COVID-19 trials registries data warehouse

https://www.clinicaltrialsregister.eu/ctr-search/trial/2020-001659-42/ES

Fundación para la Investigación Biomédica de Córdoba - Antonio Luque

uicec@imibic.org

2020-04-20

Completed

RCT

Randomized

Parallel

Open label

single-center

Treatment

1. Age ≥ 18 and <85 years 2. Diagnosis confirmed by COVID-19 PCR 3. Radiological image compatible with COVID-19 4. Present any of the following clinical-functional criteria considered RISK: 4.a. Respiratory distress: Tachypnea> 26 breaths / minute 4. b. PaO2 / FiO2 oxygenation index ≤ 300 4.c. Alteration of one or more of the following parameters: 4.c.i. DD> 1,000 µg / L 4.c.ii. Ferritin> 800 ng / mL 4.c.iii. Lymphocytes <800 cells / µL 4.c.iv. PCR> 100 mg / L 4.c.v. LDH> 500 U / L 4.c.vi. IL-6> 15 pg / mL 5. Direct or delegated verbal informed consent 1. Edad ≥ 18 y < 85 años 2. Diagnostico confirmado mediante PCR de COVID-19 3. Imagen radiológica compatible con COVID-19 4. Presentar alguno de los siguientes criterios clínico-funcionales considerados de RIESGO: 4.a. Distrés respiratorio: Taquipnea > 26 respiraciones/minuto 4. b. Índice de oxigenación PaO2/FiO2 ≤ 300 4.c. Alteración de uno o más de los siguientes parámetros: 4.c.i. DD > 1.000 µg/L 4.c.ii. Ferritina > 800 ng/mL 4.c.iii. Linfocitos < 800 cél/µL 4.c.iv. PCR > 100 mg/L 4.c.v. LDH > 500 U/L 4.c.vi. IL-6 > 15 pg/mL 5. Consentimiento informado verbal directo o delegado

1. Signs of active bleeding 2. Immunosuppression by cancer or transplant 3. Intolerance or allergy to AT or its components 4. Pregnancy 1. Signos de sangrado activo 2. Inmunosupresión por cáncer o trasplante 3. Intolerancia o alergia a AT o sus compontes 4. Embarazo

2

Fundación para la Investigación Biomédica de Córdoba

18

84

Spain

Severe disease at enrollment

6: Severe disease at enrollment

46

Combined variable: mortality or worsening rate with need for non-invasive mechanical ventilation or with need for invasive mechanical ventilation. Variable combinada: tasa de mortalidad o de empeoramiento con necesidad de ventilación mecánica no invasiva o con necesidad de ventilación mecánica invasiva.

Declared number of arm (2.0) differs from found arms (1.0)

Phase 2

[{"arm_notes": "", "treatment_id": 104, "treatment_name": "Antithrombin iii", "treatment_type": "Coagulation modifiers", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]