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 |
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E.1.1.2 | Therapeutic area | Diseases [C] - Virus Diseases [C02] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10051905 |
E.1.2 | Term | Coronavirus infection |
E.1.2 | System Organ Class | 100000004862 |
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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 |
Check whether adding Inhaled corticoids (budesonide) reduces or not the risk of ARDS and improves prognosis in COVID19 patients admitted with pneumonia |
Comprobar si el añadir tratamiento con corticoides inhalados (budesonida) en pacientes COVID19 ingresados por neumonía reduce el riesgo de distrés respiratorio agudo y mejora su pronóstico. |
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E.2.2 | Secondary objectives of the trial |
• Assess the effect of IC in the duration of hospital stay • Complications during admittance • Circulating levels of systemic inflammation markers • Mortality at 30 and 90 days after hospital discharge |
-evaluar el efecto de este tratamiento en la duración de la estancia hospitalaria, -las complicaciones durante el ingreso, -los niveles circulantes de marcadores de infamación sistémica -la mortalidad a los 30 y 90 días del alta hospitalaria |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. COVID19 2. Age >18 and <80 3. Admitted for pneumonia (status #3 and #4 OMS scale) 4. Informed consent |
1. Pacientes con COVID19 2. Pacientes >18 y <80 años de edad 3. Pacientes ingresados por neumonía (estatus #3 and #4 de la escala de la OMS) 4. Aceptación y firma de consentimiento informado |
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E.4 | Principal exclusion criteria |
1. Pregnancy 2. Contraindications for inhaled corticoids therapy 3. Participating in another intervention trial on COVID19 4. Current treatment with inhaled or systemic corticosteroids |
1. Embarazo 2. Pacientes en los que el tratamiento en investigación esté contraindicado. 3. Participación en otro estudio de intervención con COVID19 4. En tratamiento actual con corticoides sistémicos y o inhalados |
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E.5 End points |
E.5.1 | Primary end point(s) |
proportion of subjects with therapeutic failure. Is a composite outcome: patients requiring mechanical ventilation, high flow oxygenotherapy, receiving systemic corticoids and/or anti IL1 , anti IL-6 and/or dying for any cause |
proporción de pacientes presentan fracaso terapéutico. Se trata de una variable compuesta: incluye ventilación mecánica (invasiva o no invasiva), oxigenoterapia de alto flujo, tratamiento con corticoides sistémicos y/o tratamiento con anti-IL-1, anti IL-6 o que fallecen por cualquier causa. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Day 15 after initiating treatment |
Día +15 desde inicio de tratamiento |
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E.5.2 | Secondary end point(s) |
1- Clinical evolution (discharge, ARDS, death, ICU refusal) 2- Temperature heart rate, blood pressure, PaO2/FiO2 3-Systemic biomarkers 4- Duration of hospital stay 5- Complications during admittance (infectious, CV, metabolic, others) 6- Mortality for any cause 7- vital status 8- changes in clinical status (OMS 7 point scale) |
1-Evolución clínica (alta, ARDS, exitus, denegación UCI por otros motivos) 2-Temperatura, frecuencia cardíaca, tensión arterial y PaO2/FiO2 3- Biomarcadores sistémicos 4- Duración del ingreso (días) 5- Complicaciones durante el ingreso (infecciosas, cardiovasculares, metabólicas, otras) 6- mortalidad por cualquier causa 7- estado vital 8- Variación en el estatus clínico utilizando la escala ordinal de 7 puntos de la OMS |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
1- admission, day 3, day 7 and discharge 2- admission, day 3, day 7 and discharge 3-admission, day 3, day 7 and discharge 4- at discharge 5- at discharge 6- at exitus 7- at exitus, day +30 and day +90 (if applicable) 8- day 3, day 7, day 15 and discharge |
1 a la inclusión, día 3, día 7 y alta hospitalaria 2- a la inclusión, día 3, día 7 y alta hospitalaria 3-a la inclusión, día 3, día 7 y alta hospitalaria 4- al alta 5- al alta 6- exitus 7- exitus, día +30 y día +90 (si procede) 8- al día 3, día 7, día 15 y alta hospitalaria
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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 | No |
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) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
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 | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
tratamiento estandar |
standar of care |
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E.8.2.4 | Number of treatment arms in the trial | 2 |
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 | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 7 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
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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LVLS |
Ultima visita de último sujeto |
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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 | 6 |
E.8.9.1 | In the Member State concerned days | |