COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04770740

A Dofferhoff

Not reported

2021-02-25

Completed

RCT

Randomized

Parallel

Blind label

single-center

Treatment

inclusion criteria: - 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

- 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

2

Canisius-Wilhelmina Hospital

18

100

Netherlands

Severe disease at enrollment

6: Severe disease at enrollment

40

Plasma desmosine levels;Plasma dp-ucMGP levels

None

Not reported

[{"arm_notes": "", "treatment_id": 1373, "treatment_name": "Vitamin k2", "treatment_type": "Vitamins and dietary supplements", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]