E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Acute Respiratory Distress Syndrome caused by COVID19 infection |
Síndrome de Distrés Respiratorio Agudo causado por la infección COVID19 |
|
E.1.1.1 | Medical condition in easily understood language |
Acute Respiratory Distress Syndrome caused by COVID19 infection |
Síndrome de Distrés Respiratorio Agudo causado por la infección COVID19 |
|
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 | 21.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10001052 |
E.1.2 | Term | Acute respiratory distress syndrome |
E.1.2 | System Organ Class | 10038738 - Respiratory, thoracic and mediastinal disorders |
|
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 |
|
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 |
To evaluate the effect of 48-hour treatment with inhaled sevoflurane on arterial oxygenation, assessed by PaO2/FiO2 on day two, in patients with ARDS-CoVid19 |
Evaluar el efecto del tratamiento durante 48 horas con sevoflurano inhalado sobre la oxigenación arterial, evaluado mediante la PaO2/FiO2 en el segundo día, en pacientes con SDRA-CoVid19 |
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E.2.2 | Secondary objectives of the trial |
- to quantify the effects of sevoflurane on pro-inflammatory cytokine levels during ARDS-CoVid19 - evaluate the 30-day mortality. |
cuantificar los efectos del sevoflurano sobre los niveles de citoquinas proinflamatorias durante el SDRA-CoVid19 - evaluar la mortalidad a los 30 días. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Age 18 years or more. - Diagnosis of Acute Respiratory Distress Syndrome caused by COVID19 infection. - Signature of Patient's Consent or Verbal Consent of Legal Representative |
- Edad Igual o superior a 18 años. - Diagnóstico de Síndrome de Distrés Respiratorio Agudo causado por infección de COVID19. - Firma de consentimiento del Paciente o Consentimiento verbal de su representante Legal |
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E.4 | Principal exclusion criteria |
- Intracranial hypertension - Hypersensitivity to the active ingredient (propofol or sevoflurane) or to any of the excipients - Current volume < 250ml - History of malignant hyperthermia - Liver failure - Neutropenia (<0.5x109) - Pregnant or lactating women - Have received chemotherapy in the last month since their inclusion in the study |
- Hipertensión intracraneal - Hipersensibilidad al principio activo (propofol o sevoflurano) o a alguno de los excipientes. - Volumen corriente < 250ml - Antecedentes de hipertermia maligna - Insuficiencia hepática - Neutropenia (<0.5x109) - Mujeres embarazadas o en periodo de lactancia - Haber recibido quimioterapia en el último mes desde su inclusión en el estudio |
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E.5 End points |
E.5.1 | Primary end point(s) |
Efficacy will be assessed according to the defined objectives of oxygenation, reduction of inflammatory markers |
La eficacia se valorará según los objetivos definidos de oxigenación, disminución marcadores inflamatorios y mortalidad a los 30 días. |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
2 days - PaO2/FiO2 and TNF, IL-1b, IL-6 e IL-8 día 2. |
2 días: PaO2/FiO2 and TNF, IL-1b, IL-6 e IL-8 día 2. |
|
E.5.2 | Secondary end point(s) |
30-day mortality. |
mortalidad a los 30 días. |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
|
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) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
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
| No |
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 | 2 |
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 | No |
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 | 6 |
E.8.9.1 | In the Member State concerned days | |