Impact of Colchicine and Low-dose Naltrexone on COVID-19

Inclusion Criteria

• Male and (non-pregnant, non-breastfeeding) females aged 18 years or older
• Requiring admission to Methodist or Regions Hospital due to laboratory-confirmed COVID-19
• Meets criteria of only up to moderate COVID-19 disease as defined by a clinical score of 2 or 3 at the time of enrollment, and one or more of the following:
• Dyspnea limiting usual activities on baseline O2 needs
• Respiratory rate >/= 30/min on O2 or room air
• Blood oxygen saturations /=7 days at the time of screening.
• Clinical estimation of attending physician that the patient will require mechanical respiratory support within 48 hours of enrollment
• Patients in which EITHER symptom onset OR a positive COVID-19 laboratory test occurred >14 days prior to enrollment.
• Patients with concomitant influenza A or B at time of hospitalization if tested as part of ED/hospital admission.
• Female patients who are pregnant or breastfeeding at time of hospital admission
• Diagnosis of Chronic Kidney Disease stage ≥4 as documented in the patient's problem list (not based on CrCI calculations alone)
• CrCl < 30 mL/min or requiring renal replacement therapy (e.g. intermittent hemodialysis, continuous renal replacement therapy, peritoneal dialysis) at screening
• History of cirrhosis or advanced liver disease, or active hepatic viral infection
• Transplant of kidney, lung, heart, or liver in the past 2 years
• Uncontrolled severe gastrointestinal disorders, Crohn's disease, ulcerative colitis, chronic diarrhea, diarrhea predominant irritable bowel syndrome, active stomach or intestinal ulcer, or one that was treated within the last 6 months
• Patients currently receiving agents that are p-glycoprotein AND strong CYP3A4 inhibitors with CrCl < 60 mL/min, or any combination of drug interactions that is not amenable to dosage adjustment (refer to list of medications with potential Colchicine and Naltrexone interactions).
• Patients actively undergoing chemotherapy for an active malignancy, or history of a hematologic malignancies
• Chronic or current use of colchicine or any mu-opioid antagonist.
• Chronic, scheduled opioid therapy (i.e. not intermittent as needed use), or, prior to enrollment, an acute condition requiring continued pain control that is unattainable without ongoing opioid therapy.
• Pre-existing condition that is being treated with tocilizumab, anakinra, sarilumab, other interleukin-antagonists, TNF-inhibitors, or JAK inhibitors.
• NOTE: Patients treated with tocilizumab will be permitted to enroll if their care team is prescribing it for COVID-19. Use of tocilizumab at baseline for another indication will continue to be excluded.
• Participation in any other clinical trial of an experimental treatment for COVID-19, note:
• While convalescent plasma is no longer recommended within HP, it can be given if deemed appropriate by the medical team once ≥ 24 hours has elapsed since enrollment;
• Patients previously enrolled in the C3PO study can enroll in this study, as any convalescent plasma received would have been outpatient;
• Remdesivir is allowed per standard protocol;
• Dexamethasone is allowed per standard protocol
• Patients actively enrolled in hospice or that are DNI or on palliative care
• History of hypersensitivity reaction to colchicine or its inactive ingredients
• History of hypersensitivity reaction to naltrexone or its inactive ingredients
• Incarcerated or a ward of the state
• Any patient considered an unsuitable candidate, for any reason, by study investigators.