Lockridge nortonhealthcare. Gragui nyulangone. Fetter ahn. Low uvmhealth. Courtney swedish. Close Menu. Alicia Hill afhill uabmc. Carl Patronas cbpatronas health. Tiffany Tran tiffany. Hayley Pomeroy Hayley. Lexie Hackman lexie9 vt. Monika Nowosiad-Magda mnowosiadmagda health. Uk Sok Shin UkSok. Derek Haase drh57 georgetown.
Stephanie Mraz stephanie. Kathleen Langbehn kathleen. Yanet Babcock ybabcock med. Angela Aungst aaungst health. Heidi Bien hbien mgh. Aurelie Martin-Puig aurelie. Kim Duval kduval med. The first week or so of illness typically consists of a viral syndrome like the flu with symptoms such as fevers and cough. Patients who experience a milder course usually start to recover after the first week; those on a more severe course may develop worse symptoms often respiratory which usually occurs during the second week after the onset of symptoms.
The period between onset of symptoms and the development of worsening disease is a critical treatment window that is an opportunity to intervene and slow or halt disease progression. COVID is an unusual and serious public health crisis, and there is significant interest in finding effective therapies, specifically in repurposing approved medications with widespread availability and known safety profiles. The medication is generally well tolerated by patients taking the medication over periods of time greater than the two week course used in this study.
Please see consent document for more information including potential side effects. However, the trial was underpowered for clinically important endpoints and enrolled patients at an advanced stage of disease, a median of 13 days after symptom onset, when antiviral activity is likely much less important. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
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Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Last Update Posted : January 10, See Contacts and Locations. Study Description. Show detailed description. Hide detailed description. Detailed Description:. MedlinePlus related topics: Multiple Sclerosis.
FDA Resources. Arms and Interventions. Participants will be stratified by whether they are at higher versus lower risk for long-term disability and then randomized to a higher-efficacy versus a traditional, first-line disease-modifying therapy DMT class. First-line disease-modifying therapy Traditional Therapy for treatment of multiple sclerosis Traditional Therapy choices and maximum allowable doses: Glatiramer acetate Copaxone, Glatopa, and other generics , 20 mg subcutaneously SC daily, or 40 mg SC three times a week Intramuscular interferon Avonex , 30 mcg intramuscularly IM weekly Subcutaneous interferon Betaseron, Extavia, Rebif , 0.
Outcome Measures. The change in overall burden of MS will be defined for the COVID related substudy as the occurrence of breakthrough disease relapses or new MRI activity or the development of new or worsening baseline MS symptoms, which are for TREAT-MS and will continue to be during the substudy documented at clinical visits, whether in-person or on tele-visits.
Time taken to complete the timed 25 foot walk test, measured twice in units of seconds, will be averaged and evaluated. Time taken to complete the nine-hole peg test, measured twice for each hand dominant and non-dominant in units of seconds, will be averaged for each hand and evaluated. The paced auditory serial addition test that measures processing speed will be administered once; number and percent correct will be evaluated.
Low-contrast letter acuity binocular, 2. Among participants identified to have a relapse, relapse recovery will be defined as complete or incomplete based on patient self-report. Among participants identified to have a relapse, relapse recovery will be defined as complete or incomplete based on neurologic examination those who have increased Functional System scores, corresponding to the relapse symptoms, of 1.
The SDMT is commonly used in MS to assess processing speed and will be administered orally and used to evaluate changes in cognition throughout the study. Multiple Sclerosis Impact Scale MSIS is an instrument used for measuring the physical 20 items and psychological nine items impact of multiple sclerosis.
The incidence of change in employment to "disabled" or "looking for work, unemployed," will be evaluated for all participants through an electronic PRO. Incident divorce or separation, among those who previously were married or in a domestic partnership, will be evaluated for all participants through an electronic PRO.
SAEs clinically significant infections, malignancies, or the development of other serious comorbidities, as well as unplanned hospitalizations [for non-elective issues, excluding MS relapse] and death.
Adverse events meaningful enough to lead to medication discontinuation. Other Outcome Measures: Brain Magnetic Resonance Imaging MRI evidence of neurodegeneration [ Time Frame: From 6 months after starting 1st therapy up to 75 months after randomization ] Changes in brain MRI measures of neurodegeneration, including whole brain and normalized gray matter volumes, cortical thickness, subcortical gray matter compartment volumes, and measures of T2 lesion burden.
The number of relapses new or worsening neurologic symptoms lasting for 24 hours or more in the absence of fever. In addition, non-pharmacologic interventions and referrals to other healthcare providers for symptom management will also be captured. Eligibility Criteria.
Contacts and Locations. Information from the National Library of Medicine To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor. Please refer to this study by its ClinicalTrials.
Ng dignityhealth. Shin ucsf. Magenheim neurology. Steshyn neurology.
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