COVID-19 trials registries data warehouse

https://www.clinicaltrialsregister.eu/ctr-search/trial/2020-001265-36/IE

University College Dublin - QRAM

crc.monitoring@ucd.ie

2020-04-07

Terminated

RCT

Randomized

Parallel

Open label

multi-center

Treatment

Documented Covid-19 positive Evidence of progressive clinical decline: o Rising inflammatory markers over a 24 hour period (increases in CRP, d-dimer, LDH and/or ferritin above the upper limit of normal) o Presence of or progression of pulmonary infiltrates on CXR (as decided by the treating physician) o New hypoxia requiring >2l/min/28% FiO2 to maintain oxygen saturations ≥94% (or 88-92% in patients with chronic hypercapnic respiratory failure)

Pregnant or breastfeeding woman Known hypersensitivity to chloroquine or hydroxy chloroquine or any excipients Known hypersensitivity to azithromycin, erythromycin or any of the macrolide or ketolide antibiotics or any of the excipients Known deficit in G6PD Known retinopathy Patient with history of cardiac arrythmia related to QT prolongation Suspected acute cardiogenic pulmonary oedema at the time of enrolment QTc >500ms on two consecutive ECG measurements at screening Hypokalaemia (<3.0mmol/L) or hyperkalaemia (>6.1mmol/L) at screening Hypocalcaemia (<2.1mmol/L) or hypercalcaemia (>2.6mmol/L) (corrected for albumin) at screening Subjects receiving medications with a significant QT prolongation potential (if these treatments cannot be discontinued)

3

University College Dublin

18

None

Ireland

Moderate/severe disease at enrollment

4: Moderate/severe disease at enrollment

267

Composite primary endpoint is time to progression to intubation, non-invasive ventilation or death.

Declared number of arm (3.0) differs from found arms (2.0)

Phase 4

[{"arm_notes": "", "treatment_id": 607, "treatment_name": "Hydroxychloroquine", "treatment_type": "Antimalarials", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 1534, "treatment_name": "Azithromycin+hydroxychloroquine", "treatment_type": "Antibiotics+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"}]