Clinical Agreement Study Protocol – LightDeck COVID-19 Antigen Test for Point of Care

Date Added
September 14th, 2021
PRO Number
Pro00113800
Researcher
Gary Headden

List of Studies


Keywords
Coronavirus
Summary

The sponsor of this study is LightDeck Diagnostics. LightDeck has developed the LightDeck COVID-19 Antigen Test. This test operates outside the body (in-vitro). This is a point-of-care (POC) diagnostic test. It is intended to diagnose COVID-19 in people suspected of having COVID-19 by their healthcare provider within twelve (12) days of symptom onset, or in people who have no symptoms.

Institution
MUSC
Recruitment Contact
Aja Bayo
8437927944
bayo@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
Megan Santilli
843-792-2509
santilli@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