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actoferrin in the treatment of Long COVID

Completed
Conditions
Long-COVID
10047438
Registration Number
NL-OMON50577
Lead Sponsor
ongziekten
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
Not specified
Target Recruitment
72
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

- 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)

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
<p>Primary endpoint: Fatigue symptoms (measured with FAS) within 6 weeks and 3<br /><br>months after initiation of intervention.</p><br>
Secondary Outcome Measures
NameTimeMethod
<p>Secondary endpoints: Cognitive function (CFQ), Anxiety and depression (HADS),<br /><br>Inflammatory parameters in blood (e.g. IL-6, hsCRP) and muscle strength<br /><br>(Handgrip strength and 30sec Sit-to-Stand test).</p><br>
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