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PREEMPTIVE THERAPY WITH COLCHICINE IN PATIENTS OLDER THAN 60 YEARS WITH HIGH RISK OF SEVERE PNEUMONIAE DUE TO CORONAVIRUS

NCT04416334 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2023-11-08

No results posted yet for this study

Summary

This is a phase 3 clinical trial, randomized, single-center, opened, controlled, to evaluate efficacy and safety of early administration of colchicines in patients older than 60 years, with high risk of pulmonary complications due to coronavirus SARS-CoV2 (COVID-19). An approximately number of 954 subjects meeting all inclusion and none exclusion criteria will be randomized either to receive colchicines or symptomatic treatment with paracetamol during 21 days.

Conditions

  • SARS-CoV-2 Infection (COVID-19)

Interventions

DRUG

Colchicine plus symptomatic treatment (paracetamol)

Colchicine plus symptomatic treatment (paracetamol).

DRUG

Symptomatic treatment (paracetamol or best symptomatic treatment based on doctor recommendations)

Symptomatic treatment (paracetamol or best symptomatic treatment based on doctor recommendations).

Sponsors & Collaborators

  • Gerencia de atención primaria área 1

    collaborator UNKNOWN

  • Gerencia de atención primaria área 2

    collaborator UNKNOWN

  • Gerencia Atencion Primaria Area 3

    collaborator OTHER_GOV

  • Gerencia de atención primaria área 4

    collaborator UNKNOWN

  • Instituto de Investigación Marqués de Valdecilla

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-08-19
Primary Completion
2022-06-01
Completion
2022-10-11

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 NCT04416334 on ClinicalTrials.gov