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

Cell mediated immunity in COVID19 infection

Date Added
August 13th, 2020
PRO Number
Pro00101915
Researcher
Satish Nadig

List of Studies

Keywords
Infectious Diseases, Transplant
Summary

This study will examine immunity to COVID-19 infection in healthy individuals, healthy transplant patients, and patients diagnosed with COVID-19. Blood samples will be collected from participants over a period of 3 years that will be tested for immunity.

Institution
MUSC
Recruitment Contact
Caitlin Schaffner
843-792-7558
schaffne@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

A PHASE III, RANDOMIZED, DOUBLE-BLIND, MULTICENTER STUDY TO EVALUATE THE EFFICACY AND SAFETY OF REMDESIVIR PLUS TOCILIZUMAB COMPARED WITH REMDESIVIR PLUS PLACEBO IN HOSPITALIZED PATIENTS WITH SEVERE COVID-19 PNEUMONIA

Date Added
June 29th, 2020
PRO Number
Pro00101225
Researcher
Nandita Nadig

List of Studies

Keywords
Coronavirus, Infectious Diseases, Lung, Pulmonary
Summary

The purpose of this study is to compare the effects, good or bad, of study treatment with remdesivir plus tocilizumab compared with remdesivir by itself on subjects with severe COVID19 pneumonia. In this study, the subject will receive standard supportive care treatment for COVID-19 pneumonia as well as remdesivir, and will additionally receive either tocilizumab, or placebo. About 450 people will take part in this study. Depending on the early results of the study, the total number of people who will take part may be increased to up to 800.

Institution
MUSC
Recruitment Contact
Abigail Grady
(843) 792-2072
gradyabi@musc.edu

A PHASE II, OPEN-LABEL, RANDOMIZED, MULTICENTER STUDY TO INVESTIGATE THE PHARMACODYNAMICS, PHARMACOKINETICS, SAFETY, AND EFFICACY OF 8 mg/kg OR 4 mg/kg INTRAVENOUS TOCILIZUMAB IN PATIENTS WITH MODERATE TO SEVERE COVID-19 PNEUMONIA

Date Added
May 8th, 2020
PRO Number
Pro00099738
Researcher
Nandita Nadig

List of Studies

Keywords
Coronavirus, Infectious Diseases, Lung, Pulmonary
Summary

The purpose of this study is to compare the effects, good or bad, of two doses of TCZ in combination with standard of care treatment on subjects with moderate to severe COVID-19 pneumonia. This study is testing a drug called tocilizumab (TCZ). During this study, you will be hospitalized and have study procedures daily until discharged (based on your study doctor's decision). After you are discharged from the hospital, you are encouraged to come back for additional assessments; if it is not possible, you may be followed up by telephone by your study doctor or study nurse.
About 100 people will take part in this study in the United States.

Institution
MUSC
Recruitment Contact
Caroline Brailsford
(843) 792-1820
brailsfo@musc.edu

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

Date Added
April 16th, 2020
PRO Number
Pro00099382
Researcher
John Wrangle

List of Studies

Keywords
Infectious Diseases
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. This study hopes to investigate if patients with COVID-19 improve faster if they receive plasma from those who have recovered from COVID-19.

Institution
MUSC
Recruitment Contact
Ashley Warden
8437924349
jonesash@musc.edu

SCTR / MUSC COVID-19 Biorepository

Date Added
April 16th, 2020
PRO Number
Pro00098961
Researcher
Patrick Flume

List of Studies

Keywords
COVID-19, Coronavirus, Infectious Diseases, Men's Health, Non-interventional, SARS-CoV-2, Women's Health
Summary

The Medical University of South Carolina (MUSC) is developing a COVID-19 biorepository which will contain blood, urine, and other bodily fluids along with relevant medical information from individuals evaluated, exposed to, or treated for COVID-19. To learn from this pandemic ,and to develop treatments and strategies to better prepare and avert future pandemics we must study the disease and its effects. The clinical specimens in the biorepository will be available for investigators to use for future research. Compensation is provided for participation in this project for eligible participants.

Institution
MUSC
Recruitment Contact
Lauren Card
843-729-4394
coordinator@musc.edu

Rapid In-Home SARS-CoV-2 IgG Antibody Testing to Assess Community Level Immunity in Health Care Workers Working in High Risk Exposure Settings

Date Added
April 8th, 2020
PRO Number
Pro00099014
Researcher
Eric Meissner

List of Studies

Keywords
COVID-19, Coronavirus, Healthy Volunteer Studies, Infectious Diseases, SARS-CoV-2
Summary

The purpose of this study is to estimate the extent to which health care workers at MUSC who may have higher than average risk for exposure to the novel coronavirus SARS-CoV-2, which causes an illness referred to as COVID-19, may have developed immunity to infection. Two groups of people will be asked to participate in this study. The first group is comprised of health care workers with a potentially higher risk of exposure who may have provided direct care or services for persons with SARS-CoV-2 infection as part of their work duties. The second group is comprised of employees whose job duties do not involve direct contact with patients. The purpose of the research is to determine if a certain marker in blood, IgG to SARS-CoV-2, can tell if participants may have been exposed to and now recovered from SARS-CoV-2 infection and how seroprevalence changes over time during the current outbreak in this population of study subjects.

Institution
MUSC
Recruitment Contact
Lauren Card
843-729-4394
cardl@musc.edu

Outcomes Related to COVID-19 Treated with Hydroxychloroquine among In-patients with Symptomatic Disease

Date Added
April 8th, 2020
PRO Number
Pro00099215
Researcher
Andrew Goodwin

List of Studies

Keywords
Infectious Diseases, Lung, Pulmonary
Summary

This is a blinded, multicenter, placebo-controlled randomized clinical trial. In this trial, the safety and effectiveness of hydroxychloroquine for the treatment of adults hospitalized with COVID-19 will be evaluated. In this study, a medication called hydroxychloroquine is being investigated to see if it improves recovery from COVID-19 in patients admitted to the hospital. Hydroxychloroquine is used to treat malaria and some joint (rheumatologic) diseases, but it is unknown if it helps patients recover from COVID-19. Study medication will be given for 5 days. This medication could be either hydroxychloroquine or placebo. There will be up to 510 patients in the study at about 50 hospitals in the United States.

Institution
MUSC
Recruitment Contact
Abigail Grady
843-792-2072
gradyabi@musc.edu

PROSPECTIVE STUDY OF ACUTE FLACCID MYELITIS (AFM) TO DEFINE NATURAL HISTORY, RISK FACTORS, AND PATHOGENETIC MECHANISMS

Date Added
December 11th, 2019
PRO Number
Pro00094024
Researcher
Sandra Fowler

List of Studies

Keywords
Brain, Infectious Diseases, Nerve, Nervous System, Spinal Cord
Summary

This study is designed to gain a better understanding and natural history of acute flaccid myelitis (AFM).

This study will include reviewing medical records to record information about the medications taken to treat AFM and your social history (smoking, alcohol and drug use). The results of lab tests, imaging studies and tests will also be collected to determine if you have any damage to your nerves that are done by your clinical care team to diagnose your AFM.

Samples from Mouth, nose, stool and blood will be collected as a part of this study. Any remaining spinal fluid that is in the lab from the spinal tap from clinical labs will also be collected. A neurological exam and tests to determine issues with muscles, functionality and strength after being diagnosed with AFM will also be performed as a part of this study.

Institution
MUSC
Recruitment Contact
Sandra Fowler
8437922385
fowlersl@musc.edu



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