[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"post-acute-infectious-syndrome-pais\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:post-acute-infectious-syndrome-pais":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,49],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":31,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":48},"100648803","phase-2-cd19-b-cell-depletion-in-pais-mecfs-patients-100648803",false,"NCT07724834","CD19-B Cell Depletion in PAIS-ME\u002FCFS Patients","Prospective, Randomized, Double-blind, Placebo-controlled Phase 2b Trial Evaluating the Efficacy and Safety of the Anti-CD19 Monoclonal Antibody Inebilizumab Compared With Placebo in Patients With Post-acute Infection Syndromes Fulfilling ME\u002FCFS Criteria (PIONEER)","PIONEER_PAIS","Inclusion Criteria:\n\n* Male\u002Ffemale\u002Fdiverse adults who are 18-65 years old at time of enrollment\n* Subject is able and willing to give informed consent\n* Signed informed consent prior to initiation of any trial related measure\n* Diagnosis of PAIS as defined by WHO for PCS, wi th other infectious triggers\n* Diagnosis of ME\u002FCFS according to CCC criteria with PEM \\> 14 hours = PAIS\u002FCFS\n* Detection of autoantibodies (elevated ß2R adrenergic AAB) prior to immunoadsorption or prior to inclusion to PIONEER\n* Pre-treatment with immunoadsorption in the immunoadsorption studies at least 6 months before study inclusion\n* Documented clinical response to immunoadsorption (minimum increase in SF-36 PF of 10 points at week 8) followed by consecutive worsening of symptoms (minimum decrease in SF-36 PF of 10 points for at least 3 months)\n* Evidence of activated pro inflammatory immune cell status\n* Bell score at screening visit: 30-60\n* Normal thyroid function or sufficiently medicated dysfunction\n* For women of childbearing potential (WOCBP):\n\n  1. Confirmed post-menopausal state, defined as amenorrhea for at least 12 months, or\n  2. If being of childbearing potential: Negative highly sensitive urine or serum pregnancy test before randomization, and practicing a highly effective birth control method (failure rate of less than 1%)\n\nExclusion Criteria:\n\n* Contraindication against IMP or AMP\n* Hypersensitivity to the active substance or any of the other ingredients\n* Vaccination less or up to 4 weeks before first visit\n* Immunomodulative therapy \\\u003C 3 month before screening visit\n* Concomitant and previous use of IMP\n* Known SARS-CoV-2 or other infection related organ damage\u002Fcomorbidity\n* Pre-infection history of chronic fatigue syndrome or other fatigue syndromes that are due to associated diseases (e.g., cancer, autoimmune diseases \\[patients with a preexcisting Hashimoto thyroiditis and\u002For fibromyalgia without fatigue syndromes can be included\\])\n* Serious infections, including active or latent and chronic infections such as tuberculosis, HIV, Lues, hepatitis B and C\n* Immune- and immunoglobulin-deficiency or severely immunocompromised condition\n* Any other severe or unstable medical conditions (immune, cardiovascular, respiratory, endocrine, gastrointestinal, hematological, neurological, psychiatric, systemic) or any other condition deemed by the Investigator to pose unacceptable risk, interfere with IP evaluation, or confound study results.\n* At screening : aspartate transaminase (AST) \\> 2.5 × upper limit of normal (ULN), alanine transaminase (ALT) \\> 2.5 × ULN, total bilirubin \\> 1.5 × ULN (unless due to Gilbert's syndrome), platelet count \\\u003C 75,000\u002FµL, hemoglobin \\\u003C 8 g\u002FdL, eGFR\\\u003C30 mL\u002Fmin\u002F1.73 m², total immunoglobulin \\\u003C 900 mg\u002FdL, absolute neutrophil count \\\u003C 1200 cells\u002FµL, CD4 T lymphocyte count \\\u003C 300 cells\u002FµL\n* Concomitant diseases or health constellations causing general physical weakness or fatigue, like: i) renal insufficiency with eGR\\\u003C 15 or diyalsis, ii) impaired liver function with elevated liver enzymes a) Aspartate aminotransferase (AST) and b) Alanin-Aminotransferase (ALT), both \\>35 U\u002Fl for women or \\> 50 U\u002Fl for men, iii) anemia with low hemoglobin-concentrations \\\u003C13,0 g\u002FdL for males and \\\u003C12,0 g\u002FdL for females, and iv) adipositas grades II or higher (BMI: ≥ 35 kg\u002Fm 2) at screening\n* Subject is pregnant or breastfeeding\n* Subject is institutionalized by order of court or public authority\n* Subject who might be dependent on the sponsor, the investigator, or the trial site\n* Participation in another clinical trial with a medical device or an investigational medicinal product within 3 Months or 5 half-lives (whichever