Double Blind Randomized Clinical Trial of Use of Colchici... | NCT04997551

NCT04997551

Protocol Section

Identification Module

Results Section

No data available

No data is available for this block.

Annotation Section

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No data is available for this block.

Document Section

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No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Description Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
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

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
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

Eligibility Module

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.

ID	Term
D011024	Pneumonia, Viral
D011014	Pneumonia
D012141	Respiratory Tract Infections
D007239	Infections