Status:
COMPLETED
Randomized Controlled Clinical Trial to Investigate Effects of Vitamin K2 in COVID-19
Lead Sponsor:
Canisius-Wilhelmina Hospital
Collaborating Sponsors:
Kappa Bioscience AS
Conditions:
Covid19
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Coronavirus disease 2019 (COVID-19) is caused by the severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2). While the majority of people recover after mild symptoms, a portion of COVID-19 patie...
Detailed Description
The outbreak of coronavirus 2019 disease (COVID-19) has a major impact on health care worldwide. This infectious disease is caused by the severe acute respiratory syndrome coronavirus (SARS-CoV-2). Th...
Eligibility Criteria
Inclusion
- COVID-19 patients who are admitted to the CWZ with COVID-19, with a laboratory confirmed SARS-CoV-2 infection within the previous 96 hours
- Respiratory failure requiring supplemental oxygen, defined as requiring supplemental oxygen to sustain an arterial PO2 ≥70mmHg (measured by arterial blood gas) or an oxygen saturation of ≥94% (measured using a pulse oximeter)
- At least 18 years old
- Able to safely swallow the study medication or possibility of safely administering this through a nasogastric tube
- Use of prophylactic heparin or LWMH according to hospital protocols, or use of therapeutic dosages if there is a medical indication for this
- Informed consent signed by patient
Exclusion
- Use of oral anticoagulation drugs; patients may be included when they have been switched to LMWH
- Patients on vitamin K antagonists with a supra-therapeutic anticoagulation at admission who require vitamin K supplementation to correct this, or were administered vitamin K for this reason within the preceding 5 days
- Patients already using vitamin K supplements at admission
- Participation in another intervention study
- Direct admission to an intensive care unit (ICU) for invasive ventilation at presentation
- Confirmed active pulmonary embolism or deep venous thrombosis prior to inclusion
- Known allergy to any of the components of the study medication or placebo
- Patients who are hemodialysis dependent at admission
- Pregnancy at the time of inclusion
- Diagnosed malignancy at the time of inclusion
Key Trial Info
Start Date :
February 22 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2022
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT04770740
Start Date
February 22 2021
End Date
March 1 2022
Last Update
June 13 2022
Active Locations (1)
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1
Canisius Wilhelmina Hospital
Nijmegen, Gelderland, Netherlands, 6532SZ