Clinical trial NCT04997551: Double Blind Randomized Clinical Trial of Use of Colchicine Added to Standard Treatment in Hospitalized With Covid-19
Official title: Double Blind Randomized Clinical Trial of Use of Colchicine Added to Standard Treatment in Hospitalized Patients With Covid-19 Infection
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: COVID-19 Infection
Keywords: covid-19
colchicine
Lead sponsor: Biogipuzkoa Health Research Institute
Sponsor class: OTHER
First posted: 2021-08-09
Enrollment: 752
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: 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.
timeFrame: 30 days (from day +1 to day +30)
measure: 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.
timeFrame: 30 days (from day +1 to day +30)
Secondary outcomes:
measure: Proportion of patients in each of the items of the clinical scale detailed below on days +3, +7, +14 and +30:
timeFrame: 30 days (from day +1 to day +30)
measure: Time (days) until death
timeFrame: 30 days (from day +1 to day +30)
measure: Proportion of patients in whom fever ≥37.8 ºC persists on days +3, +7, +14 and +30.
timeFrame: 30 days (from day +1 to day +30)
measure: Evolution of the levels of C-Reactive Protein (CRP), LDH, D-dimer, ferritin, lymphocytes on days +3, +7, +14 and +30.
timeFrame: 30 days (from day +1 to day +30)
measure: Proportion of patients who have received tocilizumab / other antiL6 or antiL1 drug / corticosteroids on days +3, +7, +14 and +30.
timeFrame: 30 days (from day +1 to day +30)
measure: Proportion of patients experiencing serious unexpected adverse reactions that require discontinuation of the investigational product.
timeFrame: 30 days (from day +1 to day +30)
Other outcomes:
Locations:
city: San Sebastián
country: Spain
facility: Biodonostia Health Research Institute
state: Guipuzcoa
Study officials:
References: