Colonizing Microbiome as a Determinant of COVID-19 Outcome Save

Date Added
August 4th, 2020
PRO Number
Pro00102644
Researcher
Alexander Alekseyenko

List of Studies


Profiles_link
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

Intermediate-size Expanded Access of Remestemcel-L, Human Mesenchymal Stromal Cells, for Multisystem Inflammatory Syndrome in Children (MIS-C) Associated with Coronavirus Disease (COVID-19) Save

Date Added
July 28th, 2020
PRO Number
Pro00102047
Researcher
Allison Eckard

List of Studies

Silhouette
Keywords
Coronavirus, Pediatrics
Summary

Remestemcel-L will be evaluated in children or adolescents with multisystem inflammatory syndrome (MIS-C) associated with coronavirus disease (COVID-19) who have baseline myocardial complications. The primary objective of this study is to assess the safety and tolerability of remestemcel-L in Multisystem Inflammatory Syndrome in Children (MIS-C) associated with coronavirus disease (COVID-19).

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

A Phase 3 Open-label, Randomized, Controlled Study to Evaluate the Efficacy and Safety of Intravenously Administered Ravulizumab Compared with Best Supportive Care in Patients with COVID-19 Severe Pneumonia, Acute Lung Injury, or Acute Respiratory Distress Syndrome Save

Date Added
July 16th, 2020
PRO Number
Pro00101619
Researcher
Bryan Garcia

List of Studies

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Keywords
Coronavirus, COVID-19
Summary

The purpose of the study is to see if a medication called Ravulizumab (ULTOMIRIS) may reduce lung injury in people with pneumonia, acute lung injury (ALI), or acute respiratory distress syndrome (ARDS) that is associated with a COVID 19 infection. ULTOMIRIS is an investigational medication, meaning that it has not been approved by the FDA to treat these conditions. Participants will be randomly assigned (like flipping a coin) to receive the study medication or not receive the study medication. Participants who receive study drug will receive the study drug in their vein up to 4 times in a 2 week period. Study participation will last about 29 days.

Institution
MUSC
Recruitment Contact
April Rasberry
(843) 792-2375
rasberry@musc.edu

Transition to Telemental Health: Assessing the Transition from In-Person to Telemental Health Delivery of Trauma-Focused Treatment During the COVID-19 Pandemic in Puerto Rico Save

Date Added
July 14th, 2020
PRO Number
Pro00099684
Researcher
Andel Nicasio

List of Studies

Keywords
Adolescents, Coronavirus, Non-interventional
Summary

This study will document the transition from in-person to telemental health delivery of trauma-focused psychotherapy during the COVID-19 pandemic in Puerto Rico. The study includes interviews and online surveys with health providers, caregivers and youth.

Institution
MUSC
Recruitment Contact
Andel Nicasio
843-806-8018
nicasio@musc.edu

Clinical Evaluation of the Panbio™ COVID?19 Ag Antigen Test in Symptomatic Subjects (CATSS) Save

Date Added
July 2nd, 2020
PRO Number
Pro00100813
Researcher
Gary Headden

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Profiles_link
Keywords
Coronavirus
Summary

The study is intended to use human tissue samples obtained from the nasal cavity in COVID-19 symptomatic subjects to establish the clinical sensitivity and specificity of the Panbio™ COVID-19 Ag Rapid Test by comparison to the reference method used by an central laboratory. The study will collect 2 nasal swabs from each subject enrolled, with one swab tested immediately after
collection and the other swab placed in viral transport medium (VTM) immediately after collection for shipment to a central lab for reference testing.

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

REDUCING THE SARS-COV-2 VIRAL LOAD BY HARNESSING THE POWER OF T-CELLS Save

Date Added
June 25th, 2020
PRO Number
Pro00100487
Researcher
Besim Ogretmen

List of Studies


Profiles_link
Keywords
Coronavirus, Immune System
Summary

This protocol is designed to identify donors who recovered from COVID 19 to isolate their PBMCs and T cells for ex vivo reprogramming and expansion in the presence of SARS-CoV-2 spike protein.

Institution
MUSC
Recruitment Contact
Besim Ogretmen
843-792-0940
ogretmen@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 Save

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

List of Studies


Profiles_link
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

NCI COVID-19 in Cancer Patients Study (NCCAPS): A Longitudinal Natural History Study Save

Date Added
June 23rd, 2020
PRO Number
Pro00100976
Researcher
David Cachia

List of Studies

Silhouette
Keywords
Cancer, Coronavirus
Summary

This study is for people receiving treatment for cancer and who have been tested for SARS CoV-2, the coronavirus that causes the coronavirus disease called COVID-19 and are either waiting for the results of this test or have already hada positive test result.

Researchers are trying to learn more about people with cancer who also have been diagnosed with COVID-19 using blood samples, medical information, and copies of medical images.

Institution
MUSC
Recruitment Contact
HCC Clinical Trials Office
843-792-9321
hcc-clinical-trials@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 Save

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

List of Studies


Profiles_link
Keywords
Coronavirus, COVID-19
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

Influenza and Other Emerging Respiratory Pathogens Surveillance Registry Save

Date Added
May 21st, 2020
PRO Number
Pro00099865
Researcher
Andrew Atz

List of Studies


Profiles_link
Keywords
Children's Health, Coronavirus
Summary

The largest published COVID-19 pediatric series to date included only 13 patients considered to be critically ill and only described the Chinese outbreak. There are essentially no data outside of this and nothing to begin to understand the prevalence of severe/critical pediatric COVID-19, the risk factors associated with this illness, outcomes from COVID-19, and factors (patient or treatment) that may be associated with an improved or worsened outcome. This study will identify all children admitted to an inpatient unit with a diagnosis of COVID-19. Clinical data will be collected through medical record review to describe in detail the demographics and clinical characteristics, including clinical course and treatment, of infected children who require hospitalization.

Institution
MUSC
Recruitment Contact
Andrew Atz
843-876-1698
atzam@musc.edu

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