1. Research Projects Underway

The following includes proposals as well as projects underway. An asterisk indicates that the project has received seed grant funding from the USF COVID-19 Rapid Response Research Grants program:

Morsani College of Medicine

ACE2 as key pathological link between respiratory virus and brain‐heart perturbations
Borlongan, Cesar

SARS‐CoV‐2 Nsp6 and Orf9c Interactions with Sigma Receptors as Potential Therapeutic Targets
Breslin, Jerome

Neurocognitive and Psychosocial Outcomes of Coronavirus Disease 2019: A Pilot Study
Hill‐Jarrett, Tanisha

Use of Hydroxychloroquine
Wilson, Jason

Therapeutic efficacy of hydroxychloroquine in hyperoxic lung injury model
Kolliputi, Narasaiah

* SARS‐COVID‐19 tissue‐specific susceptibility in different ethnic backgrounds
McDonald, Thomas

SARS‐CoV‐2 DNA Vaccine
Heller, Loree

Deciphering the Innate Immune Interferon Pathway Evasion Mechanisms of SAR‐CoV‐2
Roy, Arunava

* Serological correlates to immunity in SARS‐CoV‐2 infection
Kim, Kami

* A novel therapy for high‐risk critically ill COVID‐19 patients
Mohapatra, Subhra

Inhibitor discovery targeting SARS‐COV‐2 cell entry
Chen, Yu

Characterization of SARS‐CoV‐2 Antibody Responses in a Pediatric Population and Quantification of Attack Rates in their Households
Randis, Tara

Implementation of Virtual Prenatal Care in the Era of COVID‐19
Fryer, Kimberly

Renin Angiotensin (RAS) and Bradykinin (BK) Microenvironments on SARS‐CoV19 ACE2 Receptor Sensitivity: Effect of ACE inhibitors and ARBs
Magness, Ronald

Cell Type Specific Characterization of SARS‐CoV‐2 Spike Glycoprotein‐Mediated Common and Differentially Regulated Cytokine and Innate Immune Response Genes.
Guzeloglu-Kayisli, Ozlem

Experience and Perception of Oncology Care by Patients and Oncologists at the Moffitt
Pinilla, Javier

Effects of Limited Rehabilitation and Best Practices for Home‐Based Rehabilitation
Kim, Seok Hun

Hydroxychloroquine and vaping as modifiers of cardiac outcomes in COVID-19
Noujaim, Sami

Design of viral replicating interferon mRNA and selective delivery to tissues affected by SARS-CoV-2
Totary-Jain, Hana

Coronavirus interaction with host cells via spike protein attachment to cell surface heparan sulfate
Wang, Lianchun

Capturing and decoding human airway microbiomes
Ferreira, Gloria

Development of a Novel Dendritic Cell Based Vaccine Against COVID-19
Ugen, Ken

Effects of CoV-2 Infection on colorectal cancer Since CoV-2 alters gut microbiota
Mohapatra, Subhra

Mapping epitopes of SARS-CoV-2 proteins using binding inhibitory monoclonal antibodies Adams, John; Kim, Kami; Teng, Michael; Unnasch, Tom

Modeling SARS-CoV2-cell-type specific susceptibility in different ethnic backgrounds
Teng, Michael; Kim, Kami; McDonald, Tom

Novel SARS-CoV-2 neutralizing agents
Mohapatra, Subhra

Protease site linkages to HLA binders, to aid development of lung cancer patient specific, COVID-19 vaccine.
Blanck, George

Structural characterization of SARS-CoV-2 Mpro inhibitors
Chen, Yu; Teng, Michael

Uncovering global epidemics from the first quarantine
Ferreira, Gloria

Validation of DHHC palmitoyl transferases as coronavirus drug targets
Deschenes, Bob

Taneja College of Pharmacy

Remdesivir Ophthalmic Drops for Prevention of Covid‐19 Transmission via eye
Sutariya, Vijaykumar

* A 2‐in‐1 Nanoaerosols Development to Mitigate COVID‐19 Spread in Both Humans and PPE Manufacturing
Limayem, Alya

