Improving the Collaborative Health of Minority COVID-19 Survivor and Carepartner Dyads Through Interventions Targeting Social and Structural Health Inequities.

Date Added
May 6th, 2021
PRO Number
Pro00110062
Researcher
Gayenell Magwood

List of Studies


Keywords
Cardiovascular, Coronavirus, Diabetes, Hypertension/ High Blood Pressure, Minorities, Stroke
Summary

Underserved, racial and ethnic minority communities are experiencing higher rates of COVID-19 cases and associated mortality compared to whites due to long standing social and structural inequities that also drive disparities in chronic diseases such as stroke, cardiovascular disease, diabetes, and hypertension. Patients with underlying chronic diseases who are recovering from COVID-19 depend on the support of family and friends (informal caregivers/care partners) who are being exposed to the same pandemic and racial stressors, exposure that can affect the health and quality of life of both partners. The primary goal of this study is to test the efficacy of an adapted, telehealth-enhanced intervention that targets barriers impacting family illness management behaviors of Black/African American (AA) adult COVID-19 survivors and carepartner dyads for improved quality of life and COVID/chronic illness health related outcomes.

Institution
MUSC
Recruitment Contact
Gayenell Magwood
8437920685
magwoodg@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

The CRISIS2 Study: A phase 2, randomized, double blind, placebo-controlled, multi-center study assessing the safety and anti-coronavirus response of suppression of host nucleotide synthesis in out-patient adults with SARS-CoV-2

Date Added
November 17th, 2020
PRO Number
Pro00105979
Researcher
Eustace Riley

List of Studies

Keywords
Coronavirus
Summary

The CRISIS2 trial will study out-patients (non-hospitalized patients) who have a
positive SARS-CoV-2 test and are symptomatic. Subjects will be randomized to
receive standard of care (SOC) + 5 days of brequinar or SOC + 5 days of placebo.
The purpose of this study is to determine if the in vitro antiviral activity of
brequinar can be duplicated in patients infected with SARS-CoV-2 by measuring
the effect of brequinar on viral shedding. Importantly, the safety and tolerability of
brequinar will also be determined in these patients. The results of this proof-of concept study will inform future studies that will help determine if brequinar is a
safe and effective drug for the treatment of SARS-CoV-2 infection.

Institution
Self Regional
Recruitment Contact
Heather Rich
864-943-2416
heather.rich@selfregional.org

Collection of respiratory biological specimens by a health care professional (HCP) on participants who have or are suspected of having COVID-19 in the acute care setting.

Date Added
November 17th, 2020
PRO Number
Pro00105604
Researcher
Gary Headden

List of Studies


Keywords
Coronavirus
Summary

You are being asked to participate in a research study because you have been diagnosed or are suspected of having COVID-19 infection. The reason for this study is to collect nasal swabs from people diagnosed or suspected of having the 2019-nCoV (coronavirus) to use in the future to possibly help make new tests for detecting this virus, and/or make current tests better.
A company called Becton Dickinson & Company, the sponsor of the study, is paying for this study. Becton Dickinson & Company is also paying the study doctor to do this study.Approximately 2000 people will be enrolled across the US.

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

Breath Test Feasibility Trial for COVID-19 Infection Diagnosis

Date Added
November 16th, 2020
PRO Number
Pro00102970
Researcher
Gerard Silvestri

List of Studies


Keywords
Coronavirus, Lung
Summary

This studyis designed to look at the effectiveness of a new technology call Nanotechnology Biomarker Tagging (NBT) in detecting COVID-19 infection using breath samples of patients. Participation in this study is expected to take less than one month and will consist of a breath sample being taken by the research team, a cheek swab being taken by the research team, a questionnaire that will be completed by the participant with the help of the research teams, and a review of your medical record.

Institution
MUSC
Recruitment Contact
Michael Balassone
843-792-6696
Balassom@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

An Observational Cohort Study to Determine Late Outcomes and Immunological Responses after Infection with SARS- CoV-2 in Children with and without Multisystem Inflammatory Syndrome (MIS-C)

Date Added
October 6th, 2020
PRO Number
Pro00104091
Researcher
Natasha Ruth

List of Studies


Keywords
Coronavirus, Pediatrics
Summary

We will aim to enroll children who have had a nasal swab test showing infection with SARS-CoV-2, the virus that causes COVID-19, or children with a serious complication of COVID-19 called the Multi-system Inflammatory Syndrome in Children (MIS-C). This study does not offer any treatment for COVID-19 or MIS-C. The purpose of the study is to collect information that will help us understand what happens to children and young adults who get infected with SARS-CoV-2, and how their immune system responds. Most of the information that we will collect is part of usual care for young people who have COVID-19 or MIS-C. In addition, we will do some extra clinical and blood tests. Children and young adults who are enrolled in the study will be followed for one year. Our goal is to enroll up to 250 children and young adults (up to the time of your 21st birthday) from about 20 hospitals in the United States. At our center we plan to enroll about 20 participants.

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

Long-TerM OUtcomes after the Multisystem Inflammatory Syndrome In Children: MUSIC

Date Added
September 30th, 2020
PRO Number
Pro00103636
Researcher
Kimberly McHugh

List of Studies


Keywords
Coronavirus, Pediatrics
Summary

This observational study will determine the spectrum and time course of coronary artery involvement, left ventricular (LV) systolic function, and arrhythmias or conduction system disturbances within the first year from illness onset, and to define associated clinical and laboratory factors in a cohort of MIS-C affected patients.

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

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



-- OR --