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 2, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, 2-PART STUDY TO EVALUATE EDP-938 REGIMENS IN SUBJECTS AGED 28 DAYS TO 24 MONTHS INFECTED WITH RESPIRATORY SYNCYTIAL VIRUS (RSV)

Date Added
January 4th, 2022
PRO Number
Pro00113213
Researcher
Ronald Teufel

List of Studies


Keywords
Infant, Infectious Diseases
Summary

Respiratory syncytial virus (RSV) is the most common cause of lower respiratory tract. infection (LRTI) among infants and young children, resulting in annual epidemics worldwide. Despite more than 50 years of attempted vaccine development, there are no licensed vaccines. While RSV prevention exists in the form of a specific RSV IgG (palivizumab) requiring 5 once monthly injections, it is licensed only for infants who experience the greatest morbidity and mortality from RSV: preterm infants born ≤ 35 weeks GA, children with chronic lung disease of prematurity, children with hemodynamically significant congenital heart disease. EDP-938 is a novel, orally administered, non-fusion replication inhibitor of respiratory syncytial virus (RSV) that is being developed as a potential treatment for RSV infection.

Institution
MUSC
Recruitment Contact
Megan Bickford
843-876-3394
bickfome@musc.edu

Immunobiology of Influenza Critical Illness in Young People (PICFLU2)

Date Added
November 24th, 2021
PRO Number
Pro00112536
Researcher
Elizabeth Mack

List of Studies


Keywords
Infectious Diseases, Pediatrics
Summary

The Pediatric Intensive Care Influenza Study #2 (PICFLU2) is a multiyear, multicenter prospective observational study in patients aged ≤ 21 years hospitalized in pediatric Intensive Care Units (PICUs) and Stepdown (or intermediate) Care Units (SDUs) in the US designed to evaluate of the immunobiology of influenza virus-related critical illness in young hosts.

Institution
MUSC
Recruitment Contact
Lauren Wakefield
843-792-0603
wakefila@musc.edu

A Phase 2, Open-label, Uncontrolled, Single-dose Study to Evaluate the Safety and Tolerability, Pharmacokinetics and Occurrence of Antidrug Antibody for Nirsevimab in Immunocompromised Children < 24 Months of Age.

Date Added
August 10th, 2021
PRO Number
Pro00113136
Researcher
Andrew Atz

List of Studies


Keywords
Infant, Infectious Diseases
Summary

Respiratory syncytial virus (RSV) is the most common cause of lower respiratory tract infection (LRTI) among infants and young children, resulting in annual epidemics worldwide. Children with congenital or acquired immunodeficiencies, transplant recipients, and those receiving immunosuppressive therapy are at increased risk for severe RSV-associated disease resulting in prolonged hospitalizations, admissions to the intensive care unit (ICU), and the need for mechanical ventilation. Nirsevimab is not a vaccine, but a monoclonal antibody. Monoclonal antibodies are laboratory-made proteins that mimic the immune system's ability to fight off harmful antigens such as viruses. Nirsevimab is being developed as a cost-effective long acting product to protect all infants from RSV disease in a once-per-RSV-season dosing as opposed to the only current FDA approved RSV specific monoclonal antibody which requires 5 monthly injections. Approximately 100 subjects will be enrolled. Subjects will be followed for approximately 1 year after a single dose of nirsevimab and will have 4 in person visits and numerous telephone check ins during the year of follow up.

Institution
MUSC
Recruitment Contact
Megan Bickford
843-876-3394
bickfome@musc.edu

A Phase 3 Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multicenter Study Evaluating the Efficacy and Safety of Remdesivir in Participants with Severely Reduced Kidney Function who are Hospitalized for COVID-19"

Date Added
July 29th, 2021
PRO Number
Pro00109135
Researcher
Blaithin McMahon

List of Studies


Keywords
Coronavirus, Infectious Diseases, Kidney
Summary

The purpose of this study is to see if Remdesivir (RDV) in the presence of severely reduced kidney function, can improve the health of adults and children following hospitalization for COVID 19. The study is using Remdesivir compared to placebo infusions to determine the safety and efficacy of Remdesivir in severely reduced kidney function in COVID 19 subjects. The study is sponsored by Gilead Sciences. Patients will be randomized 2:1 to the Remdesivir or placebo. The duration of the study is 60 days.

Institution
MUSC
Recruitment Contact
Linda Walker
843-792-6109
walkerlp@musc.edu

ACTIV-6: COVID-19 Outpatient Randomized Trial to Evaluate Efficacy of Repurposed Medications

Date Added
July 6th, 2021
PRO Number
Pro00111013
Researcher
Leslie Lenert

List of Studies