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 Save

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

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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 Save

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

List of Studies

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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 Save

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

List of Studies


Profiles_link
Keywords
Coronavirus, COVID-19, 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
Ricardo Cantu
843-792-8894
coordinator@musc.edu

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

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

List of Studies


Profiles_link
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

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

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

List of Studies


Profiles_link
Keywords
Coronavirus, COVID-19, 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

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) Save

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

List of Studies


Profiles_link
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 Save

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

List of Studies

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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

Therapeutic Drug Monitoring of Beta-lactam Antibiotics Among Hospitalized Patients: A Pilot Study Save

Date Added
September 9th, 2019
PRO Number
Pro00086047
Researcher
P. brandon Bookstaver

List of Studies

Keywords
Infectious Diseases
Summary

Intravenous beta-lactams are used in over 14 million patients annually. Many of these patients, especially those who are critically ill, obese or are renally impaired have altered pharmacokinetics that may impact drug exposure. The inability to monitor serum concentrations routinely of these antibiotics limits our knowledge of appropriate dosing and may impact clinical outcomes. This project will be a pilot collaboration between Prisma Health Midlands Richland and the University of South Carolina to determine feasibility of a local TDM protocol. We will obtain two blood samples from 10 patients hospitalized currently receiving one of the target agents (ceftriaxone, cefepime or piperacillin/tazobactam) and with positive cultures. These data will be research use only as part of the pilot evaluation and will not be used for clinical decision making.

Institution
Palmetto
Recruitment Contact
Jeannette Bouchard
8034342925
jbouchar@cop.sc.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) Save

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

List of Studies


Profiles_link
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

Multicenter Randomized Pragmatic Clinical Trial Comparing Two-versus-Three Antibiotic Therapy for Pulmonary Mycobacterium Avium Complex Disease Save

Date Added
July 16th, 2019
PRO Number
Pro00089685
Researcher
Patrick Flume

List of Studies


Profiles_link
Keywords
Infectious Diseases, Lung, Pulmonary
Summary

The purpose of this study is to better understand treatment practices for Mycobacterium avium complex (MAC) disease. This study is comparing the effectiveness and tolerability of taking 2 drugs compared to 3 drugs in people with MAC disease.

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

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