Hyperinflammation associated with Pneumonia due to COVID19
Conditions
Interventions
Pharmaceutical Form: Tablet
INN or Proposed INN: colchicine
CAS Number: 64-86-8
Other descriptive name: COLCHICINE
Concentration unit: mg milligram(s)
Concentration type: range
Concentration number: 0
Sponsors
Sociedad Española de Cardiología
Eligibility
Sex/Gender
All
Inclusion criteria
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. 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
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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.;Secondary Objective: - 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. ;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.;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. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): No;Timepoint(s) of evaluation of this end point: No | — |
Countries
Spain
Contacts
Public ContactAlberto Cecconi
Sociedad Española de Cardiología
Outcome results
None listed