There are 5 clinical trials

Clinical Trials

1 COLCHICINE TO COUNTERACT INFLAMMATORY RESPONSE IN COVID-19 PNEUMONIA

Cytokines and chemokines are thought to play an important role in immunity and immunopathology during virus infections [3]. Patients with severe COVID-19 have higher serum levels of pro-inflammatory cytokines (TNF-α, IL-1 and IL-6) and chemokines (IL-8) compared to individuals with mild disease or healthy controls, similar to patients with SARS or MERS . The change of laboratory parameters, including elevated serum cytokine, chemokine levels, and increased NLR in infected patients are correlated with the severity of the disease and adverse outcome, suggesting a possible role for hyper-inflammatory responses in COVID-19 pathogenesis. Importantly, previous studies showed that viroporin E, a component of SARS-associated coronavirus (SARS-CoV), forms Ca2C-permeable ion channels and activates the NLRP3 inflammasome. In addition, another viroporin 3a was found to induce NLRP3 inflammasome activation . The mechanisms are unclear. Colchicine, an old drug used in auto-inflammatory disorders (i.e., Familiar Mediterranean Fever and Bechet disease) and in gout, counteracts the assembly of the NLRP3 inflammasome, thereby reducing the release of IL-1b and an array of other interleukins, including IL-6, that are formed in response to danger signals. Recently, colchicine has been successfully used in two cases of life-threatening post-transplant capillary leak syndrome. These patients had required mechanically ventilation for weeks and hemodialysis, before receiving colchicine, which abruptly restored normal respiratory function and diuresis over 48 hrs [4].

NCT04322565 Coronavirus Infections Pneumonia, Viral Drug: Colchicine

MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome Pneumonia, Viral Pneumonia

HPO:Pneumonia

2 Colchicine Coronavirus SARS-CoV2 Trial (COLCORONA)

This is a phase 3, multi-center, randomized, double-blind, placebo-controlled multicenter study to evaluate the efficacy and safety of colchicine in adult patients diagnosed with COVID-19 infection and have at least one high-risk criterion. Approximately 6000 subjects meeting all inclusion and no exclusion criteria will be randomized to receive either colchicine or placebo tablets for 30 days.

NCT04322682 Corona Virus Infection Drug: Colchicine Drug: Placebo oral tablet

MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome Virus Diseases

3 The GReek Study in the Effects of Colchicine in Covid-19 cOmplications Prevention

Based on data regarding the effect of colchicine on the inflammasome NLP3 and microtubule formation and associations thereof with the pathogenetic cycle of SARS-COV-2, the question arises whether colchicine, administered in a relatively low dose, could potentially have an effect the patients' clinical course by limiting the myocardial necrosis and pneumonia development in the context of COVID-19. If present, this effect would be attributed to its potential to inhibit inflammasome and (less probably) to the process of SARS-CoV-2 endocytosis in myocardial and endothelial respiratory cells.

NCT04326790 Corona Virus Disease 19 (Covid 19) Drug: Colchicine Drug: Standard treatment

MeSH:Virus Diseases

4 COlchicine in Moderate Severity Hospitalized Patients Before ARDS to Treat COVID-19 (the COMBAT-COVID-19 Pilot Study)

COVID-19 infection is a respiratory infectious disease caused by a virus called SARS-CoV-2 . This virus is transmitted from person to person through close contacts or respiratory droplets. Symptoms usually start 4 or 5 days after exposure. Some common symptoms include fever, dry cough, feeling tired, muscle aches, and trouble breathing. Although it may affect all organs in our body, it mainly attacks our lungs' ability to help us breathe. There are currently no FDA approved medications to treat COVID-19 infection. Patients are given medications to help alleviate the symptoms. When patients are admitted to the hospital, they are given medications to reduce fever, relieve pain and supplement oxygen. In severe cases, patients are put on a ventilator, a machine designed to to support the lungs. There are a number of drugs undergoing clinical study to see if they are effective in treating the COVID-19 virus. At Maimonides Medical Center, the investigators are taking the appropriate steps to find an effective treatment for COVID-19. The COMBAT COVID-19 Pilot Study is designed for patients diagnosed with COVID-19 infection who require oxygen supplementation to be treated with colchicine to reduce the chance of needing a mechanical ventilator. Colchicine is an FDA approved medication that is used to treat inflammatory disorders such as Gout and Familial Mediterranean Fever. It has also been used to treat other inflammatory conditions such as inflammation around the heart and been demonstrated to help patients who have had an acute heart attack. Colchicine is a readily available drug which is usually well tolerated by patients. The investigators believe that colchicine may reduce the inflammation in the lungs. If so, the lungs may be able heal at a quicker pace and we hope that this may reduce the need for mechanical ventilation. The research will be a randomized trial, patient will be randomly selected to be in either the colchicine treatment group or the standard medicines group. The treatment group will receive colchicine for 14 days or until the day of discharge. The standard medicines group will receive the usual medical therapy as determined by attending physician.

NCT04363437 Coronavirus Infection Drug: Colchicine Drug: Usual Care

MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome

5 Double-blind, Placebo-controlled Clinical Trial of the Use of Colchicine for the Management of Patients With Mild and Severe SARS-Cov2 Infection

The world is currently facing a pandemic due to the outbreak of a new coronavirus causing acute respiratory failure called SARS-Cov2. The majority of patients (8 out of 10) are known to have mild disease, manifested by respiratory tract symptoms associated with fever, headache, and body pain. However, it is possible that the disease progresses to a severe stage, whith the need for mechanical ventilation support associated with high morbidity and mortality. The progression of the disease is mainly due to the appearance of uncontrolled inflammation that also favors the development of disseminated clots. So far, there is no effective treatment to combat coronavirus; however, the use of anti-inflammatory drugs is potentially effective in preventing complications from the disease. In this regard, low dose colchicine is relatively safe and effective as an anti-inflammatory. It has been used for many years in the control of inflammation secondary to the accumulation of uric acid crystals. The aim of this study is to test if the administration of colchicine at a dose of 1.5 mg the first day and subsequently 0.5 mg BID until completing 10 days of treatment is effective as a treatment for inflammation related symptoms in patients with mild and severe disease secondary to coronavirus infection. The primary outcome is improvement of symptoms related to inflammation and avoiding progression to severe and critical stages of the disease. Colchicine can be discontinued before the end of 10 days in case of serious adverse effects or if the patient progresses to the critical stages of the disease.

NCT04367168 COVID Drug: Colchicine Drug: Placebo oral tablet

MeSH:Inflammation

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