A Phase 2 interventional study of Colchicine and Usual Care in Coronavirus Infection, sponsored by Maimonides Medical Center. Terminated at 1 site in United States. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2022-02-18.
Sponsored by Maimonides Medical Center · Phase 2, Interventional, and Treatment
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.
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 of care at Maimonides Medical Center while group B patients will receive colchicine in addition to standard of care.
Treatment arm
In addition to the local standard of care for COVID 19 patients, the patient will receive colchicine PO as such:
Patients who are on HMG-Co A Reductase Inhibitors (atorvastatin, fluvastatin, pravastatin, simvastatin), fibrates, genfibrozil, amiodarone, dronedarone or digoxin should have the colchicine dosage reduced to a loading dose of 0.6mg followed by 0.3mg after two hours (day 1) followed by 0.3mg BID for 14 days or until discharge.
If patients have significant gastrointestinal symptoms after loading, the dosage may be reduced to 0.3mg BID for the rest of the 14 day course or until discharge. If gastrointestinal symptoms continue, the medication should then be discontinued. Patients who experience sensory motor neuropathy, or symptoms and laboratory findings consistent with rhabdomyolysis should prompt immediate discontinuation of the drug. If renal function deteriorates during the treatment course and CrCl \<30ml/min, colchicine should also be discontinued.
Control arm Usual medical therapy (can include medications such as hydroxychloroquine, azithromycin)
Patients should NOT receive, Remdesivir, IL-6 inhibitors (Tociluzimab, Sarilumab), JAK inhibitors, IL-1 inhibitors, or other immunomodulators for COVID-19 before randomization. Since the primary clinical endpoint is progression of disease, if the patient requires beyond 8L nasal cannula, eg. high flow O2 or mechanical ventilation, the primary clinical endpoint is met and the above experimental medications will be permitted. To rephrase, the patient will be allowed, Remdesivir, IL-6 inhibitors and other immunomodulators if then deemed medically necessary by the treating physician.
929 studies on the registry are indexed under Coronavirus Infections; 50 are open to participants now.
This study's enrollment of 21 is below the median of 107 across 541 interventional studies indexed under Coronavirus Infections.
Browse Coronavirus Infections studies →Maimonides Medical Center is the lead sponsor of 50 studies on the registry; 1 is open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 6 (86%) have results posted.
Counted across the registry records on this site, refreshed daily.
Significant COVID-19 symptoms are defined by one or more of the following:
Exclusion Criteria:
Drug: Colchicine
Drug: Usual Care
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.
Percentage of Patients Requiring Supplemental Oxygen Beyond 8L Nasal Cannula
Time frame: through study completion, estimated 2 months
Percentage of Patients Who Will Require Mechanical Ventillation
Time frame: through study completion, estimated 2 months
Mortality
Time frame: through study completion, estimated 2 months
| Milestone | Colchine | Usual Care |
|---|---|---|
| Started | 10 | 11 |
| Completed | 10 | 11 |
| Not completed | 0 | 0 |
| Participants | Colchine | Usual Care |
|---|---|---|
| Percentage of Patients Requiring Supplemental Oxygen Beyond 8L Nasal Cannula | 1 | 1 |
| Participants | Colchine | Usual Care |
|---|---|---|
| Percentage of Patients Who Will Require Mechanical Ventillation | 1 | 0 |
| Participants | Colchine | Usual Care |
|---|---|---|
| Mortality | 0 | 1 |
Collected over 2 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Colchine | 0/10 (0%) | 0/10 (0%) | 0/10 (0%) |
| Usual Care | 1/11 (9.1%) | 0/11 (0%) | 0/11 (0%) |
| Age, Continuous(years) | Colchine | Usual Care | Total |
|---|---|---|---|
| Mean | 60.9 ± 18.1 | 67.1 ± 20.4 | 64.47 ± 19.19 |
| Sex: Female, Male(Participants) | Colchine | Usual Care | Total |
|---|---|---|---|
| Female | 4 | 5 | 9 |
| Male | 6 | 6 | 12 |
| Race and Ethnicity Not Collected(Participants) | Colchine | Usual Care | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
| Region of Enrollment(participants) | Colchine | Usual Care | Total |
|---|---|---|---|
| United States | 10 | 11 | 21 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: No
This study is terminated, as verified in Jan 2022. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Maimonides Medical Center