Colchicine for the Treatment of Hyperinflammation associated with Pneumonia due to COVID-19

Sociedad Española de Cardiología0 个研究点目标入组 240 人开始时间: 2020年5月26日最近更新: 2020年11月30日

适应症

试验速览

暂无简介。

•1. Patient hospitalized for COVID pneumonia19 (microbiological confirmation and chest X-ray compatible with pneumonia are required).
•2. Hyperinflammation.
•3. Verbal informed consent (written consent on paper would carry a risk of contagion for healthcare personnel) (Model consent is attached). The patient's consent will be noted in the patient's medical record.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 240
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•1. Hemodynamic instability patient
•2. Patient already with invasive or non-invasive ventilation (CPAP / BiPAP).
•3. Pregnant, lactating or considering pregnancy in the following 6 months. In women with the possibility of undiagnosed pregnancy, pregnancy should be ruled out using a negative urine test
•4. Patients with indication of treatment with Kaletra.
•5. Patients included in other clinical trials.
•6. Patient with cirrhosis, active hepatitis or severe liver failure
•7. Patient with chronic inflammatory disease in active phase.
•8. Diarrhea that does not respond to diet or medication.
•9. Chronic immunosuppressive treatment Neutrophils <500 cell / mmc and / or platelets <50,000 cell / mmc.
•10. Severe renal failure (renal glomerular filtration <30ml / min / 1.7m2).
•11. Be already under treatment with colchicine.
•12. Under 18 years of age.

发起方

Sociedad Española de Cardiología