A phase 2, double blind, randomized, placebo controlled clinical trial to investigate the safety and effects of oral vitamin K2 supplementation in COVID-19.

Phase 2

Completed

• Conditions: coronavirus infection; COVID-19; SARS-CoV-2 infection; 10047438

• Registration Number: NL-OMON55080
• Lead Sponsor: Canisius Wilhelmina Ziekenhuis

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2021-07-12
• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 40

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

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Main study parameter/endpoint<br /><br>- Plasma dp-uc MGP levels before and during vitamin K supplementation in<br /><br>intervention versus control patients<br /><br>- Plasma desmosine levels before and during vitamin K supplementation in<br /><br>intervention versus control patients </p><br>