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Trial to Study the Benefit of Colchicine in Patients With COVID-19

NCT04350320 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 102

Last updated 2021-01-12

No results posted yet for this study

Summary

COVID-19 is associated with a cytokine storm that leads to respiratory distress, multiorgan failure and elevated mortality. Oral colchicine exhibits high anti-inflammatory capacity attributed to the inhibition of microtubules polymerization, inflammasome and production of IL-1β and IL-6, which could prevent the inflammatory storm in COVID-19 patients at risk. We present a randomized clinical trial, controlled, open-label and pragmatic, including COVID-19 patients requiring hospitalization but no intensive care yet. Colchicine will be started within the first 48 hours and then administered for four weeks using a descending dose. The benefit will be study in terms of clinical evolution (WHO 7-point scale) and IL-6 levels, as well as other clinical and biochemical secondary end-points. In the case of positive results, the clinical impact would be relevant given that this oral medication is widely accessible which would help to prevent the inflammatory complications associated with COVID-19.

Conditions

  • COVID19

Interventions

DRUG

Colchicine Tablets

standard therapy for COVID-19 according to the stablished hospital protocols.

DRUG

Standard therapy for COVID-19 according to the stablished hospital protocols.

standard therapy for COVID-19 according to the stablished hospital protocols.

Sponsors & Collaborators

  • Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia

    lead OTHER

Principal Investigators

  • Domingo A Pascual Figal, MD · HCUVA

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-04-30
Primary Completion
2020-10-20
Completion
2020-12-30

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04350320 on ClinicalTrials.gov