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Actively enrolling
These COVID-19 related clinical studies are actively enrolling.Ashish Khanna, Anesthesiology
- IRB Approval Number: IRB00067933
- Project Description: The BVA-100 is a software package designed to calculate human blood volume using the method of tracer dilution. It uses tagged serum albumin (a commonly used tag is 131I, resulting in “131I -HSA”). We will prospectively enroll patients with COVID19 and analyze blood samples after injection of tracer, to describe the blood volume, the volume of blood components, and the capillary leak and their trajectory during the early phase of hospitalization of patients with SARS-CoV-2 infection. We will also describe the association of these variables with the occurrence of additional organ failure, and patient-centered outcomes.
- Groups/Depts: Anesthesiology, Section on Critical Care Medicine
John Gaillard | Anesthesiology
- IRB Approval Number: IRB00067285
- Project Description: Using stem cells for COVID patients to decrease inflammation in lungs.
Doug Jaffe, Anesthesiology
- IRB Approval Number: IRB0006483
- Project Description: Registry
- Groups/Depts: Anesthesiology
John Gaillard, Anesthesiology
- IRB Approval Number: IRB00065487
- Project Description: A Phase 2b, Randomized, Blinded and Placebo Controlled Trial to Evaluate the Safety and Efficacy of Longeveron Allogeneic Human Mesenchymal Stem Cells Infusion in Patients with Aging Frailty
- Groups/Depts: WFIRM, Anesthesiology
Ashish Khanna, Anesthesiology
- IRB Approval Number: IRB00064652 / Participating site along with: Mayo Clinic, Boston Medical, Critical Care Research Network
- Project Description: To create a real time COVID-19 registry of current ICU/hospital care patterns to allow evaluations of safety and observational effectiveness of COVID-19 practices.
- Groups/Depts: Anesthesiology, Critical Care Medicine
- Support: Society of Critical Care Medicine, DISCOVERY Research Network
Boris Pasche, Co-project leaders: Metin Gurcan, Umit Topaloglu, & Jimmy Ruiz, Cancer Biology
- IRB Approval Number: IRB00064701
- Project Description: The goals of this supplement are to develop a mortality risk predictor for cancer patients undergoing treatment who are infected by the SARS-CoV-2 virus and a machine learning model to assess the effect of SARS-CoV-2 on Adverse Event prevalence. The research team will also explore potential benefits in reducing the risk of SARS-CoV-2 infection and covid-19 mortality.
- Groups/Depts: Cancer Center, Cancer Biology, Internal Medicine & Hematology and Oncology, Center for Biomedical Informatics
Umit Topaloglu | Cancer Biology
- IRB Approval Number: IRB00068799
- Project Description:
The wide adoption of electronic health records (EHRs) systems has accumulated large amounts of patients’ clinical data, which becomes an enabling resource for clinical and translational research such as evidence generation for clinical characterization and treatment outcomes. One known challenge of secondary use of EHRs for clinical research is that detailed patient information required by a study (e.g., symptoms, social determinants, mental status related to COVID-19) often resides in clinical narratives. Therefore, natural language processing (NLP) technologies have been extensively investigated in the medical domain to accelerate the use of clinical narratives for rapid clinical research.
The mission of Open Health Natural Language Processing (OHNLP) innovation award has been to build an open science infrastructure to promote efficient use of NLP through i) improving usability and portability of NLP systems through multi-site collaboration, ii) researching on the best practices for clinical NLP, iii) generating PHI-free NLP resources through the adoption of privacy-preserving techniques, and iv) promoting the use of NLP for clinical research. Despite the successes of open source NLP tools as well as their demonstrated applications across the OHNLP collaboratory sites, the adoption rate of those open source NLP tools in other major CTSA sites is still slower than expected.
