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COlchicine in Moderate-severe Hospitalized Patients Before ARDS to Treat COVID-19

NCT04363437 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2022-02-18

Study results available
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Summary

The most prevalent complication of COVID-19 infection is respiratory failure from severe acute respiratory syndrome (SARS), the leading cause of mortality. There is increasing indication that the decompensation in severe COVD-19 infection may be due to a cytokine storm syndrome. This hyperinflammatory syndrome results in a fulminant and fatal hypercytokinemia and multiorgan failure.

Approximately 15% of patients with COVID-19 infection are hospitalized and 20-30% of these hospitalized patients require ICU care and/or mechanical ventilation. Overall mortality in hospitalized patients is approximately 20-25%. There is significant interest in therapies that can be given upstream to reduce the rate of mechanical ventilation and thus mortality.

We hypothesize that treatment with colchicine in COVID-19 moderate-severe patients may decrease the risk of progression into ARDS requiring increased oxygen requirements, mechanical ventilation, and mortality.

Conditions

  • Coronavirus Infection

Interventions

DRUG

Colchicine

People in the colchine group will be given a starting dose of 1.2 mg followed, by 0.6mg after 2 hours if they do not have significant gastrointestinal symptoms, on day 1. After that, they will take colchicine 0.6mg twice a day for 14 days or until discharged or release from the hospital.

DRUG

Usual Care

COVID Patients in this arm will receive usual care COVID19 treatment and will not receive colchine.

Sponsors & Collaborators

  • Maimonides Medical Center

    lead OTHER

Principal Investigators

  • Felix Yang, MD · Maimonides Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-04-26
Primary Completion
2020-07-31
Completion
2020-07-31
FDA Drug
Yes

Countries

  • United States

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 NCT04363437 on ClinicalTrials.gov