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Sections: Correlations,
Clinical Trials, and HPO
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| Name (Synonyms) | Correlation | |
|---|---|---|
| drug1965 | Interferon-Beta Wiki | 0.29 |
| drug2534 | Neutral writing control Wiki | 0.29 |
| drug3440 | SARS-CoV-2 rS/Matrix-M Adjuvant, Day 0 - Phase 2 Wiki | 0.29 |
| Name (Synonyms) | Correlation | |
|---|---|---|
| drug3439 | SARS-CoV-2 rS/Matrix-M Adjuvant, Day 0 - Phase 1 Wiki | 0.29 |
| drug1313 | EMDR Wiki | 0.29 |
| drug2625 | Normal saline solution (NSS), Placebo, Day 21 - Phase 1 Wiki | 0.29 |
| drug3548 | Secukinumab 150 MG/ML Subcutaneous Solution [COSENTYX] Wiki | 0.29 |
| drug3438 | SARS-CoV-2 rS/Matrix-M Adjuvant - Phase 1 Wiki | 0.29 |
| drug2152 | Local standard of care Wiki | 0.29 |
| drug2624 | Normal saline solution (NSS), Placebo, Day 189 - Phase 2 Wiki | 0.29 |
| drug2622 | Normal saline solution (NSS), Placebo - Phase 1 Wiki | 0.29 |
| drug2626 | Normal saline solution (NSS), Placebo, Day 21 - Phase 2 Wiki | 0.29 |
| drug2623 | Normal saline solution (NSS), Placebo - Phase 2 Wiki | 0.29 |
| drug3435 | SARS-CoV-2 rS - Phase 1 Wiki | 0.29 |
| drug2119 | Let It Out (LIO)-C Wiki | 0.29 |
| drug3437 | SARS-CoV-2 rS/Matrix-M Adjuvant - Day 189 - Phase 2 Wiki | 0.29 |
| drug3070 | Prednisone tablet Wiki | 0.29 |
| drug2166 | Lopinavir-Ritonavir Drug Combination Wiki | 0.29 |
| drug2171 | Lopinavir/Ritonavir + hydoxychloroquine Wiki | 0.29 |
| drug4064 | Transcendental meditation Wiki | 0.29 |
| drug2122 | Levamisole Pill + Budesonide+Formoterol inhaler Wiki | 0.29 |
| drug3404 | Ruxolitinib 5 MG Wiki | 0.29 |
| drug1097 | Covid-19 Standard of Care Wiki | 0.29 |
| drug3441 | SARS-CoV-2 rS/Matrix-M Adjuvant, Days 0 and 21 - Phase 2 Wiki | 0.29 |
| drug369 | Assessment of work-related stress Wiki | 0.20 |
| drug3518 | Saliva sample collection Wiki | 0.20 |
| drug850 | Cardiac and electrodermal recordings Wiki | 0.20 |
| drug364 | Assessment of behavioral response to emotional stimulation Wiki | 0.20 |
| drug4754 | standard therapy Wiki | 0.17 |
| drug4749 | standard of care Wiki | 0.17 |
| drug3701 | Standard Care Wiki | 0.14 |
| drug356 | Aspirin Wiki | 0.14 |
| drug3384 | Rivaroxaban Wiki | 0.13 |
| drug3764 | Standard treatment Wiki | 0.11 |
| drug2981 | Placebo oral tablet Wiki | 0.10 |
| drug4168 | Usual Care Wiki | 0.10 |
| drug3192 | Questionnaire Wiki | 0.05 |
| drug2916 | Placebo Wiki | 0.01 |
| Name (Synonyms) | Correlation | |
|---|---|---|
| D002055 | Burnout, Professional NIH | 0.48 |
| D000077062 | Burnout, Psychological NIH | 0.34 |
| D000073397 | Occupational Stress NIH | 0.13 |
| Name (Synonyms) | Correlation | |
|---|---|---|
| D045169 | Severe Acute Respiratory Syndrome NIH | 0.06 |
| D003866 | Depressive Disorder NIH | 0.05 |
| D013315 | Stress, Psychological NIH | 0.05 |
| D018352 | Coronavirus Infections NIH | 0.05 |
| D040921 | Stress Disorders, Traumatic NIH | 0.05 |
| D007249 | Inflammation NIH | 0.05 |
| D014947 | Wounds and Injuries NIH | 0.05 |
| D013313 | Stress Disorders, Post-Traumatic NIH | 0.05 |
| D011024 | Pneumonia, Viral NIH | 0.03 |
| D003863 | Depression, NIH | 0.03 |
| D014777 | Virus Diseases NIH | 0.03 |
| D011014 | Pneumonia NIH | 0.02 |
| Name (Synonyms) | Correlation | |
|---|---|---|
| HP:0000716 | Depressivity HPO | 0.05 |
| HP:0002090 | Pneumonia HPO | 0.02 |
Navigate: Correlations HPO
There are 12 clinical trials
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].