In reality, delivering practical NLP solutions for clinical research requires the existence of an institutional text analytics infrastructure that can be challenging to have due to the incentive and regulatory complexity. - Groups/Depts: WFBMI
Umit Topaloglu, Cancer Biology
- IRB Approval Number: IRB00066044
- Project Description: The NIH COVID-19 Data Warehouse is an NIH data sharing resource, operated under a contract containing clinical and imaging data from individuals who have received a Coronavirus Disease 2019 (“COVID-19”) test or whose symptoms are consistent with COVID-19. Data will also be collected from individuals infected with pathogens such as SARS 1, MERS, and H1N1 to support comparative studies
- Groups/Depts: Cancer Biology
Umit Topaloglu, Cancer Biology
- IRB Approval Number: IRB00065104
- Project Description: Examines de-identified information on cancer patients diagnosed with COVID-19 from 79 institutions around the world.
- Groups/Depts: Cancer Center
Umit Topaloglu, Cancer Biology
- IRB Approval Number: IRB00069077
- Project Description: This is a project for N3C Oncology Domain Team, which aims to identify risks factors for cancer patients based on primary site and morphology on a larger scale: Death and severity of COVID-19 (e.g. ICU use, WHO Ordinal Scale) will be used for outcome analysis. It will also involve development of cancer phenotype definitions on N3C platform to be used for this study.
- Groups/Depts: Cancer Biology
Steven Feldman, Dermatology
- IRB Approval Number: IRB00064565 / Study initiated in conjunction with the SECURE-IBD registry established by the University of North Carolina at Chapel Hill
- Project Description: Proposes to create a de-identified, web-based registry of COVID-19 cases in psoriasis patients. Providers will be able to access a web page with a survey that will request information about how COVID-19 affected their psoriasis patient.
- Groups/Depts: Dermatology
Simon Mahler, Pulm/Critical Care
- IRB Approval Number: IRB00067933
- Project Description: A Multicenter, Randomized, Open-label Parallel Group Pilot Study to Evaluate Safety and Efficacy of High Dose Intravenous Immune Globulin (IVIG) plus Standard Medical Treatment (SMT) versus SMT alone in Subjects with COVID-19 Requiring Admission to the Intensive Care Unit. Protocol GC2007
- Groups/Depts: Emergency Medicine, Pulm/Critical Care
Simon Mahler, Emergency Medicine
- IRB Approval Number: IRB00065925
- Project Description: SARS-Cov-2 POC assay.
- Groups/Depts: Emergency Medicine
Chris Miles, Family Medicine
- IRB Approval Number: IRB00064816
- Project Description: Chart Review to estimate of the incidence of COVID-19 among Division 1 student athletes as well as the demographics, presenting features and the return to activity to determine best practices.
- Groups/Depts: Family Medicine
Metin Gurcan, Internal Medicine
- IRB Approval Number: IRB00067850
- Project Description: The purpose of the collaborative is to accumulate a set of row level data on patients with COVID Testing or Persons under investigation (PUI). This is a strong example of the CTSA hubs working together collaboratively toward a common goal for our communities
- Groups/Depts: CTSI, Wake Forest Center for Biomedical Informatics
Jessica Valente, Internal Medicine
- IRB Approval Number: IRB00067723
- Project Description: The purpose of this study is to assess the patient, student, and preceptor satisfaction and perceived effectiveness of telehealth at DEAC (student-run free clinic) during the COVID-19 pandemic. This will be done by reviewing patient, student, and preceptor perspectives on the use of telehealth compared to in-person clinical care.
- Groups/Depts: Internal Medicine
Caryn Morse | Internal Medicine – Infectious Disease
- IRB Approval Number: IRB00068685
- Project Description: The overall objective of the study is to evaluate the clinical efficacy and safety of different investigational therapeutic agents relative to the control arm among hospitalized adults who have COVID19
Aimee Wilkin, Infectious Diseases
- IRB Approval Number: IRB00068299
- Project Description: This is an adaptive platform trial to investigate therapies for COVID-19 among symptomatic outpatients. It is a phase II trial with the option of transitioning to phase III based on interim results of phase II evaluation.
- Groups/Depts: Infectious Diseases
John Sanders, IM-Infectious Disease
- IRB Approval Number: IRB00064912
- Project Description: A prospective, cohort study of clients/patients and health care workers from two large medical systems serving 12 million lives in Georgia, South Carolina, and North Carolina to evaluate baseline seroprevalence rates for SARS-CoV-2, track seroconversion rates over 1 year, hazard risk from close contacts, estimate efficacy of personal protective equipment, and assess sequelae of infection.