is longer) before screening visit","ALL","18 Years","65 Years",{"count":21,"type":22},38,"ESTIMATED","INTERVENTIONAL",[25],"PHASE2","Post-acute infection syndromes (PAIS) are long-lasting health problems that can develop after an infection. They include post-COVID-19 syndrome and similar illnesses following other infections. Some people with PAIS develop myalgic encephalomyelitis\u002Fchronic fatigue syndrome (ME\u002FCFS), a serious and disabling illness that can greatly limit everyday activities. People with ME\u002FCFS may experience severe fatigue, reduced physical and mental function, pain, sleep problems, and problems with the regulation of heart rate and blood pressure. A key feature is post-exertional malaise (PEM), in which symptoms become worse after physical or mental activity. The biological causes of PAIS and ME\u002FCFS are not fully understood, and there is currently no established treatment that targets the underlying disease process.\n\nResearch suggests that changes in the immune system may contribute to PAIS and ME\u002FCFS in some patients. In particular, B cells (a type of immune cell) and autoantibodies (antibodies that react with the body's own structures) may play a role. Previous studies of immunoadsorption, a procedure that removes antibodies from the blood, have shown improvements in some patients with ME\u002FCFS. These findings support further investigation of treatments that target B cells in selected patients.\n\nThe PIONEER\\_PAIS study will investigate whether inebilizumab can improve physical function in adults with PAIS who meet the diagnostic criteria for ME\u002FCFS. The study includes a selected group of patients with evidence of autoantibodies and immune activation who previously improved after immunoadsorption but later experienced worsening of their symptoms. Inebilizumab is a monoclonal antibody that targets CD19, a protein found on B cells, and leads to the depletion of these cells.\n\nParticipants will be randomly assigned to receive either inebilizumab or placebo (saline solution) as an infusion into a vein. Inebilizumab will be given at a dose of 300 mg on Day 1, Day 15, and Week 24. The study is double-blind, meaning that neither the participants nor the study team assessing them will know which treatment they receive.\n\nThe main research question is whether treatment with inebilizumab leads to a greater improvement in physical function (PF) than placebo. PF will be measured using the PF scale of the SF-36 health questionnaire, comparing the change from the start of the study to Month 9 (Week 36).\n\nThe study will also examine other aspects of health and daily functioning, including fatigue, post-exertional malaise, pain and headache, disability, symptoms related to the autonomic nervous system, muscle strength and fatigability, heart rate and blood pressure responses during standing, daily step count, and cognitive function. Adverse events will be monitored to assess the safety of the treatment. In addition, the study includes biomarker research focusing on B cells, autoantibodies, and other markers in the blood.\n\nThis research aims to explore biological characteristics that may be associated with response to treatment and may help inform future studies of B-cell-targeted treatment in PAIS and ME\u002FCFS.",[28,29,30],"Post-acute Infectious Syndrome (PAIS)","Post-COVID 19 Condition (PCC or Long COVID)","Myalgic Encephalomyelitis\u002FChronic Fatigue Syndrome (ME\u002FCFS)",[32,33,34,35],"PAIS","Long COVID","ME\u002FCFS","Fatigue","NOT_YET_RECRUITING","2026-07-21",{"date":39,"type":40},"2026-07-24","ACTUAL",{"date":42,"type":22},"2026-12-01",{"date":44,"type":22},"2029-03-01",{"name":46,"class":47},"Charite University, Berlin, Germany","OTHER",1,{"id":50,"slug":51,"hasResults":11,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":55,"eligibilityCriteria":56,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":57,"targetDuration":4,"studyType":23,"phases":59,"briefSummary":60,"conditions":61,"keywords":63,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":48},"100647803","phase-2-post-acute-infectious-syndrome---aripiprazole-symptom-evaluation-pais-arise-100647803","NCT07714213","Post-acute Infectious Syndrome - Aripiprazole Symptom Evaluation (PAIS-AriSE)","Prospective, Randomized, Double-blind, Placebo-controlled Phase 2a Trial of Low-dose Aripiprazole in Patients With Neuropsychiatric Impairment in Post-acute Infectious Syndrome (PAIS) Including Post-COVID-19 Condition (PCC)","PAISE-AriSE","Inclusion Criteria:\n\n* Male, female or diverse adult who is 18 years or older at the time of informed consent\n* Potential