|drug2345||Oral administration of Colchicine plus Herbal Phenolic Monoterpene Fractions Wiki||0.30|
|drug2598||Positive feedback Wiki||0.30|
|drug886||Control Period Wiki||0.30|
|drug3663||Virtual Peer Support Platform Wiki||0.30|
|drug2633||Prednisone tablet Wiki||0.30|
|drug3062||Self Study Wiki||0.30|
|drug1831||Lianhua Qingwen Wiki||0.30|
|drug3209||Standard Treatment Wiki||0.30|
|drug2932||Ruxolitinib 5 MG Wiki||0.30|
|drug3060||Secukinumab 150 MG/ML Subcutaneous Solution [COSENTYX] Wiki||0.30|
|drug2681||Prospective study with two measurement points investigating the impact of viral mitigation protocols on parental burnout Wiki||0.30|
|drug937||Covid-19 Standard of Care Wiki||0.30|
|drug1850||Local standard of care Wiki||0.30|
|drug4118||standard of care Wiki||0.17|
|drug4123||standard therapy Wiki||0.17|
|drug3257||Standard treatment Wiki||0.12|
|drug2557||Placebo oral tablet Wiki||0.11|
|drug3603||Usual Care Wiki||0.10|
|D000077062||Burnout, Psychological NIH||0.33|
|D013315||Stress, Psychological NIH||0.06|
|D014947||Wounds and Injuries NIH||0.06|
There are 11 clinical trials
Cytokines and chemokines are thought to play an important role in immunity and immunopathology during virus infections . 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 .
Description: Time to clinical improvement: defined as time from randomization to an improvement of two points from the status at randomization on a seven-category ordinary scaleMeasure: Clinical improvement Time: Day 28
Description: Live discharge from the hospital (whatever comes first)Measure: Hospital discharge Time: Day 28
Description: Number of death patientsMeasure: Death Time: Day 28
Description: 7-category ordinal scaleMeasure: Clinical status Time: Day 7, Day 14
Description: Number of patients with mechanical ventilhationMeasure: Mechanical ventilhation Time: Day 28
Description: Days of hospitalizationMeasure: Hospitalization Time: Day 28
Description: Days to death from treatment initiationMeasure: Time from treatment initiation to death Time: Day 28
Description: negativization of two consecutive pharyngo-nasal swab 24-72 hrs apartMeasure: Time to Negativization COVID 19 Time: Day 21
Description: Time to remission of fever in patients with T>37.5°C at enrollmentMeasure: Fever Time: Day 1,4,7,14,21,28
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.
Description: The primary endpoint will be the composite of death or the need for hospitalization due to COVID-19 infection in the first 30 days after randomization.Measure: Number of participants who die or require hospitalization due to COVID-19 infection Time: 30 days post randomization
Description: The secondary endpoint is the occurrence of death in the 30 days following randomization.Measure: Number of participants who die Time: 30 days post randomization
Description: The secondary endpoint is the need for hospitalization due to COVID-19 infection in the 30 days following randomization.Measure: Number of participants requiring hospitalization due to COVID-19 infection Time: 30 days post randomization
Description: The secondary endpoint is the need for mechanical ventilation in the 30 days following randomization.Measure: Number of participants requiring mechanical ventilation Time: 30 days post randomization
ACT is a randomized clinical trial to assess therapies to reduce the clinical progression of COVID-19.
Description: composite of hospitalization or deathMeasure: Outpatient trial - Colchicine vs. control and Aspirin vs. control Time: 45 days post randomization
Description: invasive mechanical ventilation or deathMeasure: Inpatient trial - Interferon-β vs. control and Colchicine vs. control Time: 45 days post randomization
Description: invasive mechanical ventilation or deathMeasure: Inpatient trial - Aspirin and rivaroxaban vs. control Time: 45 days post randomization
Description: disease progression by 2 points on a 7-point scaleMeasure: Outpatient and Inpatient trials - Colchicine vs. control, Interferon-β vs. control Time: 45 days post randomization
Description: composite of major adverse cardiovascular events (MI, stroke, ALI, VTE, death), and disease progression by 2 points on a 7-point scaleMeasure: Outpatient and Inpatient trials - Aspirin vs. control, Aspirin and rivaroxaban vs. control Time: 45 days post randomization
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.
