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

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 Save

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

List of Studies

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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 Save

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

List of Studies

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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

A Phase 2, Randomized, Double-blind Study to Evaluate the Efficacy and Safety of VX-561 in Subjects Aged 18 Years and Older With Cystic Fibrosis Save

Date Added
April 23rd, 2019
PRO Number
Pro00087417
Researcher
Bryan Garcia

List of Studies

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Keywords
Cystic Fibrosis, Lung, Pulmonary
Summary

The purpose of this study is to learn more about the effectiveness and safety of VX-561 used in patients with cystic fibrosis. Patients who have cystic fibrosis and are currently taking a stable dose of ivacaftor (IVA) are invited to take part in this research study. VX-561 is a form of IVA, an approved medication for some types of CF, that lasts longer in the body, allowing the medicine to be taken once a day instead of twice a day. Participation could last for approximately 20 weeks. There will be approximately 88 people participating in this study.

Institution
MUSC
Recruitment Contact
Abbi Reed
(843) 792-1820
reedab@musc.edu

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