An Observational Long-Term Safety Surveillance Study Of Participants From Corbus Sponsored Lenabasum Pivotal Clinical Trials

Date Added
July 15th, 2020
PRO Number
Pro00101371
Researcher
Patrick Flume

List of Studies

Keywords
Cystic Fibrosis, Lung, Pulmonary
Summary

This observational research study will collect safety information from subjects who received study treatment (lenabasum or placebo) in a Corbus-sponsored pivotal clinical trial. This is being done to understand how stopping the study treatment affects the subject, and to make sure that the subject is not experiencing any side effects from stopping the study treatment. The subject will not be given any investigational drugs, including lenabasum or a placebo, in this study. The subject will be assessed (by telephone or office visit) approximately every 6 months for up to 2 years from the time of the last safety visit in a pivotal trial, unless Corbus stops studying lenabasum or decides to stop the study itself. The number of potential phone calls will depend on when the subject joins the study, but will not exceed 5 total. Approximately 100 subjects are expected to take part in this study in North America, Europe, and Asia-Pacific (APAC).

Institution
MUSC
Recruitment Contact
Nadine O'Connor
(843) 792-6890
oconnorn@musc.edu

Transbronchial Biopsy Assisted by Robot Guidance in the Evaluation of Tumors of the Lung (TARGET trial)

Date Added
July 6th, 2020
PRO Number
Pro00097400
Researcher
Nicholas Pastis

List of Studies

Keywords
Cancer, Cancer/Lung, Lung, Pulmonary
Summary

Physicians currently have difficulty getting a biopsy of lung spots that are far from the center of the lung. The bronchoscopes that are currently used to reach these spots are sometimes difficult to maneuver and are unable to reach these spots. This study will test the performance of a new robotic bronchoscope that uses navigation software to find the distant spots in the lung so physicians can successfully get a biopsy.

Institution
MUSC
Recruitment Contact
Abby Wenzel
843-792-8233
goodsona@musc.edu

A PHASE III, RANDOMIZED, DOUBLE-BLIND, MULTICENTER STUDY TO EVALUATE THE EFFICACY AND SAFETY OF REMDESIVIR PLUS TOCILIZUMAB COMPARED WITH REMDESIVIR PLUS PLACEBO IN HOSPITALIZED PATIENTS WITH SEVERE COVID-19 PNEUMONIA

Date Added
June 29th, 2020
PRO Number
Pro00101225
Researcher
Nandita Nadig

List of Studies

Keywords
Coronavirus, Infectious Diseases, Lung, Pulmonary
Summary

The purpose of this study is to compare the effects, good or bad, of study treatment with remdesivir plus tocilizumab compared with remdesivir by itself on subjects with severe COVID19 pneumonia. In this study, the subject will receive standard supportive care treatment for COVID-19 pneumonia as well as remdesivir, and will additionally receive either tocilizumab, or placebo. About 450 people will take part in this study. Depending on the early results of the study, the total number of people who will take part may be increased to up to 800.

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

Prospective Phase 0 Study to Investigate Pseudomonas aeruginosa and Staphylococcus aureus Bacterial Load, Patient Characteristics and Exploratory Biomarkers in Adult Patients with Cystic Fibrosis or Non-Cystic Fibrosis Bronchiectasis

Date Added
June 25th, 2020
PRO Number
Pro00100720
Researcher
Patrick Flume

List of Studies

Keywords
Cystic Fibrosis, Lung, Pulmonary
Summary

The purpose of this research study is to collect phlegm and blood to learn more about the presence of bacteria in patients with Cystic Fibrosis (CF) or Non-Cystic Fibrosis Bronchiectasis (NCFB). This exploratory research study does not involve the administration of any medication. There are approximately 4 visits (1 visit to see for subject eligibility, and 3 visits during the study) to complete the study participation. The study will take two months. About 100 subjects will take part study-wide.

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

A Multicenter, Randomized, Double-blind, Chronic-dosing, Parallel-group, Placebo-controlled Phase 3 Study to Evaluate the Efficacy and Safety of Benralizumab 100 mg in Patients with Moderate to Very Severe Chronic Obstructive Pulmonary Disease (COPD) with a History of Frequent COPD Exacerbations and Elevated Peripheral Blood Eosinophils (RESOLUTE)

Date Added
May 12th, 2020
PRO Number
Pro00096200
Researcher
Tatsiana Beiko

List of Studies

Keywords
Lung, Pulmonary
Summary

Benralizumab is a drug that can potentially reduce the number of exacerbations (attacks of restricted breathing) for people with chronic obstructive pulmonary disease (COPD). Benralizumab is given as an injection under the skin. Eligible participants will have a 50% chance of being placed in the treatment group (Benralizumab 100mg/mL) or a placebo (inactive substance). The study is double blind so neither the treatment team nor the participant will know what treatment they received. The study will take place for a minimum of one year, but can last up to three years. The study will officially end when every participant has completed one year of treatment.

