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

Phase 1

• Conditions: Hyperinflammation associated with Pneumonia due to COVID19; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2020-001841-38-ES
• Lead Sponsor: Sociedad Española de Cardiología

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-05-26
• Last Update Posted: 30 November 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 240

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

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified