A Study of Apabetalone in Subjects With Long -COVID
RecruitingThis is an open label, multicentre, phase II clinical trial that aims to assess the efficacy and safety of oral Apabetalone with background dapagliflozin for up to 12 weeks in T2DM patients with a history of probable or confirmed SARS-CoV-2 infection, with symptoms within 3 months from the onset of COVID-19 that last for at least 2 months and cannot be explained by an alternative diagnosis.
PhasePhase 2 / Phase 3
TypeInterventional
Age18 Years
WhereAmman, Jordan + 2 more
SponsorResverlogix Corp
▾Tap for detailsClick for full details — eligibility, all locations, contacts Covid-19 Long Haul Preventative and Health Promotion Care Clinical Trial Acceleration Program.
NCT06441955 · COVID-19, Long Haul
RecruitingInvestigators are conducting a study on alternative treatments for patients who have received an current or previous positive COVID-19 diagnosis with mild-serve symptoms or undiagnosable condition after testing positive for severe acute COVID-19 infection and are experiencing long-haul symptoms. The symptoms of long COVID can include extreme tiredness (fatigue), shortness of breath, memory and concentration issues (brain fog), heart palpitations, dizziness, joint pain, muscle aches, cough, headaches, anxiety, and depression. It's important to note that there are various other symptoms that individuals can experience after a COVID-19 infection, such as loss of smell, chest pain or tightness, difficulty sleeping (insomnia), pins and needles, depression, anxiety, tinnitus, earaches, nausea, diarrhea, stomach aches, loss of appetite, cough, headaches, sore throat, and changes to the sense of smell or taste. To be included in the study, participants must have had symptoms for more than 4 weeks. The goal of the study is to measure biomarkers, identify new ones through clinical trials, and individualize and optimize treatment plans, which may or may not include COVID-19 post-market antivirals, vaccines, and medical care. It's essential to conduct thorough clinical trials to understand the long-term effects of COVID-19 and to develop personalized treatment plans for individuals experiencing long-haul symptoms.
PhasePhase 4
TypeInterventional
Age18 Years – 65 Years
WhereBethesda, Maryland, United States
SponsorWell- Konnect Healthcare Services and Research Firm
▾Tap for detailsClick for full details — eligibility, all locations, contacts Physiology of Long COVID-19 and the Impact of Cardiopulmonary Rehabilitation on Quality-of-Life and Functional Capacity
NCT05566483 · Post-acute Sequelae of SARS-CoV-2 Infection
RecruitingThe primary objectives of this study are to determine whether exercise training is an effective strategy for treatment of Long COVID and characterize the cardiorespiratory and autonomic physiology in these patients to precisely characterize mechanisms contributing to this syndrome.
PhaseNA
TypeInterventional
Age18 Years
WhereAurora, Colorado, United States
SponsorUniversity of Colorado, Denver
▾Tap for detailsClick for full details — eligibility, all locations, contacts Recovering From COVID-19 Lingering Symptoms Adaptive Integrative Medicine Trial - Effect of Hyperbaric Oxygen Therapy for the Treatment of Post COVID Condition
NCT06452095 ·
Long COVID, Post Acute Sequelae of COVID-19, Post-COVID-19 Condition
RecruitingThe RECLAIM study platform will be used to explore whether the use of Hyperbaric Oxygen therapy (HBOT) improves the symptoms of post covid cognitive dysfunction. Hyperbaric oxygen therapy is a well-established medical treatment. HBOT promotes healing by delivering a high concentration of oxygen into the body. This high level of oxygen has a number of known benefits, such as growth of new blood vessels, as well as regulating immune and inflammation responses. It helps protect the brain and other nervous tissue from inflammation. HBOT may also have antiviral effects. Collectively, it has the potential to target the underlying mechanisms believed to play a critical role in the development of Long COVID. Many individuals with Long COVID complain of fatigue, brain fog, muscle aches and other symptoms. There is evidence to suggest that these symptoms may be a problem with the blood vessels, resulting in abnormal delivery of oxygen to tissues. Thus, our group is investigating whether HBOT improves post-COVID cognitive dysfunction.