Description: Time to clinical deterioration (2 levels in the WHO R&D Blueprint scale)Measure: Clinical deterioration in the semiquantitative ordinal scale suggested by the WHO R&D committee Time: 3 weeks
Description: Maximal concentration of high-sensitivity cardiac troponinMeasure: Maximal concentration of cardiac troponin Time: 10 days
The ECLA PHRI COLCOVID Trial is a simple, pragmatic randomized open controlled trial to test the effects of colchicine on moderate/high-risk hospitalized COVID-19 patients with the aim of reducing mortality.
Description: Number of participants who dieMeasure: All-cause mortality Time: During hospitalization or until death, whichever comes first, assessed up to 30 days
Description: Number of participants who require intubation for mechanical ventilation or dieMeasure: Composite outcome:composite of intubation for mechanical ventilation or death. Time: During hospitalization or until death, whichever comes first, assessed up to 30 days
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.
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.
Description: Resolution of fever, myalgia and arthralgia and 50% improvement of total lymphocyte count, D-dimer, fibrinogen and ferritinMeasure: Number of patients with improvement in body temperature, myalgia, arthralgia, total lymphocyte count, D-dimer, fibrinogen and ferritin levels Time: Up to 24 days
Description: At least one of the following: respiratory failure, respiratory rate > 30 rpm, oxygen saturation < 92%, PaO2/FiO2 < 300 mmHgMeasure: Progression to severe disease Time: Up to 10 days
Patients with mild and severe coronavirus disease 2019 (COVID 19) will be randomized 3:1:1:3 into four groups: colchicine, ruxolitinib, secukinumab, and control groups. Patients will get investigated therapy for 10 days. Patients will be follow-up during 45 days after randomization. Change in clinical assessment score COVID 19 (CAS COVID 19) between baseline and 12th day will be evaluated as the primary endpoint. Risk of death or mechanical ventilation during 45 days after randomization will also be assessed
Description: CAS COVID 19 measures clinical and laboratory parameters in 7 domains: respiratory rate (< 18 - 0 point; 18-22 - 1 point; 23-26 - 2 point; >26 - 3 point) body temperature (35.5 - 37.0 - 0 point; < 35.5 - 1 point; 37.1 - 38.5 - 1 point; > 38.5 - 2 point) Sp02 without support oxygen (> 93% - 0 point; 90-93% - 1 point; < 90% - 2 point) ventilation (not required - 0 point; low-flow ventilation - 1 point; Non-invasive positive pressure ventilation - 2 point; mechanical ventilation - 3 point) C-reactive protein (> 10 - 0 point; 10-59 - 1 point; 60-120 - 2 point; > 120 - 3 point) d - dimer (< 0.51 - 0 point; 0.51 - 2.0 - 1 point; 2.01 - 5.0 - 2, > 5.0 - 3 point) exposure area on lung CT (no pneumonia - 0; 1-24% - 1 point; 25-50% - 2; 51-75% - 3, > 75% - 4). Minimal number of points - 0; max - 20. Lower the score-better healthMeasure: change from baseline in clinical assessment score COVID 19 (CAS COVID 19) Frame: baseline Time: baseline, day 12
Description: time to death or mechanical ventilationMeasure: Combine endpoint: Time to death or mechanical ventilation Time: 45 days
Description: Change from baseline in C-reactive proteinMeasure: C-reactive protein Time: baseline, day 12, day 45
Description: Change from baseline in D-dimerMeasure: D-dimer Time: baseline, day 12, day 45
Description: Change from baseline in EQ-5D-3L™ The EQ-5D-3L essentially consists of 2 pages: the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS). The EQ-5D-3L descriptive system comprises the 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, and extreme problems. The patient is asked to indicate his/her health state by ticking the box to the most appropriate statement. This decision results into a 1-digit number, . The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state. The EQ VAS records the patient's self-rated health on a vertical visual analogue scale where the endpoints are labelled 'Best imaginable health state' and 'Worst imaginable health state'. The VAS can be used as a quantitative measure of health outcome by patient's own judgement.Measure: EuroQol Group. EQ-5D™ Time: baseline, day 12, day 45
Description: Change from baseline in exposure area on lung CTMeasure: exposure area on lung CT Time: baseline, day 12, day 45
Study to compare the efficacy and safety of colchicine and glucocorticoids compared with the standard of treatment for moderate/severe COVID-19 in a fragile and vulnerable population, admitted to a geriatric hospital unit or in a transicional care center
