Abstract
Background Long-COVID is a heterogeneous condition with a variety of symptoms which persist at least 3 months after SARS-CoV-2 infection with often profound impact on quality of life. Lactoferrin is an iron-binding glycoprotein with anti-inflammatory and anti-viral properties. Current hypothesises regarding long-COVID aetiology include ongoing immune activation, viral persistence, and auto-immune dysregulation. Therefore, we hypothesized that long-COVID patients may potentially benefit from lactoferrin treatment.
Aims To investigate the effect of lactoferrin on various long-COVID domains: fatigue, anxiety, depression, cognitive failure, and muscle strength.
Methods We performed a randomized, double-blind placebo-controlled trial in long-COVID patients aged 18–70 years within 12 months after proven SARS-CoV-2 infection. Patients were randomized (1:1) to 6 weeks lactoferrin (1200 mg daily) or placebo. At 3 hospital visits (T0, T6, and T12 weeks) patient reported outcome measures (PROMs) were collected, physical performance tests were performed, and blood was drawn. The difference in fatigue at T6 was the primary outcome.
Results Seventy-two participants were randomized to lactoferrin (N=36) or placebo (N=36). We showed a significant decrease in fatigue between T0 and T6 in both study arms, but without significant difference between the study arms, respectively 3.9 [95% CI: 2.3–5.5] and 4.1 [95% CI: 2.3–5.9](p=0.007 and p=0.013). In none of the other outcomes a significant difference was found in favour of the lactoferrin arm at T6 or T12.
Conclusion 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 PROMs or physical functioning.
Footnotes
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Conflict of interest: None of the authors have any conflicts of interest to report.
Funder: This study was supported by Chiesi Farmaceutici S.p.A, Via Palermo 26 A, 43122, Parma, Italy.
Conflict of interest: M.E. Hellemons reports consulting fees from Takeda, Pfizer, outside the submitted work; Payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing or educational events for Boehringer Ingelheim, outside the submitted work; current editorial board member for the ERJ Open Research, disclosure made outside the submitted work.
Conflict of interest: Gert-Jan Braunstahl reports support for the present manuscript from Bonusan B.V. Grants or contracts from Sanofi, GSK, AstraZeneca, outside the submitted work; consulting fees from GSK, Novartis, AstraZeneca, Sanofi, outside the submitted work; Payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing or educational events for GSK, Sanofi, AstraZeneca, outside the submitted work; Chairman NVALT asthma section, Secretary ERS task force Allergy and Immunology, and Scientific advisory board Longfonds, disclosures made outside the submitted work.
Conflict of interest: Laurien Oswald reports payment or honoraria from STichting medische opleidingen for lectures, disclosure made outside the submitted work.
Conflict of interest: Anne-Lotte Redel has nothing to disclose.
Conflict of interest: Fatana Miry has nothing to disclose.
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- Received January 12, 2024.
- Accepted March 16, 2024.
- Copyright ©The authors 2024
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