PhaseNA
TypeInterventional
Age18 Years
WhereToronto, Ontario, Canada
SponsorUniversity Health Network, Toronto
▾Tap for detailsClick for full details — eligibility, all locations, contacts Improving Post COVID-19 Syndrome With Hyperbaric Oxygen Treatments
NCT06082518 · Post COVID-19 Condition, Post-COVID-19 Syndrome, Post-COVID Syndrome
RecruitingOver 500 million people have been infected with COVID-19, and to date, more than 6 million people have died. Many individuals who have recovered from COVID-19 continue to experience symptoms even after they have been "cured" of the disease. This condition is known as post COVID-19 condition, which can have serious health consequences. A common symptom among these individuals is chronic fatigue, characterized by persistent tiredness or lack of energy. This study aims to explore a novel treatment for symptoms of post COVID-19 condition, known as hyperbaric oxygen therapy. This approach has shown promise in helping people with post COVID-19 conditions and treating some other causes of fatigue. Hyperbaric oxygen therapy involves placing patients in a small chamber where they receive high oxygen gas levels. However, this treatment is expensive and time-consuming, and it is unclear if this treatment can be effectively assessed in a large-scale research study. This small study will help us decide if conducting a large research study is feasible. The investigators aim to assess if hyperbaric oxygen therapy can improve symptoms of post COVID-19 condition, such as fatigue.
PhaseNA
TypeInterventional
Age18 Years
WhereToronto, Ontario, Canada
SponsorSunnybrook Health Sciences Centre
▾Tap for detailsClick for full details — eligibility, all locations, contacts Immunoadsorption in Autoimmune Long COVID
RecruitingSome people continue to have serious symptoms long after COVID-19, such as extreme fatigue and feeling worse after activity. In some patients, this may happen because the immune system is attacking the body by mistake. This study will test a treatment called immunoadsorption, which filters the blood to remove harmful antibodies. People with long COVID who have these antibodies will be randomly assigned to receive either the real treatment or a placebo. The main goal is to see whether fatigue improves after one month, and whether other symptoms and daily functioning improve over six months. This research will help us find out if this treatment can benefit the group of long COVID patients with immune-related disease.
PhasePhase 2
TypeInterventional
Age18 Years – 65 Years
WhereAmsterdam, Netherlands
SponsorAcademisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
▾Tap for detailsClick for full details — eligibility, all locations, contacts The term post-acute COVID-19 syndrome or Long COVID is a disabling syndrome that persists beyond the 3-month convalescence period after COVID-19 infections. This syndrome affects mostly women (\~80%), present with chronic tachycardia and Orthostatic intolerance symptoms without any identifiable cause. In addition, non-specific symptoms such as fatigue, headache, and "brain fog", commonly described in POTS patients are also present in this novel condition, recently named post-COVID-19 tachycardia syndrome, POTS variant. Reduced Vagal activity and unresolved inflammation is post-COVID-19 POTS is hypothesized as the cause of Long COVID
PhaseNA
TypeInterventional
Age18 Years
WhereNashville, Tennessee, United States
SponsorVanderbilt University Medical Center
▾Tap for detailsClick for full details — eligibility, all locations, contacts Lumbrokinase for Adults With Long Covid, Post-treatment Lyme Disease Syndrome, and Myalgic Encephalomyelitis/Chronic Fatigue Syndrome
NCT06511050 ·
Long Covid, Post-treatment Lyme Disease Syndrome, Chronic Fatigue Syndrome
RecruitingThis will be a pilot multi-arm clinical trial investigating the feasibility of Lumbrokinase (LK) as an intervention in three clinical cohorts: * Long Covid (LC) * Post-treatment Lyme disease syndrome (PTLDS) * Myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS)
PhasePhase 1 / Phase 2
TypeInterventional
Age18 Years
WhereNew York, New York, United States
SponsorIcahn School of Medicine at Mount Sinai
▾Tap for detailsClick for full details — eligibility, all locations, contacts A Study of Post COVID-19 Mechanisms for Chronic Lung Sequelae
RecruitingThe purpose of this study is to understand why some people experience long term effects, such as shortness of breath and fatigue, after a severe COVID-19 infection
Phase—
TypeObservational
Age18 Years
WhereRochester, Minnesota, United States
SponsorMayo Clinic
▾Tap for detailsClick for full details — eligibility, all locations, contacts Cognitive-Sensorimotor Function in Long-COVID
NCT06850350 · Post-acute Sequelae of SARS-CoV-2 Infection
