NCT05874037Befejeződött2/3. fázis
Fluvoxamine for Long COVID-19
Fluvoxamine as a Treatment for Long COVID-19: A Randomized Placebo Controlled Trial
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. okt. 7.
Rövid összefoglaló (regiszter, angolul)
This clinical trial aims to test the effects of fluvoxamine as a treatment for Long COVID. Fluvoxamine is an FDA approved SSRI for Obsessive Compulsive Disorder (OCD), that has already had success in preventing hospitalization in patients with COVID-19 (STOP COVID and TOGETHER trials). This trial is testing whether fluoxamine helps to improve symptoms and the negative impacts of long COVID in residents of Missouri and Illinois.
- Állapot (regiszter)
- Befejeződött
- Fázis (regiszter)
- 2/3. fázis
- Vizsgálattípus
- Beavatkozással járó
- Résztvevők száma
- 191 (tényleges)
- Első benyújtás
- 2023. máj. 22.
- Kezdés
- 2023. máj. 15.
- Elsődleges befejezés
- 2025. márc. 15.
- Fő szponzor
- Washington University School of Medicine
- Betegségek
- Long COVID és ME/CFS
- NCT-szám
- NCT05874037
Mit vállalsz
- Vizsgálat típusa: Beavatkozással járó · 2/3. fázis
- Bevont résztvevők: 191
- 2023. máj. 15. és az elsődleges befejezés (2025. márc. 15.) között
- 1 helyszín, 1 országban
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
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Korábbi kezelés
- Immunocompromised from the following: solid organ transplant, BMT, high dose steroids (>20mg prednisone per day), or tocilizumab
- Individuals who take alprazolam or diazepam and are unwilling to cut the medication by 25% (rationale: fluvoxamine modestly inhibits the metabolism of these drugs).
- Participants taking theophylline, tizanidine, clozapine, or olanzapine (drugs with a narrow therapeutic index that are primarily metabolized by CYP 1A2, which is inhibited by fluvoxamine) will be reviewed with a study investigator and excluded unless the investigator concludes that the risk to the participant is low (this would be unlikely; example: participant takes tizanidine only as needed and is willing to avoid it during study duration).
Más betegség
- Illness severe enough to require hospitalization at the time of starting the study.
- Already enrolled in another COVID 19 medication trial (not including vaccination or prophylaxis trials)
- Taking phenytoin (rationale: fluvoxamine inhibits its metabolism), clopidogrel (rationale: fluvoxamine inhibits its metabolism from pro-drug to active drug which raises risk of cardiovascular events), and St John's wort (rationale: fluvoxamine + St John's wort are considered contraindicated because of the risk of serotonin syndrome)
- Individuals who report they have bipolar disorder or are taking medication for bipolar disorder (lithium, valproate, high-dose antipsychotic), unless the investigator concludes that the risk for mania is unlikely (ie it is doubtful that the patient actually has bipolar disorder).
Egyéb
- Unstable medical comorbidities (eg decompensated cirrhosis), per patient report and/or medical records.
- Unable to provide informed consent
- Unable to perform the study procedures, including not being a resident of the states of Missouri or Illinois
- Taking donepezil (rationale: donepezil is a S1R agonist), or sertraline (rationale: sertraline is a strong sigma-1 antagonist).
- Taking SSRIs or SNRIs.
Kiket keres a vizsgálat
- Men and woman age 25 and older;
- Not currently hospitalized
- Participant self-report of past acute COVID episode with symptom onset and/or initial positive test at least 3 months since initial COVID symptoms and/or test confirming SARS-CoV-2 infection Note: Since some people with long COVID may not have been able to obtain testing during the acute phase of illness, history of a positive COVID-19 test is not required. We will collect data regarding the results of any past COVID-19 testing, but this will not affect eligibility for the trial.
- Currently symptomatic with self-reported worsening of cognitive function for at least the past 2 months, that could not be better explained by other reasons (i.e. alternative diagnosis or medication changes).
- Able to provide informed consent.
- Currently reside in Missouri or Illinois
Életkor a regiszterben: 25 év – - · Nem: nők és férfiak · Egészséges önkénteseket nem fogad
Helyszínek (1)
Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.
| Helyszín | Város | Ország | Helyszín állapota |
|---|---|---|---|
| Washington University School of Medicine | St Louis | Egyesült Államok | Ismeretlen állapot |
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