Expanded Access to Convalescent Plasma for the Treatment of Pediatric Patients with COVID-19

Date Added
August 4th, 2020
PRO Number
Pro00102411
Researcher
Andrew Atz

List of Studies


Keywords
Coronavirus, Pediatrics
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. We think that patients with COVID-19 may improve faster if they receive plasma from those who have recovered from COVID-19, because it may have the ability to fight the virus that causes COVID-19.
We are performing this study to see if children admitted to the hospital with COVID-19 may have an improved chance of recovery by receiving plasma from someone who has recovered from COVID-19.

Institution
MUSC
Recruitment Contact
Ebony Dawkins Mikell
843-876-8692
panacceb@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)

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

List of Studies


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 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)

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

List of Studies


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

Trials and ReseArch NetworkS FOR More South Carolina (TRANSFORM SC) Child Health Recruitment Registry

Date Added
June 9th, 2017
PRO Number
Pro00063569
Researcher
Andrew Atz

List of Studies


Keywords
Asthma, Autism, Children's Health, Diabetes, Obesity
Summary

The TRANSFORM network is focused on improving child health outcomes in SC through research on conditions of highest priority for future generations. These include conditions like asthma, autism, diabetes, obesity and early childhood outcomes. To accelerate research study recruitment activities for future projects that TRANSFORM sites may participate in, the TRANSFORM network sites will create a research recruitment registry of families interested in volunteering for research. Participants will enter their own as well as their child(ren)'s information into the electronic registry which can be used to identify people to contact for future studies.

Institution
MUSC
Recruitment Contact
Mary Freeman
843-792-5762
freemanme@musc.edu

A Prospective, Randomized, Open Label, Multi-center Study of the Safety and Pharmacokinetics of Apixaban versus Vitamin K Antagonist or LMWH in Pediatric Subjects with Congenital or Acquired Heart Disease Requiring Chronic Anticoagulation for Thromboembolism Prevention

Date Added
December 13th, 2016
PRO Number
Pro00058654
Researcher
Andrew Atz

List of Studies


Keywords
Cardiovascular, Drug Studies, Pediatrics
Summary

This is a prospective, randomized, open-label, Phase II, multi-center clinical trial for pediatric subjects with congenital or acquired heart disease who are on blood thinners. Subjects will be assigned by chance (2:1) to apixaban,vitamin K antagonist or low molecular weight heparin.

Recruitment will start first for subjects 2 years old to less than 18 years old.
Recruitment will then be followed by subjects 3 months to less than 2 years old.
Recruitment for subjects from 0 to less than 3 months of age will be delayed until study data for infants less than 3 years is available.

Institution
MUSC
Recruitment Contact
Kalyan Chundru
843-792-1213
choudhar@musc.edu

Single Ventricle Reconstruction III: Brain Connectome and Neurodevelopmental Outcomes

Date Added
July 14th, 2016
PRO Number
Pro00056838
Researcher
Andrew Atz

List of Studies


Keywords
Children's Health
Summary

We will combine state-of-the-art brain imaging techniques in 140 Single Ventricle Reconstruction Trial (SVR) III patients and 100 control subjects with innovative brain connectome or "graph" analyses to determine if brain connectivity graph measurements will provide novel neuroimaging biomarkers for neurodevelopmental disabilities and improve our understanding of their inciting mechanisms in the SVR survivors. Only 6 of the SVR III patients and no controls will be enrolled at MUSC.

Institution
MUSC
Recruitment Contact
Kalyan Chundru
843-792-1213
choudhar@musc.edu



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