PREEMPTIVE THERAPY WITH COLCHICINE IN PATIENTS OLDER THAN 60 YEARS WITH HIGH RISK OF SEVERE PNEUMONIAE DUE TO CORONAVIRUS

• Status: Recruiting
• Trial end date: 2021-12-31
• Target enrollment: 0
• Participant gender: All

Summary

This is a phase 3 clinical trial, randomized, single-center, opened, controlled, to evaluate efficacy and safety of early administration of colchicines in patients older than 60 years, with high risk of pulmonary complications due to coronavirus SARS-CoV2 (COVID-19). An approximately number of 954 subjects meeting all inclusion and none exclusion criteria will be randomized either to receive colchicines or symptomatic treatment with paracetamol during 21 days.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Instituto de Investigación Marqués de Valdecilla
• Collaborators: Gerencia Atencion Primaria Area 3; Gerencia de atención primaria área 1; Gerencia de atención primaria área 2; Gerencia de atención primaria área 4
• Treatments: Acetaminophen; Colchicine

Criteria

Inclusion Criteria:

1. Patients of both sexes who are at least 60 years old.

2. Diagnosis of COVID-19 infection in the last 72 hours and confirmed by PCR

3. Patient in outpatient follow-up (not hospitalized or under consideration) or institutionalized in senior centers/residences

4. The patient must possess at least two of the following high-risk criteria

1. 60 years of age or older AND

2. Any of the following: Diabetes mellitus, high blood pressure, known pulmonary disease (including asthma or chronic obstructive pulmonary disease), known heart failure, known coronary disease, bicytopenia, pancytopenia, or the existence of simultaneous neutrophilia and lymphopenia

5. The patient must be able and willing to comply with the requirements of this study protocol.

Exclusion Criteria:

1. Hospitalized patient or under immediate consideration of doing so

2. Patient taking colchicine for other indications

3. Patient with history of allergic reaction or sensitivity to colchicine

4. Patient with inflammatory bowel disease, gastric ulcer, chronic diarrhea or malabsorption

5. Patient with pre-existing progressive neuromuscular disease

6. Patient with kidney damage and estimated glomerular filtrate rate <30 ml/m at 1732

7. Patient undergoing chemotherapy for cancer, including haematological malignancies.

8. Patients being treated with CYP3A4 and/or glycoprotein inhibitor drugs

9. Immunosuppressive treatment

10. History of cirrhosis, chronic active hepatitis, severe chronic disease defined by GOT or GPT values exceeding 3 times the upper limit of normal.

11. If the investigator considers it, for any reason, to be an inadequate candidate.

12. Patient and/or legal representative will not have signed the informed consent form.