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| Column | Value |
|---|---|
| Trial registration number | EUCTR2020-001379-34-ES |
|
Full text link
Last imported at : Oct. 26, 2020, 7:26 a.m. Source : EU Clinical Trials Register |
https://www.clinicaltrialsregister.eu/ctr-search/trial/2020-001379-34/ES |
|
First author
Last imported at : Oct. 26, 2020, 7:26 a.m. Source : EU Clinical Trials Register |
|
|
Contact
Last imported at : Oct. 26, 2020, 7:26 a.m. Source : EU Clinical Trials Register |
gestioncientifica@incliva.es |
|
Registration date
Last imported at : Oct. 26, 2020, 7:26 a.m. Source : EU Clinical Trials Register |
2020-04-14 |
|
Recruitment status
Last imported at : Jan. 20, 2022, 2:30 a.m. Source : EU Clinical Trials Register |
Terminated |
|
Study design
Last imported at : Oct. 26, 2020, 7:26 a.m. Source : EU Clinical Trials Register |
RCT |
|
Allocation
Last imported at : Oct. 26, 2020, 7:26 a.m. Source : EU Clinical Trials Register |
Randomized |
|
Design
Last imported at : Oct. 26, 2020, 7:26 a.m. Source : EU Clinical Trials Register |
Parallel |
|
Masking
Last imported at : Oct. 26, 2020, 7:26 a.m. Source : EU Clinical Trials Register |
Open label |
|
Center
Last imported at : Oct. 26, 2020, 7:26 a.m. Source : EU Clinical Trials Register |
multi-center |
|
Study aim
Last imported at : Oct. 26, 2020, 7:26 a.m. Source : EU Clinical Trials Register |
Prevention |
|
Inclusion criteria
Last imported at : Oct. 26, 2020, 7:26 a.m. Source : EU Clinical Trials Register |
- 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 |
|
Exclusion criteria
Last imported at : Oct. 26, 2020, 7:26 a.m. Source : EU Clinical Trials Register |
- 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 |
|
Number of arms
Last imported at : Oct. 26, 2020, 7:26 a.m. Source : EU Clinical Trials Register |
2 |
|
Funding
Last imported at : Oct. 26, 2020, 7:26 a.m. Source : EU Clinical Trials Register |
Instituto de Investigación Sanitaria INCLIVA |
|
Inclusion age min
Last imported at : Oct. 26, 2020, 7:26 a.m. Source : EU Clinical Trials Register |
18 |
|
Inclusion age max
Last imported at : Oct. 26, 2020, 7:26 a.m. Source : EU Clinical Trials Register |
None |
|
Countries
Last imported at : Oct. 26, 2020, 7:26 a.m. Source : EU Clinical Trials Register |
Spain |
|
Type of patients
Last imported at : Oct. 26, 2020, 7:26 a.m. Source : EU Clinical Trials Register |
High risk patients |
|
Severity scale
Last imported at : Oct. 26, 2020, 7:26 a.m. Source : EU Clinical Trials Register |
N/A |
|
Total sample size
Last imported at : Oct. 26, 2020, 7:26 a.m. Source : EU Clinical Trials Register |
50 |
|
primary outcome
Last imported at : Oct. 26, 2020, 7:26 a.m. Source : EU Clinical Trials Register |
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. |
|
Notes
Last imported at : Oct. 26, 2020, 7:26 a.m. Source : EU Clinical Trials Register |
nan |
|
Phase
Last imported at : Oct. 26, 2020, 7:26 a.m. Source : EU Clinical Trials Register |
Phase 4 |
|
Arms
Last imported at : Oct. 26, 2020, 7:26 a.m. Source : EU Clinical Trials Register |
[{"arm_notes": "", "treatment_id": 1186, "treatment_name": "Sevoflurane", "treatment_type": "Central nervous system agents", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 1029, "treatment_name": "Propofol", "treatment_type": "Central nervous system agents", "pharmacological_treatment": "Pharmacological treatment"}] |