E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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E.1.1.1 | Medical condition in easily understood language |
COVID-19 after infection with SARS-CoV-2 |
COVID-19 efter infektion med Ny Coronavirus |
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E.1.1.2 | Therapeutic area | Diseases [C] - Virus Diseases [C02] |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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
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Formålet med det domæne, som Danmark deltager i, er at bestemme effektiviteten af antikoagulations- og blodpladebehandling for patienter med COVID-19. Det antages, at sandsynligheden for dødelighed af alle årsager 28 dage efter indskrivning vil variere afhængigt af intensiteten af antikoagulation og anvendelse af blodplader. Følgende interventioner er tilgængelige: - Standarddosis tromboseprofylakse - Midlertidig dosis tromboseprofylakse - Standarddosis tromboseprofylakse |
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E.2.2 | Secondary objectives of the trial |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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 |
- Alder over eller lig med 18 år - Indlagt på et akut hospital - Bekræftet SARS- CoV-2 ved nukleidsyretest i de sidste 14 dage - Kan randomiseres inden for 14 dage efter symptomdebut - Mindst et symptom eller tegn, der kan tilskrives SARS-CoV-2-infektion |
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E.4 | Principal 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 |
- Får i øjeblikket akut intensiv vejrtrækningsstøtte (invasiv eller ikke-invasiv ventilation) eller vasopressor / inotrop support - Tidligere deltagelse i forsøget - Behandlingshold finder, at indskrivning i undersøgelsen ikke er i patientens interesse - Døden anses for at være nært forestående og uundgåelig inden for de næste 24 timer |
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E.5 End points |
E.5.1 | 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.
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Det primære endepunkt for dette forsøg er død på grund af enhver årsag eller behov for ny intensiv respirationsstøtte (invasiv eller ikke-invasiv ventilation) eller vasopressor / inotrop support i de 28 dage efter randomisering. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
28 and 90 days |
28 og 90 dage |
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E.5.2 | 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 |
Sekundært slutpunkt: 1) Tid til klinisk bedring i de første 28 dage efter tilmelding 2) WHO's ordinære skala resultat på dag 14 og 28 efter randomisering 3) Dødelighed af alle årsager 28 og 90 dage efter randomisering 4) Dage i live og fri for hospital 28 dage efter randomisering 5) Dage i live og fri for invasiv eller ikke-invasiv ventilation 28 dage efter randomisering 6) Tilstedeværelse af patient rapporteret resultat af åndenød på dag 14, 28 og 90 7) Livskvalitet målt ved spørgeskema på dag 28 og 90 |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Day 28 and 90 |
Dag 28 og 90 |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | Yes |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | Yes |
E.8.1.7.1 | Other trial design description |
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E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 3 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
E.8.5 | The trial involves multiple Member States | No |
E.8.5.1 | Number of sites anticipated in the EEA | 1 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
Australia |
India |
New Zealand |
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E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | 11 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 6 |