Safety and Tolerability of Allogeneic Umbilical Cord Derived Mesenchmal Stromal Cells (UC-MSCs) to Limit COVID associated ComplicatioNs: An open label, phase 1 study in hospitalized patients (SAMPSON-1)

Date Added
April 12th, 2022
PRO Number
Pro00115966
Researcher
Charlie Strange

List of Studies


Keywords
Coronavirus, Lung
Summary

COVID-19 Pneumonia is a viral pneumonia caused by the SARS-CoV-2 virus.
Umbilical cord derived mesencymal stromal cells (MSCs) are a form of stem cell (special human cells that are able to develop into many different cells types) that is derived from the placenta of a mother who has had a Caeserian Section. These cells are believed to suppress the body's immune response to the virus by changing the circulating inflammatory cells in the bloodstream. Hospitalized individuals who are within 7 days of the onset of a viral pneumonia illness will be given 2 doses of MSCs at days 1 and 3 after consent. These MSC cells will be administered into a vein in your arm through an intravenous line and safety will be tested. How much oxygen a patient needs will be recorded over 90 days.

Institution
MUSC
Recruitment Contact
Charlie Strange
8437923174
strangec@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
Zerlinna Teague
8437920965
recruitment@musc.edu

Inhaled RLF-100 for the Treatment of Severe COVID-19 without respiratory failure

Date Added
December 14th, 2021
PRO Number
Pro00117349
Researcher
John Tejada

List of Studies

Keywords
COVID-19, Coronavirus
Summary

NeuroRx is a study of Inhaled RLF-100 for the treatment of severe COVID-19 without respiratory failure. The objective is to demonstrate the safety and efficacy of the inhaled RLF-100 in preventing progression from severe to critical covid-19. This is an inhaled treatment given three times daily for 7 days.

Institution
Self Regional
Recruitment Contact
Erin Wallace
864-323-6866
erin.smith@selfregional.org

Care Retention and Engagement of Veterans Living with HIV during the COVID-19 Pandemic

Date Added
December 1st, 2021
PRO Number
Pro00113239
Researcher
Ruth Adekunle

List of Studies

Keywords
Coronavirus, HIV / AIDS, Minorities
Summary

The COVID-19 pandemic has affected all persons, though disadvantaged populations such as persons living with HIV are likely to be disproportionally impacted by the physical, economic, and psychological toll of the global pandemic. This study aims to better understand how COVID-19 has impacted care for veterans living with HIV.

Institution
MUSC
Recruitment Contact
Ruth Adekunle
843-876-3092
adekunle@musc.edu

National Institute of Allergy and Infectious Diseases (NIAID) "BOOSTER EFFECTS WITH AUTOIMMUNE TREATMENTS IN PATIENTS WITH POOR RESPONSE TO INITIAL COVID-19 VACCINE"

Date Added
September 7th, 2021
PRO Number
Pro00113395
Researcher
Diane Kamen

List of Studies


Keywords
Autoimmune disease, Coronavirus, Lupus, Rheumatoid, Scleroderma, Vaccine
Summary

This research is being done to see if an additional shot of COVID-19 vaccine, called a "booster", will help people with autoimmune disease who are taking medications that weaken their immune system develop a better response to the vaccine. The study is also being done to see if temporarily stopping the medication you take for your autoimmune disease will help your immune system have a positive response to the vaccine booster.

This study will use the COVID-19 vaccines that are authorized under an Emergency Use Authorization by the United States Food and Drug Administration (FDA) for initial vaccination, but they are not currently authorized or approved to be used as booster vaccinations – so their use in this study is experimental. This includes the Pfizer, Moderna, and Johnson & Johnson COVID-19 vaccines.

This study is enrolling people over the age of 18 who have a diagnosis of lupus, scleroderma, or rheumatoid arthritis. You will be asked to come to the clinic for up to 8 research visits over 13 months. There might be no direct medical benefit to you for being in this study. The information learned from this study may someday benefit people with autoimmune disorders. Compensation is available for participation.

Institution
MUSC
Recruitment Contact
Stephanie Bray
843-792-8997
brays@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