COVID-19 trials registries data warehouse

https://www.clinicaltrialsregister.eu/ctr-search/trial/2020-001209-22/GB

University of Oxford - Chief Investigator

principle@phc.ox.ac.uk

2020-03-25

Recruiting

RCT

Randomized

Parallel

Open label

multi-center

Treatment

Participant is willing and able to give informed consent for participation in the study. Participant is willing to comply with all trial procedures Onset of symptoms of possible COVID-19 in the community (continuous cough and/or high temperature) within 7 days of inclusion Patients aged ≥50-64 years with any of the following listed comorbidities: - known weakened immune system due to a serious illness or medication (e.g. chemotherapy) - known heart disease - known asthma or lung disease - known diabetes not treated with insulin - known mild hepatic impairment - known stroke or neurological problem OR Patients aged ≥65 with or without comorbidity

Pregnancy Breastfeeding Known severe hepatic impairment Known severe renal impairment Known acute porphyrias Type 1 diabetes or insulin dependent Type 2 Diabetes mellitus Known G6PD deficiency Known myasthenia gravis Known severe Psoriasis Known severe neurological disorders (especially those with a history of epilepsy may lower seizure threshold) Previous adverse reaction to, or currently taking, hydroxychloroquine Known retinal disease Judgement of the recruiting clinician deems ineligibile

2

University of Oxford / Clinical Trials and Research Governance

50

None

United Kingdom

Mild disease at enrollment

1: Mild disease at enrollment

3000

Hospital admission or mortality related to suspected COVID-19.

Declared number of arm (2.0) differs from found arms (4.0)

Phase 3

[{"arm_notes": "", "treatment_id": 607, "treatment_name": "Hydroxychloroquine", "treatment_type": "Antimalarials", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]