Observational and Outcomes

 

Study & PI
Summary
A Multi-center Study to Describe the Epidemiology, Clinical Presentation, and Outcomes of Pediatric Patients with COVID-19 across the United States

PI: Allison Agwu
Clinical information and outcome data from pediatric patients (<21 years old) with a diagnosis of COVID-19 will be extracted from EPIC. Eligible subjects will be identified by current Johns Hopkins Pediatric Infectious Disease attending providers.
Clinical Presentations and Outcomes of COVID-19 Infection in Solid Organ Transplant (SOT) Recipients and Non-SOT Patients: A Retrospective Observational Cohort Study of the JH-CROWN Registry

PI: Robin Avery
This protocol proposes to: a) understand comparative outcomes and risks for death in solid organ transplant (SOT) patients as compared to the general population (non-SOT) hospitalized with COVID, and b) compare inflammatory markers and other laboratory parameters in SOT recipients and non-SOT patients to explore whether inflammatory responses are blunted in SOT recipients, and whether acute kidney injury and transaminitis are more frequent in SOT recipients
Arrhythmia Burden after Recovery from COVID-19 (The ABC Study)

PI: Andreas Barth
This study explores the hypothesis that a substantial subgroup of COVID-19 patients have ventricular arrhythmias that persist in the early recovery period, and may contribute to poorer clinical outcomes, including a higher risk for sudden cardiac death. Eligible subjects are patients who have recovered from COVID-19 infection that has required hospitalization at JHH or JHBMC who will undergo non-invasive 14-day continuous ECG monitoring. The majority of patients are expected to be Baltimore City residents, which will provide critical information in a population that is currently underrepresented in available studies.
The Impact of COVID-19 on Maternal and Neonatal Outcomes

PI: Irina Burd
This prospective, exploratory study will recruit pregnant women admitted to JHH for delivery with a positive or negative COVID 19 status and their newborns. Biospecimens including maternal and cord blood, as well as maternal and fetal placenta samples, will be evaluated for biomarkers of placental inflammation and early onset neonatal sepsis. Data about the pregnancy course, as well as pregnancy and neonatal outcomes, will be abstracted from maternal and neonatal medical records.
Survey of Opioid Treatment Program’s Response to COVID-19

PI: Geetanjali Chander
Leaders of Opioid Treatment Programs’ (OTPs) across the nation will be surveyed to assess their responses to recently announced changes by the Substance Abuse and Mental Health Services Administration (SAHMSA), for dispensing methadone during the COVID-19 pandemic. A locally developed survey instrument will focus on areas including allowing extra “take-home” doses for asymptomatic patients, decision-making on what constitutes “stable” and “less-stable” patients, and utilization of telemedicine.
Community Collaboration to Combat Coronavirus (C4-WARD)

PI: Jason Farley
This study proposes to recruit and follow a representative population-based cohort in Baltimore City to better understand the burden, transmission dynamics, and clinical, social and economic consequences of COVID-19.
Connected Emergency Care Patient Safety Learning Lab

PI: Jeremiah Hinson
This ongoing study aims to reduce health and financial harms caused by suboptimal, Emergency Department (ED) based diagnosis, treatment and disposition decisions, made for patients diagnosed with or suspected of having lower respiratory tract infections. This is accomplished by using advanced data science methods and EHR-integrated clinical decision support. Though this protocol already encompasses the population of COVID-19 patients and their clinical management, because it is now the major respiratory infection being encountered in the ED, an amendment was submitted that formally identifies this research as being related to COVID-19.
A Prospective Study to Evaluate the Disease Status in Patients with Sickle Cell Disease: A Globin Regional Data and Discovery (GRNDaD) Network

PI: Sophie Lanzkron
The purpose of this longitudinal study is to create a multi-site registry of patients with sickle cell disease, including collection and storage of biospecimens for biomarker analysis and future research. A recent amendment was approved to collect information related to a COVID-19 diagnosis and related complications.
Personality Traits Related to Stress and Development of PTSD-like Symptoms During the COVID-19 Pandemic

PI: Frederick Lenz
This study uses an online mental health survey to measure changes over time in anxiety, depression and stress levels. Adult participants will be surveyed once a month until when a public vaccination program can be carried out.
Evaluating Danaher Biomarkers in the Emergency Department for Digital Decision Support

