Other COVID-19 Protocols

 

Last updated May 27, 2020

 

For details, expand each category.

To view approved therapeutic protocols, click here.

 

SPECIMEN REPOSITORIES

Non-Bronchoscopic Lavage (NB-BAL) for Intubated Critically Ill Patients with COVID-19 Infection | PI: Franco D’Alessio

Non-bronchoscopic lavage can safely allow repeated sampling of the alveolar space in intubated critically ill patients with COVID-19.  The availability of these samples will enable studies to better understand the etiology of COVID-19 related respiratory failure, as well as to help guide development of therapeutics for this disease.

 

Acute Human Influenza Detection and Treatment in Healthcare Centers in the United States and Taiwan | PI: Richard Rothman

This study seeks to improve the detection and treatment of the influenza virus. However, this protocol has been recently amended to enable the collection of samples from all individuals who have acute respiratory symptoms, including individuals infected with SARS-CoV-2. Specimens gathered through this study will be used to evaluate new and innovative molecular based assays to better characterize factors associated with severe disease and advance earlier recognition of this disease.

 

Clinical Characterization Protocol for Severe Infectious Diseases (CCPSEI) | PI: Lauren Sauer

This enables the prospective collection of data and biological samples from participants infected with SARS CoV-2 virus. Information gathered from COVID-19 patients participating in this study will be invaluable in helping to understand the clinical features of patients with COVID-19 and in the analysis of downstream research questions specific to the clinical course of COVID-19, the development of medical countermeasures and diagnostic tests, and, basic biology questions associated with SARS-CoV-2. Adults and children may be enrolled in this study.

 

Qualification of Donors for Convalescent Plasma Collection | PI: Evan Bloch

The primary purpose of this protocol is to collect and subsequently test blood and saliva samples obtained from adults with a confirmed history of COVID-19 to identify and qualify donors for convalescent plasma collection that may be used in future research studies.

 

The Johns Hopkins COVID-19 Remnant Specimen Repository | PI: Lauren Sauer

This resource maintains a curated repository of specimens collected for clinical purposes from adults as well as children evaluated at the Johns Hopkins Medical Institutions for identification of suspected or confirmed COVID-19, which are no longer needed for clinical care. These samples will be used to support IRB-approved research projects, recruitment efforts into clinical trials, quality improvement projects, and pilot projects. This repository will serve as a complement to other approved repositories for use of clinical data.

SPECIMEN ANALYSES

SARS-CoV-2 Surveillance for Infected Individuals or High Risk Subjects and Antibody Reverse Engineering | PI: David Graham

The ultimate goal of this study is to determine if reverse engineered antibodies against the Spike (S) protein of SARS-CoV-2 can be developed as both a therapy and prophylaxis for COVID-19. IRB approval of this protocol is currently limited to a Phase I pilot, feasibility study carried out on post-infection, convalescent healthcare workers, to define the population from whom the peripheral blood mononuclear cells (PBMC) are to be isolated for this process.

 

SARS- CoV-2 in Human Tissues | PI: David Nauen

In collaboration with the Howard Hughes Medical Institute, de-identified postmortem samples from patients with COVID-19 as well as potentially uninfected individuals, will be used to study infection by SARS-CoV-2 and tissue responses. Primary means of investigation include light and electron microscopy, as well as studies of RNA and protein. Tissues of interest include heart, lung, and brain.

DIAGNOSTICS

Validation of a COVID-19 Test Using the TagPath™ COVID-19 Combo Kit (Applied Biosystems) | PI: Karen Carroll

The purpose of this effort is to validate testing of the recently approved TaqPath™ COVID-19 Combo Kit (Applied Biosystems). Results of this testing will be applied as a quality check for additional validation of the Johns Hopkins laboratory developed assay.

 

Assessment of Serum Antibodies Against the SARS CoV-2 Virus and Serum Cytokines: Use for Validation of Clinical Assay and Subsequent Publication | PI: Patrizio Caturegli

Residual sera from patients who test positive and negative in a PCR assay for SARS CoV-2, will be used to validate commercially available assays to detect serum antibodies against COVID-19 antigens (i.e. the spike protein or the nucleoprotein), and serum cytokines (to include  IL-1 beta, IL-6, IL-8, and TNF-alpha).

 

Clinical Evaluation of Point of Care Testing Kits for SARS-CoV-2 Antibodies | PI: William Clarke

Multiple lateral flow point-of–care test kits for detecting IgG and IgM associated with SARS-CoV-2 infection will be evaluated to better understand the reproducibility and analytical sensitivity of these assays. All results will be compared to measurements obtained by ELISA testing.

