

Aim 1: Determine the basal profile of non-genomic factors in patients at the time of exposure to SARS-CoV-2 and correlate with the three clinical patient outcome categories (A, B, C) as observed through their clinical course. 

Hypothesis: Baseline cytokine (IL-1β, IL-6, IL-4, IL-10, IFN-g and TNF-a) and the immune cellular repertoire (helper/CD4+, cytotoxic/CD8+, T-regulatory cells, natural killer cells) constitute the inherent biologic immunity of an individual and underpins their vulnerability to SARS-CoV-2 infectivity and/or its subsequent sequalae. 

Aim 2: Investigate if mutations or polymorphisms in genes (CXCR6, ACE2 and SLC6A20) linked to SARS-CoV-2 correlates with the ...

Compare Patient-Collected Saliva and Health Care Worker Collected Nasopharyngeal and Nasal Mid-Turbinate Swabs for Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Detection by nucleic acid amplification testing (NAAT). All tests will be performed using previously-validated, EUA NAATs that are available in the Clinical Microbiology laboratory, including the Mayo Clinic laboratory developed test (LDT).

The purpose of this study is to determine the safety and feasibility of the POC AI-ECG’s ability to detect active SARS-Cov-2 infection in humans, and to determine specificity, sensitivity, and diagnostic accuracy of POC AI-ECG’s detection of human with COVID-19 when compared to a PCR test.

The purpose of this research is to evaluate a clinical assay designed to measure biomarkers that will help us understand COVID-19.

Coronavirus disease 2019 (COVID-19) is an infectious disease caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The disease was first identified in 2019 in Wuhan, China, and has since spread globally resulting in over 1 million confirmed cases in the US and 81,000 deaths to date. While the majority of cases result in mild symptoms, some progress to pneumonia and multi-organ failure, challenging our hospital capacity and available medical staff. Current estimates of confirmed COVID-19 cases miss those who have recovered from infection prior to widespread testing, those with mild or no symptoms, and those with symptoms who have ...

An important means to control the COVID-19 pandemic is the rapid identification of infected individuals to allow quarantine and therapy to be promptly delivered.  At home testing will soon be available, but requires reagents and introduces a delay.  The possibility of combining a limited number of Mid-Turbinate (MT) nasal swab tests, Dried Blood Spot (DBS) serology, and smartphone-enabled electrocardiogram (ECG) tests may permit daily rapid, under one minute tests potentially, if this method proves to be effective. We plan to enroll 900 participants to determine if we can detect conversion in all modalities.

The purpose of this study is to collect residual (waste) blood, urine, and stool specimens remaining from clinician order testing and corresponding clinical and patient provided data from COVID-19 patients with confirmed or suspected infection with the novel SARS-CoV-2 virus to enable high quality research. 

The purpose of this study is to understand when patients are shedding active COVID virus RNA as detectable by viral culture, and if there are any correlates of the cessation of active viral shedding, such as presence of certain immunoglobulins.

Additionally, this study will take a discovery approach to the immune response to better understand how the body recovers or worsens during disease, and if there are opportunities to use that knowledge to develop treatments.

The pupose of this study is to evaluate near-patient methods, including both point of care (POC) and patient-performed testing.

It is unclear if and how COVID19 can be passed from mother to child. Therefore, we aim to collect maternal and fetal samples from COVID19-infected pregnant women and compare them to pregnant women who have clinical indications for COVID 19 testing at the time of hospital admission but end up being COVID19- (control group). Pregnant women who are either COVID19+ or COVID19- with symptoms will be followed during this study. Our objective is to understand the prevalence of maternal fetal transmission, risk factors and outcomes of a COVID19+ pregnancy, and how the virus can be passed from mother to baby ...

The specific aims of the study are to:

Aim 1. To determine the feasibility of a community-engaged research partnership to support rapid SARS-CoV-2 testing for symptomatic patients of all ages in the underserved population during the COVID-19 crisis. We will pilot a rapid testing strategy at OCHC using Mayo Clinic Laboratory (MCL) diagnostic processing.

Aim 2. Compare the effectiveness of community-driven messaging in increasing uptake of rapid SARS-CoV-2 testing compared with usual sources of health information. We will draw a simple random sample of OCHC patients (N=1000, age 18+) with 1:1 randomization of communication about COVID-19 ...

The purpose of this study is to develop algorithms that will enable earlier identification and testing triggers for COVID-19 in otherwise asymptomatic patients, and to identify baseline characteristics from patients who ultimately test positive for COVID-19 that may predict clinical trajectory during the evolution of disease.

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.