PI: Scott Levin
This is a cross-sectional, observational study of ED patients who receive a CBC in the ED as part of standard of care that investigates the capability of a combination of biomarkers (Monocyte Distribution Width [MDW] and/or Cepheid Xpert Xpress Flu/RSV [Xpert Flu]) to help develop prediction models for clinical outcomes. This is achieved by differentiating emergency department (ED) patients according to: illness severity markers; confirmed Flu/RSV; presence of co-infections ( i.e. SARS-CoV-2 with or without confirmation by laboratory testing); and/or sepsis.
COVID-19 Risk with Immune-modulating Medication Study (COVID-19 RIMS)

PI: Ellen Mowry
This study seeks to establish a virtual cohort of approximately 10,000 Johns Hopkins patients for the purpose of evaluating if immune-modulating medications increase a person’s risk of developing coronavirus infection (COVID-19) and to what extent other factors which may affect its severity. Potential participants will first be identified by querying EPIC for an autoimmune/inflammatory disease diagnosis and subsequently invited to join the study via MyChart messaging. Study subjects will be asked to complete repeated online questionnaires detailing demographic and lifestyle characteristics as well as COVID-19 symptoms, test results, and travel histories. This information will be linked with separate projects that include clinical performance outcome measures, biosamples, medical images, or other information in Epic or in disease registries.
North American Multiple Sclerosis COVID-19 Clinical Database

PI: Scott Newsome
This internet-based survey study will capture data including information about the participant’s multiple sclerosis diagnosis, immunomodulatory medications, COVID-19 treatments, and patient outcomes.
Older Adults’ Perspectives about Different Formats of Telehealth during COVID-19- Implications for Access, Value and Policy

PI: Stephanie Nothelle
Individuals aged 65 or older and/or their caregiver who have had at least one primary care telemedicine visit within JHM during the COVID-19 pandemic will be administered a one-time telephone survey to assess their experience.
Clinical Features of COVID-19 Disease in Critically Ill Patients in the US: A Multi-center Study

PI: Chirag Parikh
Via this protocol, data will be contributed to the “STOP-COVID: Study of the Treatment and Outcomes in Critically Ill Patients with COVID-19”, multi-center, observational study that is being conducted by Drs Shruti Gupta, MD, MPH and David E. Leaf, at Brigham and Women’s Hospital. The information obtained from this study, which will include 500 patients admitted to the ICU with a confirmed diagnosis of COVID -19 (100 participants to be recruited from Johns Hopkins Hospital and Johns Hopkins Bayview Medical Center), will be used to help determine the independent risk factors for hospital mortality and acute organ injury.
Assessing COVID-19 Related Trends in Everyday Activity (The ACTIVE Study)

PI: Naresh Punjabi
This study explores the change in activity patterns resulting from travel restrictions and “stay at home” orders which have been mandated as protective measures against the COVID-19 pandemic. Adults will be administered an online survey that will also provide information to help determine independent correlates of change in activity patterns in the general population, such as age, sex, race, socioeconomic status, self-reported stress levels, and prevalent comorbidity.
North American COVID-19 ST-Segment Elevation Myocardial Infarction (NACMI) Registry

PI: Jon Resar
This study enables the creation of a registry with information about adult COVID-19 patients with cardiovascular symptoms in order to help identify patterns of myocardial injury, develop a risk model for cardiac complications, understand short and long-term major adverse cardiac events, and design clinical trials testing different treatment modalities.
Multi-center Retrospective Observational Trial of Children Hospitalized with COVID-19 Infection

PI: Rebecca Riggs
The objective of this protocol is to collect de-identified demographic and clinical data on all patients admitted to the Johns Hopkins Children’s Center (JHCC) with COVID-19 infection between March 1 and April 17, 2020. This information will be used to create an early profile of COVID-19 in this population that includes the severity of illness, mode of presentation, comorbidities, use of ICU, use of pharmacological therapies and early outcomes.
Anxiety and the Impact on Healthcare Employees

PI: Tamar Rodney
Healthcare workers caring for patients during the COVID-19 pandemic will be surveyed to determine the prevalence and sources of anxiety symptoms they may be experiencing and how the severity of these symptoms affects their ability to do their job. Factors that contribute to their resilience and ability to continue to effectively function in their roles will also be investigated. This information will be used to help inform decisions about increasing the availability of counselling and screening opportunities for individuals identified at risk and raise an awareness of the sources of anxiety and stress among healthcare workers that may be unique to a pandemic.
Acute Human Influenza Detection and Treatment in Health Care Centers in Zambia

PI: Richard Rothman
This study, studying acute human influenza in Zambia, was amended to extend its aims to include an evaluation of the burden and epidemiology of COVID-19 disease in rural southern Zambia.
Collecting and Characterizing Danaher Biomarkers in the Emergency Department