RecruitingGrowing evidence indicates that many people who have chronic post-acute sequelae of SARS-CoV-2 infection (PASC) will experience ongoing neurological and musculoskeletal impairment that can affect gait and balance. Identifying the factors contributing to these impairments and how they influence functional mobility is the first step towards creating effective evaluation and treatment protocols. In this study the investigators will examine cognition, vision, proprioception, muscle strength, gait and balance in persons with and without PASC to understand how PASC may impact functional mobility through a cognitive-sensorimotor lens. Gait and balance will be studied in environments that stress cognitive and sensory abilities. Study outcomes will be critical for the development of evidence-based Veteran Health Administration diagnostic and standard-of-care protocols to address gait and balance dysfunction in Veterans with PASC for restoring their functional mobility and independence.
Phase—
TypeObservational
Age18 Years
WhereChicago, Illinois, United States
SponsorVA Office of Research and Development
▾Tap for detailsClick for full details — eligibility, all locations, contacts Long COVID Brain Fog: Cognitive Rehabilitation Trial
NCT06095297 ·
Long COVID, Brain Fog, Cognitive Impairment
RecruitingThis study will compare two approaches to cognitive rehabilitation in adults with long COVID with persistent, mild to moderate, cognitive impairment. One approach will feature (A) web-based computer "games" that trains how quickly individuals process information that they receive through their senses; (B) in-lab training on everyday activities with important cognitive components, (C) procedures designed to transfer improvements in cognition from the treatment setting to everyday life, and (D) a non-invasive form of vagus nerve stimulation (VNS), i.e., trans-auricular VNS (taVNS). Component B will include work-related tasks. This approach is termed Constraint-Induced Cognitive Therapy (CICT). The other approach will feature (A) web-based computer "games" that train reaction time and eye-hand coordination; (B) in-lab training on relaxation, healthy nutrition, and healthy sleep, (C) procedures designed to promote integration of these lifestyle changes into everyday life, and (D) taVNS. This approach is termed Brain Fitness Training (BFT). A subset of participants, who qualify for and and desire vocational rehabilitation (VR), will receive VR from the Alabama Department of Rehabilitation Services (ADRS) in addition to CICT or BFT. ADRS VR will include career counseling, prescription of on-the-job accommodations, and guidance on return-to-work. Those in the CICT + VR group will also receive on-the-job coaching from a peer mentor for a month after completing training. CICT, with or without VR, will involve 30 hours of training. Ten 3-hour in-lab, face-to-face, therapist-directed sessions will be scheduled. These sessions will feature one hour of gaming; the remainder will be committed to in-lab training on the target behaviors and the procedures designed to promote transfer of therapeutic gains to daily life and improving skills essential to work; the set of the latter procedures is termed the Transfer Package. ta-VNS will administered for 10 minutes before gaming and in-lab target behavior training. To accommodate the demands of participants' other activities, training sessions will be permitted to be scheduled as tightly as every weekday over 2 weeks or as loosely as every other weekday or so over 4 weeks. If a family caregiver is available, they will receive training on how to best support participants in their therapeutic program. After training ends, four follow-up phone calls will be scheduled approximately one-week apart with participants to promote integration of the skills gained during training into everyday life. BFT, with or without VR, will involve 30 hours of training following the same schedule as for CICT. Ten 3-hour in-lab, face-to-face, therapist-directed sessions will be scheduled. These sessions will feature one hour of gaming; the remainder will be committed to in-lab training on the target behaviors (healthy sleep, nutrition and relaxation habits) and the procedures designed to promote transfer of behavior change to daily life. ta-VNS will be administered for 10 minutes before gaming and in-lab target behavior training. If a family caregiver is available, they will receive training on how to best support participants in their therapeutic program. After training ends, four follow-up phone calls will be scheduled approximately one-week apart with participants to promote integration of the skills gained during training into everyday life. Participants will be randomly assigned to the interventions. Randomization will be stratified by whether participants qualify for and desire VR from ADRS or not. If yes, participants will be randomized in equal numbers to CICT + VR or BFT + VR. If no, participants will be randomized in equal numbers to CICT or BFT. Testing will happen one month before treatment, one day before treatment, one day afterwards, and 6-months afterwards. Outcomes measured will include cognitive processing speed, cognitive function on laboratory tests, and spontaneous performance of everyday activities with important cognitive components in daily life. Another important outcome measure will be whether or not participants were able to return back to work or had significant improvements in their work activities.