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 scale
Measure: Clinical improvement Time: Day 28Description: Live discharge from the hospital (whatever comes first)
Measure: Hospital discharge Time: Day 28Description: Number of death patients
Measure: Death Time: Day 28Description: 7-category ordinal scale
Measure: Clinical status Time: Day 7, Day 14Description: Number of patients with mechanical ventilhation
Measure: Mechanical ventilhation Time: Day 28Description: Days of hospitalization
Measure: Hospitalization Time: Day 28Description: Days to death from treatment initiation
Measure: Time from treatment initiation to death Time: Day 28Description: negativization of two consecutive pharyngo-nasal swab 24-72 hrs apart
Measure: Time to Negativization COVID 19 Time: Day 21Description: Time to remission of fever in patients with T>37.5°C at enrollment
Measure: Fever Time: Day 1,4,7,14,21,28This 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 randomizationDescription: The secondary endpoint is the occurrence of death in the 30 days following randomization.
Measure: Number of participants who die Time: 30 days post randomizationDescription: 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 randomizationDescription: 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 randomizationACT is a randomized clinical trial to assess therapies to reduce the clinical progression of COVID-19.
Description: composite of hospitalization or death
Measure: Outpatient trial - Colchicine vs. control and Aspirin vs. control Time: 45 days post randomizationDescription: invasive mechanical ventilation or death
Measure: Inpatient trial - Interferon-β vs. control and Colchicine vs. control Time: 45 days post randomizationDescription: invasive mechanical ventilation or death
Measure: Inpatient trial - Aspirin and rivaroxaban vs. control Time: 45 days post randomizationDescription: disease progression by 2 points on a 7-point scale
Measure: Outpatient and Inpatient trials - Colchicine vs. control, Interferon-β vs. control Time: 45 days post randomizationDescription: composite of major adverse cardiovascular events (MI, stroke, ALI, VTE, death), and disease progression by 2 points on a 7-point scale
Measure: Outpatient and Inpatient trials - Aspirin vs. control, Aspirin and rivaroxaban vs. control Time: 45 days post randomizationBased 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 weeksDescription: Maximal concentration of high-sensitivity cardiac troponin
Measure: Maximal concentration of cardiac troponin Time: 10 daysThe 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 die
Measure: All-cause mortality Time: During hospitalization or until death, whichever comes first, assessed up to 30 daysDescription: Number of participants who require intubation for mechanical ventilation or die
Measure: Composite outcome:composite of intubation for mechanical ventilation or death. Time: During hospitalization or until death, whichever comes first, assessed up to 30 daysThe 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 ferritin
Measure: Number of patients with improvement in body temperature, myalgia, arthralgia, total lymphocyte count, D-dimer, fibrinogen and ferritin levels Time: Up to 24 daysDescription: At least one of the following: respiratory failure, respiratory rate > 30 rpm, oxygen saturation < 92%, PaO2/FiO2 < 300 mmHg
Measure: Progression to severe disease Time: Up to 10 daysPatients 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 health
Measure: change from baseline in clinical assessment score COVID 19 (CAS COVID 19) Frame: baseline Time: baseline, day 12Description: time to death or mechanical ventilation
Measure: Combine endpoint: Time to death or mechanical ventilation Time: 45 daysDescription: Change from baseline in C-reactive protein
Measure: C-reactive protein Time: baseline, day 12, day 45Description: Change from baseline in D-dimer
Measure: D-dimer Time: baseline, day 12, day 45Description: 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 45Description: Change from baseline in exposure area on lung CT
Measure: exposure area on lung CT Time: baseline, day 12, day 45Study 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 daysDescription: 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 >=2
Measure: Number and grade of adverse events at group of colchicine and glucocorticoids throughout the treatment and in the two weeks following treatment Time: 28 daysDescription: Percentage of patients who stop medication due to adverse events.