PI: Richard Rothman
This cross-sectional, observational study of ED patients who receive a CBC in the ED as part of standard of care has two major objectives:1) Test the hypothesis that biomarkers (Monocyte Distribution Width [MDW] and/or Cepheid Xpert Xpress Flu/RSV test results – including cycle threshold [CT] values) both in isolation and together may be useful in diagnostic decision-making for patients with suspected infectious disease; and 2) Explore biomarker expression patterns to determine whether there are discernable and reliable indicators of SARS-CoV-2 infection or predictors of COVID-19 illness severity.
Promoting Maternal Mental Health and Wellbeing in Neonatal Intensive Care

PI: Erica Sibinga
Building on earlier pilot results, the objective of this study is to further develop and evaluate a mindfulness intervention for mothers of infants in the NICU, for the purpose of improving stress management, reducing the symptoms of anxiety and depression, and preventing depression relapse. With the onset of the COVID-19 pandemic, surveys administered to study subjects were amended to include questions about COVID-19 and coronavirus.
Resident Perceptions on the Impact of COVID on their Residency Training

PI: Shameema Sikder
This survey-based study is open to all ophthalmology residents. Information is being collected that will provide their perceptions about the impact of COVID-19 on their training and subsequent ability to practice upon graduation.
Prospective Data Collection for the Spine Service of the Johns Hopkins Department of Orthopedic Surgery

PI: Richard Skolasky
This ongoing study is developing a registry of patient reported outcomes and assessments to help advance the understanding of spine disease and treatment. To study the accommodations that have been required to allow musculoskeletal spine patients to obtain clinical care during the COVID-19 pandemic, a survey was developed to explore its impact on their access to basic needs and medical care (musculoskeletal and other), quality of life, mental health, and knowledge about COVID-19 risk factors and symptoms.
Patient Perceptions of Telemedicine Visits

PI: Uma Srikumaran
This protocol aims to better understand patients’ perceptions about rendering healthcare services via telemedicine and to gain information to subsequently address any unrecognized barriers to acceptance. This will be accomplished by surveying approximately 250 patients who participate in telemedicine visits, via questionnaires which will be provided before and immediately following their appointment.
Flattening the InAccessiblity Curve

PI: Bonnielin Swenor
A web based survey will be administered to adults who self- identify as having low vision or being blind for the purpose of better understanding how the COVID-19 pandemic impacts their lives in the areas of healthcare; transportation; employment; education; social experiences; access to meals, food, and supplies; and voting.
COVID-19 in Inflammatory Bowel Disease Patients

PI: Brindusa Truta
The objectives of this study are to better define the epidemiology (incidence and risk factors), clinical manifestation, mortality and morbidity and gained immunity to SARS-CoV-2 in patients diagnosed with Inflammatory Bowel Disease (including Crohn’s disease, ulcerative colitis and indeterminate colitis). Eligible participants are receiving their care at the Johns Hopkins Hospital, and will be followed by the means of electronic questionnaires and review of their health record.
ExtraCorporeal Membrane Oxygenation for 2019 Novel Coronavirus Acute Respiratory Disease (The ECMOCARD Study)

PI: Glenn Whitman
This prospective and retrospective, international, observational study of patients admitted to the ICU with lab-confirmed COVID-19 infection will gather data that will assist in pandemic planning both locally as well as globally. The information collected will help improve descriptions of clinical features, severity of pulmonary dysfunction, incidence of ICU admission, use of mechanical ventilation, coagulatory and thrombotic derangement, and ECMO technical characteristics, duration of ECMO, complications, and survival of patients with COVID-19.
Patient Experience with Outpatient TeleHealth Clinical Services at Kennedy Krieger Institute During COVID-19

PI: Theodore Zabel
This quality improvement project is focused on developing a process for evaluating patient and parent experiences with outpatient telehealth-based clinical services at the Kennedy Krieger Institute during the initial months of the COVID-19 pandemic.
Nutrition and Exercise in Critical Illness (The NEXIS Trial): A Pilot Study and Randomized Trial of Combined Cycle Ergometry and Amino Acids in the ICU

PI: Dale Needham
A prospective cohort study of hospitalized COVID-19 patients and their caregivers was added to this ongoing clinical investigation. The goals for this sub-study are to compare patients with severe and non-severe COVID, assess the short-term and longer-term inflammatory/immunological responses in COVID -19 disease, as well as study physical, cognitive and mental health outcomes over a 12 month longitudinal follow-up period. The prevalence of mental health symptoms among the primary caregivers of patients with severe COVID-19 will also be investigated.
Host Genetics and COVID-19

