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The ECLA PHRI COLCOVID Trial. Effects of Colchicine on Moderate/High-risk Hospitalized COVID-19 Patients.

NCT04328480 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1279

Last updated 2021-04-27

No results posted yet for this study

Summary

The ECLA PHRI COLCOVID Trial is a simple, pragmatic randomized open controlled trial to test the effects of colchicine on moderate/high-risk hospitalized COVID-19 patients with the aim of reducing mortality and/or new requirement for mechanical ventilation.

Conditions

Interventions

DRUG

Colchicine

The colchicine dosage schedule will vary according to the following scenarios: 1. In patients not receiving Lopinavir/Ritonavir * Loading dose of 1.5 mg followed by 0.5 mg after two hours (day 1) * The next day 0.5 mg bid for 14 days or until discharge. 2. In patients receiving Lopinavir/Ritonavir * Loading dose of 0.5 mg (day 1) * After 72 hours from the loading dose, 0.5 mg every 72 hours for 14 days or until discharge. 3. Patients under treatment with Colchicine that are starting with Lopinavir/Ritonavir * Dose of 0.5 mg 72 hours after starting Lopinavir/Ritonavir. * Continue with 0.5 mg every 72 hours for 14 days or until discharge. Only the oral route will be used except in the case of patients associated with mechanical ventilation or with contraindications to the oral route, in whom it will be administered by nasogastric tube.

OTHER

Local standard of care

Local standard of care for COVID-19 SARS moderate /high-risk patients

Sponsors & Collaborators

  • Population Health Research Institute

    collaborator OTHER

  • Estudios Clínicos Latino América

    lead OTHER

Principal Investigators

  • Rafael Diaz, MD · ECLA- ICR

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-04-17
Primary Completion
2021-04-25
Completion
2021-04-26

Countries

  • Argentina

Study Locations

More Related Trials

Entities

Diseases

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 NCT04328480 on ClinicalTrials.gov