PhaseNA
TypeInterventional
Age18 Years
WhereBirmingham, Alabama, United States
SponsorUniversity of Alabama at Birmingham
▾Tap for detailsClick for full details — eligibility, all locations, contacts Second Prospective Cohort of Patients Entering the Multidisciplinary Care Pathway for Post-Covid Syndromes - SyPoCo2 Cohort
RecruitingThe study aims to identify clinical profiles of long-COVID patients and correlate them with immunological and molecular data in order to identify prognostic biomarkers and potential therapeutic targets.
Phase—
TypeObservational
Age18 Years
WherePierre-Bénite, France + 1 more
SponsorHospices Civils de Lyon
▾Tap for detailsClick for full details — eligibility, all locations, contacts Cross-Sectional Evaluation of Persistence of SARS-CoV-2 Remnants After Recovery From Acute Infection
NCT06577467 · PASC Post Acute Sequelae of COVID-19
RecruitingBackground: SARS-CoV-2 is the virus that causes COVID-19. Some people who recover from COVID-19 have symptoms that last long after the active infection ends. This is called long COVID. Sometimes, long COVID can affect the nerves and cause problems with sleep, thinking, the senses, and movement. Researchers want to find out whether people with long COVID have retained inactive remnants of SARS-CoV-2 in their bodies. Objective: To collect tissue samples to see if people with long COVID have remnants of SARS-CoV-2 in their bodies. Eligibility: People 18 years or older who have recovered from COVID-19, both with and without neurologic symptoms. Design: Participants will have 2 to 6 inpatient or outpatient visits over 4 months. Each visit will last 4 to 5 days. Participants will be screened to make sure it is safe to collect tissue samples from their body. They will have a physical and dental exam. They will have imaging scans and a test of their heart function. They will complete questionnaires about their health. They will give blood, urine, saliva, and stool samples. Their sense of taste and smell will be tested. Tissue samples will be taken from the digestive tract, lungs, colon, skin, muscle, lymph nodes, nasal passages, and mouth. Participants may be numbed or sedated for some of the procedures. Swabs will be used to collect cells from inside the mouth and nose. Participants will undergo lumbar puncture. A thin needle will be inserted into their lower back to draw out a sample of the fluid around their spinal cord. Participants will have follow-up phone calls after each clinic visit.
