Double Blind Randomized Clinical Trial of Use of Colchicine Added to Standard Treatment in Hospitalized With Covid-19

NCT ID: NCT04997551

Last Updated: 2021-08-09

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 752 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-08
• Study Completion Date: 2022-01-01

Brief Summary

EC CORONACOLCHI is a multicenter, double-blind and randomized clinical trial with two branches. Patients who meet all the inclusion criteria and none of the exclusion criteria will be randomized 1: 1 to be included in one of the following groups:

• Experimental group: colchicine for 2 weeks orally at the doses described, added to the standard treatment of COVID-19.
• Control group: placebo for 2 weeks orally added to standard COVID-19 treatment.

Conditions

COVID-19 Infection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Colchicine

EC Experimental group: colchicine for 2 weeks orally added to standard treatment.

Group Type: ACTIVE_COMPARATOR

Colchcine

Intervention Type: DRUG

In patients not taking lopinavir / ritonavir or any other CYP3A4 or P-glycoprotein inhibitor drugs:

• Day 1: 1 single dose of 1 mg orally, in a single dose.
• Days 2 to 6: 0.5 mg every 12 hours v.o.
• Days 7 to 14: 0.5 mg / 24 hours v.o. In patients taking drugs that inhibit the CYP3A4 system or the P-glycoprotein, these drugs will be attempted to be discontinued. The dose in these cases will be: o 0.5 mg every 72 hours v.o. while taking the drug that interacts.

or 0.5 mg every 24 hours v.o. when, after suspending the interacting drug, at least 5 half-lives of the suspended drug have elapsed, from the last intake of said drug (in the case of lopinavir / ritonavir this would be a total of 24-30 hours) until the 14th day.

In patients older than 80 years or patients with CKD-EPI estimated glomerular renal failure filtration rate between 30 and 50 ml / min / 1.73 m2), the colchicine / placebo dose will be:

o Days 1 to 14: 0.5 mg / day

Placebo

Control group: placebo for 2 weeks added to standard treatment.

Group Type: PLACEBO_COMPARATOR

Colchcine

Intervention Type: DRUG

In patients not taking lopinavir / ritonavir or any other CYP3A4 or P-glycoprotein inhibitor drugs:

• Day 1: 1 single dose of 1 mg orally, in a single dose.
• Days 2 to 6: 0.5 mg every 12 hours v.o.
• Days 7 to 14: 0.5 mg / 24 hours v.o. In patients taking drugs that inhibit the CYP3A4 system or the P-glycoprotein, these drugs will be attempted to be discontinued. The dose in these cases will be: o 0.5 mg every 72 hours v.o. while taking the drug that interacts.

or 0.5 mg every 24 hours v.o. when, after suspending the interacting drug, at least 5 half-lives of the suspended drug have elapsed, from the last intake of said drug (in the case of lopinavir / ritonavir this would be a total of 24-30 hours) until the 14th day.

In patients older than 80 years or patients with CKD-EPI estimated glomerular renal failure filtration rate between 30 and 50 ml / min / 1.73 m2), the colchicine / placebo dose will be:

o Days 1 to 14: 0.5 mg / day

Interventions

Colchcine

In patients not taking lopinavir / ritonavir or any other CYP3A4 or P-glycoprotein inhibitor drugs:

• Day 1: 1 single dose of 1 mg orally, in a single dose.
• Days 2 to 6: 0.5 mg every 12 hours v.o.
• Days 7 to 14: 0.5 mg / 24 hours v.o. In patients taking drugs that inhibit the CYP3A4 system or the P-glycoprotein, these drugs will be attempted to be discontinued. The dose in these cases will be: o 0.5 mg every 72 hours v.o. while taking the drug that interacts.

or 0.5 mg every 24 hours v.o. when, after suspending the interacting drug, at least 5 half-lives of the suspended drug have elapsed, from the last intake of said drug (in the case of lopinavir / ritonavir this would be a total of 24-30 hours) until the 14th day.

In patients older than 80 years or patients with CKD-EPI estimated glomerular renal failure filtration rate between 30 and 50 ml / min / 1.73 m2), the colchicine / placebo dose will be:

o Days 1 to 14: 0.5 mg / day

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 1 - Acute symptoms compatible with SARS-CoV-2 infection: fever, cough, myalgia, dysgeusia / ageusia, dyspnea, pulmonary infiltrates on X-ray / CT, or any sign / symptom attributable to said infection
• 2. Microbiologically confirmed infection by SARS-CoV-2 (PCR and / or CLIA or ELISA serology or with a valid microbiological diagnostic test with antigen test).
• 3.> 18 years.
• 4. <2 weeks from the onset of symptoms.
• 5. Admitted (with or without pneumonia) and ambulant (with pneumonia demonstrated by X-ray or CT)
• 6. Some analytical degree of moderate inflammation defined by PCR between 20 and 80 mg / L and / or ferritin between the high limit of normality (LAN) and 3 times said LAN
• 7. Signing of the Informed Consent, or acceptance of oral consent before witnesses.

Exclusion Criteria

• 1. Drug allergy.
• 2. Intolerance to lactose and / or cow's milk proteins.
• 3. Renal failure with GFR <30 ml / min.
• 4. Liver cirrhosis or severe liver failure
• 5. Pregnancy or breastfeeding.
• 6. Blood dyscrasias or cardiac disorders that in the opinion of the investigator contraindicate the use of colchicine.
• 7. Pre-existing degenerative neuromuscular disease.
• 8. Acute or chronic diarrhea or malabsorptive syndrome that in the judgment of the clinician contraindicates the use of colchicine.
• 9. CRP> 80 mg / L or ferritin> 3 times LAN
• 10. Shock or hemodynamic instability.
• 11. Respiratory distress measured by PaO2 / FIO2 <300 or baseline O2 saturation ≤ 93%.
• 12. Patients undergoing mechanical ventilation.
• 13. Chronic treatment with any drug that, in the opinion of the investigator, interacts with colchicine and cannot be discontinued during the clinical trial, unacceptably increasing the risk of toxicity (digoxin, cyclosporine, etc.)
• 14. Have received any dose of colchicine, tocilizumab, any antiL6 or antiL1 drug.
• 15. Current treatment with corticosteroids (except chronic corticosteroid therapy without recent increase in dose).
• 16. Participation in any other clinical trial of patients with COVID-19.
• 17. Any other condition that, in the opinion of the investigator, contraindicates the use of colchicine or puts the subject at risk due to their participation in the study.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Biogipuzkoa Health Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Biodonostia Health Research Institute

San Sebastián, Guipuzcoa, Spain

Countries

Spain

Other Identifiers

EC CORONACOLCHI

Identifier Type: -

Identifier Source: org_study_id