PI: David Thomas
This study proposes to genotype individuals across the disease spectrum and assess human genetic determinants of COVID-19 outcomes. This investigation is needed to try and understand why environmental and host factors cannot fully explain the heterogeneity seen in patient’s outcomes following SARS-CoV-2 infection. Information derived from this study will help inform therapeutic strategies and vaccine development.
Genetic Sequencing for Outbreak Investigation of Sars-CoV-2 in Long-term Care Facilities

PI: Morgan Katz
This study evaluates a salivary-based approach for SARS-CoV-2 viral analysis of samples from both the residents and staff of long term care facilities. The proposed testing process will help to better understand the duration of infectious viral shedding for symptomatic and asymptomatic residents and staff. This information will help develop guidance on the ability of staff to work and the easing of COVID-19 transmission-based isolation precautions for residents.
COVID-19 Risk in Individuals Diagnosed with Ataxia

PI: Liana Rosenthal
This study plans to establish a virtual cohort of participants who have been diagnosed with cerebellar ataxia and then follow those individuals to determine potential risk factors associated with COVID-19 in a population with a neurodegenerative disease. Attention will be paid to factors that these individuals may experience, such as less exercise, less interaction with healthcare professionals, and a potential increase in depression and anxiety, which may modify their disease course. Participants will be asked to complete a repeated online questionnaire detailing demographic, lifestyle and medication characteristics, as well as COVID-19 symptoms, test results, and travel histories. This information will be linked with separate ongoing projects which include additional clinical information, such as performance outcome measures, biosamples, medical images and other relevant information in disease registries.
Prevalence of SARS-CoV-2 Infections in Congregate Living Facilities in Maryland

PI: Stephan Sisson
This study will collect symptoms and prevalence testing for SARS-CoV-2 in residents and staff at congregate living facilities around Maryland as has been requested and authorized by local health department officials. This information will be used to assess the burden of SARS-CoV-2 infections in these settings and to inform cohorting practices.
Viral Infection and Respiratory illness Universal Study [VIRUS]: COVID-19 Registry and Validation of C2D2 (Critical Care Data Dictionary)

PI: Jon Steuernagle


This study creates a real time COVID-19 registry of current ICU/hospital care patterns to allow evaluations of safety and observational effectiveness of COVID-19 practices and to determine the variations in practice across hospitals. The information obtained will help with the creation of a set of standards and definitions which better reflect critical care research and will ultimately increase the quality of single and multi-center COVID studies.
The Impact of COVID-19 on Families with Young Children in the PREDICT Cohort

PI: Raquel Hernandez
This cross-sectional, observational study involves a single remote (web or phone-based) survey of participants who have been enrolled in the birth or early childhood cohorts of the ongoing PREDICT study. The goal of this ancillary study is to understand how families with young children are impacted by the social, economic, and health disruptions of the COVID-19 pandemic response. Data collected as part of the PREDICT study will be used to characterize the participants’ pre-pandemic circumstances, as well as their ongoing health status and health care utilization.
JHUSOM Medical Student COVID-19 Seroprevalence Study

PI: Bhakti Hansoti
The objectives of this study are to determine the percent of medical students with serum antibodies to SARS-CoV-2, as well as characteristics associated with the presence of these antibodies. The characteristics that will be explored include reported COVID-19 symptoms in the last 3 months, degree of exposure to COVID-19 positive patients (social network mapping), clinical rotation, performing high-risk procedures, and social exposures. Eligible participants, which includes students undertaking both clinical (MS2,3 & 4) and non-clinical rotations (MS1), will be asked to complete a questionnaire on their potential exposures and symptoms; as well as have blood drawn for SARS-CoV-2 antibody testing at 0, 4 and 8 months. Any students who self report testing COVID-19 positive in the interim will be surveyed to obtain information about their exposures in real time.
COVID-19 Clinician Survey

PI: Russell Margolis


Clinicians who treat patients that are diagnosed with early psychosis will be surveyed about their experiences with the relatively rapid transition from providing mental health services mostly in-person to tele/remote delivery during the COVID-19 pandemic. This work is being conducted by a consortium of early psychosis centers. The information obtained will be used to help inform decisions about continuing expanded tele-mental health services for this population.
Survey of COVID-19 Symptoms

PI: Casey Overby Taylor
This web-based survey study aims to: (1) explore symptoms among coronavirus disease (COVID-19) positive patients, (2) examine the association between symptoms and comorbidities, and (3) examine the association between the symptoms and demographic data. The goals are to try to identify predictors for severe illness from demographics, comorbidities and symptoms data. Eligible subjects are adults who use the Amazon Mechanical Turk (MTurk) website, are residents of the United States and have either tested positive for COVID-19 or have a family member in their household who has tested positive.
The Utilization and Impact of Immune-modulating Dietary Supplements on Chronic Liver Disease Patients during the SARS-CoV-2 Pandemic

