Influenza Vaccine Effectiveness for Preventing Laboratory-Confirmed Severe Influenza-Associated Illness and Understanding Coronavirus Disease 2019 (Overcoming COVID-19) in US Children

Date Added
September 17th, 2020
PRO Number
Pro00102181
Researcher
Elizabeth Mack

List of Studies

Keywords
Coronavirus, Pediatrics
Summary

The Overcoming Cohort study is a studies looking for variations in DNA,for populations less than or 25 years of age, that either protect people from COVID-19 disease or make them more susceptible. The study will sequence patients' entire genome or the smaller group of genes that code for proteins (exome). The study would gain a better understanding of COVID-19 that would improve diagnostic, prevention, and treatment measures.

Institution
MUSC
Recruitment Contact
Ebony Dawkins Mikell
843-876-8692
panacceb@musc.edu

Assessing prior SARS-CoV-2 infection among the general population in Charleston, South Carolina: a community seroprevalence study

Date Added
September 1st, 2020
PRO Number
Pro00103008
Researcher
Michael Sweat

List of Studies

Keywords
COVID-19, Coronavirus, Infectious Diseases, Non-interventional, SARS-CoV-2
Summary

Understanding the current epidemiology of COVID-19 is of urgent importance in light of the continued pandemic. Given current testing guidelines, the number of individuals within the Charleston, South Carolina area who have had COVID-19 is unknown. Many such individuals may have been asymptomatic or mildly symptomatic. Thus, the number of confirmed cases, those who are or have been symptomatic and tested for COVID-19, is most likely a significant underrepresentation of the community seroprevalence of the virus. The purpose of this study is to determine the number of prior COVID-19 infections that are present in the Charleston area among adults, and to evaluate characteristics associated with infection with SARS-CoV-2, the virus which causes COVID-19.

Institution
MUSC
Recruitment Contact
Michael Sweat
843-876-1082
sweatm@musc.edu

Testing a wearable telemedicine-controllable taVNS device for NeuroCovid Recovery and Rehab

Date Added
September 1st, 2020
PRO Number
Pro00101270
Researcher
Mark George

List of Studies

Keywords
Anxiety, Coronavirus, Depression, Pain
Summary

The purpose of the research is to test out a new form of treatment where we stimulate a nerve in your ear. This is called transcutaneous (through the skin) auricular (ear) vagus nerve stimulation (taVNS) which means that you will receive stimulation through the ear. The taVNS device looks like an ear bud you would use with your smart phone or computer. We are investigating whether or not taVNS can treat neurologic symptoms of COVID-19 which are termed NEUROCOVID. Some symptoms you may experience are new onset anxiety, depression, vertigo, loss of smell, headaches, fatigue, irritability, etc. This study is entirely online and all assessments will be completed virtually.

Institution
MUSC
Recruitment Contact
Sarah Huffman
843 8765141
huffmans@musc.edu

Colonizing Microbiome as a Determinant of COVID-19 Outcome

Date Added
August 4th, 2020
PRO Number
Pro00102644
Researcher
Alexander Alekseyenko

List of Studies

Keywords
Coronavirus, Immune System, Infectious Diseases, Non-interventional, SARS-CoV-2
Summary

COVID-19 testing involves collection of swabs from nasopharyngeal cavities where the SARS-CoV-2 virus replicates. Many other commensal and pathogenic microbes may be found in the same host niche. Collectively, these microbes are called the microbiome. We hypothesize that the colonizing microbiome at the time of diagnosis may provide leads for early stratification of cases into risk categories, future clinical manifestations of the disease, and insights into treatment strategies.

Institution
MUSC
Recruitment Contact
Bashir Hamidi
843-792-8657
hamidib@musc.edu

Expanded Access to Convalescent Plasma for the Treatment of Pediatric Patients with COVID-19

Date Added
August 4th, 2020
PRO Number
Pro00102411
Researcher
Andrew Atz

List of Studies

Keywords
Coronavirus, Pediatrics
Summary

People who recover from COVID-19 do so, at least in part, because their blood contains substances called antibodies, which are capable of fighting the virus that causes the illness. It turns out that for some other diseases caused by respiratory viruses, giving people the liquid portion of blood, called plasma, obtained from those who have recovered from the virus, leads to more rapid improvement of the disease. We think that patients with COVID-19 may improve faster if they receive plasma from those who have recovered from COVID-19, because it may have the ability to fight the virus that causes COVID-19.
We are performing this study to see if children admitted to the hospital with COVID-19 may have an improved chance of recovery by receiving plasma from someone who has recovered from COVID-19.

