To reduce fatigue symptoms with the use of a bovine lactoferrin supplement in patients suffering from Long COVID.
ID
Source
Brief title
Condition
- Viral infectious disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary endpoint: Fatigue symptoms (measured with FAS) within 6 weeks and 3
months after initiation of intervention.
Secondary outcome
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).
Background summary
Lactoferrin is an antimicrobial iron-binding glycoprotein that can modulate the
immune system and lower oxidative stress levels. Recent evidence indicates a
faster recovery from (acute) COVID-19 after using (bovine) lactoferrin
supplements. Yet, the effect of lactoferrin in patients suffering from long
COVID has not yet been studied. Since immune dysregulation, higher oxidative
stress levels and viral persistence could explain at least part of the Long
COVID persisting symptoms, including fatigue, muscle weakness, cognitive
dysfunction and anxiety and depression, we want to initiate a clinical- and
laboratory study looking into the effects of bovine lactoferrin in these
patients.
Study objective
To reduce fatigue symptoms with the use of a bovine lactoferrin supplement in
patients suffering from Long COVID.
Study design
Investigator-initiated double-blind randomized controlled trial.
Intervention
Lactoferrin 4 x 300 mg capsules (total 1200 mg/day) (Bonusan) versus identical
placebo capsules; given daily during 6 weeks.
Study burden and risks
Bovine lactoferrin is a food ingredient that has been used for years in infant
and follow-up formulae and is an approved food supplement. It has antimicrobial
properties and can modulate the immune system and lower oxidative stress
levels.
The burden is regarded as low; participants have to take 2 capsules 2 times a
day for 6 weeks (total 1200 mg daily). Lactoferrin in these concentrations is
considered safe by the European Food Safety Authority (EFSA) and is without
risk of adverse effects. The 6- and 12-week visits will be scheduled as much as
possible together with regular doctor's visits. During these time points, 18 ml
of blood will be taken, as well as questionnaires and 2 muscle strength tests.
Kleiweg 500
Rotterdam 3055AP
NL
Kleiweg 500
Rotterdam 3055AP
NL
Listed location countries
Age
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)
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL79017.100.21 |
| Other | NL9742 |