Phase—
TypeObservational
Age18 Years – 110 Years
WhereBethesda, Maryland, United States
SponsorNational Institute of Neurological Disorders and Stroke (NINDS)
▾Tap for detailsClick for full details — eligibility, all locations, contacts Study to Evaluate the Efficacy and Safety of Plitidepsin in Adults With Post-COVID-19 Condition (PCC)
NCT06766825 · Post COVID-19 Condition,
Long COVID Syndrome, Persistent COVID-19
RecruitingThe study aims to prove that plitidepsin could be an efficacious, safe, and well-tolerated therapy for PCC. To this end, we will perform a randomized, double-blind study comparing the clinical and laboratory benefits of plitidepsin vs. placebo in 90 subjects with moderate to severe functional disability. The study consists of an intervention period and a follow-up period, with a total of 135 +/-3 days approximately between both periods. During the intervention period, four treatment cycles will be administered, scheduled every 15 days (every 2 weeks), with intravenous (IV) infusion over three consecutive days. After completing the intervention period, a 90-day (+/-5) follow-up period will be conducted. Subjects in arm A will receive the plitidepsin 1.5 mg/day 1h-IV during the four treatment periods on Days 1 to 3, Days 15 to 17, Days 29 to 31 and Days 43 to 45. Subjects in arm B will receive 1h-IV placebo 1 vial /day during the first two treatment periods and will receive the plitidepsin 1.5 mg/day 1h-IV during the last two treatment periods. Subjects in arm C will receive 1h-IV placebo 1 vial/day during the four treatment periods.
PhasePhase 2
TypeInterventional
Age18 Years
WhereBadalona, Barcelona, Spain
SponsorFundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia
▾Tap for detailsClick for full details — eligibility, all locations, contacts Retinal Neurovascular Coupling in Patients Previously Infected With COVID-19
NCT05650905 ·
COVID-19, Post-COVID-19 Syndrome
RecruitingThe Study objective is to measure retinal neurovascular coupling and blood flow parameters in patients previously infected with COVID-19, long COVID-19 and healthy age- and sex- matched control subjects
Phase—
TypeObservational
Age18 Years
WhereVienna, State of Vienna, Austria
SponsorMedical University of Vienna
▾Tap for detailsClick for full details — eligibility, all locations, contacts Magnetic Resonance Analysis of Neural Inflammatory Factors and External Stimulation
RecruitingThe goal of this clinical trial is to test whether a type of rapid outpatient brain stimulation that uses magnetic fields, called accelerated intermittent theta burst stimulation (iTBS), can treat symptoms such as brain fog, depression, and anxiety in patients with Long COVID. The main questions it aims to answer are: * Is iTBS effective and feasible for reducing Long COVID symptoms? We will measure these symptoms using the Symptom Burden Questionnaire. * Are there changes in inflammatory brain chemicals associated with treatment with iTBS? We will be looking at levels of choline in the brain, which is thought to be related to inflammation. Researchers will compare sham versus active forms of iTBS to see if the active group has greater improvement in symptoms. Participants will complete symptom surveys, cognitive tests, and magnetic resonance imaging scans at the beginning, middle, and end of treatment.
PhasePhase 2
TypeInterventional
Age18 Years – 80 Years
WhereAlbuquerque, New Mexico, United States
SponsorUniversity of New Mexico
▾Tap for detailsClick for full details — eligibility, all locations, contacts Does Taurine Supplementation Improve Vascular Function and Orthostatic Responses in Long COVID?
RecruitingMillions have developed Long COVID (LC), and recent findings show an association between taurine deficiency (an amino acid) and symptoms in LC. Cost-effective and accessible interventions are needed to improve welfare and reduce healthcare costs. We will investigate the efficacy of 12-weeks of taurine supplementation (self-administered), on vascular function and the cardio/cerebrovascular responses to upright posture. We will measure resting vascular function with an EndoPAT device, resting heart rate variability, and the blood pressure, heart rate, and brain blood flow responses to 5 minutes of head-up tilt before and after weeks of taurine supplementation in LC. We hypothesize that the 12 weeks of supplementation will improve both resting vascular function and the responses to upright tilt. In turn, we hypothesize that symptoms will also improve (as measured by questionnaires).