Institution
MUSC
Recruitment Contact
Ebony Dawkins Mikell
843-876-8692
panacceb@musc.edu

Intermediate-size Expanded Access of Remestemcel-L, Human Mesenchymal Stromal Cells, for Multisystem Inflammatory Syndrome in Children (MIS-C) Associated with Coronavirus Disease (COVID-19)

Date Added
July 28th, 2020
PRO Number
Pro00102047
Researcher
Allison Eckard

List of Studies

Keywords
Coronavirus, Pediatrics
Summary

Remestemcel-L will be evaluated in children or adolescents with multisystem inflammatory syndrome (MIS-C) associated with coronavirus disease (COVID-19) who have baseline myocardial complications. The primary objective of this study is to assess the safety and tolerability of remestemcel-L in Multisystem Inflammatory Syndrome in Children (MIS-C) associated with coronavirus disease (COVID-19).

Institution
MUSC
Recruitment Contact
Ebony Dawkins Mikell
843-876-8692
panacceb@musc.edu

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Assessing the Efficacy and Safety of Anti-Spike SARS-CoV-2 Monoclonal Antibodies in Preventing SARS-Cov-2 Infection in Household Contacts of Individuals Infected with SARS-CoV-2

Date Added
July 22nd, 2020
PRO Number
Pro00101604
Researcher
Eric Meissner

List of Studies

Keywords
Coronavirus, SARS-CoV-2
Summary

This research study is looking at investigational drugs to prevent the COVID-19 (Coronavirus 2019) disease from occurring in people who have been exposed to the SARS-CoV-2 virus.The study aims to determine whether the study drugs lower infection by the virus, whether they reduce the need for medical visits and the amount of time spent away from day-to-activities due to COVID-19, and whether they can cause side effects. Participation in the study will last approximately 32 weeks and will require up to 14 visits to the research clinic.Compensation will be provided.

Institution
MUSC
Recruitment Contact
Nicholas Ciappa
843-792-1221
ciappa@musc.edu

A Phase 3 Open-label, Randomized, Controlled Study to Evaluate the Efficacy and Safety of Intravenously Administered Ravulizumab Compared with Best Supportive Care in Patients with COVID-19 Severe Pneumonia, Acute Lung Injury, or Acute Respiratory Distress Syndrome

Date Added
July 16th, 2020
PRO Number
Pro00101619
Researcher
Bryan Garcia

List of Studies

Keywords
COVID-19, Coronavirus
Summary

The purpose of the study is to see if a medication called Ravulizumab (ULTOMIRIS) may reduce lung injury in people with pneumonia, acute lung injury (ALI), or acute respiratory distress syndrome (ARDS) that is associated with a COVID 19 infection. ULTOMIRIS is an investigational medication, meaning that it has not been approved by the FDA to treat these conditions. Participants will be randomly assigned (like flipping a coin) to receive the study medication or not receive the study medication. Participants who receive study drug will receive the study drug in their vein up to 4 times in a 2 week period. Study participation will last about 29 days.

Institution
MUSC
Recruitment Contact
April Rasberry
(843) 792-2375
rasberry@musc.edu

Transition to Telemental Health: Assessing the Transition from In-Person to Telemental Health Delivery of Trauma-Focused Treatment During the COVID-19 Pandemic in Puerto Rico

Date Added
July 14th, 2020
PRO Number
Pro00099684
Researcher
Andel Nicasio

List of Studies

Keywords
Adolescents, Coronavirus, Non-interventional
Summary

This study will document the transition from in-person to telemental health delivery of trauma-focused psychotherapy during the COVID-19 pandemic in Puerto Rico. The study includes interviews and online surveys with health providers, caregivers and youth.

Institution
MUSC
Recruitment Contact
Andel Nicasio
843-806-8018
nicasio@musc.edu

Clinical Evaluation of the Panbio™ COVID‐19 Ag Antigen Test in Symptomatic Subjects (CATSS)

Date Added
July 2nd, 2020
PRO Number
Pro00100813
Researcher
Gary Headden

List of Studies

Keywords
Coronavirus
Summary

The study is intended to use human tissue samples obtained from the nasal cavity in COVID-19 symptomatic subjects to establish the clinical sensitivity and specificity of the Panbio™ COVID-19 Ag Rapid Test by comparison to the reference method used by an central laboratory. The study will collect 2 nasal swabs from each subject enrolled, with one swab tested immediately after
collection and the other swab placed in viral transport medium (VTM) immediately after collection for shipment to a central lab for reference testing.

Institution
MUSC
Recruitment Contact
Aja Bayo
843-792-7944
bayo@musc.edu



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