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

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

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

A Phase 3 Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of MEDI8897, a Monoclonal Antibody With an Extended Half-life Against Respiratory Syncytial Virus, in Healthy Late Preterm and Term Infants (MELODY)

Date Added
September 24th, 2019
PRO Number
Pro00090069
Researcher
Andrew Atz

List of Studies


Keywords
Infant, Infectious Diseases, Pediatrics
Summary

The purpose of this study is to evaluate how effective MEDI8897 is at preventing lung disease caused by Respiratory Syncytial Virus (RSV) and to evaluate the safety and tolerability of MEDI8897 in healthy infants compared with placebo. A placebo is a saline solution that looks like the study drug but it does not contain the active ingredient.

Institution
MUSC
Recruitment Contact
Kalyan Chundru
8437921213
choudhar@musc.edu

A Phase 3 Open-Label Clinical Study to Evaluate the Safety and Tolerability of Rebiotix RBX2660 (microbiota suspension) in Subjects with Recurrent Clostridium difficile Infection

Date Added
September 10th, 2019
PRO Number
Pro00089814
Researcher
Scott Curry

List of Studies


Keywords
Digestive System, Infectious Diseases
Summary

An open-label clinical study in which all subjects will receive the same investigational drug, for people with recurrent Clostridium difficile infection (CDI), which is an infection in the intestines. This infection causes severe diarrhea. Recurrent Clostridium difficile (C. diff) infection is being studied as part of a medical research study for an investigational new drug called RBX2660, an enema made of a solution of stool (poop or feces).

Institution
MUSC
Recruitment Contact
Scott Curry
843-876-8646
currysr@musc.edu

A Phase 2/3 Randomized, Double-blind, Palivizumab-controlled Study to Evaluate the Safety of MEDI8897, a Monoclonal Antibody With an Extended Half-life Against Respiratory Syncytial Virus, in High-risk Children (MEDLEY)

Date Added
August 27th, 2019
PRO Number
Pro00090138
Researcher
Andrew Atz

List of Studies


Keywords
Infant, Infectious Diseases, Pediatrics
Summary

MEDLEY is a clinical study researching an investigational medication called MEDI8897, for babies at high risk for respiratory syncytial virus (RSV) disease. The study is looking to see how safe MEDI8897 is, and if it works as well as a medication, Synagis, already approved to protect against RSV.
Babies may be eligible for the study if they are in their first year of life and:
• were born prematurely (at 35 weeks or earlier) or have a heart or lung condition
• have not received any RSV preventive medication. Subjects will receive 5 monthly intramuscular injections throughout RSV season (October to March)

Institution
MUSC
Recruitment Contact
Kalyan Chundru
8437921213
choudhar@musc.edu



-- OR --