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Lactoferrin in the treatment of Long COVID

Lactoferrin in the treatment of Long COVID - LARGO-study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON50577
Enrollment
72
Registered
2021-12-08
Start date
2022-01-20
Completion date
Unknown
Last updated
2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Long-COVID

Interventions

Lactoferrin 4 x 300 mg capsules (total 1200 mg/day) (Bonusan) versus identical placebo capsules
given daily during 6 weeks.

Sponsors

Longziekten
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Subjects aged 18-70 years with proven COVID-19 (positive COVID-19 RT-PCR- or antibody test) - Persistent or newly developed long COVID symptoms at least 12 weeks post-primary SARS-CoV-2 infection - Patients with a positive COVID-19 RT-PCR- or antibody test not older than 9 months

Exclusion criteria

Exclusion criteria: - Patients admitted to the ICU (COVID-19-related) - COVID-19-related cardiac or pulmonary tissue damage - Acute infection or current systemic immunological disorders - Oral and/or inhaled use of corticosteroids or use of other immune-modulatory medication - Current psychiatric disorders - Communication difficulties - Pregnant or lactating women - Age >70 years - Patients with milk allergy or a known or suspected allergy or any contraindications to lactoferrin or microcrystalline cellulose (lactoferrin can be used by individuals with lactose intolerance)

Design outcomes

Primary

MeasureTime frame
Primary endpoint: Fatigue symptoms (measured with FAS) within 6 weeks and 3 months after initiation of intervention.

Secondary

MeasureTime frame
Secondary endpoints: Cognitive function (CFQ), Anxiety and depression (HADS), Inflammatory parameters in blood (e.g. IL-6, hsCRP) and muscle strength (Handgrip strength and 30sec Sit-to-Stand test).

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)