A blood-based at-home detection of SARS-CoV-2
Mohapatra, Shyam

AI-Enhanced chest CT as a screening diagnostic for hospitalized patients.
Mohapatra, Shyam

Cardiotoxicity of Covid-19 infection, using mouse model.
Panguluri, Siva

Covid-19 Detection subsystems: (a) a bio-sensor frontend to immobilize the virus, and (b)
an electronics backend to reliably measure minute changes in properties of interest.
Pathak, Yashwant

Identify effects of Covid-19 components in diabetes and aging using in vitro models
Tipparaju, Srinivas

Pre- and post-exposure prophylaxis/treatment for COVID-19: Microbiome-inspired metabolomes (MiMs) as anti-virals for COVID-19 prophylaxis/treatment
Mohapatra, Shyam

Repositioning use of FDA approved drugs for Covid-19 related illness
Sneed, Kevin

Rspike project
Allen-Gipson, Diane

Using peptides from spike protein of COVID-19 and test them as vaccine on mice for screening purposes, identified two epitopes as good antigen for vaccine development.
Cao, Chuanhai

College of Public Health

Impact of COVID‐19 on Food Insecurity and Health Among Older Adults in Tampa Bay
Himmelgreen, David

Evaluating the impact of COVID‐19 on Persons with Opioid Use Disorders
Hills, Holly

Association between long‐term exposure to air pollutants and severity of COVID‐19 illness
Mbah, Alfred

How Many Deaths in Florida are Attributable to COVID‐19? An Analysis of Excess All‐Cause Mortality and by Demographic Group and Specific Cause of Death
Quast, Troy

Customizing communication in a pandemic emergency: Prototype of a web‐based risk‐assessment tool
Pasha, Mahmooda

Building a Pre‐COVID‐19 Longitudinal Analysis of Firearms, Intimate Partner Violence, and Associated Risks and Costs Among Women in Healthcare Settings in Florida
Liller, Karen

Remote Delivery of Accelerated Resolution Therapy (ART) for Acute Stress Disorder (ASD) Among Healthcare Workers Caring for and/or Following Precautions for COVID‐19 Patients
Kip, Kevin

Psychological impact of social isolation on family stress and resiliency among survivors of family violence during the COVID‐19 pandemic.
Salinas, Abraham

Assessing Impacts of COVID‐19 on Student Physical, Psychosocial and Academic Well‐being
DeBate, Rita

Testing an e‐surveillance system to improve clinical and behavioral care among patients self‐isolating from COVID‐19
Vamos, Cheryl

*Planning for Hurricane Shelter Operations during a Pandemic
Marshall, Jennifer

Understanding Impact of Policies to Mitigate COVID‐19 Pandemic on Pregnant Women
Martinez Tyson, Dinorah

College of Nursing

* The USF Rapid‐Risk Assessment and Intervention for COVID‐19
Menon, Usha

Communication Technology for COVID ICU Patients Behavioral, Information
Rodriguez, Carmen

Feasibility of a Virtual Mindfulness Based Stress Reduction Program for Cancer Caregivers during COVID‐19
Lengacher, Cecile

USF Health Office of Research

Evidence‐based driven dashboard for COVID‐19 clinical trials
Tsalatsanis, Athanasios

Department of Medical Engineering (College of Engineering & Morsani College of Medicine)

Portable biomedical testing system based on Mobile ELISA
Pyayt, Anna

* Rapid Development of COVID‐19 Therapies and Evaluation of Side Effects
Frisina, Robert

