Colchicine COVID-19 Trial Underway

In the clinical trial called COLCORONA colchicine is being used to reduce the excessive inflammatory reaction caused by coronavirus that may lead to acute respiratory distress syndrome (ARDS), organ failure and death.

If you become infected with coronavirus, your immune system sends useful immune chemicals to the affected areas of the lungs to help fight the infection, which is good because this is how you recover from an infection.  However in some people there is an overreaction by the immune system called a “cytokine storm” causing too many immune messengers to be made. This means major parts of the body become very inflamed and they can not work properly.  The lungs become congested which causes severe breathing problems and pneumonia. The heart, liver and kidneys can also become very inflamed which can lead to serious complications, even organ failure and death.

Colchicine will be used for its anti inflammatory effects when treating COVID-19.  By reducing the excessive inflammation, it is hoped that the body’s immune system will be able to fight coronavirus, and reduce the complications of pneumonia, organ failure and death

There are two major manufacturers of colchicine in the United States, Takeda and Hikma, who together manufacture the majority of the drug.

Dr. Pillinger, of NYU Langone Health says that the greatest use of colchicine in the United States is for gout but  not used chronically, so a much smaller number of patients are using colchicine at any one time. It’s also used for other inflammatory conditions, primarily calcium pyrophosphate crystal disease and familial Mediterranean fever. Cardiologists also regularly prescribe colchicine in pericarditis for short-term use.

“Overall, the number of patients using colchicine is much larger than that for the use of hydroxychloroquine, for example, suggesting that the immediate risk of shortage could be lower. However, if individuals started using it off label, or prescribing inappropriately for the COVID-19 indication, the supply would rapidly run short,” he says.

Dr. Pillinger says “the COLCORONA trial is exactly the kind of trial that would be needed for assessing colchicine, and it is big enough and happening quickly enough to get an answer. But if people start to use colchicine off label, we may never know the truth.”

He notes that colchicine must also be dose adjusted for kidney disease, and, in some of the COVID-19 patients, kidney function changes rapidly. So again, its use would require expert supervision even if there were evidence for its utility. “This is not an agent to use randomly; the studies will be rushed out quickly and hopefully will give us the knowledge to know what to do,” he says.

PRESS RELEASE:

The Montreal Heart Institute announces that its Research Center is launching today a COVID-19 clinical study in Canada to determine whether short-term treatment would reduce the risk of pulmonary complications and related deaths.

The clinical study, named COLCORONA, coordinated by the Montreal Health Innovations Coordinating Center (MHICC) is funded by the Government of Quebec and supported by Pharmascience and CGI.

COLCORONA will evaluate the phenomenon of major inflammatory storm present in adults suffering from severe complications related to COVID-19. The researchers hypothesized that the treatment could reduce the complications associated with COVID-19. The clinical study will involve the recruitment of approximately 6,000 participants followed for 30 days. Initial results will be available a few days after study completion.

Participants eligibility criteria:

  • Be tested positive for COVID-19;
  • Be 40 years and over;
  • Not hospitalized;
  • Be willing to take the drug or placebo daily for 30 days;
  • Be willing to participate in two follow-up calls by phone or videoconference.

Women who do not take contraceptives, those who are pregnant and those who are breastfeeding are not eligible for the clinical study.

People with a positive COVID-19 diagnosis who are interested in participating in the clinical study are encouraged to speak to their health care professional or call 1-877-536-6837. Phone lines will be open as of 7h00 AM EDT Monday March 23rd.

To learn more about the COLCORONA clinical study, go to www.colcorona.org.

Physicians Weekly

View Comments

  • I am an FMF patient who uses colchicine daily to control flares.

    As I care about Covid patients, and hope that this drug works to ease their suffering, my supply chain is presently not only disrupted but the price has doubled overnight.

    I hope that something is being done to increase manufacturing to compensate for this trial because it feels a bit terrifying to me to consider the possibility of losing availability.

    In addition to that if big pharma starts price goughing because this drug is suddenly in demand. The epipens I used to carry with me...that safety net... is no longer affordable, simply because of one pharma company's greed.

    If I run out if Colchicine, I will go through untenable suffering, literally dryheaving for hours for the pain. Because of the opioid addiction epidemic in this country, I was previously not allowed access to any kind if pain management before I received a diagnosis of periodic fever. I don't want to go back to that circumstance, fighting for my life.

    The medical industry must play a role in advocateing for a patient's right to access affordable prescriptions. I pay dearly for medical insurance with a high deductible...and my meds are out of pocket. My colchicine lifeline just got yanked on. This is a bit terrifying.

  • Is it possible that the anti-inflammatory MSM I use for arthritis relief could offer similar protection from cytokine storms? Are there any trials indicating this? It seems to me that if it is a possibility it could prevent hospitalizations, a trial should be done, because it is readily available to all, but we need to know the risks and benefits, contraindications and dosages.

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