Summary
Fluvoxamine is tracked by OSMF as an investigational option for Long COVID; no regulator has approved it for this indication, and most post-viral conditions have no approved disease-modifying therapy at all. ClinicalTrials.gov lists 4 registered trials linking Fluvoxamine to Long COVID: 1 is currently recruiting; 3 have completed. The most advanced is Phase 3 (NCT04510194, sponsored by University of Minnesota). It plans or enrolled 1323 participants. Registration activity spans 2021 to 2026. The literature layer holds 14 publications for this pair: 1 systematic review, 4 clinical trial publications and 9 other publications. Because at least one synthesis-level source exists (systematic review, meta-analysis or Cochrane review), this pair has been assessed beyond single studies, although the synthesis may concern a different indication.
Long COVID / PASC is tracked on the OSMF post-viral programme alongside ME/CFS, Long COVID, POTS and MCAS. Across the programme, 423 candidate agents are logged for Long COVID, most of them preliminary; this page isolates the record for one of them.
Evidence table
| Evidence tier | B · Moderate |
|---|---|
| Evidence score | 47.5 (trials 17.5, literature 20.0, tier 10, approved bonus 0.0) |
| Registered trials | 4 total: 1 recruiting, 0 active / not yet recruiting, 3 completed, 0 other |
| Linked publications | 14 (9 other publications, 4 clinical trial publications, 1 systematic review) |
| Agent type | Drug (Drug (Pharmaceutical)) |
| Development stage (any indication) | Investigational |
| Mechanism / class | Anti-inflammatory |
| Data sources | OSMF therapeutic agent database, ClinicalTrials.gov, PubMed |
How the evidence score is calculated
- Each registered trial scores by status (recruiting / active / enrolling 3, completed 2.5, not yet recruiting 2, unknown 1, terminated / withdrawn / suspended 0.5) plus a phase bonus (phase 3-4 +2, phase 2 +1, phase 1 +0.5). The trial component is capped at 30.
- Each literature item scores by design (Cochrane review 5, meta-analysis 4, systematic review 3, RCT 3, clinical trial publication 2, curated reference 1.5, other PubMed record 1). The literature component is capped at 30.
- The existing evidence tier adds 15 (A / Strong), 10 (B / Moderate), 5 (C / Preliminary) or 0 (D / Anecdotal).
- Agents approved for any indication (max clinical phase 4) add 5, because an approved agent has an established safety profile that lowers the barrier to repurposing trials.
- The score ranks what has been studied, not what works. It does not read effect sizes or directions of effect.
Registered clinical trials
| NCT ID | Title | Status | Phase | Enrolment |
|---|---|---|---|---|
| NCT04510194 | COVID-OUT: Early Outpatient Treatment for SARS-CoV-2 Infection (COVID-19) University of Minnesota · 2021 | completed | Phase 3 | 1,323 |
| NCT06128967 | A Multicenter, Adaptive, Randomized, doublE-blinded, Placebo-controlled Study in Participants With Long COVID-19: The REVIVE Trial Cardresearch · 2023 | completed | Phase 3 | 399 |
| NCT07359482 | sElective Serotonin reuPtake inhibitoRs In posT-covid After COVID-19 Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) · 2026 | recruiting | Phase 3 | 160 |
| NCT05874037 | Fluvoxamine for Long COVID-19 Washington University School of Medicine · 2023 | completed | Phase 2 | 191 |
Published literature
- Clinical trial publication (PubMed validation search) PubMed record PMID 41911553
- Clinical trial publication (PubMed validation search) PubMed record PMID 38690892
- Clinical trial publication (PubMed validation search) PubMed record PMID 37302406
- Clinical trial publication (PubMed validation search) PubMed record PMID 37003990
- Review (PubMed validation search) PubMed record PMID 39313202
- Review (PubMed validation search) PubMed record PMID 38782355
- Review (PubMed validation search) PubMed record PMID 37402856
- Review (PubMed validation search) PubMed record PMID 36968793
- Review (PubMed validation search) PubMed record PMID 36946597
- Review (PubMed validation search) PubMed record PMID 35420565
- Review (PubMed validation search) PubMed record PMID 34236922
- Experimental study (PubMed validation search) PubMed record PMID 37333243
- Experimental study (PubMed validation search) PubMed record PMID 34342416
- Systematic review (PubMed validation search) PubMed record PMID 38862591
Mechanism and notes
Recorded mechanism or class: Anti-inflammatory.
Clinical notes: Sigma-1 + SSRI; early COVID + some Long COVID data. 50-100mg. CYP interactions, GI/insomnia. Preliminary for select symptoms; not core fatigue/autonomic first choice.
Safety: Nausea, insomnia, somnolence; significant CYP1A2 and CYP2C19 interactions. Avoid in combination with thioridazine, pimozide. Monitor for serotonin syndrome if combined with other serotonergics.
Dosing in studies: 50–100 mg/day (often 100 mg); short courses (10–15 days) in early studies; some PASC protocols 4–8 weeks.
Frequently asked questions
Is Fluvoxamine approved for Long COVID?
Fluvoxamine is tracked by OSMF as an investigational option for Long COVID; no regulator has approved it for this indication, and most post-viral conditions have no approved disease-modifying therapy at all. Approval status for the specific indication should always be confirmed with the relevant regulator and prescribing information.
Is Fluvoxamine in clinical trials for Long COVID?
ClinicalTrials.gov lists 4 registered trials linking Fluvoxamine to Long COVID: 1 is currently recruiting; 3 have completed. The most advanced is Phase 3 (NCT04510194, sponsored by University of Minnesota). It plans or enrolled 1323 participants. Registration activity spans 2021 to 2026.
What does the evidence show for Fluvoxamine in Long COVID?
Fluvoxamine has both completed registered trials and synthesis-level publications linked to Long COVID. That is the strongest profile in this database, but the summaries here do not extract effect sizes, so read the linked reviews for direction and magnitude of benefit. OSMF's existing evidence tier for this pair is B (Moderate), taken from the OSMF therapeutic agent database, which grades agents by the volume and design of condition-specific evidence rather than by effect size.
Cite this page
Data: ClinicalTrials.gov, PubMed, Open Targets, ChEMBL, DGIdb and the OSMF therapeutic agent database. Last updated 2026-10-07. Page built 2026-10-07.