2. USF Funded COVID-19 related Clinical Studies

• 3D Printed Nasal Swabs: At the request of USF Health Senior Vice President (SVP), Dr. Charles J. Lockwood, USF Health Morsani College of Medicine faculty, in partnership with faculty at Northwell Health (New York, NY), developed, bench lab-tested, and clinically validated 3D printable flocked nasopharyngeal (NP) swabs that can be used to obtain viral RNA samples for COVID-19 testing. The NP swabs were designed using FDA-cleared software and printed on FDA-cleared 3D printers using FDA-cleared surgical grade material that can withstand the high temperature of the sterilization process. The swabs are comparable to commercially available, conventional NP swabs composed of nylon or polyester to obtain enough viral particles to make a reliable diagnosis of COVID-19. The FDA has given clearance for the use of 3D printed swabs that use medical/dental grade materials. Institutions with access to approved printers and material can produce and use these swabs for testing. Only institutions or companies holding a medical device license can legally manufacture and sell 3D printed swabs to others. USF Health and Northwell Health hold the provisional patent for this technology but will share the print file with institutions around the country who have the FDA-cleared technology and materials to print their own swabs. USF Health has disseminated the 3D formula to medical centers throughout the U.S. with the States of Ohio and Virginia using it to relieve their testing bottlenecks. The formula has also been provided to other countries (https://www.nature.com/articles/d41586-020-01246-3).
• Viral Transport Media: To address the national shortage of COVID-19 collection kits, USF Health SVP, Dr. Charles J. Lockwood charged a task force to develop do-it-yourself (DIY) homemade specimen collection kits, in early March. In addition to the 3D printed flocked NP swabs described above, a team led by Morsani College of Medicine faculty, Drs. Sarah Yuan, Bob Deschenes, Tom Taylor-Clark, Umit Kayisli, and Michael Teng designed viral transport media (VTM) based on the World Health Organization recipe. This was validated compared to the gold standard commercially available VTM in vitro. Subsequent tests have shown efficacy in transporting clinical samples from COVID-19 patients. Multiple commercial/hospital testing labs have accepted the homemade kits. To date, USF Health has delivered about 3,000 VTM kits (with 3D printed NP swabs) to the USF Health faculty practice and its affiliated hospitals including Tampa General Hospital, Moffitt Cancer Center, and the James A. Haley VA as well as Hillsborough County. Dr. Taylor-Clark organized the procurement of raw materials, product packaging, and distribution of finalized kits to various health agencies. Dr. Teng conducted comparative analysis of homemade and standard VTM using another respiratory virus. Dr. Umit Kayisli and team have led the production line, currently producing more than 1,000 kits per week.
• Antibodies and immunity: This project explores the presence of antibodies to the COVID-19 virus, SARS-CoV-2, and ensuing immunity using a combination of commercially available, FDA (EUA) approved tests to determine which will best detect whether a person is immune to the virus or not. The research is important to determine whom among the medical staff are potentially immune to SARS-CoV-2, who can return to work safely because they have developed an immunity to the virus. Such a validated test will also allow researchers to more accurately calculate case fatality rates among the general population. The PI of these serological validation studies is Dr. Kami Kim, director of the Division of Infectious Disease & International Medicine, Department of Internal Medicine, Morsani College of Medicine.
• Susceptibility in different ethnic backgrounds: This project attempts to understand the infection rate and outcome disparities among ethnic groups infected with SARS-CoV-2. COVID-19 victims are disproportionately represented by those with pre-existing cardiovascular conditions (e.g., hypertension and heart failure) and by specific ethnic groups (i.e., African-Americans and Hispanics) who have double the infection rates and mortality in some of disease hotspots. This project explores important unanswered questions on racial disparities and COVID-19, including whether ethnic differences in infection rates and cardiovascular complications are solely due to socioeconomic disparities, or if there are cellular-level or other medical explanations.  PI: Thomas McDonald, PhD, Division of Cardiovascular Sciences, Department of Internal Medicine, Morsani College of Medicine, and a member of the USF Health Heart Institute.
• Contact tracing app: Researchers are developing a new approach to advance contact-tracing for communicable diseases through the Bluetooth-LE signal of smartphones. The first phase of research seeks to develop a secure system for critical organizations allowing their members to report their condition and to isolate/test members who have been in contact with confirmed cases. A second phase of the project would allow volunteer participants to report their condition and learn if they have been in close contact with confirmed cases without revealing their identity. PI: Jean-Francois Biasse, PhD, USF College of Arts & Sciences and director of the Center for Cryptographic Research.
• Sterilizing masks to prevent shortages: This team project addresses the shortage of N95 masks using a newly created technology to rapidly sterilize and restore the masks’ filtration effectiveness. Using the mechanism of corona discharge to destroy viruses and bacteria, this technology is under development to rapidly sterilize personal protective equipment (PPE) such as single-use N95 masks for health care workers and make them reusable. The aim of the technology is to further reduce PPE shortage issues while protecting the safety of medical personnel. The researchers also also working to develop the technology to offer an efficient sterilization solution for commonly shared surfaces to prevent COVID-19 spread. The USF inventors filed a new patent application on the technology and are working to establish an industry partnership to rapidly advance the research and development of these new devices. PI: Ying Zhong, PhD, USF College of Engineering.
• Loneliness during social distancing: The COVID-19 pandemic has fractured social support systems and the effects of loneliness are likely magnified during social distancing, especially among those with pre-existing psychological vulnerabilities, such as depression and anxiety. This project will document and analyze the impact of COVID-19 on psychosocial and physical well-being and work to create new tools and solutions to help vulnerable people maintain social connections while adhering to social distancing guidelines. PI:  Fallon R. Goodman, PhD, USF College of Arts & Sciences and director of the Emotion and Resilience Laboratory.
• Hurricane shelter operations during a pandemic: This research will outline key considerations for sheltering and evacuation in the era of COVID-19. The potential risk of COVID-19 infections spreading among shelter residents and between shelter residents and staff increases with proximity. The researchers plan to address these complex concerns by conducting a gap analysis of current shelter plans and available resources that meet national guidelines and best practices. PI: Jennifer Marshall, PhD, USF Health College of Public Health. 

