A Phase 2, Open-label, Uncontrolled, Single-dose Study to Evaluate the Safety and Tolerability, Pharmacokinetics and Occurrence of Antidrug Antibody for Nirsevimab in Immunocompromised Children < 24 Months of Age.

Date Added
August 10th, 2021
PRO Number
Pro00113136
Researcher
Andrew Atz

List of Studies


Keywords
Infant, Infectious Diseases
Summary

Respiratory syncytial virus (RSV) is the most common cause of lower respiratory tract infection (LRTI) among infants and young children, resulting in annual epidemics worldwide. Children with congenital or acquired immunodeficiencies, transplant recipients, and those receiving immunosuppressive therapy are at increased risk for severe RSV-associated disease resulting in prolonged hospitalizations, admissions to the intensive care unit (ICU), and the need for mechanical ventilation. Nirsevimab is not a vaccine, but a monoclonal antibody. Monoclonal antibodies are laboratory-made proteins that mimic the immune system's ability to fight off harmful antigens such as viruses. Nirsevimab is being developed as a cost-effective long acting product to protect all infants from RSV disease in a once-per-RSV-season dosing as opposed to the only current FDA approved RSV specific monoclonal antibody which requires 5 monthly injections. Approximately 100 subjects will be enrolled. Subjects will be followed for approximately 1 year after a single dose of nirsevimab and will have 4 in person visits and numerous telephone check ins during the year of follow up.

Institution
MUSC
Recruitment Contact
Megan Bickford
843-876-3394
bickfome@musc.edu

A Phase 3 Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multicenter Study Evaluating the Efficacy and Safety of Remdesivir in Participants with Severely Reduced Kidney Function who are Hospitalized for COVID-19"

Date Added
July 29th, 2021
PRO Number
Pro00109135
Researcher
Blaithin McMahon

List of Studies


Keywords
Coronavirus, Infectious Diseases, Kidney
Summary

The purpose of this study is to see if Remdesivir (RDV) in the presence of severely reduced kidney function, can improve the health of adults and children following hospitalization for COVID 19. The study is using Remdesivir compared to placebo infusions to determine the safety and efficacy of Remdesivir in severely reduced kidney function in COVID 19 subjects. The study is sponsored by Gilead Sciences. Patients will be randomized 2:1 to the Remdesivir or placebo. The duration of the study is 60 days.

Institution
MUSC
Recruitment Contact
Linda Walker
843-792-6109
walkerlp@musc.edu

ACTIV-6: COVID-19 Outpatient Randomized Trial to Evaluate Efficacy of Repurposed Medications

Date Added
July 6th, 2021
PRO Number
Pro00111013
Researcher
Leslie Lenert

List of Studies


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

This study will repurpose medications that have already been approved for use by the Food and Drug Administration (FDA) for other indications to treat non-hospitalized patients that are at least 30 years old with mild to moderate COVID-19. The effectiveness of reducing COVID-19 symptoms will be evaluated by comparing the medication to a placebo or fake treatment with no therapeutic value. Participation will last about 90-days and all study visits are designed to be performed over the phone or remotely. Participants will be compensated for their time and participation in this research study.

Institution
MUSC
Recruitment Contact
Elizabeth Szwast
843-792-4675
hinsone@musc.edu

COVID-19: A Mulicenter, Adaptive, Randomized, Blinded Controlled Trial of the Safety and Efficacy of Investigational Therapeutics for Hospitalized Patients with Acute Respiratory Distress Syndrome Associated with COVID-19

Date Added
April 8th, 2021
PRO Number
Pro00109695
Researcher
Andrew Goodwin

List of Studies


Keywords
Coronavirus, Drug Studies, Infectious Diseases, Lung, Pulmonary, SARS-CoV-2
Summary

TESICO (Therapeutics for Severely Ill Inpatients with COVID-19) is a master protocol to evaluate the safety and efficacy of investigational agents aimed at improving outcomes for patients with acute respiratory failure related to COVID-19.

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

A Multicenter, Adaptive, Randomized, Blinded Controlled Trial of the Safety and Efficacy of Investigational Therapeutics for Hospitalized Patients with COVID-19

Date Added
January 27th, 2021
PRO Number
Pro00102997
Researcher
Andrew Goodwin

List of Studies


Keywords
Coronavirus, Infectious Diseases, Lung, Pulmonary
Summary

This study is testing an experimental drug called "LY3819253" that will provide antibodies that is thought to fight the COVID-19 virus.The subject will receive the study drug (either the experimental study drug or the placebo) only once, on the day he/she joins the study (study "Day 0"). The subject will get it by an intravenous (IV) drip through a tube attached to a needle in the arm. This is called an infusion. As part of the study the subject will also get a study drug called remdesivir once a day intravenously for up to 10 days while in the hospital, as care for COVID-19, unless the study doctor thinks remdesivir would not be safe to be taken. The study will last for 90 days.

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

Identification of Molecular and Genetic Variations Underlying Skin Diseases

Date Added
November 3rd, 2020
PRO Number
Pro00096209
Researcher
Colleen Cotton

List of Studies

Keywords
Cancer, Genetics, Infectious Diseases, Inflammation, Rare Diseases, Skin
Summary

Genetic changes to human skin contribute to a wide variety of conditions and diseases that affect over 20% of the population. However, the genes and molecules that are responsible for human skin development and disease are not fully understood, preventing the development of treatment options. This proposal seeks to better understand one disease in particular, linear morphea, a form of Sclerederma that can affect the skin, muscle, and bone. This study will recruit subjects to collect and use skin tissue for the purpose of identifying the genetic causes of linear morphea.

Institution
MUSC
Recruitment Contact
Alexandra Ritter
757-777-6673
ritteral@musc.edu

COVID-19: Biology and Longitudinal Epidemiology of PETAL COVID-19 Observational Study

Date Added
October 15th, 2020
PRO Number
Pro00103211
Researcher
Andrew Goodwin

List of Studies


Keywords
Coronavirus, Infectious Diseases, Lung, Pulmonary, SARS-CoV-2
Summary

BLUE CORAL is an observational, biorepository study for patients who are hospitalized with COVID-19. The study collects various data and biospecimens, such as blood, urine, and tracheal aspirates, during the patient's hospital stay. The data and biospecimens collected will be used to provide greater knowledge on the biology and epidemiology of COVID-19.

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

A Multi-center, Randomized, Case-controlled, Ascending-dose Study of Extracorporeal Mesenchymal Stromal Cell Therapy (SBI-101 therapy) in COVID-19 Subjects with Acute Kidney Injury Receiving Renal Replacement Therapy

Date Added
October 13th, 2020
PRO Number
Pro00101070
Researcher
Blaithin McMahon

List of Studies


Keywords
Coronavirus, Infectious Diseases, Kidney
Summary

To assess the safety, tolerability and effects of SBI-101 therapy in COVID-19 subjects with acute kidney injury (AKI) receiving renal replacement therapy. The study product is a device that is added to the dialysis machine and is being developed by Sentien Biotechnologies. Not everyone will receive the study product. A total of 8 subjects will receive the study product and 4 subjects will receive their standard of care treatment. The study product, called SBI-101, is a device that is added to the dialysis machine. Inside the device are human mesenchymal stromal cells (MSC). These cells do not enter your blood. The study duration is approximately 6 months.

Institution
MUSC
Recruitment Contact
Marcie Pregulman
843-792-8166
pregulma@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

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



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