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Trial - EUCTR2020-001366-11-LT


Column Value
Trial registration number EUCTR2020-001366-11-LT
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/LT

First author
Last imported at : Oct. 26, 2020, 7:26 a.m.
Source : EU Clinical Trials Register

Vilnius University Hospital Santaros Klinikos - Laimonas Griskevicius

Contact
Last imported at : Oct. 26, 2020, 7:26 a.m.
Source : EU Clinical Trials Register

laimonas.griskevicius@santa.lt

Registration date
Last imported at : Oct. 26, 2020, 7:26 a.m.
Source : EU Clinical Trials Register

2020-04-07

Recruitment status
Last imported at : Oct. 26, 2020, 7:26 a.m.
Source : EU Clinical Trials Register

Recruiting

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

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.

Number of arms
Last imported at : May 20, 2021, 1:30 a.m.
Source : EU Clinical Trials Register

7

Funding
Last imported at : Oct. 26, 2020, 7:26 a.m.
Source : EU Clinical Trials Register

Vilnius University Hospital Santaros Klinikos

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

100

Countries
Last imported at : Oct. 26, 2020, 7:26 a.m.
Source : EU Clinical Trials Register

Lithuania

Type of patients
Last imported at : Oct. 26, 2020, 7:26 a.m.
Source : EU Clinical Trials Register

Moderate/severe/critical disease at enrollment

Severity scale
Last imported at : Oct. 26, 2020, 7:26 a.m.
Source : EU Clinical Trials Register

5: Moderate/severe/critical disease at enrollment

Total sample size
Last imported at : Oct. 26, 2020, 7:26 a.m.
Source : EU Clinical Trials Register

200

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.

Notes
Last imported at : May 20, 2021, 1:30 a.m.
Source : EU Clinical Trials Register

Declared number of arm (5.0) differs from found arms (6.0)

Phase
Last imported at : Oct. 26, 2020, 7:26 a.m.
Source : EU Clinical Trials Register

Phase 4

Arms
Last imported at : May 20, 2021, 1:30 a.m.
Source : EU Clinical Trials Register

[{"arm_notes": "", "treatment_id": 671, "treatment_name": "Interferon beta 1a", "treatment_type": "Interferons", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 12, "treatment_name": "Acalabrutinib", "treatment_type": "Kinase inhibitors", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 1099, "treatment_name": "Remdesivir", "treatment_type": "Antivirals", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 121, "treatment_name": "Artesunate", "treatment_type": "Antimalarials", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 631, "treatment_name": "Imatinib", "treatment_type": "Kinase inhibitors", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 650, "treatment_name": "Infliximab", "treatment_type": "Other targeted therapies", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]