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

NCT04997551 | Unknown Phase 3

• 1 other identifier: EC CORONACOLCHI
• Study Type: interventional
• Target: 752
• Locations: 1 country
• Sites: 1

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

Keywords

covid-19; colchicine

Outcome Measures

Primary Outcomes (2)

• Proportion of patients who present death, need for mechanical ventilation or respiratory distress (Pa02 / FiO2 <300 or baseline O2 saturation ≤93%) on days +7, +14 and +30.

  Although the definition of respiratory distress usually includes a radiological criterion, as long as the oxygenation deficit is not attributable to another cause by the clinician, we do not consider it essential to perform a chest X-ray to confirm the diagnosis of distress because it does not correspond to clinical practice routine and the X-ray result does not change the patient's management.

  30 days (from day +1 to day +30)

• Each of the items (proportion of patients who suffer death, need for mechanical ventilation and development of respiratory distress) separately on days +7, +14 and +30.

  30 days (from day +1 to day +30)

Secondary Outcomes (6)

• Proportion of patients in each of the items of the clinical scale detailed below on days +3, +7, +14 and +30:

  30 days (from day +1 to day +30)

• Time (days) until death

  30 days (from day +1 to day +30)

• Proportion of patients in whom fever ≥37.8 ºC persists on days +3, +7, +14 and +30.

  30 days (from day +1 to day +30)

• Evolution of the levels of C-Reactive Protein (CRP), LDH, D-dimer, ferritin, lymphocytes on days +3, +7, +14 and +30.

  30 days (from day +1 to day +30)

• Proportion of patients who have received tocilizumab / other antiL6 or antiL1 drug / corticosteroids on days +3, +7, +14 and +30.

  30 days (from day +1 to day +30)

Study Arms (2)

Colchicine

ACTIVE COMPARATOR

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

Drug: Colchcine

Placebo

PLACEBO COMPARATOR

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

Drug: Colchcine

Interventions

Colchcine 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

Colchicine; Placebo

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• \. Microbiologically confirmed infection by SARS-CoV-2 (PCR and / or CLIA or ELISA serology or with a valid microbiological diagnostic test with antigen test).
• \> 18 years.
• \. \<2 weeks from the onset of symptoms.
• \. Admitted (with or without pneumonia) and ambulant (with pneumonia demonstrated by X-ray or CT)
• \. 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
• \. Signing of the Informed Consent, or acceptance of oral consent before witnesses.

You may not qualify if:

• \. Drug allergy.
• \. Intolerance to lactose and / or cow's milk proteins.
• \. Renal failure with GFR \<30 ml / min.
• \. Liver cirrhosis or severe liver failure
• \. Pregnancy or breastfeeding.
• \. Blood dyscrasias or cardiac disorders that in the opinion of the investigator contraindicate the use of colchicine.
• \. Pre-existing degenerative neuromuscular disease.
• \. Acute or chronic diarrhea or malabsorptive syndrome that in the judgment of the clinician contraindicates the use of colchicine.
• \. CRP\> 80 mg / L or ferritin\> 3 times LAN
• \. Shock or hemodynamic instability.
• \. Respiratory distress measured by PaO2 / FIO2 \<300 or baseline O2 saturation ≤ 93%.
• \. Patients undergoing mechanical ventilation.
• \. 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.)
• \. Have received any dose of colchicine, tocilizumab, any antiL6 or antiL1 drug.
• \. Current treatment with corticosteroids (except chronic corticosteroid therapy without recent increase in dose).

Sponsors & Collaborators

• Biogipuzkoa Health Research Institute: lead

Study Sites (1)

Biodonostia Health Research Institute

San Sebastián, Guipuzcoa, 20014, Spain

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 3, 2021
• First Posted: August 9, 2021
• Study Start: September 8, 2020
• Primary Completion: September 1, 2021
• Study Completion: January 1, 2022
• Last Updated: August 9, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)