Ganciclovir to Prevent Reactivation of Cytomegalovirus in Patients with Acute Respiratory Failure and Sepsis

Date Added
April 20th, 2022
PRO Number
Pro00113274
Researcher
Andrew Goodwin

List of Studies


Keywords
Pulmonary
Summary

The purpose of this research is to find out if a drug called ganciclovir can prevent cytomegalovirus (CMV) reactivation, in which the virus wakes up from an inactive state, in patients with respiratory failure associated with severe sepsis. In order for you to take part in this study, we verified that you also have previously had an infection with a virus called Cytomegalovirus (CMV). Ganciclovir is an FDA approved drug that has been widely used for the prevention and treatment of CMV in patients with weakened immune systems. A total of 482 patients will be enrolled in this study at sites throughout the US.

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

CONNECTS Master for Clinical Trials targeting macro-, micro-immunothombosis, vascular hyperinflammation, and hypercoagulability and rein-angiotensin-aldosterone system (RAAS) in hospitalized patients with COVID-19 (ACTIV-4 Host Tissue)

Date Added
March 24th, 2022
PRO Number
Pro00114224
Researcher
Andrew Goodwin

List of Studies


Keywords
Coronavirus, Infectious Diseases, Lung, Pulmonary
Summary

The overarching goal of the Master Protocol is to find effective strategies for inpatient management of patients with COVID-19. Therapeutic goals for patients hospitalized for COVID-19 include hastening recovery and preventing progression to critical illness, multiorgan failure, or death. Our objective is to determine whether modulating the host tissue response with agents targeting the RAAS improves clinical outcomes among patients with COVID-19.
Potential agents to investigate on this platform include TXA127 and TRV027. Both have potential beneficial effects on the RAAS system in COVID-19. We postulate that SARS-CoV-2 spike protein interaction with the ACE2 receptor leads to unchecked activity of AngII, and RAAS-targeting therapies will counterbalance pathologic RAAS effects. We will evaluate the efficacy of TXA127 and TRV027 in restoring RAAS balance.

Institution
MUSC
Recruitment Contact
Nadine O'Connor
843-792-1221
oconnorn@musc.edu

A Phase 2a, Single-Blind, Placebo-Controlled, Parallel-Group Study to Assess Safety, Tolerability, and Pharmacokinetics of Brensocatib Tablets in Adults With Cystic Fibrosis

Date Added
March 17th, 2022
PRO Number
Pro00117670
Researcher
Patrick Flume

List of Studies


Keywords
Cystic Fibrosis, Lung, Pulmonary
Summary

This is an experimental, single-blind, randomized, placebo-controlled, clinical research study of a study drug called brensocatib. The goal of the study is to find a safe and accepted brensocatib dose in people with cystic fibrosis. This study will also help to learn the pharmacokinetic (or "PK") and pharmacodynamic (or "PD") properties of brensocatib. As the Sponsor (Insmed Incorporated) wants to assess the effect of brensocatib in participants with cystic fibrosis, samples of sputum and blood will be collected in this study. About 36 to 48 adults will take part in this study and the duration of this study is expected to be 84 days or less.

Institution
MUSC
Recruitment Contact
Zerlinna Teague
(843) 792-0965
shannonz@musc.edu

Alpha-1 Antitrypsin Disease Cohort: Longitudinal Biomarker Study of Disease Consortium

Date Added
March 16th, 2022
PRO Number
Pro00117423
Researcher
Charlie Strange

List of Studies


Keywords
Autoimmune disease, Liver, Lung, Non-interventional, Pulmonary, Rare Diseases
Summary

The purpose of this study is to create a de-identified, public use,
repository of data of Chronic Obstructive Pulmonary Disease (COPD)
patients with by Alpha-1 antitrypsin deficiency (AATD), a rare genetic
condition that can cause COPD and emphysema.

Institution
MUSC
Recruitment Contact
Kristin Neff
843-792-1219
neffk@musc.edu