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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-IT |
|
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/IT |
|
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 |
evelina.tacconelli@univr.it |
|
Registration date
Last imported at : Oct. 26, 2020, 7:26 a.m. Source : EU Clinical Trials Register |
2020-04-20 |
|
Recruitment status
Last imported at : Jan. 5, 2025, 10:55 p.m. Source : EU Clinical Trials Register |
Completed |
|
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 Adulti (età =18) che acconsentono alla partecipazione allo studio ricoverati in ospedale con COVID-19 accertata e che non stanno già ricevendo nessuno dei farmaci in studio |
|
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. Allergie note o controindicazioni ai farmaci in studio e senza trasferimento pianificato entro 72 ore in un ospedale che non aderisce allo studio |
|
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 |
AZIENDA OSPEDALIERA UNIVERSITARIA INTEGRATA VERONA |
|
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 |
Italy |
|
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 |
600 |
|
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. Mortalità per tutte le cause, suddivisa per gravità di malattia al momento della randomizzazione. |
|
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 3 |
|
Arms
Last imported at : Oct. 26, 2020, 7:26 a.m. Source : EU Clinical Trials Register |
[{"arm_notes": "", "treatment_id": 607, "treatment_name": "Hydroxychloroquine", "treatment_type": "Antimalarials", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "Solidarity trial, take sample size of only member state and keep Italy in countries instead of all countries in solidarity", "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"}] |