actoferrin in the treatment of Long COVID
- Conditions
- Long-COVID10047438
- 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
- 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
- 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
Name Time Method <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
Name Time Method <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>