Clinical trial of anti-coagulant drug for COVID-19 inpatients

Australasian COVID-19 Trial (ASCOT) ADAptive Platform Trial - ASCOT ADAPT

Status

Not yet recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2020-005963-29-DK

Enrollment

2400

Registered

2020-12-18

Start date

2021-03-12

Completion date

Unknown

Last updated

2021-10-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COVID-19

Interventions

Trade Name: Innohep Product Name: Tinzeparin Pharmaceutical Form: Injection Trade Name: Klexane Product Name: Enoxaparin Pharmaceutical Form: Injection Trade Name: Fragmin Product Name: Dalteparin P

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - 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

Exclusion criteria

Exclusion criteria: - 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

Design outcomes

Primary

Measure	Time frame
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. 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: - Standard dose thromboseprophylaxis - Intermediate dose thromboseprophylaxis - Therapeutic dose thromboseprophylaxis ;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. ;Timepoint(s) of evaluation of this end point: 28 and 90 days	—

Measure

Time frame

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. 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: - Standard dose thromboseprophylaxis - Intermediate dose thromboseprophylaxis - Therapeutic dose thromboseprophylaxis ;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. ;Timepoint(s) of evaluation of this end point: 28 and 90 days

—

Secondary

Measure	Time frame
Secondary end point(s): Secondary endpoint: 1) Time to clinical recovery during the first 28 days after enrollment 2) WHO Ordinal Scale Outcome at days 14 and 28 after randomisation 3) All-cause mortality at 28 and 90 days after randomisation 4) Days alive and free of hospital by 28 days after randomisation 5) Days alive and free of invasive or non-invasive ventilation by 28 days after randomisation 6) Presence of patient reported outcome of shortness of breath at days 14, 28 and 90 7) Quality of life measured by questionnaire at days 28 and 90;Timepoint(s) of evaluation of this end point: Day 28 and 90	—

Measure

Time frame

Secondary end point(s): Secondary endpoint: 1) Time to clinical recovery during the first 28 days after enrollment 2) WHO Ordinal Scale Outcome at days 14 and 28 after randomisation 3) All-cause mortality at 28 and 90 days after randomisation 4) Days alive and free of hospital by 28 days after randomisation 5) Days alive and free of invasive or non-invasive ventilation by 28 days after randomisation 6) Presence of patient reported outcome of shortness of breath at days 14, 28 and 90 7) Quality of life measured by questionnaire at days 28 and 90;Timepoint(s) of evaluation of this end point: Day 28 and 90

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Countries

Australia, Denmark, India, New Zealand

Contacts

Public ContactThomas Benfield

Department of Infectious Diseases, Hvidovre Hospital

thomas.lars.benfield@regionh.dk+4538622305

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026