BridgeMD
ESPRIT study
EU CTIS ID: 2024-519540-32-00
What this study is testing
To determine if fluvoxamine treatment (50 mg to 200 mg daily dosing) results in lower levels of fatigue severity than placebo after 12 weeks of treatment.
- Phase III and phase IV (Integrated)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Adults aged 18 to 70 years
- Severely fatigued (CIS fatigue score ≥ 35) at screening
- Fatigue started/increased significantly after Covid-19 (self-declared)
- Self-reported confirmation of having a SARS-CoV-2 infection by: • Positive SARS-CoV-2 nucleic acid amplification test (NAAT), such as PCR; • Positive SARS-CoV-2 rapid diagnostic test, including home-administered tests; • COVID-19 diagnosis by a medical specialist (GP or in-hospital), based on the above or other clinical test or assessments.
- Command of Dutch or English language to complete questionnaires
- Able to participate in video calling
You likely can't join if
- Use of medication with interaction with fluvoxamine that cannot be discontinued
- Hospitalized in the acute phase of Covid-19
- Psychiatric/somatic disorders that could explain the severity of fatigue
- Neurodegenerative disorders (i.e. M Parkinson, Multiple sclerosis, M Alzheimer)
- Suicidality (current or recent) (according to validated WHO suicide screener)
- Starting or started with other medication intended to reduce post-covid symptoms during the last 2 months
See the full eligibility criteria
- Adults aged 18 to 70 years
- Severely fatigued (CIS fatigue score ≥ 35) at screening
- Fatigue started/increased significantly after Covid-19 (self-declared)
- Self-reported confirmation of having a SARS-CoV-2 infection by: • Positive SARS-CoV-2 nucleic acid amplification test (NAAT), such as PCR; • Positive SARS-CoV-2 rapid diagnostic test, including home-administered tests; • COVID-19 diagnosis by a medical specialist (GP or in-hospital), based on the above or other clinical test or assessments.
- Command of Dutch or English language to complete questionnaires
- Able to participate in video calling
- Willing and able to provide informed consent
- Allowing the trial team to exchange medical information that is relevant for the participants’ safety and trial assessments with their general practitioner and pharmacy.
- Use of medication with interaction with fluvoxamine that cannot be discontinued
- Hospitalized in the acute phase of Covid-19
- Psychiatric/somatic disorders that could explain the severity of fatigue
- Neurodegenerative disorders (i.e. M Parkinson, Multiple sclerosis, M Alzheimer)
- Suicidality (current or recent) (according to validated WHO suicide screener)
- Starting or started with other medication intended to reduce post-covid symptoms during the last 2 months
- Pregnancy (a positive urine or serum pregnancy test)/ unwilling to use standard contraception
- Brugada- or Long QT interval syndrome
- epilepsy, porphyria, history of severe liver impairment
- • Clinical laboratory test results at the baseline visit requiring immediate medical attention (refer to Appendix 6 and 7).
- known allergies to fluvoxamine or placebo/excipients
- known current alcohol or drug use problems
- Bleeding disorders and past medical history of bleeding gastric or duodenal ulcers or other significant bleeding disorders
- Additional exclusion criteria optional neuro-imaging sub-study: claustrophobia
- Additional exclusion criteria optional neuro-imaging sub-study: having metal implants
- Additional exclusion criteria optional neuro-imaging sub-study: inability to lay still for 45 minutes
- Additional exclusion criteria optional neuro-imaging sub-study: Neurotrauma/ large stroke or brain abnormalities interfering with image analyses
- Additional exclusion criteria optional neuro-imaging sub-study: Inability to come to the Amsterdam UMC
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.