COVID-19 Research Index

This is a randomized phase 2 single-blinded study of low dose oral selinexor versus placebo to evaluate the activity and safety, as well as reduction in mortality in patients with severe COVID-19.

Responding to the unprecedented challenge of fighting coronavirus disease 2019 (COVID-19), the U.S. Government is supporting a national Expanded Access Program to collect and provide convalescent plasma to patients in need across the country. Plasma from recovered COVID-19 patients contains antibodies that may help fight the disease.

Working collaboratively with industry, academic, and government partners, Mayo Clinic will serve as the lead institution for the program.

The primary objective of this study is to provide expanded access of remdesivir (RDV) for the treatment of severe acute respiratory syndrome coronavirus (SARS-CoV2) infection.

An Open label, Phase 2 Study Evaluating the Efficacy and Safety of High-Titer Anti-SARS-CoV-2 plasma in hospitalized patients with COVID-19 infection.

Investigate the health implications of personal protective equipment and the clinical environment to healthcare workers and patients in order to better inform future responses to strains on the healthcare system.

Explore how operating room (OR) resource allocation impacted healthcare institutions during the COVID-19 pandemic of 2020. In preparation for and during the COVID-19 pandemic, many hospitals and health systems cancelled elective surgeries and were not conducting those surgeries for an extended period of time. This change had significant impacts on health systems leading to reallocation of resources (e.g. space, supplies, employees), decreased revenue, employee furloughs, and a backlog of patients that need to be rescheduled once operations resume. The COVID-19 pandemic exposed vulnerabilities in health system decision-making and approaches to resource allocation. Potential Team Products: Grant, Education Materials (i.e. decision-making metric for OR resource allocation, technologies for healthcare training), Process (i.e. organizational decision-making tool).

Reduce stress on healthcare workers caused by COVID-19. Healthcare workers who worked in the high-risk hospital units during the SARS outbreak were significantly more likely to have high PTSD symptom levels than healthcare workers who were not treating infected patients or patients suspected of infection. Potential Team Products: Grant for virtual app to provide counseling.

Understand COVID-19 genetic susceptibility and increased education among Milwaukee’s most vulnerable populations. Research Project # 1: Will ACE2 assay allow us to calculate the risk of DD-polymorphism? Potential Team Products: Pilot Grant, Assay.

Investigate healthcare practices and actions toward African Americans during COVID-19 social distancing. African Americans lead the health disparities (HBP, HD, Diabetes, Obesity) and coronavirus cases (positive and death) in Wisconsin. How has healthcare providers addressed these challenges mental, physically and spiritually?

Provide support to substance users (patients) impacted by COVID-19 restrictions (i.e. safe-at-home, homeless, liquor stores are essential, etc.). Individuals may have increased access and use to alcohol, opioids or other substances that they turned to during the social distancing and seclusion of being at home/homelessness. Conduct retrospective chart review of morbidity and mortality in persons with substance use disorders (SUDs) and increases in opioid overdoses. Potential Team Products: Grant for community outreach/service.

Improve the COVID-19-related health outcomes in underrepresented minority/underserved communities via an ‘app’ for hand-held device (i.e., Health Radius smartphone app) with capabilities for symptom tracking, contact tracing, and exposure alerts. Potential Team Products: Handheld device application (app); Grant submission/acquisition; Expansion of CTSI Community Connectome membership/partnership.

Develop tools and techniques to help with battling the COVID-19 pandemic and even consider tools for future pandemics. There is a significant backlog of testing for the COVID-19 virus in the US. Even with individual labs conducting 30,000 tests a day more than 100,000 tests remain untested. Furthermore, time taken with current testing methods is several days. New devices are being built but remain to be validated. One aptamer-based device on market remains unvalidated.

This team’s purpose will improve: (1) Diagnosis and Testing; (2) Healthcare System and Operations; (3) All patients, healthcare staff, and healthcare systems will benefit from this research; (4) Service industries and the general public. There is a significant backlog of testing for the COVID-19 virus in the US. Even with individual labs conducting 30,000 tests a day more than 100,000 tests remain untested. Furthermore, time taken with current testing methods is several days. New devices are being built but remain to be validated. One aptamer-based device on market remains unvalidated. Potential Team Products: This team is interested in developing an instant, inexpensive COVID-19 diagnostic testing kit, similar to that of a pregnancy test, with the ability to do at home and with an indicator of change in color.

