| Trial registration number
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NL9742 |
Full text link
Last imported at : Sept. 29, 2021, 7 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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https://trialregister.nl/trial/9742
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First author
Last imported at : Sept. 29, 2021, 7 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Gert-Jan Braunstahl
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Contact
Last imported at : Sept. 29, 2021, 7 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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g.braunstahl@franciscus.nl
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Registration date
Last imported at : Sept. 29, 2021, 7 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
|
2021-09-23
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Recruitment status
Last imported at : Jan. 21, 2022, 2 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Recruiting
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Study design
Last imported at : Sept. 29, 2021, 7 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
|
RCT
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Allocation
Last imported at : Sept. 29, 2021, 7 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Randomized
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Design
Last imported at : Sept. 29, 2021, 7 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
|
Parallel
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Masking
Last imported at : Sept. 29, 2021, 7 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Blind label
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Center
Last imported at : Sept. 29, 2021, 7 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
|
unclear
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Study aim
Last imported at : Sept. 29, 2021, 7 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
|
Long covid
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Inclusion criteria
Last imported at : Sept. 29, 2021, 7 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
|
- 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- Adult patients with age >18 years
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Exclusion criteria
Last imported at : Sept. 29, 2021, 7 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
|
- 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)
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Number of arms
Last imported at : Sept. 29, 2021, 7 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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2
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Funding
Last imported at : Sept. 29, 2021, 7 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Stichting O&O Franciscus Gasthuis & Vlietland
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Inclusion age min
Last imported at : Sept. 29, 2021, 7 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
|
18
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Inclusion age max
Last imported at : Sept. 29, 2021, 7 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
|
70
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Countries
Last imported at : Sept. 29, 2021, 7 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Netherlands
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Type of patients
Last imported at : Sept. 29, 2021, 7 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Patients recovered from covid
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Severity scale
Last imported at : Sept. 29, 2021, 7 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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N/A
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Total sample size
Last imported at : Sept. 29, 2021, 7 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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72
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primary outcome
Last imported at : Sept. 29, 2021, 7 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
|
- Do fatigue symptoms diminish faster with the use of lactoferrin combined with usual care compared to usual care solely?
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Notes
Last imported at : Sept. 29, 2021, 7 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
|
|
Phase
Last imported at : Sept. 29, 2021, 7 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
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Not reported
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Arms
Last imported at : Jan. 21, 2022, 2 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)
|
[{"arm_notes": "", "treatment_id": 711, "treatment_name": "Lactoferrin", "treatment_type": "Vitamins and dietary supplements", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]
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