• Construction of face shields: To address the potential shortage of PPE at both USF Health and Tampa General Hospital, USF College of Engineering Mini-Circuits Design for X Laboratory’s senior research engineer Michael Celestin, PhD, designed, prototyped, and developed an assembly line to produce face shields. Dr. Celestin’s team uses materials such as mylar, elastic and foam to produce one face shield per minute. The team is on track to manufacture 10,000 face shields over the next month.

3. Clinical Trials Underway or Under Consideration

• An Adaptive Phase 2/3, Randomized, Double-Blind, Placebo-Controlled Study Assessing Efficacy and Safety of Anti-IL-6 Sarilumab for Hospitalized Patients with Severe to Critical COVID-19 disease. PI: Kami Kim, MD, director of the Division of Infectious Disease & International Medicine, USF Health Morsani College of Medicine.
• Emergency Use Remdesivir (antiviral drug in the class of nucleotide analogs) for COVID-19 infections.  Seetha Lakshmi, MD, Division of Infectious Disease & International Medicine, USF Health Morsani College of Medicine.
• Healthcare Worker Exposure Response and Outcomes of Hydroxychloroquine Trial (HERO-HCQ Trial).  As a vanguard site, USF Health/TGH will be among the first wave of 16 sites to begin the registry and trial. About 50 more sites are planned. PI: Seetha Lakshmi, MD
• A randomized open-label study assessing the safety and anti-coronavirus response of combined suppression of host nucleotide synthesis in hospitalized adults with COVID-19 using Brequinar (Dihydroorotate dehydrogenase inhibitor of host pyrimidine synthesis) and Ribavirin (an FDA-approved antiviral agent) in hospitalized but not critical patients. PI: Karel Calero, MD, Division of Pulmonary, Critical Care and Sleep Medicine, USF Health Morsani College of Medicine.
• Study of Ruxolitinib in patients with COVID-19 associated cytokine storm (Jak-1 inhibitor). PI: Karel Calero, MD.
• Phase 1b, randomized, double-blinded, placebo-controlled study of hydroxychloroquine in newly diagnosed outpatient adults with COVID-19. PI: Asa Oxner, MD, Department of Internal Medicine, Morsani USF Health Morsani College of Medicine.
• A Multicenter, Prospective, Randomized, Open-Label Phase 2 Study to Assess Safety and Efficacy of ANG-3777 in Patients Hospitalized with Confirmed COVID-19 Pneumonia. CDA executed 4/3/20. PI: Karel Calero, MD
• Antiviral remdesivir in COVID-19 positive pediatric patients. PI: Carina Rodriguez,  MD, chief of Division of Pediatric Infectious Diseases, Department of Pediatrics, USF Health Morsani College of Medicine.