E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Hyperinflammation associated with Pneumonia due to COVID19 |
Hiperinflamación asociada a la Neumonía por COVID19. |
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E.1.1.1 | Medical condition in easily understood language |
Hyperinflammation associated with Pneumonia due to COVID19 |
Hiperinflamación asociada a la Neumonía por COVID19. |
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E.1.1.2 | Therapeutic area | Diseases [C] - Virus Diseases [C02] |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To determine whether the use of colchicine in patients hospitalized for COVID-19 pneumonia and with hyperinflammation data reduces the start of non-invasive ventilation (CPAP / BiPAP), admission to the ICU, start of invasive ventilation or death. |
Determinar si el uso de colchicina en paciente hospitalizado por neumonía por COVID19 y con datos de hiperinflamación reduce el inicio de ventilación no invasiva (CPAP/BiPAP), ingreso en UCI, inicio de ventilación invasiva o muerte. |
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E.2.2 | Secondary objectives of the trial |
- To determine if the use of colchicine in a hospitalized patient due to COVID-19 pneumonia and hyperinflammation data is capable of limiting the overproduction of inflammatory cytokines while maintaining a good safety profile for the patient.
- To determine if the use of colchicine in a patient hospitalized for COVID-19 pneumonia and hyperinflammation data reduces the days of hospitalization.
- To determine if the use of colchicine in a hospitalized patient due to COVID19 pneumonia and hyperinflammation data reduces myocardial damage.
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- Determinar si el uso de colchicina en paciente hospitalizado por neumonía por COVID19 y datos de hiperinflamación es capaz de limitar la sobre-producción de citoquinas inflamatorias manteniendo un buen perfil de seguridad para el paciente.
- Determinar si el uso de colchicina en paciente hospitalizado por neumonía por COVID19 y datos de hiperinflamación reduce los días de hospitalización.
- Determinar si el uso de colchicina en paciente hospitalizado por neumonía por COVID19 y datos de hiperinflamación reduce el daño miocárdico. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
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.
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1. Paciente hospitalizado por neumonía por COVID19 (se exige confirmación microbiológica y Rx tórax compatible con neumonía).
2.Hiperinflamación.
3. Consentimiento informado verbal (el consentimiento escrito en papel conllevaría riesgo de contagio para el personal sanitario) (Se adjunta modelo de consentimiento). El consentimiento del paciente quedará anotado en la historia clínica del paciente. |
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E.4 | Principal exclusion criteria |
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.
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1. Paciente con inestabilidad hemodinámica
2. Paciente ya con ventilación invasiva o no invasiva (CPAP/BiPAP).
3. Mujer embarazada, en periodo de lactancia o que esté considerando quedarse embarazada en los 6 meses sucesivos. En mujeres con posibilidad de embarazo no diagnósticado se deberá descartar embarazo mediante un test de orina negativo.
4. Pacientes con indicación de tratamiento con Kaletra.
5. Pacientes incluidos en otros ensayos clínicos.
6. Paciente con cirrosis, hepatitis activa o fallo hepático grave
7. Paciente con enfermedad crónica inflamatoria en fase activa.
8. Diarrea que no responde a dieta o medicación.
9. Tratamiento inmunosupresor crónico
10. Neutrófilos < 500 cell/mmc y/o plaquetas <50000 cell/mmc
11. Insuficiencia renal severa (filtrado glomerular renal < 30ml/min/1.7m2).
12. Estar ya en tratamiento con colchicina.
13. Menores de 18 años. |
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E.5 End points |
E.5.1 | Primary end point(s) |
1. Support compound with CPAP / BiPAP, ICU admission, invasive ventilation or death.
2. Cytokine levels (IL-6) and inflammatory parameters (PCR, ESR, ferritin, fibrinogen, blood count) at recruitment, at 48 hours and on the fifth day of treatment.
3. Ultrasensitive troponin on the fifth day of treatment. |
1. Compuesto de soporte con CPAP/BiPAP, ingreso en UCI, ventilación invasiva o muerte.
2. Niveles de citoquinas (IL-6) y parámetros inflamatorios (PCR, VSG, ferritina, fibrinógeno, hemograma) al reclutamiento, a las 48 horas y el quinto día de tratamiento.
3. Troponina ultrasensible en el quinto día de tratamiento. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
- Hospitalization
- At recruitment, at 48 hours and on the fifth day of treatment.
- On the fifth day of treatment.
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- Durante el ingreso Hospitalario
- Al reclutamiento, a las 48 horas y el quinto día de tratamiento.
- En el quinto día de tratamiento |
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E.5.2 | Secondary end point(s) |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 8 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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The efficacy analysis of the trial will end at the moment of hospital discharge or the patient's exit.
In order to complete the safety profile, patients will be followed up by telephone 60 days after hospital discharge to check the vital status and detect the presence of thrombotic complications (admission for venous or arterial thromboembolism). |
El análisis de eficacia del ensayo terminará en el momento del alta hospitalaria o del exitus del paciente.
De cara a completar el perfil de seguridad, se realizará un seguimiento telefónico de los pacientes a los 60 días del alta hospitalaria para comprobar el status vital y detectar la presencia de complicaciones trombóticas (ingresos por tromboembolismo venoso o arterial). |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | 4 |
E.8.9.1 | In the Member State concerned days | |