COVID-19 trials registries data warehouse

https://www.clinicaltrialsregister.eu/ctr-search/trial/2020-001605-23/ES

Investigation Institute Bioaraba - Inés Pérez Francisco

INES.PEREZFRANCISCO@osakidetza.eus

2020-05-31

Terminated

RCT

Randomized

Parallel

Open label

single-center

Treatment

- RT-PCR confirmed. - 18-80 years. - Pneumonia confirmed by Rx chest: pneumonia CURB<=1 y Sat O2>92% -RT-PCR positivo - entre 18 y 80 años - con neumonía confirmada mediante Rx toral: neumonía CURB<=1 y Sat O2 <92%

->7 days from the onset of symptoms - Severe disease Covid 19, defined by any of the following: FR<30 per min, sat O2 breathing ambient air<92%, sepsis or septic shock - Pregnancy - Kidney or liver terminal disease - History of allergy to hydroxycloroquine and/or azithromycin - Patients presenting contraindications to study drugs - Hyprsensitivity to azithromycin, erythromycin, to any other macrolide or ketolide antibioticor any of the following excipients: pregelatinized corn starch, sodium crocarmellose, sodium laurel sulfate, magnesium stearate, anhydrous calcium hydrogen phosphate, hypromellose, titanium dioxide (E-171), triacetin. - Electrocardiographic abnormalities: treatment is not started or discontinued if QTc (Brazett formula)>500ms and risk-benefit is valued between a460-500 ms. Does not start treatment if ECG shows changes in channel-patties and risk-benefit is valued if there are other abnormalities. - Patients with glucose 6 phosphate dehydrogenase deficiency. - > 7 días de inicio de los síntomas. - Enfermedad por COVID-19 grave, definida por cualquiera de los siguientes: FR>30 por minuto, saturación de O2 respirando aire ambiente <92%, sepáis o shock séptico. - Embarazo - Enfermedad renal o hepática terminal - Antecedentes de alergia a hidroxicloroquina y/o azitromicina o anafilaxia - Pacientes que presenten contraindicaciones a los medicamentos del estudio - Hipersensibilidad a azitromicina, eritromicina, a cualquier otro antibiótico macrólido o ketólido o a alguno de los siguientes excipientes: almidonesón de maíz pregelatinizado, almidón de maíz, croscarmelosa sódica, laurilsulfato de sodio, estrato de magnesio, hidrogenofosfato de calcio anhidro, hipromelosa, dióxido de titanio (E-171), triacetina. - Alteraciones electrocardiográficas: no se comienza tratamiento o se discontinua si QTc (formula Brazett)>500 ms y se valora riesgo-beneficio entre 460 y 500 ms. No se inicia tratamiento si ECG muestras alteraciones de canalopatías y se valora riesgo-beneficio si hay otras anormalidades. - Pacientes con deficit de glucosa 6 fosfato

2

Basque Health Service

18

80

Spain

Moderate disease at enrollment

3: Moderate disease at enrollment

108

Respiratory severity scale Brescia-COVID Escala de severidad respiratoria Brescia-COVID

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

Phase 4

[{"arm_notes": "", "treatment_id": 1562, "treatment_name": "Hydroxychloroquine+lopinavir+ritonavir", "treatment_type": "Antimalarials+antivirals", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 1534, "treatment_name": "Azithromycin+hydroxychloroquine", "treatment_type": "Antibiotics+antimalarials", "pharmacological_treatment": "Pharmacological treatment"}]