COlchicine in Moderate-severe Hospitalized Patients Before ARDS to Treat COVID-19
Condition: Coronavirus Infection
MeSH terms: Coronavirus Infections
Intervention: Colchicine; Usual Care
Intervention description: 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.; COVID Patients in this arm will receive usual care COVID19 treatment and will not receive colchine.
Intervention MeSH terms: Colchicine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 21.0
Sex: All
Minimum age: 18 Years
Maximum age: 100 Years
Healthy volunteers: No
Keywords: colchicine; anti-inflammatory

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.
    

Eligibility 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