(1) Elucidate the impact of the COVID19 pandemic on caregiver and family well-being; (2) Determine family factors which decrease the risk of poor psychological outcomes. Investigate effects of COVID-19 and social distancing on caregivers and their families. Potential Team Products: Survey on effects of COVID-19 on family life.

Projects involve tracking COVID-19 using mobile phone location data and artificial intelligence. Reduce COVID-19 transmission through mobile phone alerts that signal movement into geographic regions where the probability of live virus on exposed surfaces is high. Potential Team Products: Mobile App.

Leverage existing biomedical data, in conjunction with biological data, to build models of disease risk that can be used to direct future protective actions and risk assessments during the progression of the current pandemic and potential future re-emergences of disease. Potential Team Products: Prospective or retrospective bio-specimen study; multi-hub collaborative project; registry/epidemiologic review of current cases in the Milwaukee area.

Investigate how the community perceives the information and response to COVID-19? Increase education to the most vulnerable populations susceptible to COVID-19. Understanding the effectiveness of the COVID-19 messages that are being distributed to the community and how they are being perceived. Potential Team Products: Surveys, content development, community education/engagement.

Research idea involves discharge follow up and the idea of using virtual visits the next day to ensure compliance with discharge instructions but also to improve patient satisfaction scores.

Develop in vitro, cell culture, or animal model that can be used by multiple investigators to better understand how the virus behaves inside the body and test potential therapies. Potential Team Products: Vaccine and/or antiviral therapy, grant submission.

Investigate the biological roles of various proteins in SARS-Cov2 and their roles in supporting treatment & vaccine development. Potential Team Products: Grant, Device (Novel device to isolate and concentrate virus from various samples).

This team has the following goals: (1) To test N- Acetylcysteine (NAC) in COVID-19 patients. NAC targets cytokine storm, which is instrumental in severe inflammation seen in COVID-19 patients. Potential Team Products: NIH grant, pilot clinical trial. (2) A Phase II/III Randomized Controlled Trial of Salmeterol vs. Placebo for Inpatients with COVID-19 (The Salmeterol Trial) A Phase II/III Randomized Controlled Trial of Salmeterol vs. Placebo for Outpatients with COVID-19 (The Salmeterol Outpatient Trial). Potential Team Products: NIH grant, multicenter clinical trial through either SIREN, MARCH or TIN. Patent application.

Explore current literature to access unmet clinical needs in areas of prevention, diagnosis and treatment of HLB (Heart, Lung & Blood) conditions affected by COVID-19. Potential Team Products: 1. Dr. Marius Schmidt is pursuing special crystallographic methods with CoV-2 enzymes using X-ray Free Electron Lasers. 2. Dr. John Imig is working on a molecule to control cytokine storm, which is undergoing a phase-2 study through his collaborator in CA. 3. Drs. Paula North, Aoy Mitchell and Michael Frank have access to some DNA detection/diagnostic technology developed in their CLIA lab that could be modified for looking at pulmonary endothelial cells for identifying prognostic markers.

Evaluate demographic and medical history of hospitalized COVID-19 positive patients, identify determinants of disease progression, characterize medication use to identify contraindicated medications, and synthesize findings with lung and bronchus biospecimens to examine potential mechanism in COVID-19 infection. Potential Team Products: Submission to NSF Rapid Funding opportunity, new guidance for clinical practices.

Develop and market a test to improve patient outcomes. Can a cfDNA test predict de-compensation in COVID patients. Most COVID-19 patients recover with either none or mild symptoms. However, about 15% of cases progress to ARDS with sequelae affecting multiple organ systems. This 15% are difficult to predict and this test will help with building predictor models in identifying possible worse progression of the disease. Potential Team Products: Lab test that predicts acute de-compensation in COVID patients.

Investigate whether the use of RVAD at intubation decreases the chance of multiple system failure for those without co-morbidities. Conventional treatment for those who are diagnosed with ARDS is mechanical ventilation. RVAD support using ProTec Duo is an alternative that allows for less damage to the lungs from mechanical ventilation.

This team’s scope has the potential to improve: (1) Diagnosis/Testing, (2) Treatment, (3) Prevention, (4) Healthcare System/Operations. Investigate the neuroinvasive potential of COV2 via pulmonary nerves and the consequences to the control of breathing. Understand the physiologic mechanism and target therapeutics that will prevent and treat the hematologic and systemic manifestations of COVID-19. Determine the contribution of platelet activating antibodies. Potential Team Products: (1) Diagnostic testing components; (2) Treatments: Currently working with plasma; (3) Clinical Trial Design; (4) Provide leadership in biological correlate group.