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New treatment option for Post-COVID
Official title sElective Serotonin reuPtake inhibitoRs In posT-covid After COVID-19
ClinicalTrials.gov ID: NCT07359482
What this study is testing
What is Fluvoxamine?
Fluvoxamine is an investigational medicine, given as an once-daily, being studied as a potential treatment for post-covid.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Fatigue, cognitive problems, post-exertional malaise (PEM) and postural orthostatic tachycardia syndrome (POTS) are common and debilitating symptoms after COVID-19. The pathophysiology of post-COVID is not well understood and there is no established biomedical treatment.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70
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)
- Fatigue symptoms must be present for at least 3 months following the acute infection.
- Self-reported confirmation of having a SARS-CoV-2 infection by: Positive SARS-CoV-2 nucleic acid amplification test (NAAT), such as PCR; Positive...
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 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)
- Fatigue symptoms must be present for at least 3 months following the acute infection.
- 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...
- 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 GP 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 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) or unwilling to use standard contraception
- Brugada- or Long QT interval syndrome
- epilepsy, porphyria, history of severe liver impairment
- 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
- claustrophobia (optional MRI substudy)
- having metal implants (optional MRI substudy)
- inability to lay still for 45 minutes (optional MRI substudy)
- Neurotrauma/ large stroke or brain abnormalities interfering with image analyses (optional MRI substudy)
- Inability to come to the Amsterdam UMC (optional MRI substudy).
The study team makes the final eligibility decision.
Where it's taking place
- Amsterdam-Zuidoost, Netherlands
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 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Amsterdam-Zuidoost, Netherlands. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.