Oklahoma COVID19 Registry and Repository
This information was kindly provided by Dr. Van Wagoner of the COVID-19 Therapeutic Task Force and will be updated as new information becomes available. Contact for Research questions: Katlyn-Beecken@ouhsc.edu
RESEARCH PROTOCOL
Title of Project: Oklahoma COVID19 Registry and Repository
COVID-19 Therapeutic Task Force
Principal Investigator: Nelson Agudelo Higuita, MD
Co-Principal Investigator: Jennifer L. Holter Chakrabarty, MD
Investigators: Douglas A. Drevets, MD; Brent R. Brown, MD; Sara K. Vesely, PhD; Judith A. James, MD, PhD; Houssein Youness, MD; Jordan P. Metcalf, MD; Michael S. Bronze, MD; Samid M. Farooqui, MD; Carrie Yuen, MD; Timothy VanWagoner, PhD; Leslie M. Driskill, MS
Abstract
There are no FDA-approved or clinically proven therapies for SARS-CoV-2 (the novel agent of coronavirus disease - COVID-19), nor are there any published data or case studies available from the Midwest/Southern region. Therapies known to have in vitro activity against coronaviruses or previously used to treat similar coronaviruses, such as SARS and MERS, are being explored as treatments for severe acute respiratory syndrome caused by COVID-19. Some emerging trends have been shared through media outlets, but very few published, methodical analyses of data from actual patient records or samples are available.
This investigation was designed and will be executed by the COVID-19 Therapeutics Treatment Task Force, which is responsible for developing COVID-19 treatment algorithms to be implemented by clinicians treating hospitalized COVID-19 positive patients at OU Medical Center. The study will collect observational data from existing medical records and during routine standard of care treatment, thus maximizing the collection of information while minimizing strain on supplies and personnel. Operational aspects of the study were designed so that study activities will pose no additional risk of exposure for personnel or patients. This exploratory study will compare outcomes between different treatments, demographics, pre-existing conditions, and other available data to help guide best practices, future studies, and to meet the critically urgent need for information about treatment outcomes. Samples will be collected and tested to provide molecular data to parallel clinical information and outcomes, as well as to help identify biomarkers which may help identify patients at higher risk for severe disease. These combined data may also help inform which patients might maximally benefit from expensive, scarce, immune-directed therapies. These data will be especially useful for healthcare providers in the Midwest/Southern region and rural areas, as all published studies to date have been disseminated from highly populated urban areas or coastal regions within the US. These studies do not address some of the challenges or advantages patients and their families in rural settings may face.
To ensure sure that the specimens are used in a scientific and efficient manner, the PI of this study will review any proposed research to use specimens or clinical information collected in the repository. All identifiers will be removed from patient data (clinical data and specimens) to protect privacy. If study participant gives consent, stored samples may be used in the future for tests not yet planned
Specific Aims
Aim 1: To prospectively collect outcomes in patients diagnosed with COVID-19 in both inpatient settings
Aim 2: To determine factors that correlate with severity, mortality, duration of hospitalization, and other outcomes among COVID-19 positive patients
Aim 3: To assess the challenges, beliefs, and barriers patients may face during and after a positive COVID-19 diagnosis
Aim 4: To collect and store biospecimens from COVID-19 positive patients for future investigations of COVID-19 and other diseases
Aim 5: To establish if collection of oral swish/gargle sample is adequate for diagnosis of COVID, decreasing risk of collection of sample/swab requirements.
Aim 6: To establish if current therapy strategies are more effective in individuals with cytokine/inflammatory upregulation (ie elevated IL-6, interferon, macrophage activation)
Aim 7: To identify if current treatment therapies change microbiome and augment treatment outcomes
Aim 8: To identify the course of conversion to immunity through IgM and IgG serology, and identify clearance of virus.
The proposed research will provide a better understanding of risk factors for COVID-19 infection, factors associated with improved outcomes, and insight to potential best practices for COVID-19 treatment.