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

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

List of Studies


Keywords
COVID-19, Coronavirus
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

APPLAUD: A DOUBLE-BLIND, RANDOMIZED, PLACEBO CONTROLLED, PHASE II STUDY OF THE EFFICACY AND SAFETY OF LAU-7B IN THE TREATMENT OF CYSTIC FIBROSIS IN ADULTS

Date Added
November 12th, 2019
PRO Number
Pro00094338
Researcher
Bryan Garcia

List of Studies


Keywords
Cystic Fibrosis, Lung, Pulmonary
Summary

The purpose of this study is to learn more about the effectiveness and safety of the investigational drug called fenretinide (LAU-7b). The FDA has approved the testing of fenretinide in this study. Researchers hope that treatment with fenretinide will preserve lung function by reducing the persistent inflammation in the lung and to improve its capacity to defend against bacteria such as Pseudomonas aeruginosa. The drug will be administered by capsules. Your participation in this study will last approximately 7 months and includes 8 study visits to the study center (which will last approximately 2-5 hours) and 6 telephone calls. The phone calls are expected to last 10-15 minutes and depend on the amount of information you report.

Institution
MUSC
Recruitment Contact
Max Lento
(843) 792-9697
lento@musc.edu

Study to Understand Disease Course Inflammation and Endotype of South Carolinians with Nontuberculous Mycobacteria

Date Added
June 18th, 2019
PRO Number
Pro00089284
Researcher
Bryan Garcia

List of Studies


Keywords
Healthy Volunteer Studies, Infectious Diseases, Lung, Non-interventional, Pulmonary
Summary

The goal of this cohort and biorepository is to collect data and blood specimens on individuals with Nontuberculous Mycobacteria (NTM), pulmonary disease, and healthy adults to better understand the illness and ultimately improve the care and survival of those with these conditions.

Institution
MUSC
Recruitment Contact
Abigail Grady
843-792-2072
gradyabi@musc.edu



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