PI: Gerard Mullin
This survey study will assess how prevalent the use of dietary supplements and potentially toxic off-label medications is in patients with chronic liver disease during the pandemic. Their attitude towards dietary supplements, off-label medications, and dietary patterns related to SARS CoV-2 during the COVID-19 pandemic will be examined. This information will be used to help healthcare providers connect usage patterns to possible flares of these patients’ underlying liver disease, with the goal to try to offer better overall care during this pandemic.
The Impact of COVID-19 on the Regional Epidemiology of Child Abuse Evaluations

PI: Leticia Ryan
This is a retrospective cohort study to describe novel trends in the regional epidemiology of child abuse evaluations during the COVID- 19 pandemic. Both the incidence and rates of pediatric patients evaluated for maltreatment, as well as the demographic and clinical characteristics of these occurrences, will be compared to earlier time periods. We will collaborate with other regional hospitals to complete this study.
COVID-19 Antibody Testing of Recipients of Solid Organ Transplants

PI: Jacqueline Garonzik Wang
The goals of this study include determining the prevalence of SARS-CoV-2 antibodies in adult kidney and/or liver transplant recipients and their non-transplanted household members, as well as investigating the presentation of COVID-19 in transplant recipients, and the possible influence of immunosuppressive regimens on disease presentation. Eligible participants who received their transplants after 2000, and their non-transplanted household members, will be contacted at 4 time points and asked to submit blood samples for testing via a home test kit provided by the study, and to complete a survey regarding their medical history, history of COVID-19 symptoms and testing, as well as their knowledge, concerns, and behaviors related to COVID-19.
Post-viral Associated Olfactory Loss (PVOL): Patient Education Project

PI: Nicholas Rowan


Early reports have suggested that anosmia can be a symptom of COVID-19 and other upper respiratory tract infections. This project aims to improve patient and societal knowledge of the symptoms of post-viral associated olfactory loss (PVOL) and the importance of treating it early using smell-training. Patients presenting in the investigator’s rhinology clinic with symptoms or concern for PVOL will be given information outlining its manifestations and instructions for how to initiate olfactory training at home.
COVID-19 "HOPE" Research Participant Registry - Hopkins Opportunities for Participant Engagement

PI: Daniel Ford


This registry creates a central access point for COVID-19 researchers trying to recruit persons with and without SARS-CoV-2 infection who
are interested and willing to participate in research studies. Potential subjects will enroll themselves into the registry, answer questions describing their medical history, and be matched with potential SARS-CoV-2 studies of interest.
Epidemiology and Clinical Outcomes of COVID-19 in India (ECO19 Study)

PI: Matthew Robinson
A prospective cohort study of adults in India who test positive for SARS-CoV2 infection, as well as a control group with suspected COVID -19 who test negative, will be conducted to address key knowledge gaps in the epidemiology of disease severity and poor clinical outcomes in India. All participants will be prospectively evaluated for up to 6 months for socio-demographic, clinical, routine laboratory, lung imaging and pulmonary function data. A specimen repository will also be established from confirmed COVID-19 cases and controls.
Venous Thromboembolism (VTE) Prevention and Diagnosis in COVID-19 Patients: Practice Patterns and Clinical Outcomes: A Multi-Center Observational Study

PI: Daniel Brotman
Information will be collected to characterize the use and outcomes of various pharmacological venous thromboembolism (VTE) prevention strategies used in the management of hospitalized COVID-19 ICU and non-ICU patients. Among patients receiving these various prophylaxis strategies, the rates of clinically diagnosed and radiographically confirmed VTE, as well as the rates of major bleeding episodes will be examined. Other goals include characterizing VTE diagnostic approaches used in COVID-19 patients and examining patterns of D-dimer levels in relation to practice decisions in both ICU and non-ICU patients.
Observational Surveillance Study of COVID-19 Patients for Risk Factors, Clinical Course, and Outcomes

PI: David Hager
The goal of this study is to provide a more robust characterization of the epidemiology of COVID-19, as well as additional data which are needed to characterize the full spectrum of clinical disease associated with COVID-19. Patients with positive COVID-19 tests across both the inpatient and outpatient settings will be serially assessed to ascertain rates of subsequent hospitalizations, use of mechanical ventilation, intensive care requirements, and survival, as well as symptom burden, and return to normal activity.