Measure: Percentage of patients who stop medication due to adverse events. Time: 28 daysDescription: 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 daysOpen-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 mortality
Measure: All Cause Mortality Time: 90 daysDescription: Need for Mechanical Ventilation
Measure: Mechanical Ventilation Time: 90 daysDescription: Need for Mechanical Circulatory Support
Measure: Mechanical Circulatory Support Time: 90 daysDescription: Time to Primary Endpoint
Measure: Time to Deterioration Time: 90 daysDescription: Number of participants with treatment-related adverse events as assessed by CTCAE v4.0".
Measure: Adverse Events Time: 90 daysDescription: Peak Troponin Levels
Measure: Troponin Time: 90 daysDescription: Troponin Levels Change from Baseline
Measure: Delta Time: 90 daysDescription: Change from Baseline on BNP levels
Measure: BNP Time: 90 daysDescription: Changes from Baseline on C Reactive Protein
Measure: Changes in C Reactive Protein Time: 90 daysDescription: Hospital Length of Stay
Measure: LOS Time: 90 daysDescription: Re-Hospitalization Rates
Measure: Re-Hospitalization Time: 90 daysDescription: Changes in D Dimer from Baseline
Measure: Changes in D Dimer Time: 90 daysThis 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, death
Measure: 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 randomizationCOVID-19 is associated with a cytokine storm that leads to respiratory distress, multiorgan failure and elevated mortality. Oral Colchicine exhibits high anti-inflammatory capacity attributed to the inhibition of microtubules polymerization, inflammasome and production of IL-1β and IL-6, which could prevent the inflammatory storm in COVID-19 patients at risk. The investigators present a randomized, controlled, open-labeled, and pragmatic clinical trial to study the treatment effect of Colchicine in COVID-19 patients requiring hospitalization, but no intensive care yet. Colchicine will be started within the first 48 hours and continue for 14 days using a descending dose. The benefits will be studied in terms of clinical evolution (WHO 7-point scale) and IL-6 levels, as well as other clinical and biochemical secondary end-points. In the case of positive results, the clinical impact would be relevant given that this oral medication is affordable and widely accessible which would help to prevent the inflammatory complications associated with COVID-19.
Description: Changes in the patients' clinical status through the 7 points ordinal scale (WHO R&D Blueprint expert group)
Measure: Improvement in the clinical status Time: up to 14 daysDescription: Improvement in the clinical status
Measure: Changes in IL-6 concentrations Time: up to 14 daysDescription: Time needed to reduce at least 2 points in the 7-point Ordinal Scale for Clinical Improvement by WHO R&D Blueprint expert group (0-7)
Measure: Improvement in the clinical status Time: up to 14 daysDescription: Sequential Organ Failure Assessment (SOFA score) (0-14)
Measure: Changes in the score for the Sequential Organ Failure Assessment (SOFA score) Time: up to 14 daysDescription: National Early Warning Score (NEWS scale)
Measure: Changes in the punctuation in the National Early Warning Score Time: up to 14 daysAlphabetical listing of all HPO terms. Navigate: Correlations Clinical Trials
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