COVID-19 trials registries data warehouse

https://www.clinicaltrialsregister.eu/ctr-search/trial/2020-001366-11/IE

University College Cork - Coordinating Investigator;University College Cork - Chief Investigator

j.eustace@ucc.ie

2020-04-17

Completed

RCT

Randomized

Parallel

Open label

multi-center

Treatment

o adults (age ≥18 years, which allows consent), o recently hospitalised (or already in hospital) with laboratory-confirmed COVID, o not expected to be transferred within 72 hours, o with, in the view of their doctors, no contra-indication to any potentially relevant study drug.

Under 18 years of age Known allergy or contra-indications to any of the investigational products Anticipated transfer within 72 hours to a non-study hospital. Positive Pregnancy test

3

Department of Health ; World Health Organisation

18

None

Australia;Canada;France;India;Ireland;Italy;Norway;Spain;Switzerland

No restriction on type of patients

0: No restriction on type of patients

1000

The primary outcome is all-cause mortality, subdivided by severity of disease at the time of randomisation. The main secondary analyses will assess in-hospital mortality subdivided by initial respiratory support. Further secondary analyses will assess initiation of ventilation in lower-risk patients, and, separately, duration of hospital stay in lower-risk patients (A-B) and in higher-risk patients (C-F).

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

Phase 4

[{"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": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]