- Groups/Depts: IM-Infectious Disease, Cardiovascular Medicine, JAVARA
John Williamson | Internal Medicine - Infectious Disease
- IRB Approval Number: IRB00068709
- Project Description: This is a platform trial to conduct a series of randomized, double-blind, placebo-controlled trials using common assessments and endpoints in hospitalized adults diagnosed with COVID-19. It is a proof-of-concept study with the intent of identifying promising treatments to enter a more definitive study. Patients meeting study criteria will have COVID-19 disease of any duration who require supplemental oxygen, including non-invasive or invasive mechanical ventilation. Putative therapeutic agents vary and will change on the platform over time. Current agents on the platform involve immune modulators with potential to limit inflammation and cytokine storm associated with COVID-19. Enrolled patients will be assessed daily while hospitalized and may be asked to participate in up to four follow-up visits after discharge, which may be conducted by telephone. The total duration of participation for enrolled subjects is approximately 2 months.
John Sanders, Internal Medicine – Infectious Disease
- IRB Approval Number: IRB00064912
- Project Description:
- Population-based surveillance of the general public, healthcare workers, and other target populations provides broad socio-demographic, geographic and clinical coverage, including detection of subclinical cases of COVID-19
- Combination of syndromic- and sero-surveillance to maximize reach while achieving specificity needed for many epidemiologic and scientific questions concerning COVID-19 prevention
- Use of innovative technologies for electronic/mobile patient engagement and in-home serology testing or sample collection
- Incorporation of EHR data to maximize opportunities to explore many research questions related to risk factors and clinical consequences of COVID-19 infection
- Real-time analytics and reports for federal, state and local health officials
- Significant public and private partnerships providing additional contract value to the CDC
- Rapidly scalable design to support options to extend the surveillance to other areas of the country of strategic importance for the CDC
- Population-based surveillance of the general public, healthcare workers, and other target populations provides broad socio-demographic, geographic and clinical coverage, including detection of subclinical cases of COVID-19
- Groups/Depts: Internal Medicine – Infectious Disease
Werner Bischoff, Infectious Diseases
- IRB Approval Number: IRB00064866
- Project Description: This observational study will describe the aerosolization patterns of SARS-COV-2 in adult patients in a real-life setting by: 1. determining the particle size distribution and the quantity of airborne pathogens dispersed by symptomatic participants; 2. establishing a spatial model of airborne emission and dispersal in clinical settings (emergency department and inpatient units; 1 foot vs. 3-6 feet vs. 8-10 feet); and 3. obtaining information regarding the potential association of illness severity and risk factors to the scale of airborne dispersal. It will also assess the effect of having a patient wearing a surgical mask on the environmental burden with SARS-CoV-2.
- Groups/Depts: Infectious Disease
Caryn Morse | Internal Medicine – Infectious Disease
- IRB Approval Number: IRB00067391
- Project Description: A randomized, double-blind, placebo-controlled Phase 2/3 study to evaluate the safety and efficacy of DSTAT in patients with Acute Lung Injury (ALI) due to COVID-19. This study is designed to determine if DSTAT can accelerate recovery and prevent progression to mechanical ventilation in patients severely affected by COVID-19.
Caryn Morse | Internal Medicine – Infectious Disease
- IRB Approval Number: IRB00067943
- Project Description: Designed as a multi-center, randomized, double-blind, placebo-controlled study to assess the efficacy and safety of EIDD-2801 on SARS-CoV-2 Virus Shedding in Newly Hospitalized Adults with polymerase chain reaction (PCR)-Confirmed COVID-19.
Aimee Wilkin, Internal Medicine – Infectious Disease
- IRB Approval Number: IRB00069962
- Project Description: An international, observational study of adults with positive SARS-CoV-2 infection managed as outpatients.