participant is willing, understanding and able to provide informed consent\n* Signed informed consent prior to initiation of any trial-related measure\n* History of confirmed or suspected (PCR or serology or rapid antigen detection, certificate of attending physician, sick note) infectious disease\n* Ongoing symptoms of PAIS\u002FPCC for ≥ 3 months\n* Self-reported neuropsychiatric symptoms at screening\n* For women of childbearing potential (WOCBP):\n\n  1. Confirmed post-menopausal state, defined as amenorrhea for at least 12 months, or\n  2. If being of childbearing potential: Negative highly sensitive urine or serum pregnancy test before randomization, and practicing a highly effective birth control method (failure rate of less than 1%)\n\nExclusion Criteria:\n\n* Prior chronic neuroimmunological or neurodegenerative disease\n* Severe psychiatric disease (psychosis, bipolar disorder, severe major depression with inpatient treatment) within the last 10 years\n* Current malignant disease (including space-occupying brain tumors)\n* Concomitant antipsychotic medication\n* Patient is allergic or has contraindication to Aripiprazole or lactulose and cellulose\n* Patient is pregnant or breastfeeding\n* WOCBP who are unwilling to use an effective method of contraception as defined in inclusion criterion above\n* Bell disability scale \\\u003C 30\n* Participation in another interventional clinical trial within the last 3 months or within five half-lives of the investigational product (whichever is longer)\n* Patient is institutionalized by order of court or public authority\n* Patient who might be dependent on the sponsor, the investigator or the trial site\n* Place of living does not allow the potential participant to attend the planned study visits\n* Other conditions that are likely to affect the safety of the study treatment (e.g. severely impaired immune status)",{"count":58,"type":22},138,[25],"Post-acute infectious syndrome (PAIS), including post-COVID-19 condition (PCC or Long COVID), can develop after an infection and may cause persistent symptoms such as fatigue, problems with memory and concentration (\"brain fog\"), mood changes, and reduced quality of life. In some people, these symptoms continue for months or longer and can substantially affect daily activities. Currently, there are no approved treatments that specifically target these symptoms.\n\nAripiprazole is a medicine that is approved to treat certain psychiatric disorders. At low doses, it may affect brain signaling and immune processes that are thought to contribute to symptoms experienced by people with PAIS. Small observational studies have suggested that low-dose aripiprazole may improve symptoms such as fatigue and cognitive impairment in people with related conditions, but its effectiveness and safety have not yet been confirmed in a randomized controlled trial.\n\nThe purpose of this study is to evaluate whether low-dose aripiprazole is safe and more effective than placebo in improving fatigue and other neuropsychiatric symptoms in adults with PAIS.\n\nThis is a phase 2b, randomized, double-blind, placebo-controlled crossover trial. Approximately 138 participants with PAIS will be enrolled. Participants will be randomly assigned to one of two treatment sequences. One group will receive low-dose aripiprazole for 8 weeks followed by placebo for 8 weeks. The other group will receive placebo first, followed by low-dose aripiprazole. The two treatment periods will be separated by a 2-week washout period. Neither the participants nor the study team will know which treatment is being given during each treatment period.\n\nThe primary objective is to determine whether low-dose aripiprazole improves fatigue after the first 8-week treatment period compared with placebo. Fatigue will be assessed using the Chalder Fatigue Questionnaire. Secondary objectives include evaluating the effects of treatment on physical functioning, quality of life, memory and cognitive performance, mood, post-exertional malaise, illness-related anxiety and distress, and fatigue in participants who meet diagnostic criteria for myalgic encephalomyelitis\u002Fchronic fatigue syndrome (ME\u002FCFS). Safety will be assessed throughout the study by monitoring adverse events.\n\nThe results of this study may help determine whether low-dose aripiprazole is a safe and effective treatment option for people with PAIS",[28,62],"Post-COVID-19 Condition (PCC or Long COVID)",[32,33,35,64],"Cognitive deficits","2026-07-15",{"date":67,"type":40},"2026-07-20",{"date":69,"type":22},"2026-10-01",{"date":71,"type":22},"2028-12-31",{"name":73,"class":47},"Christiana Franke"]