coronavirus infection
Conditions
Interventions
vitamin K2 MK-7 3 tablets of 333mcg 1dd / placebo
Sponsors
Canisius Wilhelmina Ziekenhuis
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: COVID-19 patients who are admitted to the CWZ with COVID-19 as primary reason for admission, with a laboratory confirmed SARS-CoV-2 infection within the previous 14 days. 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 criteria
Exclusion criteria: 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 active malignancy at the time of inclusion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main study parameter/endpoint - Plasma dp-uc MGP levels before and during vitamin K supplementation in intervention versus control patients - Plasma desmosine levels before and during vitamin K supplementation in intervention versus control patients | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary study parameter/endpoint -Difference between the number of grade 3 and grade 4 adverse events between the intervention and control group during treatment, with special attention for: progression of respiratory insufficiency, thrombotic events, pulmonary embolism or deep venous thrombosis, bleeding, renal insufficiency, cardiac decompensation, liver enzyme abdnormalities and/or liver failure -Serum PIVKA-II levels before and during vitamin K supplementation in intervention versus control patients Exploratory study parameters - Serum (undercarboxylated) protein S levels before and after vitamin K supplementation - Incidence of respiratory failure defined as either intubation and mechanical ventilation or death (with respiratory failure as a likely direct or indirect cause of death) in the intervention versus control group - Change in disease severity as measured by low-dose chest CT on day 5 and 10 versus baseline in intervention versus control groups - Plasma levels of active MGP before and after vitamin K supplementation - Normative APC sensitivity ratio and prothrombin (Echis Carinato test) and TFPI concentration before and after vitamin K supplementation - Inflammatory parameters including CRP, d-dimer, ferritine, IL-6, TNF-*, IFN-* and s-IL-2r as measured by ELISA or Multiplex in both intervention and control groups - Other markers related to the pathogenesis, susceptibility and severity of COVID-19 in both intervention and control groups. - Vitamin K epoxide reductase complex subunit 1 (VKORC-1) gene polymorphisms and vitamin D receptor gene polymorphisms | — |
Countries
Netherlands
Outcome results
None listed