- Groups/Depts: Internal Medicine – Infectious Disease
Swati Pawa, IM-Gastroenterology
- IRB Approval Number: IRB00064614
- Project Description: Registry
- Groups/Depts: IM-Gastroenterology
Stephen Peters, Internal Medicine - Pulmonary
- IRB Approval Number: IRB00048727
Subcontract (Columbia) - Project Description: (C4R is a Sub-study as part of this study)This amendment adds a new sub-study consent (C4R) which will send a C4R specific COVID questionnaire, and collection of a dried blood spot (DBS) to ascertainment of hospitalization and death records in participants who develop COVID related disease. This sub-study is available to Spiromics II subjects who have been participating in the quarterly phone calls. The NHLBI has since funded C4R - the Collaborative Cohort of Cohorts for COVID19 Research (C4R) - a consortium to collect COVID questionnaire data from existing ongoing. This amendment is to add a sub-study to administer a standardized COVID19 questionnaire during quarterly phone calls and have kits sent home to collect a DBS blood specimen.
- Groups/Depts: Internal Medicine - Pulmonary, Critical Care, Allergy and Immunologic Diseases & Dr. Bertoni, PHS
Victor Ortega | Internal Medicine - Pulmonary
- IRB Approval Number: IRB00067565
- Project Description: This is a questionnaire-based study administered at Cystic Fibrosis Center clinic visits at Wake Forest Baptist Medical Center in-person and online. Online surveys will be administered on a monthly basis and are designed to further capture COVID-19 event while capturing compliance with prescribed pulmonary therapies and recommended precautions. These questionnaires will also investigate the psychosocial implications of the COVID-19 pandemic.
- Groups/Depts: Internal Medicine - Pulmonary, Critical Care, Allergy and Immunologic Diseases
Clark Files, Internal Medicine - Pulmonary
- IRB Approval Number: IRB00067337
- Project Description: Randomized placebo controlled trial of alkaline phosphatase to mitigate sepsis induced acute kidney injury.
- Groups/Depts: Internal Medicine - Pulmonary, Critical Care, Allergy and Immunologic Diseases
Jeffery Shenberger, Neonatology
- IRB Approval Number: IRB00065058
- Project Description: Chart Review the effects on pregnant women who test positive for COVID-19 infection between 14 days before through 3 days after delivery, and any effects on their infants.
- Groups/Depts: OB-GYN, Neonatology
Anthony Bleyer, Nephrology
- IRB Approval Number: Approved IRB00064578
- Project Description: Proposes the use of an existing registry that gathers data on rare inherited kidney disease to collect de-identified on COVID-19 patients to look at the relationship between mortality outcomes associated with defined demographic, pharmaceutical, and other health data. Proposed as a prospective registry of patients from US and several European countries.
- Groups/Depts: Nephrology, Compliance, EPIC Team, Legal (for GDPR review)
Aarti Sarwal, Neurology
- IRB Approval Number: IRB00066346
- Project Description: To create a real time registry of COVID-19 patients admitted to ICUs who also demonstrate evidence of myocardial injury or dysfunction. We plan to study how outcomes vary between patients with different presentations of myocardial injury or dysfunction and develop a severity score that could be used to predict outcomes in this patient population.
- Groups/Depts: Neurology
Aarti Sarwal, Neurology
- IRB Approval Number: IRB00065677
- Project Description: Data Use Agreement De-identified data will be uploaded into a database via redcap.
- Groups/Depts: Neurology
Aarti Sarwal, Neurology
- IRB Approval Number: IRB00064796
- Project Description: Chart Review
- Groups/Depts: Neuro-ICU
Callie Brown, Pediatrics
- IRB Approval Number: IRB00065632
- Project Description: Incoming Data/Data Use Agreements from Multiple Sites (6-Atrium, Prisma Upstate, Prisma Downstate, MUSC, UNC-CH, Duke, East Carolina)
- Groups/Depts: Pediatrics
Andrew South, Pediatrics
- IRB Approval Number: IRB00067320
- Project Description: Data regarding clinical characteristics and risk factors for patients who have SARS-CoV-2 infection and COVID-19 are needed urgently. Bioinformatics allows us to obtain and analyze a large amount of electronic health record (EHR) data to define these characteristics and risk factors. The Consortium for Clinical Characterization of COVID-19 by EHR (4CE) is an international consortium investigating the COVID-19 pandemic using EHR data. Using the resources of the Wake Forest School of Medicine Center for Biomedical Informatics, the investigators propose to obtain de-identified and aggregate EHR data from Wake Forest Baptist Health using the open source tool i2b2 and contribute data to 4CE. 54 sites in the US, France, Germany, Italy, Singapore, Spain, UK, and Brazil
- Depts/Groups: Center for Biomedical Informatics
Alysha Taxter, Pediatrics - Rheumatology
- IRB Approval Number: IRB00064980
- Project Description: Registry
- Groups/Depts: Pediatrics
Clark Files, Pulmonary Critical Care
- IRB Approval Number: IRB00067555
- Project Description: A randomized, blinded, controlled platform trial to test the safety and efficacy of monoclonal antibodies against SARS-CoV2 vs. placebo plus standard care treatment of adult patients hospitalized for COVID-19.
