Clinical trial of anti-coagulant drug for COVID-19 inpatients
- Conditions
- COVID-19Therapeutic area: Diseases [C] - Virus Diseases [C02]
- Registration Number
- EUCTR2020-005963-29-DK
- Lead Sponsor
- niversity of Melbourne
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 2400
- Age above or equal 18 years
- Admitted to an acute-care hospital
- Confirmed SARS- CoV-2 by nucleid acid testing in the past 14 days
- Able to be randomised within 14 days of symptom onset
- At least one symptom or sign attributable to SARS-CoV-2 infection
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 10
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10
- Currently receiving acute intensive respiratory support (Invasive or non-invasive ventilation) or vasopressor/inotropic support
- Previous participation in the trial
- Treating team deems enrolment in the study is not in the best interest of the patient
- Death is deemed to be imminent and inevitable within the next 24 hours
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The objective of the domain, in which Denmark are participating, is to determine the effectiveness of anticoagulation and antiplatelet therapy for patients with COVID-19.<br>It is hypothesised that the probability of all-cause mortality at 28 days after enrollment will differ based on the intensity of anticoagulation and use of antiplatelet agents. The following interventions are available:<br>- Standard dose thromboseprophylaxis<br>- Intermediate dose thromboseprophylaxis<br>- Therapeutic dose thromboseprophylaxis<br>;Secondary Objective: Not applicable;Primary end point(s): The primary endpoint for this trial is death from any cause or requirement of new intensive respiratory support (invasive or non-invasive ventilation) or vasopressor/inotropic support in the 28 days after randomisation. <br><br><br>;Timepoint(s) of evaluation of this end point: 28 and 90 days
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Secondary endpoint:<br>1) Time to clinical recovery during the first 28 days after enrollment <br>2) WHO Ordinal Scale Outcome at days 14 and 28 after randomisation<br>3) All-cause mortality at 28 and 90 days after randomisation<br>4) Days alive and free of hospital by 28 days after randomisation<br>5) Days alive and free of invasive or non-invasive ventilation by 28 days after randomisation<br>6) Presence of patient reported outcome of shortness of breath at days 14, 28 and 90<br>7) Quality of life measured by questionnaire at days 28 and 90;Timepoint(s) of evaluation of this end point: Day 28 and 90