The clinical trial named Colcorona will analyze whether colchicine, a drug commonly prescribed for gout, can be effective an effective treatment for patients with COVID-19. Researchers hypothesize colchicine’s anti-inflammatory effects can reduce the overreaction of the autoimmune system called the cytokine storm- the harmful response that creates the coronavirus health complications.
Colcorona was started by the Montreal Heart Institute in Quebec on March 23, 2020. In association with NYU Langone Health, the trial has recently received more funding from the National Heart, Lung, Blood Institute (NHLB). UC San Francisco and NYU School of Medicine are the first two U.S. clinical sites. Also, the study has several sites in Canada and more opening in Europe.
Recruiting remains open for 6000 patients. The general participant criteria for the study is as follows:
- Test positive for COVID-19 within the last 24 hours
- Be 40 years and older with at least one high-risk criteria (diabetes, hypertension, asthma, respiratory disease, heart disease, blood cell deficiencies)
- 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 video conference
- 70 years and older with no high-risk condition
For more information on the study, visit the official Colcorona clinical trial page on ClinicalTrials.gov.
The following sections will take a closer look at the possibilities how colchicine’s can treating COVID-19 patients.
Colchicine is Known to Reduce Inflammation
Colcrys, the colchicine brand name, is an FDA-approved drug prescribed to treat pain and inflammation caused by gout. A primary symptom of gout is joint irritation due to a buildup of uric acid crystals.
[For a complete description and usage of colchicine, check out: Gloperba: Liquid Version Of Antigout Drug Colchicine]
Colchicine reduces the immune system’s activation of inflammatory cells, leukotrienes and cytokines. Second, colchicine bonds to disease-fighting white blood cells and prevents the cells from overreacting to infected cells. For gout, the results are less pain and inflammation at the aggravated joint.
The Cytokine Storm is the Reason for Coronavirus Complications
Cytokines are protein compounds critical in triggering the body’s autoimmune responses. In most cases, the immune system and cytokines are stimulated by a trauma, virus or infection.
When you have an infection or disease, your immune system sends immune cells to the infected area. This is the normal and healthy response of your body trying to heal itself.
However, a cytokine storm is an overproduction of cytokines and immune cells that attack healthy cells and tissues instead of just fighting the virus. This overreaction does the body more harm than good. As a result, infected organs become extremely inflamed and weak.
With COVID-19, one of the first serious complication is severe congestion in the lungs. Difficulty in breathing results from fluid buildup and pneumonia. Additionally, the cytokine storm may cause widespread inflammation to other major organs like the heart, liver and kidneys. Hyper inflammation can lead to organ damage or failure.
This harmful condition is similar to past outbreaks like the Spanish flu and swine flu because the immune system continues to release cytokines. Apparently, patients with strong immune systems are more prone to serious complications or death.
Why Colchicine for Colcorona Trial?
As more patient data from all over the world come in, reports show COVID-19 infects the heart immediately after the lungs. Early reports found cardiac damage in about one in five patients leading to heart failure.
In April, a study from Greece showed encouraging results on 120 coronavirus patients given colchicine. After two weeks of daily doses, infected lungs and hearts showed significant signs of improvement.
“The fact for the current moment is that hospitalized patients that are taking colchicine showed a substantial inflammation reduction in comparison with those that did not take colchicine, independent of having (or not) problems with their heart.”Professor of Cardiology Christos Stefanadis from the School of Medicine at the University of Athens.
The hypothesis from Greece supports a relative study from December 2019 that concluded colchicine improved blood flow in the heart. Evidently, the drug reduces inflammation of the myocardium- the muscular tissue of the heart. The study, called ColCot, was lead by Dr. Jean-Claude Tardif, who is also the lead investigator for Colcorona.
Colcorona Trial Objectives and Process
“The primary objective of this study is to determine whether short-term treatment with colchicine reduces the rate of death and lung complications related to COVID-19. The secondary objective is to determine the safety of treatment with colchicine in this patient population.”– ClinicalTrials.gov. Colchicine Coronavirus SARS-CoV2 Trial (COLCORONA) (COVID-19)
The Colcorona trial aims to enroll 6,000 newly diagnosed patients. To keep patients isolated at home, the study will use a ‘contactless’ procedure. The trial supply of colchicine will be shipped to their homes within 48 hours of being diagnosed and registered.
Two groups will be randomly designated either a 0.5 mg dose of colchicine or a placebo for 30 days. Both the medication and placebo will likely be in tablet form. No indication of using Gloperba, the liquid version of colchicine, as an alternative.
The Colcorona protocol allows patients to participate while quarantined at homes and avoid visiting clinics. Eligible patients will apply for the trial by phone or at a regional study site. They will sign digital consent forms via cell phone or computer.
Follow-up phone or video calls will occur 15 and 30 days after initial dose. Within this 30 days period, researchers anticipate to have sufficient data to determine the efficacy of colchicine against COVID-19.
If proven effective, administering colchicine early to people who tested positive can lower hospitalization rates and deaths.
Additionally, colchicine has an advantage because it has been approved by the FDA. It can immediately enter Phase 3, clinical trials; testing on people with COVID-19. Other drugs that are not FDA-approved will need to pass Phase 1 & 2 laboratory testing, which can take up to months.
COLCORONA Trial – Contact Information
Colcorona Clinical Trial is available in Montreal, New York City tri-state area of New York, New Jersey and Connecticut, California, Madrid-Spain, British Columbia, Ontario with more locations opening.
If you know anyone eligible and willing to take participate, here is the contact information for Colcorona:
- Visit: www.colcorona.com, https://en.colcorona.net/
- Call: 1-877-536-6837
- Email: firstname.lastname@example.org
In community-treated patients including those without a mandatory diagnostic test, the effect of colchicine on COVID-19-related clinical events was not statistically significant. Among patients with PCR-confirmed COVID-19, colchicine led to a lower rate of the composite of death or hospital admission than placebo. Given the absence of orally administered therapies to prevent COVID-19 complications in community-treated patients and the benefit of colchicine in patients with PCR-proven COVID-19, this safe and inexpensive anti-inflammatory agent could be considered for use in those at risk of complications. Notwithstanding these considerations, replication in other studies of PCR-positive community-treated patients is recommended.– The Lancet