A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Assessing the Efficacy and Safety of Anti-Spike SARS-CoV-2 Monoclonal Antibodies in Preventing SARS-Cov-2 Infection in Household Contacts of Individuals Infected with SARS-CoV-2

Date Added
July 22nd, 2020
PRO Number
Pro00101604
Researcher
Eric Meissner

List of Studies

Keywords
Coronavirus, SARS-CoV-2
Summary

This research study is looking at investigational drugs to prevent the COVID-19 (Coronavirus 2019) disease from occurring in people who have been exposed to the SARS-CoV-2 virus.The study aims to determine whether the study drugs lower infection by the virus, whether they reduce the need for medical visits and the amount of time spent away from day-to-activities due to COVID-19, and whether they can cause side effects. Participation in the study will last approximately 32 weeks and will require up to 14 visits to the research clinic.Compensation will be provided.

Institution
MUSC
Recruitment Contact
Nicholas Ciappa
843-792-1221
ciappa@musc.edu

A Master Protocol Assessing the Safety, Tolerability, and Efficacy of Anti-Spike (S) SARS-CoV-2 Monoclonal Antibodies for the Treatment of Ambulatory Patients with COVID-19

Date Added
June 24th, 2020
PRO Number
Pro00101116
Researcher
Eric Meissner

List of Studies

Keywords
Coronavirus, SARS-CoV-2
Summary

This is a study to see if an intravenous (IV) infusion of medication: REGN10933+REGN10987 is an effective and safe treatment for COVID-19. REGN10933+REGN10987 is an investigational medication which means they have not been approved by the FDA to treat COVID-19 or any other disease. Adult patients who are not hospitalized with COVID-19 (i.e. outpatient or ambulatory) and have COVID-19 symptoms may be eligible for this study. Participants will be randomly assigned to receive a onetime infusion of the medication or placebo. Study participation will last about 4 weeks and may include home home-based visits.

Institution
MUSC
Recruitment Contact
Angela Millare
843-792-3710
millare@musc.edu

A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of AT-527 in Subjects with Moderate COVID-19

Date Added
June 2nd, 2020
PRO Number
Pro00099987
Researcher
Eric Meissner

List of Studies

Keywords
COVID-19, Coronavirus
Summary

This is a study to see if an oral antiviral medication called AT-527 is an effective and safe treatment for COVID-19. AT-527 is an investigational medication, which means it has not been approved by the FDA to treat COVID-19 or any other disease. Patients who are hospitalized with COVID-19 and have moderate disease may be eligible for this study. Participants will be randomly assigned to receive active medication or placebo for 10 days. Study participation will last 2-6 weeks.

Institution
MUSC
Recruitment Contact
Max Lento
843-792-9697
lento@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

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

List of Studies

Keywords
COVID-19, Coronavirus, 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

Elucidating Mechanisms of Treatment Relapse for Interferon-Free HCV Therapy

Date Added
August 18th, 2015
PRO Number
Pro00046669
Researcher
Eric Meissner

List of Studies

Keywords
Digestive System, HIV / AIDS, Immune System, Infectious Diseases, Liver
Summary

Treatment of chronic hepatitis C virus (HCV) infection is now possible with all oral medications. While most patients achieve a sustained virologic response (SVR) after treatment, synonymous with cure, some patients relapse after treatment for reasons that are unclear. The goal of this research is to understand how a person's immune system changes during treatment of HCV infection with all oral therapy, and how these changes might impact the chances of relapse after treatment. To address these questions, blood and clinical information will be collected from study participants over the course of receiving standard of care treatment for HCV infection. This blood and clinical information will be used to conduct laboratory research focused on the immune system.

Institution
MUSC
Recruitment Contact
Lisa Martin
843-876-5699
martinl@musc.edu



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