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

A Randomized, Double-blind, Placebo-controlled Phase 3 Study to Assess the Efficacy and Safety of Ad26.COV2.S for the Prevention of SARS-CoV-2-mediated COVID-19 in Adults Aged 18 Years and Older

Date Added
December 10th, 2020
PRO Number
Pro00105462
Researcher
Patrick Flume

List of Studies


Keywords
Coronavirus, Vaccine
Summary

The purpose of this study is to see if a vaccine that is being developed to prevent people from getting sick with COVID-19 is safe and effective and also to see how well it is tolerated. Participants will receive a shot of either the vaccine or a placebo twice: once on Day 1 and a booster shot on Day 57. Participants will have blood drawn several times over a 24 month period to assess the immune system response (how your body fights off the virus). Participation will last about 24 months. Participants will receive payment in return for their time and effort.

Institution
MUSC
Recruitment Contact
Amy Chamberlain
843-792-3162
chambeam@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

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

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



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