Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06631287
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-10-04
Brief Title:
Randomized Double-Blind Placebo-Controlled Trial EValuating Baricitinib on PERSistent NEurologic and Cardiopulmonary Symptoms of Long COVID
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Randomized Double-Blind Placebo-Controlled Trial EValuating Baricitinib on PERSistent NEurologic and Cardiopulmonary Symptoms of Long COVID REVERSE-LC
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
REVERSE-LC
Brief Summary:
The overarching goal of this study is to determine if baricitinib as compared to placebo will improve neurocognitive function along with measures of physical function quality of life post-exertional malaise effect of breathlessness on daily activities post-COVID-19 symptom burden and biomarkers of inflammation and viral measures in participants with Long COVID
Detailed Description:
Since the emergence of the severe acute respiratory syndrome coronavirus 2 pathogen in late 2019 there have been over 680 million cases worldwide and over 6 million deaths In the United States alone there have been over 100 million cases and over 1 million deaths Both novel vaccines and effective therapeutics have helped reduce mortality in well-resourced countries Despite these advances millions of patients subsequently experience a devastating post-acute infection syndrome known as post-acute sequelae of SARS-CoV-2 infection PASC or better known by patients as Long COVID LC In the United States alone it is estimated that up to 18 million adults suffer from LC with persistent neurocognitive impairments NCI and cardiopulmonary symptoms such as dyspnea and exercise intolerance for months to years after acute COVID-19 Additionally up to 1 in 5 patients who were working prior to contracting SARS-CoV-2 may not return to the workforce due to cognitive and physical impairments The public health burden of LC is estimated to be the largest seen from an emerging disease in the last 100 years yet there are currently no effective interventions
These clear and objective changes in cognitive function and brain structure highlight the devastating and long-lasting effects of SARS-CoV-2 infection on survivors long-term health highlighting the need for effective therapies to improve long-term cognitive outcomes
In addition to the devastating NCI that patients with LC experience many survivors go on to experience activity-limiting dyspnea on exertion exercise intolerance and reduced physical function In fact patients who have not fully recovered physically 5 months after infection may fail to recover further by one year Patients with LC experience significant self-reported physical symptoms including persistent fatigue and dyspnea as well as objective impairments in exercise capacity and physical function upon performance testing These impairments in addition to cognitive function and mental health lead to significant reductions in quality of life for these survivors
While viral reservoirs systemic and organ-level inflammation are leading hypotheses for the mechanistic underpinnings of LC no trials to date have investigated the use of agents targeting these mechanisms Similar chronic inflammation plays a crucial role in the increased risk of cardiovascular disease CVD and NCI for people with HIV PWH as indicated by elevated soluble and cellular markers of inflammation endothelial dysfunction and hypercoagulability in this population Activation of the Janus kinase JAK-STAT pathway which drives a proinflammatory milieu has been reported during HIV infection and is associated with CVD NCI and HIV persistence Even in the absence of a viral infection these same conditions and comorbidities are driven by a very similar chronic inflammatory state
These clear and objective changes in cognitive function and brain structure highlight the devastating and long-lasting effects of SARS-CoV-2 infection on survivors long-term health highlighting the need for effective therapies to improve long-term cognitive outcomes
In addition to the devastating NCI that patients with LC experience many survivors go on to experience activity-limiting dyspnea on exertion exercise intolerance and reduced physical function In fact patients who have not fully recovered physically 5 months after infection may fail to recover further by one year Patients with LC experience significant self-reported physical symptoms including persistent fatigue and dyspnea as well as objective impairments in exercise capacity and physical function upon performance testing These impairments in addition to cognitive function and mental health lead to significant reductions in quality of life for these survivors
While viral reservoirs systemic and organ-level inflammation are leading hypotheses for the mechanistic underpinnings of LC no trials to date have investigated the use of agents targeting these mechanisms Similar chronic inflammation plays a crucial role in the increased risk of cardiovascular disease CVD and NCI for people with HIV PWH as indicated by elevated soluble and cellular markers of inflammation endothelial dysfunction and hypercoagulability in this population Activation of the Janus kinase JAK-STAT pathway which drives a proinflammatory milieu has been reported during HIV infection and is associated with CVD NCI and HIV persistence Even in the absence of a viral infection these same conditions and comorbidities are driven by a very similar chronic inflammatory state
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None