COVID-19 trials registries data warehouse

https://www.clinicaltrialsregister.eu/ctr-search/trial/2020-001527-14/NL

Erasmus MC - J.G.J.V. Aerts

j.aerts@erasmusmc.nl

2020-04-06

Recruiting

RCT

Randomized

Parallel

Open label

single-center

Treatment

Proven diagnosis of COVID-19 by positive PCR in any specimen < 48 hours prior to randomization. Age ≥ 18 year Hospitalized patients with illness of any duration, and SpO2 ≤ 94% on room air Proven diagnosis of COVID-19 by positive PCR in any specimen < 48 hours prior to randomization. Age ≥ 18 year Hospitalized patients with illness of any duration, and SpO2 ≤ 94% on room air

Severe hypoxemic respiratory failure expected to die < 72 hours after admission ICU admission < 72 hours Allergy for chloroquine or azithromycin Pregnancy QT-prolongation: pre-existent: QTc males >450ms, QTc females > 470ms at day 1 and at day 2 Myasthenia gravis Epilepsy Severe hypoxemic respiratory failure expected to die < 72 hours after admission ICU admission < 72 hours Allergy for chloroquine or azithromycin Pregnancy QT-prolongation: pre-existent: QTc males >450ms, QTc females > 470ms at day 1 and at day 2 Myasthenia gravis Epilepsy

2

Erasmus MC

18

None

Netherlands

Moderate/severe disease at enrollment

4: Moderate/severe disease at enrollment

60

The initial response to treatment will be evaluated during admission. Cure is considered when 3 criteria are present: (1) O2 sat > 94% with room air (2) 24 hours without fever (≥38°C) (3) Breathing frequency < 24/min The percentage of patients with clinical cure at day 7 will be calculated The initial response to treatment will be evaluated during admission. Cure is considered when 3 criteria are present: (1) O2 sat > 94% with room air (2) 24 hours without fever (≥38°C) (3) Breathing frequency < 24/min The percentage of patients with clinical cure at day 7 will be calculated

nan

Phase 4

[{"arm_notes": "", "treatment_id": 279, "treatment_name": "Chloroquine", "treatment_type": "Antimalarials", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 1454, "treatment_name": "Azithromycin+chloroquine", "treatment_type": "Antibiotics+antimalarials", "pharmacological_treatment": "Pharmacological treatment"}]