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A Study of Fluvoxamine for Reducing Fatigue in Patients with Post-COVID Condition

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What is this study about?

This study is looking at post COVID condition, which refers to ongoing health problems that continue or develop after having COVID-19. One of the main symptoms that many people experience after COVID-19 is severe tiredness that does not go away, also called fatigue. Some people also have difficulty thinking clearly, experience worsening of symptoms after physical or mental activity, or have problems with their heart rate and blood pressure when standing up. The study will test whether a medication called fluvoxamine can help reduce fatigue in people who continue to feel severely tired after having COVID-19. Some participants will receive fluvoxamine while others will receive placebo.

The purpose of the study is to find out if fluvoxamine treatment, given at doses between 50 and 200 milligrams per day, leads to lower levels of fatigue compared to placebo after 13 weeks of treatment. Fluvoxamine is a medication that affects certain chemical messengers in the brain, particularly one called serotonin. During the study, participants will take either fluvoxamine or placebo by mouth for about 13 weeks. The study will measure how severe the fatigue is, how well people can think and concentrate, and how their overall quality of life is affected.

The study will also look at other symptoms that can occur after COVID-19, such as the worsening of symptoms after activity and problems with heart rate changes when standing. Researchers will collect blood samples to measure various substances in the body that might be related to inflammation and other biological processes. Some participants may also have the option to take part in a smaller additional study that uses Magnetic Resonance Imaging, a type of scan that creates detailed pictures of the brain, to see how blood flow and brain activity might be affected in people with post COVID symptoms. The study will also track any side effects that participants might experience from the medication.

1 Treatment period begins

The treatment period starts once participation in the study is confirmed.

You will receive either fluvoxamine tablets or placebo tablets. Fluvoxamine is a medication that affects serotonin levels in the brain and may help reduce fatigue. A placebo looks identical to the medication but contains no active substance.

The tablets are film-coated and taken by mouth.

The dosage will range from 50 mg to 200 mg daily, depending on the treatment plan assigned to you.

This treatment will continue for 13 weeks.

2 Regular assessments during treatment

Throughout the 13-week treatment period, your condition will be assessed through questionnaires.

You will complete questionnaires about fatigue severity using scales that measure how tired you feel and how fatigue affects your daily activities.

Questionnaires will also assess cognitive functioning, which refers to your ability to concentrate, remember information, and perform mental tasks.

You will be asked about Post Exertional Malaise, which means worsening of symptoms after physical or mental effort.

Assessment of Postural Orthostatic Tachycardia Syndrome will be conducted. This condition involves an abnormal increase in heart rate when standing up. A NASA lean test may be performed to evaluate this.

Your health-related quality of life will be measured, including how your condition affects your daily functioning and disability level.

You will report any side effects experienced during treatment, as well as any withdrawal symptoms if applicable.

Blood samples will be collected to measure biomarkers. These are substances in your blood that can indicate inflammation, stress hormone levels, and other biological processes related to your condition.

3 Video call participation

You will participate in assessments through video calling at scheduled times during the study.

These video calls allow for remote monitoring of your progress and completion of certain assessments.

4 Optional brain imaging substudy

If you choose to participate in the optional brain imaging substudy, you will undergo Magnetic Resonance Imaging scans. This is a type of scan that uses magnets and radio waves to create detailed images of the brain.

Arterial Spin Labeling MRI will measure blood flow in your brain.

Functional MRI will assess how your brain functions during rest and while performing cognitive tasks. You will be asked to complete memory tasks during the scan.

Magnetic Resonance Spectroscopy will measure chemical substances in your brain that may indicate inflammation or other changes.

These scans are optional and not required for participation in the main study.

5 Assessment at week 13

At the end of the 13-week treatment period, a final assessment of your fatigue severity will be conducted.

This assessment is the main measure used to determine the effect of the treatment.

All other measurements described in previous steps will also be completed at this time point.

Who Can Join the Study?

  • You must be between 18 and 70 years old
  • You must have severe fatigue, which means scoring 35 or higher on a specific fatigue measurement scale
  • Your fatigue must have started or gotten much worse after having COVID-19, which is the illness caused by the coronavirus
  • You must be able to confirm that you had a SARS-CoV-2 infection, which is the virus that causes COVID-19, through one of these ways: a positive laboratory test such as PCR (a type of test that detects the virus genetic material), a positive rapid test including tests done at home, or a COVID-19 diagnosis made by a doctor based on tests or medical assessments
  • You must be able to read and complete questionnaires in Dutch or English
  • You must be able to participate in video calls
  • You must be willing and able to give your informed consent, which means agreeing to participate after understanding what the study involves
  • You must allow the research team to share medical information that is important for your safety and study assessments with your general practitioner (your regular doctor) and your pharmacy

Who Cannot Join the Study?

  • No exclusion criteria have been specified in the available study information

Where you can join this trial?

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Other Sites

Site Name City Country Status
Antkztgtc Uxs Amsterdam The Netherlands

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
The Netherlands The Netherlands
Recruiting
01.11.2025

Trial locations

Fluvoxamine is a medication that belongs to a group of medicines called selective serotonin reuptake inhibitors, which are commonly used to treat depression and anxiety disorders. In this trial, fluvoxamine is being tested to see if it can help reduce severe tiredness and fatigue in people who continue to experience symptoms after having COVID-19.

Placebo is an inactive substance that looks like the real medication but contains no active medicine. It is used in the trial to compare the effects of fluvoxamine against no treatment, helping researchers understand if the medication truly works.

Investigated diseases:

Post-COVID-19 Condition – Post-COVID-19 condition, also known as long COVID, is a health problem that occurs in people who have had COVID-19 and continue to experience symptoms weeks or months after the initial infection has cleared. People with this condition often suffer from severe and persistent tiredness that interferes with daily activities. Many patients also experience difficulties with concentration and thinking clearly, which can affect their work and personal life. Some individuals develop post-exertional malaise, meaning their symptoms worsen after physical or mental effort. Additionally, some patients may experience postural orthostatic tachycardia syndrome, where their heart rate increases abnormally when standing up. The condition can significantly reduce quality of life and ability to perform everyday tasks.

Trial ID:
2024-519540-32-00
Trial Phase:
Human Pharmacology (Phase I) – Other

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