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Trial - ISRCTN18066414


Column Value
Trial registration number ISRCTN18066414
Full text link
Last imported at : Aug. 5, 2021, 3:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

First author
Last imported at : Aug. 5, 2021, 3:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Ana Maria Henao Restrepo

Contact
Last imported at : Aug. 5, 2021, 3:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

henaorestrepoa@who.int

Registration date
Last imported at : Aug. 5, 2021, 3:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

2021-07-29

Recruitment status
Last imported at : Aug. 5, 2021, 3:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Recruiting

Study design
Last imported at : Aug. 5, 2021, 3:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

RCT

Allocation
Last imported at : Aug. 5, 2021, 3:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Randomized

Design
Last imported at : Aug. 5, 2021, 3:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Parallel

Masking
Last imported at : Aug. 5, 2021, 3:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Open label

Center
Last imported at : Aug. 5, 2021, 3:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

multi-center

Study aim
Last imported at : Aug. 5, 2021, 3:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Treatment

Inclusion criteria
Last imported at : Aug. 5, 2021, 3:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

The only patients invited will be those admitted to a collaborating hospital, no wider recruitment is expected. 1. Adults (age =18 years, which allows consent) 2. Recently hospitalized (or already in hospital) with laboratory-confirmed COVID 3. Not expected to be transferred within 72 hours 4. With, in the view of their doctors, no contra-indication to any potentially relevant study drug

Exclusion criteria
Last imported at : Aug. 5, 2021, 3:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Does not meet inclusion criteria

Number of arms
Last imported at : Aug. 5, 2021, 3:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

3

Funding
Last imported at : Aug. 5, 2021, 3:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

World Health Organization

Inclusion age min
Last imported at : Aug. 5, 2021, 3:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

18

Inclusion age max
Last imported at : Aug. 5, 2021, 3:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

100

Countries
Last imported at : Aug. 5, 2021, 3:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Albania;Argentina;Bahamas;Bangladesh;Belize;Bolivia;Botswana;Brazil;India;Canada;Colombia;Dominican Republic;Ecuador;Egypt;Ethiopia;Finland;Guyana;Honduras;Indonesia;Ireland;Iran;Italy;Jamaica;Kenya;Kuwait;Latvia;Lebanon;Lithuania;Malaysia;Mali;Mexico;Mozambique;Niger;Nigeria;Norway;Oman;Pakistan;Panama;Paraguay;Peru;Philippines;Portugal;Romania;Saudi Arabia;Sierra Leone;United Kingdom;Spain;Switzerland;North Macedonia;Trinidad and Tobago;Zimbabwe

Type of patients
Last imported at : Aug. 5, 2021, 3:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Moderate/severe/critical disease at enrollment

Severity scale
Last imported at : Aug. 5, 2021, 3:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

5: Moderate/severe/critical disease at enrollment

Total sample size
Last imported at : Aug. 5, 2021, 3:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

10000

primary outcome
Last imported at : Aug. 5, 2021, 3:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

In-hospital mortality in all patients measured using patient records up to the end of hospital stay

Notes
Last imported at : Aug. 5, 2021, 3:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

| Declared number of arm (3.0) differs from found arms (4.0)

Phase
Last imported at : Aug. 5, 2021, 3:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Not reported

Arms
Last imported at : Aug. 5, 2021, 3:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

[{"arm_notes": "", "treatment_id": 121, "treatment_name": "Artesunate", "treatment_type": "Antimalarials", "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": 631, "treatment_name": "Imatinib", "treatment_type": "Kinase inhibitors", "pharmacological_treatment": "Pharmacological treatment"}]