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

Primary Purpose

COVID-19 Infection

Status

Unknown status

Phase

Phase 3

Locations

Spain

Study Type

Interventional

Intervention

Colchcine

About this trial

This is an interventional treatment trial for COVID-19 Infection focused on measuring covid-19, colchicine

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Biodonostia Health Research Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Colchicine

Placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

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.

Secondary Outcome Measures

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

Not hospitalized, usual activities not limited Not hospitalized with limitation for usual activities Hospitalized, without oxygen requirements Hospitalized with oxygen requirements Hospitalized with oxygen in a reservoir, non-invasive mechanical ventilation or high-flow oxygen device Hospitalized with the need for invasive mechanical ventilation Deceased

Time (days) until death

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

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

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

Proportion of patients experiencing serious unexpected adverse reactions that require discontinuation of the investigational product.

Full Information

NCT ID

NCT04997551

First Posted

August 3, 2021

Last Updated

August 6, 2021

Sponsor

Asociacion Instituto Biodonostia

1. Study Identification

Unique Protocol Identification Number

NCT04997551

Brief Title

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

2. Study Status

Record Verification Date

August 2021

Overall Recruitment Status

Unknown status

Study Start Date

September 8, 2020 (Actual)

Primary Completion Date

September 1, 2021 (Anticipated)

Study Completion Date

January 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Asociacion Instituto Biodonostia

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

COVID-19 Infection

Keywords

covid-19, colchicine

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

752 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Colchicine

Arm Type

Active Comparator

Arm Description

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

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Colchcine

Intervention Description

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

Primary Outcome Measure Information:

Title

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.

Description

Time Frame