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Sponsor: Christiana Franke
Conditions: Post-acute Infectious Syndrome (PAIS), Post-COVID-19 Condition (PCC or Long COVID)
Interventions: Aripiprazole (low-dose, 1mg), Placebo
Countries: Germany
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. Aripiprazole 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. The 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. This 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. The 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/chronic fatigue syndrome (ME/CFS). Safety will be assessed throughout the study by monitoring adverse events. The results of this study may help determine whether low-dose aripiprazole is a safe and effective treatment option for people with PAIS
Sex: ALL
Age: 18 Years to —
Healthy volunteers: No
Study type: INTERVENTIONAL
Inclusion Criteria: * Male, female or diverse adult who is 18 years or older at the time of informed consent * Potential participant is willing, understanding and able to provide informed consent * Signed informed consent prior to initiation of any trial-related measure * History of confirmed or suspected (PCR or serology or rapid antigen detection, certificate of attending physician, sick note) infectious disease * Ongoing symptoms of PAIS/PCC for ≥ 3 months * Self-reported neuropsychiatric symptoms at screening * For women of childbearing potential (WOCBP): 1. Confirmed post-menopausal state, defined as amenorrhea for at least 12 months, or 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%) Exclusion Criteria: * Prior chronic neuroimmunological or neurodegenerative disease * Severe psychiatric disease (psychosis, bipolar disorder, severe major depression with inpatient treatment) within the last 10 years * Current malignant disease (including space-occupying brain tumors) * Concomitant antipsychotic medication * Patient is allergic or has contraindication to Aripiprazole or lactulose and cellulose * Patient is pregnant or breastfeeding * WOCBP who are unwilling to use an effective method of contraception as defined in inclusion criterion above * Bell disability scale \< 30 * Participation in another interventional clinical trial within the last 3 months or within five half-lives of the investigational product (whichever is longer) * Patient is institutionalized by order of court or public authority * Patient who might be dependent on the sponsor, the investigator or the trial site * Place of living does not allow the potential participant to attend the planned study visits * Other conditions that are likely to affect the safety of the study treatment (e.g. severely impaired immune status)
- Berlin, State of Berlin, Germany