Institution
MUSC
Recruitment Contact
Rachel Millan
8437920260
rmillan@musc.edu

A PHASE II, OPEN-LABEL, RANDOMIZED, MULTICENTER STUDY TO INVESTIGATE THE PHARMACODYNAMICS, PHARMACOKINETICS, SAFETY, AND EFFICACY OF 8 mg/kg OR 4 mg/kg INTRAVENOUS TOCILIZUMAB IN PATIENTS WITH MODERATE TO SEVERE COVID-19 PNEUMONIA

Date Added
May 8th, 2020
PRO Number
Pro00099738
Researcher
Nandita Nadig

List of Studies

Keywords
Coronavirus, Infectious Diseases, Lung, Pulmonary
Summary

The purpose of this study is to compare the effects, good or bad, of two doses of TCZ in combination with standard of care treatment on subjects with moderate to severe COVID-19 pneumonia. This study is testing a drug called tocilizumab (TCZ). During this study, you will be hospitalized and have study procedures daily until discharged (based on your study doctor's decision). After you are discharged from the hospital, you are encouraged to come back for additional assessments; if it is not possible, you may be followed up by telephone by your study doctor or study nurse.
About 100 people will take part in this study in the United States.

Institution
MUSC
Recruitment Contact
Caroline Brailsford
(843) 792-1820
brailsfo@musc.edu

A Sham Controlled Prospective Randomized Clinical Trial of the RejuvenAir System for the Treatment of Moderate to Severe Chronic Obstructive Pulmonary Disease with Chronic Bronchitis (SPRAY-CB)

Date Added
April 28th, 2020
PRO Number
Pro00090634
Researcher
Charlie Strange

List of Studies

Keywords
Breathing, Lung, Pulmonary, Shortness of Breath
Summary

This research study will be evaluating whether liquid nitrogen sprayed on the cells lining the airways (cryotherapy) can reduce the mucus produced in the lungs of patients with chronic obstructive pulmonary disease (COPD). The study involves bronchoscopies, (placement of a lighted, flexible scope into the lungs) under general anesthesia to deliver the treatment to the lungs. The study is randomized such that 2/3 of individuals get the cryotherapy and the other 1/3 get a sham (control) treatment with no cryotherapy. Participants in the sham control group will be evaluated for eligible for cryotherapy at end of year one. The Study duration is 36 months. Those initially randomized to the treatment group, they will have 7 clinic visits and 2 treatment visits. Participants randomized to sham group will have 11 clinic visits and 4 treatment visits.

Institution
MUSC
Recruitment Contact
M. Gwen Blanton
843-792-8438
blantonm@musc.edu

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Efficacy and Safety Study of Pamrevlumab in Subjects with Idiopathic Pulmonary Fibrosis (IPF)

Date Added
April 14th, 2020
PRO Number
Pro00098727
Researcher
John Huggins

List of Studies

Keywords
Lung, Pulmonary
Summary

The purpose of this study is to evaluate the potential usefulness of pamrevlumab in IPF, compared to placebo (a substance that looks like the investigational drug, but has no active agent). The total duration of your involvement on the study will be 52 weeks. If you meet the entry criteria (requirements) and decide to participate in this study, you will be randomly assigned to 1 of 2 treatment groups: Arm A: Pamrevlumab or Arm B: Placebo. The study includes clinical visits. Approximately 565 subjects will participate in this study at approximately 200 research sites globally.

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

Outcomes Related to COVID-19 Treated with Hydroxychloroquine among In-patients with Symptomatic Disease

Date Added
April 8th, 2020
PRO Number
Pro00099215
Researcher
Andrew Goodwin

List of Studies

Keywords
Infectious Diseases, Lung, Pulmonary
Summary

This is a blinded, multicenter, placebo-controlled randomized clinical trial. In this trial, the safety and effectiveness of hydroxychloroquine for the treatment of adults hospitalized with COVID-19 will be evaluated. In this study, a medication called hydroxychloroquine is being investigated to see if it improves recovery from COVID-19 in patients admitted to the hospital. Hydroxychloroquine is used to treat malaria and some joint (rheumatologic) diseases, but it is unknown if it helps patients recover from COVID-19. Study medication will be given for 5 days. This medication could be either hydroxychloroquine or placebo. There will be up to 510 patients in the study at about 50 hospitals in the United States.

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

An Open-Label Extension Study of Inhaled Treprostinil in Patients with Pulmonary Hypertension due to Chronic Obstructive Pulmonary Disease (PH-COPD)

Date Added
March 24th, 2020
PRO Number
Pro00097579
Researcher
Rahul Argula

List of Studies

Keywords
Lung, Pulmonary, Pulmonary Arterial Hypertension (PAH)
Summary

The purpose of this study is to assess safety of the study drug, inhaled treprostinil, and the ability to tolerate long-term treatment with the study drug in patients with PH-COPD. The study will also evaluate the effectiveness of the study drug over long-term treatment. Inhaled treprostinil is a medication that will be given to you by a handheld inhalation device (study nebulizer) called the Tyvaso® Inhalation System. The study is estimated to last 2 to 3 years but could be much shorter or longer. Depending on the final number of subjects who participated in the RIN-PH-304 study, either approximately 136 or approximately 314 subjects may be eligible to participate in this study from the U.S. study centers.

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



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