Summary
Montelukast Tablets Oral Treatment 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 1 registered trial linking Montelukast Tablets Oral Treatment to Long COVID: 1 is active or not yet recruiting. None of the registered studies carries a drug-development phase label, which is typical for behavioural, device and supplement protocols. It plans or enrolled 632 participants. Registered activity dates to 2025. No published literature item is linked to Montelukast Tablets Oral Treatment and Long COVID in the OSMF database yet, so the record rests on registry entries alone. Registry entries describe intent to study, not outcomes.
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 | C · Preliminary |
|---|---|
| Evidence score | 7.0 (trials 2.0, literature 0.0, tier 5, approved bonus 0.0) |
| Registered trials | 1 total: 0 recruiting, 1 active / not yet recruiting, 0 completed, 0 other |
| Linked publications | 0 |
| Agent type | Behavioural (Behavioral / Protocol / Exercise) |
| Development stage (any indication) | Investigational |
| Mechanism / class | Immunomodulatory |
| Data sources | OSMF therapeutic agent database, ClinicalTrials.gov |
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trial scores by status (recruiting / active / enrolling 3, completed 2.5, not yet recruiting 2, unknown 1, terminated / withdrawn / suspended 0.5) plus a phase bonus (phase 3-4 +2, phase 2 +1, phase 1 +0.5).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 |
|---|---|---|---|---|
| NCT06597682 | Evaluating Immunomodulatory Interventions in Post-Acute Sequelae of SARS-CoV-2 InfEction Huashan Hospital · 2025 | not yet recruiting | Not applicable | 632 |
Published literature
No publication is linked to this pair yet.
Mechanism and notes
Recorded mechanism or class: Immunomodulatory.
Clinical notes: Leukotriene antagonist (10mg daily) for MCAS/inflammatory overlap. Supported by MCAS obs + urticaria RCTs. Low-risk add-on.
Safety: Limited specific safety data in these populations. Review full prescribing information and consult specialist. Many agents used off-label or investigational.
Dosing in studies: See linked studies/trials for reported doses and durations; typical protocols vary widely.
Frequently asked questions
Is Montelukast Tablets Oral Treatment approved for Long COVID?
Montelukast Tablets Oral Treatment 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 Montelukast Tablets Oral Treatment in clinical trials for Long COVID?
ClinicalTrials.gov lists 1 registered trial linking Montelukast Tablets Oral Treatment to Long COVID: 1 is active or not yet recruiting. None of the registered studies carries a drug-development phase label, which is typical for behavioural, device and supplement protocols. It plans or enrolled 632 participants. Registered activity dates to 2025.
What does the evidence show for Montelukast Tablets Oral Treatment in Long COVID?
Trials of Montelukast Tablets Oral Treatment in Long COVID are registered but none has completed, so there is no outcome evidence from those studies yet; the record is a signal of research interest. OSMF's existing evidence tier for this pair is C (Preliminary), 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.