- Groups/Depts: Internal Med – Pulmonary
Clark Files, Pulmonary Critical Care
- IRB Approval Number: IRB00066931
- Project Description: There are significant knowledge gaps regarding demographics, clinical characteristics, trajectory of disease, timing of recovery, clinical and biologic predictors of organ failure and death, resource utilization, and post-hospital outcomes. Furthermore, there exists limited understanding of biologic pathways activated by this viral syndrome and which patients are at risk for progression to more severe illness. There are reports of unusual features of COVID-19 critical illness, such as high prevalence of endothelial dysfunction, thrombosis, and cardiomyopathy as well as catastrophic arrhythmias during recovery, which need further study. In response, the purpose of the BLUE CORAL study is to inform biology, epidemiology, and resource utilization. BLUE CORAL is a multicenter prospective cohort of 1500 patients hospitalized with severe COVID-19 at participating PETAL Network hospitals. Patients will be eligible for participation both at sites which can contribute to biospecimens and those which cannot. Similarly, patients do not have to be willing or eligible for participation in biospecimens and/or genetics procedures in order to participate in BLUE CORAL.
- Groups/Depts: Emergency Med/Internal Med – Pulmonary
Clark Files, Pulmonary Critical Care
- IRB Approval Number: IRB00060512
- Project Description: Covers 3 studies: Healthcare Worker COVID-19 Surveillance; In-Hospital surveillance for COVID_19 (dashboards); Observational surveillance for COVID-19 risk factors, clinical course, and outcomes (epi Data)
- Groups/Depts: Emergency Med/Internal Med – Pulmonary
Clark Files, Pulmonary Critical Care
- IRB Approval Number: IRB00066805
- Project Description: A randomized platform trial to provide access to repurposed and investigational agents for critically ill patients infected with SARS-CoV-2 who have severe or life-threatening COVID-19.
- Groups/Depts: Internal Med – Pulmonary
Kevin Gibbs, Pulmonary Critical Care
- IRB Approval Number: IRB00067055
- Project Description: A phase 1, double-blinded, placebo controlled safety and early efficacy trial to determine whether regulatory T-cell infusions expanded from banked cord blood units can safely decrease the morbidity and mortality of intubated patients suffering from moderate to severe ARDS secondary to COVID-19 infection.
- Groups/Depts: Internal Med – Pulmonary
Wendy Moore, Pulmonary Critical Care
- IRB Approval Number: Amendment for IRB00021507
- Project Description: A telephone and email survey for SARP 3 participants to understand the impact of COVID-19 on their asthma and their concerns regarding COVID-19.
- Groups/Depts: Pulmonary
Alex George, Pediatrics – Hematology Oncology
- IRB Approval Number: IRB00068533
- Project Description: This registry is designed to capture pediatric and adult COVID-19 cases that are occurring across the world in patients living with sickle cell disease. The goal of the registry is to report on outcomes of cases of COVID-19 in this population of patients.
- Groups/Depts: Pediatrics – Hematology Oncology
Caroline Chiles, Radiology
- IRB Approval Number: IRB00066497
- Project Description: Registry of clinical data and imaging of patients who have had a COVID-19 test since 1/1/2020
- Groups/Depts: Diagnostic Radiology