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Efficacy and safety of rivaroxaban, colchicine, and famotidine–loratadine with specialist supportive clinical care for fatigue in patients with post-COVID-19 condition in the UK: a multisite, open-label, randomised controlled trial
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Efficacy and safety of rivaroxaban, colchicine, and famotidine–loratadine with specialist supportive clinical care for fatigue in patients with post-COVID-19 condition in the UK: a multisite, open-label, randomised controlled trial

The Lancet Infectious Diseases·July 8Open Access
Infectious DiseasesPractice changingFatiguePost-COVID-19 ConditionRandomized Controlled TrialAnti-InflammatoryAnticoagulantAntihistamineH2 Receptor AntagonistAdultClaritinXareltoColchicineFamotidineLoratadineRivaroxaban

Summary

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What was studied

This phase 3, open-label RCT evaluated whether colchicine (500 µg twice daily), rivaroxaban (10 mg once daily), or famotidine–loratadine (40 mg/10 mg once daily) reduced fatigue versus usual care alone over 12 weeks in 778 non-hospitalised UK adults with long COVID, using the Fatigue Assessment Scale (FAS) as the primary endpoint.

Key findings

All groups improved: mean FAS dropped ~4.3 points across the board (36.8 → 32.5). Colchicine (−1.49 pts, p=0.041) and famotidine–loratadine (−1.48 pts, p=0.038) showed small but statistically significant additional reductions vs. no drug; rivaroxaban did not (−1.06 pts, p=0.139). Crucially, these differences were gone at 24 weeks (12 weeks after stopping). Serious adverse events occurred in 8 of 778 participants (1.0%), with 5 events in 3 rivaroxaban-group patients.

Study limitations

- Open-label design may introduce bias in patient-reported fatigue scores. - Effect sizes (~1.5 FAS points) are well below the pre-specified clinically meaningful threshold of >4.6 points (>10% of 46-point scale). - Benefits did not persist after drug withdrawal, limiting long-term clinical relevance.

Clinical implications

These three repurposed drugs are unlikely to provide meaningful or lasting fatigue relief for unselected long COVID patients — do not routinely prescribe them for this indication. Future research should focus on defined subgroups, combination regimens, or alternative delivery strategies.

Caveats

  • Rivaroxaban serious adverse events (5 events in 3 patients) are noted but described as unrelated to the trial drug; causality cannot be fully excluded in an open-label setting.
  • The adaptive platform design nested within a cluster-RCT (ICP trial) introduces complexity; subgroup analyses by site type (ICP vs. drug-only) are not reported in the abstract.
  • The 'practice_changing' flag is applied because this large RCT provides direct evidence against routine use of these drugs for long COVID fatigue — a negative/null practice-changing finding.
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  • The trial is open-label, which is a known risk of bias for subjective patient-reported outcomes like fatigue scales.

Related Questions

Explore related topics

What treatments are effective for fatigue in long COVID patients?Are anticoagulants like rivaroxaban beneficial in post-COVID-19 syndrome?What is the role of anti-inflammatory drugs in managing long COVID symptoms?

Publication Details

Year
2026
Journal
The Lancet Infectious Diseases
Sample Size
n=778
Source
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