Phase—
TypeObservational
Age18 Years – 65 Years
WhereToronto, Ontario, Canada
SponsorYork University
▾Tap for detailsClick for full details — eligibility, all locations, contacts IMPACT-D+: Immune-Modulating and Psychometric Effects of Accelerated TMS in Depression Plus Comorbid Post-COVID-19 Condition
RecruitingThis is a monocentric, randomized pilot study conducted at the Max Planck Institute of Psychiatry, Munich. The study investigates the effects of two different intermittent theta-burst stimulation (iTBS) schedules on biological and clinical outcomes in patients with depression and comorbid Post-COVID-19 condition (PCC). Participants will be randomized into two arms, both receiving a total of 30 active iTBS sessions applied to the left dorsolateral prefrontal cortex (DLPFC) at 90% resting motor threshold using a PowerMAG 100 ppTMS stimulator: * Standard Arm: One iTBS session per day, five days per week, over six weeks. * Intensified Arm: Six iTBS sessions per day, approximately one-hour apart, over five consecutive days. The primary outcomes are changes in immunological blood markers (C-reactive protein \[CRP\], tumor necrosis factor \[TNF\], interleukin-1β \[IL-1β\], interleukin-6 \[IL-6\]) and depressive symptomatology measured by Beck Depression Inventory-II (BDI-II) and Montgomery-Asberg Depression Rating Scale (MADRS). Secondary outcomes include fatigue (Fatigue Severity Scale \[FSS\], Fatigue Scale for Motor and Cognitive Functions \[FSMC\], Post-Exertional Malaise questionnaire \[PEM\]), sleep quality (Pittsburgh Sleep Quality Index \[PSQI\]), daytime sleepiness (Epworth Sleepiness Scale \[ESS\]), functioning (Sheehan Disability Scale \[SDS\]), anxiety (Beck Anxiety Inventory \[BAI\]) and an exploratory adverse effect screening. Follow-up assessments will be performed three days after treatment completion and again at three months post-intervention to evaluate both short- and medium-term effects. Biospecimen collection will include approximately 141 ml of peripheral blood per participant across three time points (baseline, post-treatment, +3 days). Samples will be analyzed for inflammatory markers and securely stored in the institutional biobank of the Max Planck Institute of Psychiatry in accordance with data protection and ethical guidelines. Safety and tolerability will be continuously monitored, including documentation of adverse events. The results of this pilot study are expected to provide preliminary evidence on whether accelerated iTBS protocols may exert differential effects on neuroinflammatory processes and depressive symptomatology in patients with Post-COVID-19 condition, thereby informing larger controlled clinical trials.
PhaseNA
TypeInterventional
Age18 Years – 65 Years
WhereMunich, Bavaria, Germany
SponsorMax-Planck-Institute of Psychiatry
▾Tap for detailsClick for full details — eligibility, all locations, contacts NENCA Study on Neurological Complications of Long COVID-19 in Children and Adolescents; Neurophysiological, Electroencephalographic and Neuroradiological Investigation
NCT06876948 ·
Long Covid-19 RecruitingThe study seeks to investigate the neurological effects caused by Covid-19 in children and adolescents in the 6-16 age group. To do this, neuropsychological scales, an EEG and an MRI were used.
PhaseNA
TypeInterventional
Age6 Years – 16 Years
WherePisa, PI, Italy
SponsorAzienda Ospedaliero, Universitaria Pisana
▾Tap for detailsClick for full details — eligibility, all locations, contacts The Effect of Allopurinol on the Risk of Cardiovascular Events in Patients with Cardiovascular Risk
NCT05943821 · Cardiovascular Diseases, Uric Acid
RecruitingNumerous studies, but not all, have suggested a positive effect of allopurinol on the cardiovascular system. The ALL-VASCOR study aims to evaluate the efficacy of allopurinol therapy for improving cardiovascular outcomes in patients at high and very high cardiovascular risk, excluding ischemic heart disease. This is particularly important due to the high cost of cardiovascular disease treatment and its status as one of the leading causes of death.
PhasePhase 3
TypeInterventional
Age40 Years – 70 Years
WherePoznan, Wielkopolska, Poland
SponsorPoznan University of Medical Sciences
▾Tap for detailsClick for full details — eligibility, all locations, contacts