 

Impact and Performance of a Rapid Diagnostic Platform for SARS-CoV-2 under Pandemic Conditions | PI: Jeremiah Hinson

The primary objective of this study is to evaluate the clinical impact of a SARS-CoV-2 standard and rapid testing algorithm used by the Johns Hopkins Health System on resource allocation and care delivery, for patients who do and do not have COVID-19. The algorithm incorporates two FDA EUA approved diagnostic tests, the Johns Hopkins-developed SARS-CoV-2 RT-PCR and Cepheid’s Xpert® Xpress SARS-CoV-2 test platform, with turnaround times of 24-36 hours and 45 minutes, respectively. The predictive performance of these 2 assays for COVID-19 related clinical outcomes will also be assessed.

 

Identification of Unrecognized HIV Infection and Other Bloodborne Pathogens in Emergency Department (ED) Patients, 2015-2016 | PI: Yu-Hsiang Hsieh

The main objective of the proposed research is to collect remnant, residual blood product from samples obtained as part of routine ED clinical care, to determine population-level, epidemiologic measurements of incidence, prevalence, and undiagnosed SARS-CoV-2 infection in patients presenting to the Emergency Department. This study will be conducted as an amendment to an ongoing study that uses the same blind seroprevalence study methodology.

 

Evaluation of Chest Imaging Characteristics for Patients with COVID-19 Pneumonia: Imaging Diagnosis and Association with Outcomes | PI: Cheng Lin

Clinical, diagnostic, and imaging (chest radiographs and computed tomography scans) characteristics of patients suspected or confirmed to have COVID-19 will be assessed to test 2 hypotheses: 1) characteristic chest CT features of COVID-19 pneumonia can be diagnostic for the disease and predictive of severe disease; and 2) radiomic features can be utilized to improve the sensitivity and specificity of COVID-19 diagnosis, as well as allow for an automated method of quantifying and characterizing lung abnormalities.

 

Diagnostic Performance of Lung Point of Care Ultrasound (POCUS) for COVID-19 | PI: Gigi Liu

The purpose of this study is to assess the ability of Lung Point of Care Ultrasound (POCUS) to diagnose COVID-19. COVID-19 RT-PCR will be used as the standard against which the sensitivity, specificity, positive predictive and negative predictive values associated with lung POCUS will be assessed. This study will be retrospective in an observational case series of adults who present to the Johns Hopkins Hospital with respiratory symptoms suggestive of COVID-19.

 

Analytical and Clinical Performance of COVID-19 Molecular Diagnostic Methods | PI: Heba Mostafa

To enable the publication of validation results that will assist other laboratories seeking to develop their own diagnostic assays for SARS-CoV-2, this project will analyze the performance of 3 different molecular assays for COVID-19 diagnosis. Samples will be deidentified for testing and will include leftover, discarded SARS-CoV-2 positive and negative specimens sent to the clinical virology lab for standard of care diagnosis, as well as archived specimens for use as negative controls.

 

Development of a Rapid Molecular Test for Point-of-Care Detection of SARS-CoV-2 | PI: Heba Mostafa

This study will enable the use of deidentified samples remaining after standard of care testing is completed to assess two point of care methods for detecting SARS-CoV-2. In collaboration with external researchers, positive and negative samples will be used to evaluate new testing technologies.

 

Evaluation of the BioRad Digital Droplet PCR (ddPCR) for the Molecular Detection of SARS-CoV-2 | PI: Heba Mostafa

This study is designed to evaluate the BioRad digital droplet PCR as a diagnostic tool for the molecular detection of SARS-CoV-2 infections in patients at Johns Hopkins. Upon successfully completing this project, which will only provide aggregate de-identified laboratory data with basic patient demographic information, and BioRad receiving regulatory approval for their assay, our institution will gain the advantage of early infection control through more sensitive testing, especially very early in the disease.

 

Evaluation of the Research Use Only (RUO) Gene Xpert SARS-CoV-2 Assay | PI: Heba Mostafa

The goal of this study is to use de-identified patient samples to help assess the performance of a real-time PCR COVID-19 assay that is being developed by Cepheid Diagnostics for FDA Emergency Use Authorization. Upon successfully completing this project, which will only provide aggregate de-identified laboratory data with basic patient demographic information, and achieving regulatory approval, COVID-19 testing capacity will increase throughout the Johns Hopkins Medicine System as all hospitals will have this FDA-cleared platform in their labs.

 

Genomic Evolution of Viral Pathogens: Impact on Clinical Severity and Molecular Diagnosis| PI: Heba Mostafa

The purpose of this study is to conduct viral surveillance using partial and whole genome sequencing. The applications of this study include understanding viral evolution and monitoring the effect of viral polymorphisms, particularly at common primer binding sites, on the sensitivity of diagnostic molecular assays and on the severity of the disease. Particularly in the setting of SARS-CoV-2, these data will help to better understand the emergence of highly pathogenic and transmissible strains of coronaviruses.

OBSERVATIONAL AND OUTCOMES

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.

 

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.

 

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.

 

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 – COVID-19 RELATED SUBMISSION – Reliance Request | 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 and ECMO, ECMO technical characteristics, duration of ECMO, complications, and survival of patients with COVID-19.