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Please consider this website is continuously evolving and still under development
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| Column | Value |
|---|---|
| Trial registration number | EUCTR2020-001366-11-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/2020-001366-11/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 |
fibucicec.hcsc@salud.madrid.org |
|
Registration date
Last imported at : Oct. 26, 2020, 7:26 a.m. Source : EU Clinical Trials Register |
2020-03-26 |
|
Recruitment status
Last imported at : March 6, 2021, 1:30 a.m. Source : EU Clinical Trials Register |
Suspended |
|
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 |
Treatment |
|
Inclusion criteria
Last imported at : Oct. 26, 2020, 7:26 a.m. Source : EU Clinical Trials Register |
consenting adults (age ≥18) hospitalised with definite COVID-19, not already receiving any of the study drugs Adultos que otorguen su consentimiento informado (mayores de 18 años) hospitalizados con COVID-19 confirmado, que no reciben ya ninguno de los tratamientos del estudio. |
|
Exclusion criteria
Last imported at : Oct. 26, 2020, 7:26 a.m. Source : EU Clinical Trials Register |
known allergy or contra-indications to investigational products anticipated transfer within 72 hours to a non-study hospital. - Alergia conocida o contraindicaciones a cualquiera de los productos en investigación. -Previsión de traslado en un plazo de 72 horas a un hospital que no participa en el estudio. |
|
Number of arms
Last imported at : Oct. 26, 2020, 7:26 a.m. Source : EU Clinical Trials Register |
5 |
|
Funding
Last imported at : Oct. 26, 2020, 7:26 a.m. Source : EU Clinical Trials Register |
FIB-HCSC ; WHO (World Health Organization) |
|
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;Switzerland |
|
Type of patients
Last imported at : Oct. 26, 2020, 7:26 a.m. Source : EU Clinical Trials Register |
No restriction on type of patients |
|
Severity scale
Last imported at : Oct. 26, 2020, 7:26 a.m. Source : EU Clinical Trials Register |
0: No restriction on type of patients |
|
Total sample size
Last imported at : Oct. 26, 2020, 7:26 a.m. Source : EU Clinical Trials Register |
2500 |
|
primary outcome
Last imported at : Oct. 26, 2020, 7:26 a.m. Source : EU Clinical Trials Register |
The primary outcome is all-cause mortality, subdivided by severity of disease at the time of randomisation. Mortalidad por todas las causas, subdividida por gravedad de la enfermedad en el momento de la aleatorización. |
|
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": 279, "treatment_name": "Chloroquine", "treatment_type": "Antimalarials", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 1099, "treatment_name": "Remdesivir", "treatment_type": "Antivirals", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 1604, "treatment_name": "Lopinavir+ritonavir", "treatment_type": "Antivirals", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 1613, "treatment_name": "Interferon beta 1a+lopinavir+ritonavir", "treatment_type": "Interferons+antivirals", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}] |