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

NCT04363437 | Terminated Phase 2 Results DMC FDA Drug

• 1 other identifier: 2020-04-12
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

colchicine; anti-inflammatory

Outcome Measures

Primary Outcomes (1)

• Percentage of Patients Requiring Supplemental Oxygen Beyond 8L Nasal Cannula

  through study completion, estimated 2 months

Secondary Outcomes (2)

• Percentage of Patients Who Will Require Mechanical Ventillation

  through study completion, estimated 2 months

• Mortality

  through study completion, estimated 2 months

Study Arms (2)

Colchine

ACTIVE COMPARATOR

Drug: Colchicine

Usual Care

ACTIVE COMPARATOR

Drug: Usual Care

Interventions

Colchicine DRUG

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.

Colchine

Usual Care DRUG

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

Usual Care

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• Requirement of oxygen supplementation \>8L nasal cannula
• Pregnancy
• Known hypersensitivity to colchicine
• Patient currently in shock or with hemodynamic instability requiring pressors
• History of cirrhosis
• Alanine Aminotransferase (ALT) or aspartate aminotransferase (AST) \> 5X upper limit of normal (ULN)
• Patients with severe renal disease, CrCl \<30ml/min
• Patients requiring invasive mechanical ventilation at screening or Clinical estimation that the patient will require mechanical respiratory support within 24 hours
• Patient is currently taking colchicine for other indications (gout or Familial Mediterranean Fever)
• Patient is on (and cannot discontinue) a strong CYP3A4 inhibitor (eg clarithromycin, indinavir, itraconazole, ketoconazole, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, atazanavir), a moderate CYP3A4 inhbitor (eg diltiazem, verapamil, fluconazole, amprenavir, aprepitant, fosamprenavir) or a P-gp Inhibitor (eg cyclosporine, ranolazine)
• Patient is undergoing chemotherapy for cancer
• Patient is considered by the investigator, for any reason, to be unsuitable candidate for the study

Sponsors & Collaborators

• Maimonides Medical Center: lead

Study Sites (1)

Maimonides Medical Center

Brooklyn, New York, 11219, United States

Location

MeSH Terms

Conditions

Coronavirus Infections

Interventions

Colchicine

Condition Hierarchy (Ancestors)

Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections

Intervention Hierarchy (Ancestors)

Alkaloids; Heterocyclic Compounds

Results Point of Contact

• Title: Dr. Felix Yang
• Organization: Maimonides Medical Center

fyang@maimonidesmed.org

7182836000

Study Officials

• Felix Yang, MD

  Maimonides Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 23, 2020
• First Posted: April 27, 2020
• Study Start: April 26, 2020
• Primary Completion: July 31, 2020
• Study Completion: July 31, 2020
• Last Updated: February 18, 2022
• Results First Posted: February 18, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)