Description: Number of patients that a short cycle of steroids (with prednisone 60 mg/d, in a single dose, for 3 consecutive days) administered together with colchicine (at doses of 0.5 to 1.5 mg/d, adjusted for weight and renal function, for 3 days and maintenance of 0.5 mg/d for 14 days in total) reduces mortality from COVID-19 in this population by at least 20%, compared to the approved standard treatment at participating centers.Measure: Number of patients that a short cycle of steroids administered together with colchicine reduces mortality from COVID-19 Time: 28 days
Description: Number and grade of adverse events at group of colchicine and glucocorticoids throughout the treatment and in the two weeks following treatment according to the incidence of: mild adverse event serious adverse events hypersensitivity (allergic) reactions of grade >=2Measure: Number and grade of adverse events at group of colchicine and glucocorticoids throughout the treatment and in the two weeks following treatment Time: 28 days
Description: Percentage of patients who stop medication due to adverse events.Measure: Percentage of patients who stop medication due to adverse events. Time: 28 days
Description: Severity of symptoms by COVID-19 in the two treatment arms (response to treatment to be assessed by overall survival at 28 days from the start of treatment).Measure: Severity of symptoms by COVID-19 in the two treatment arms Time: 28 days
Open-label randomized study comparing the current standard of care treatment of Covid-19 in hospitalized patients with evidence of cardiac injury vs. a group of the same type of patients treated with colchicine plus current standard of care.
Description: Composite of all-cause mortalityMeasure: All Cause Mortality Time: 90 days
Description: Need for Mechanical VentilationMeasure: Mechanical Ventilation Time: 90 days
Description: Need for Mechanical Circulatory SupportMeasure: Mechanical Circulatory Support Time: 90 days
Description: Time to Primary EndpointMeasure: Time to Deterioration Time: 90 days
Description: Number of participants with treatment-related adverse events as assessed by CTCAE v4.0".Measure: Adverse Events Time: 90 days
Description: Peak Troponin LevelsMeasure: Troponin Time: 90 days
Description: Troponin Levels Change from BaselineMeasure: Delta Time: 90 days
Description: Change from Baseline on BNP levelsMeasure: BNP Time: 90 days
Description: Changes from Baseline on C Reactive ProteinMeasure: Changes in C Reactive Protein Time: 90 days
Description: Hospital Length of StayMeasure: LOS Time: 90 days
Description: Re-Hospitalization RatesMeasure: Re-Hospitalization Time: 90 days
Description: Changes in D Dimer from BaselineMeasure: Changes in D Dimer Time: 90 days
This is a prospective, double blind, randomized, placebo controlled clinical trial. The participants will be randomized into two groups (group A and group B). Patients of group-A are the treatment group. They will be treated with optimal treatment based on the algorithm proposed in National Guidelines on Clinical Management of Coronavirus Disease 2019 (Covid-19) Version 7.0, 28 May 2020, along with Colchicine for 14 days. The patients in group-B will be controlled group. They will be treated with optimal treatment based on the algorithm proposed in National Guideline along with a placebo.
Description: Seven-category ordinal scale. The scale is recommended by the WHO R&D Blueprint expert group. The seven-category ordinal scale consisted of the following categories: 1, not hospitalized with resumption of normal activities; 2, not hospitalized, but unable to resume normal activities; 3, hospitalized, not requiring supplemental oxygen; 4, hospitalized, requiring supplemental oxygen; 5, hospitalized, requiring nasal high-flow oxygen therapy, noninvasive mechanical ventilation, or both; 6, hospitalized, requiring ECMO, invasive mechanical ventilation, or both; and 7, deathMeasure: Time to develop clinical deterioration, defined as the time from randomization to a deterioration of two points (from the status at randomization) on a Seven-category ordinal scale. Time: 14 days following randomization
Data processed on September 26, 2020.
An HTML report was created for each of the unique drugs, MeSH, and HPO terms associated with COVID-19 clinical trials. Each report contains a list of either the drug, the MeSH terms, or the HPO terms. All of the terms in a category are displayed on the left-hand side of the report to enable easy navigation, and the reports contain a list of correlated drugs, MeSH, and HPO terms. Further, all reports contain the details of the clinical trials in which the term is referenced. Every clinical trial report shows the mapped HPO and MeSH terms, which are also hyperlinked. Related HPO terms, with their associated genes, protein mutations, and SNPs are also referenced in the report.Drug Reports MeSH Reports HPO Reports