Effect of lactoferrin treatment on symptoms and physical performance in long COVID patients: a randomised, double-blind, placebo-controlled trial
Anne-Lotte Redel, Fatana Miry, Merel Elise Hellemons, Laurien Maria, Amarentia Oswald, Gerrit Johannes Braunstahl
doi:10.1183/23120541.00031-2024].
The randomised, double-blind, placebo-controlled LARGO trial investigated the effect of lactoferrin on long COVID symptoms. In both long COVID arms, clinical outcomes improved after 6 weeks without benefit for lactoferrin compared to placebo. https://bit.ly/3TvXHFC
Conflict of interest: A-L. Redel and F. Miry have nothing to disclose. M.E. Hellemons reports honoraria for lectures and consultancy from Boehringer Ingelheim, Pfizer and Takeda, unrelated to this study; and is an associate editor of this journal. L.M.A. Oswald reports honoraria for lectures from Stichting Medische Opleidingen. G.J. Braunstahl reports support for the present manuscript from Bonusan B.V.; honoraria for lectures and consultancy from GSK, AstraZeneca, Novartis and Sanofi Genzyme; and research grants from Sanofi Genzyme, GSK and AstraZeneca, not related to this study; and is Chairman of the NVALT Asthma Section, Secretary of the ERS Task Force on Allergy and Immunology and on the Scientific Advisory Board of Longfonds. Support statement: Bonusan B.V. contributed to this study by kindly providing the lactoferrin and placebo capsules. Bonusan B.V. had no influence on the study design, the execution of the study and the analysis of the study outcomes.
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'abstract': '<jats:sec><jats:title>Background</jats:title><jats:p>Long COVID is a heterogeneous condition '
'with a variety of symptoms that persist at least 3\u2005months after SARS-CoV-2 infection, '
'often with a profound impact on quality of life. Lactoferrin is an iron-binding glycoprotein '
'with anti-inflammatory and antiviral properties. Current hypotheses regarding long COVID '
'aetiology include ongoing immune activation, viral persistence and auto-immune dysregulation. '
'Therefore, we hypothesised that long COVID patients may potentially benefit from lactoferrin '
'treatment. The aims of the present study were to investigate the effect of lactoferrin on '
'various long COVID domains: fatigue, anxiety, depression, cognitive failure and muscle '
'strength.</jats:p></jats:sec><jats:sec><jats:title>Methods</jats:title><jats:p>We performed a '
'randomised, double-blind, placebo-controlled trial in long COVID patients aged 18–70\u2005'
'years within 12\u2005months after proven SARS-CoV-2 infection. Patients were randomised (1:1) '
'to 6\u2005weeks of lactoferrin (1200\u2005mg daily) or placebo. At three hospital visits (T0, '
'T6 and T12\u2005weeks), patient-reported outcome measures were collected, physical '
'performance tests were performed and blood was drawn. The difference in fatigue at T6 was the '
'primary outcome.</jats:p></jats:sec><jats:sec><jats:title>Results</jats:title><jats:p>72 '
'participants were randomised to lactoferrin (n=36) or placebo (n=36). We found a significant '
'decrease in fatigue, as measured with the Fatigue Assessment Scale, between T0 and T6 in both '
'study arms, but without significant difference between the study arms (lactoferrin: 3.9, 95% '
'CI 2.3–5.5, p=0.007; placebo: 4.1, 95% CI 2.3–5.9, p=0.013). No significant differences were '
'found in any of the other outcomes in favour of the lactoferrin arm at T6 or '
'T12.</jats:p></jats:sec><jats:sec><jats:title>Conclusion</jats:title><jats:p>Although both '
'long COVID arms showed improved clinical outcomes at T6, the improvement did not continue '
'until T12. Lactoferrin provided no benefit in terms of fatigue, other patient-reported '
'outcome measures or physical functioning.</jats:p></jats:sec>',
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