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

• Status: Recruiting
• Trial end date: 2020-06-14
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Maimonides Medical Center
• Treatments: Colchicine

Criteria

• Males and females >=18 years of age

• Willing and able to provide written informed consent prior to performing study procedures

• Currently hospitalized and requiring medical care for COVID-19

• Significant COVID-19 symptom, or judged by the treating provider to be at high risk of progression to severe COVID-19 infection

• Significant COVID-19 symptoms are defined by one or more of the following:

1. Dyspnea

2. Respiratory frequency ≥ 30/min

3. Blood oxygen saturation ≤ 93%

• AND one or more of the following: (positive PCR test or positive antibodies) or (CT/Chest X-ray consistent with COVID19 infection) or (anosmia).

Exclusion Criteria:

• 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 received Remdesivir, Sarilumab, Tociluzimab, Lopinavir/Ritonavir or other immunomodulator given for COVID-19 treatment (Note: Convalescent plasma infusion is not an exclusion)

• 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