Status:
TERMINATED
COlchicine in Moderate-severe Hospitalized Patients Before ARDS to Treat COVID-19
Lead Sponsor:
Maimonides Medical Center
Conditions:
Coronavirus Infection
Eligibility:
All Genders
18-100 years
Phase:
PHASE2
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 deco...
Detailed Description
Prospective, completely randomized, open labeled, controlled study. Patients will be randomized into two groups (A and B). Patients of group A will be treated under what is considered current standard...
Eligibility Criteria
Inclusion
- 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:
- Dyspnea
- Respiratory frequency ≥ 30/min
- 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
Exclusion
Key Trial Info
Start Date :
April 26 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 31 2020
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT04363437
Start Date
April 26 2020
End Date
July 31 2020
Last Update
February 18 2022
Active Locations (1)
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1
Maimonides Medical Center
Brooklyn, New York, United States, 11219