COVID-19 Convalescent Plasma Studies
Outpatient COVID-19 Plasma Research Study for Prevention (CSSC-001)
ClinicalTrials.gov Identifier: NCT04323800
Early Outpatient COVID-19 Plasma Treatment Research Study (CSSC-004)
ClinicalTrials.gov Identifier: NCT04373460
This pair of randomized, controlled, double-blind, phase 2 trials evaluated whether convalescent plasma helped prevent infection or could be used as an effective early treatment option for COVID-19. Results from the early treatment study were published in The New England Journal of Medicine. Read more about the COVID-19 Convalescent Plasma Studies.
MISTIE and MISTIE III
ClinicalTrials.gov Identifier: NCT01827046
The MISTIE Trials were randomized, placebo-controlled, international clinical trials of minimally invasive surgery (MIS) plus alteplase in the treatment of intracerebral hemorrhage (ICH). Subjects were randomized 1:1 to minimally invasive surgery plus alteplase or standard of care with no surgical intervention. The MISTIE Trial was designed to determine the safety of using the combination of MIS and clot lysis with alteplase, while the primary outcomes of the phase 3 trial focused on functional outcomes, measured by the mRS score at 180 and 365 days, and mortality. BIOS CTCC served as the clinical coordinating center and data coordinating center for these projects. Dr. Hanley holds the IND for rt-PA use in the setting of ICH.
MTI:M3 (MISTIE III substudies)
Rebleeding and Inflammation (MTI:M3) combines three MISTIE III DSMB-approved sub-investigations. These ancillary studies evaluated whether specific biomarkers can predict who will benefit the most from minimally invasive surgery. BIOS CTCC served as the coordinating center. Read more about MISTIE III.
CLEAR IVH and CLEAR III
ClinicalTrials.gov Identifier: NCT00784134
The CLEAR-IVH trial, completed in 2008, was a phase 2 feasibility and dose-finding trial conducted at 20 centers in the U.S., Canada, UK, and Germany. There were 3 phases: Safety, CLEAR A, and CLEAR B. The study enrolled 52 patients with a confirmed diagnosis of intraventricular hemorrhage (IVH) with third or fourth ventricle obstruction. Patients were given a thrombolytic, recombinant tissue plasminogen activator (tPA) via an extraventricular catheter (EVD) in one of three dosing regimens over a 3-day period. CLEAR III was a 500-patient phase 3 randomized clinical trial using a recombinant tissue plasminogen activator (Activase) to remove blood from the ventricles quickly. More than 70 major hospitals and academic institutions participated in this international clinical trial. Read more about CLEAR III.
VICTAS
ClinicalTrials.gov Identifier: NCT03509350
VICTAS was a clinical trial to test the combination of Vitamin C, thiamine, and hydrocortisone for the treatment of sepsis. All patients received the standard intensive care for sepsis, and half of the patients additionally received vitamin C, thiamine, and hydrocortisone. Data was collected regarding the use of vasopressors (drugs that increase blood pressure), respiratory support (treatments to aid breathing), and the status of the patients at 30 days and up to one year after treatment. BIOS CTCC served as the clinical trial coordinating center. Read more about VICTAS.
Antihypertensive Treatment of Acute Cerebral Hemorrhage (ATACH II)
ClinicalTrials.gov Identifier: NCT01176565
ATACH II was a pragmatic, streamlined randomized design to evaluate the efficacy of intensive SBP reduction and its effect on outcomes measures in subjects with ICH. Patients were randomized 1:1 to either standard or intensive SBP management using intravenous nicardipine hydrochloride as the primary blood pressure control agent for 24 hours from randomization. This trial was terminated early following an interim analysis that found there was no significant outcome differences between groups. BIOS CTCC served as the independent oversight committee for protocol compliance and safety.
HeadSense
ClinicalTrials.gov Identifier: NCT02773901
This prospective, open-label, non-randomized, comparative study was designed to compare the accuracy and safety of the HS-1000 device, a non-invasive intracranial pressure (ICP) monitor, to invasive ICP monitoring via an external ventricular drain. The HS-1000 measures ICP by assessing the acoustic properties of the patient’s head. BIOS CTCC served as the data management center and provided clinical coordinating center responsibilities of site start-up and site management.
EQUIGEN
ClinicalTrials.gov Identifier: NCT01733394
ClinicalTrials.gov Identifier: NCT01713777
Equigen was a bioequivalency trial comparing a branded vs. generic antiepileptic. The trial was conducted at three sites, with each enrolling 12 subjects. BIOS CTCC served as the coordinating center for this 18-month trial.
Study of Motor Learning and Acute Recovery Time Course in Stroke (SMARTS)
ClinicalTrials.gov Identifier: NCT02292251
SMARTS (SMARTS-1 and SMARTS-2) was a series of studies at Johns Hopkins exploring how the brain changes over the first year following a stroke. BIOS CTCC provided trial coordination for the pilot study, SMARTS-1. SMARTS used several non-invasive techniques, including MRI, transcranial magnetic stimulation, and measures of arm movement to learn more about how individuals recover from stroke. It is hoped that this information will help predict recovery and help researchers understand how changes in the brain relate to the performance of movement.