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

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

Stressors of Inter-ICU Transfer: Family Centered Care through Telehealth

Date Added
December 2nd, 2019
PRO Number
Pro00092555
Researcher
Nandita Nadig

List of Studies

Keywords
Anxiety, Depression
Summary

The purpose of this research study is to reduce psychological distress and improve communication and family centeredness of care for families of Ventilator Dependent Respiratory Failure (VDRF) patients that have undergone inter-ICU transfer by providing them with timely and adequate information about their transfer of care. This will be accomplished by the development and refinement of our Stressors of Inter-ICU Transfer Telehealth Tool (SITT). The study aims to assess reactions to mocked up SITT domains and support resources of 15-20 family members that have undergone inter-ICU transfer as well as 10 clinicians involved in transfer. The data will drive the refinement of the tool to best meet the needs of the families and clinicians.

Institution
MUSC
Recruitment Contact
Kyle White
8437922297
whiteky@musc.edu

The Psychological Impact of Inter-ICU Transfers

Date Added
November 6th, 2018
PRO Number
Pro00080530
Researcher
Nandita Nadig

List of Studies

Keywords
Anxiety, Depression
Summary

The purpose of this research study is to determine the psychological burden placed on the families of patients in the intensive care unit (ICU) who have ventilator-dependent respiratory failure, VDRF, as compared to the burden placed on the families of patients with VDRF who have been transferred from one ICU to another. This study aims to determine if inter-ICU transfer, compared to those who are not transferred, leave patients and families with more symptoms such as of depression, anxiety, and stress. Family members of patients admitted to the ICU will be asked to complete a survey that will last between 20 and 30 minutes. The surveys will be used to evaluate the difference in psychological distress placed on families whose loved ones are directly admitted to the ICU as compared to being transferred from one ICU to another.

Institution
MUSC
Recruitment Contact
Kyle White
(843) 792-8233
whiteky@musc.edu



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