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Sections: Correlations,
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| Name (Synonyms) | Correlation | |
|---|---|---|
| drug4012 | Thromboprophylaxis Wiki | 0.41 |
| drug4615 | non-RAS blocking antihypertensives Wiki | 0.41 |
| drug4653 | placebo for clazakizumab Wiki | 0.41 |
| Name (Synonyms) | Correlation | |
|---|---|---|
| drug551 | Best standard of care Wiki | 0.41 |
| drug838 | Candesartan Wiki | 0.41 |
| drug4020 | Tislelizumab Wiki | 0.41 |
| drug1580 | Fruquintinib Wiki | 0.41 |
| drug4701 | remdesivir Wiki | 0.41 |
| drug2072 | Ketotifen 1 MG Wiki | 0.41 |
| drug4256 | Vitamin Super B-Complex Wiki | 0.24 |
| drug910 | Chloroquine or Hydroxychloroquine Wiki | 0.24 |
| drug2170 | Lopinavir/Ritonavir Wiki | 0.20 |
| drug3384 | Rivaroxaban Wiki | 0.18 |
| drug2620 | Normal saline Wiki | 0.17 |
| drug2174 | Lopinavir/ritonavir Wiki | 0.13 |
| drug2552 | Nitazoxanide Wiki | 0.11 |
| drug2916 | Placebo Wiki | 0.07 |
| drug1775 | Hydroxychloroquine Wiki | 0.04 |
Navigate: Correlations HPO
There are 6 clinical trials
This trial investigates whether clazakizumab (an anti-interleukin (IL)-6 monoclonal antibody (mAb)) may be beneficial for the treatment of CABMR in recipients of a kidney transplant by inhibiting the production of Donor Specific Antibodies (DSA) and re-shaping T cell alloimmune responses.
Description: The aim of this study is to follow enrolled participants until 221 occurrences of all-cause allograft loss, defined as return to dialysis, allograft nephrectomy, re-transplantation, eGFR <15 mL/min/1.73 m2 or death from any cause have been observed. The analysis will be a stratified log rank test of the effect of treatment on all-cause composite allograft loss, with stratification factors of dichotomized baseline eGFR (25-45 mL/min/1.73 m2 versus >45-65 mL/min/1.73 m2), baseline proteinuria, treatment for early (within 6 months of transplant) ABMR rejection episodes (yes/no), and treatment for late (greater than 6 months post transplant) ABMR rejection episodes (yes/no). Surviving subjects without allograft loss will be censored at the time of their last assessment.
Measure: Incidence of all cause composite allograft loss Time: Five yearsThis is a single center, randomized, double-blind, placebo-controlled, exploratory phase II study enrolling 60 patients. We propose the administration of a blinded dose of an investigational product (IP) (clazakizumab or placebo[0.9% saline]) in patients with COVID-19 disease and signs of pulmonary involvement who have not yet required mechanical ventilation and/or ECMO. If a patient progresses to mechanical ventilation and/or ECMO or develops clinical signs of deteriorating COVID-19 disease, and there are no treatment related serious adverse events(SAEs), within the initial 14 day period after the first dose of the IP, at the discretion of the investigator or treating physician, open-label clazakizumab 25mg IV X 1 dose may be administered. A minimum of 24 hours should elapse between the first dose of IP and this dose of open-label clazakizumab. The patient will remain blinded as to the identity of the IP administered in the first dose.
Description: Incidence of adverse events that are unusual, unexpected, or assessed as related to the IP
Measure: Evaluate the safety of clazakizumab for the treatment of patients with COVID-19 disease and signs of pulmonary involvement Time: 14 daysDescription: Number of patients alive at 28 days
Measure: Patient survival at 28 days Time: 28 daysDescription: Number of patients alive at 60 days
Measure: Patient survival at 60 days Time: 60 daysDescription: Number of patients requiring the dose of open-label clazakizumab
Measure: Number of patients requiring the dose of open-label clazakizumab Time: 14 daysDescription: Number of days in ICU compared to placebo
Measure: Reduced duration of intensive care unit stay Time: 60 daysDescription: Number of days in hospital compared to placebo
Measure: Reduced duration of hospital stay Time: 60 daysDescription: Incidence of need for mechanical ventilation and/or ECMO at 14 days after the first administered dose in comparison to placebo
Measure: Reduced need for ventilation Time: 14 daysThe Austrian Coronavirus Adaptive Clinical Trial (ACOVACT) is a randomized, controlled, multicenter, open-label basket trial that aims to compare various antiviral treatments for COVID-19. Moreover three substudies have been integrated. Currently, patients will be randomized to receive (hydroxy-)chloroquine, lopinavir/ritonavir or standard of care. Moreover, these patients are eligible for substudy A (randomized to rivaroxaban 5mg 1-0-1 vs. standard of care), substudy B (renin-angiotensin (RAS) blockade vs. no RAS blockade for patients with blood pressure >120/80mmHg), and substudy C (clazakizumab vs standard of care, for patients with respiratory deterioration and high inflammatory biomarkers). Endpoints were chosen based on the master protocol published by the World Health Organisation and include a 7-point scale of clinical performance, mortality, oxygen requirement (both dose and type), duration of hospitalization, viral load and safety.
Description: The primary endpoint is time to clinical improvement which is defined as time from randomization to an (sustained) improvement of at least one category on two consecutive days compared to the status at randomization measured on a seven-category ordinal scale (proposed by WHO). The 7-categories of the World Health Organization proposed scale, as follows: Not hospitalized, no limitations on activities Not hospitalized, limitation on activities; Hospitalized, not requiring supplemental oxygen; Hospitalized, requiring supplemental oxygen; Hospitalized, on non-invasive ventilation or high flow oxygen devices; Hospitalized, on invasive mechanical ventilation or ECMO; Death. During hospitalization this score will be determined daily (till day 29). If a patient is released from the hospital before day 29, the score will be determined at day 11 and 29 after randomization (depending when the patient was released or by telephone call).
Measure: sustained improvement (>48h) of one point on the WHO Scale Time: Inclusion to day 29, daily evaluationDescription: The scale described in the primary endpoint is used
Measure: Time to improvement on WHO Scale Time: Inclusion to day 29, daily evaluationDescription: The scale described in the primary endpoint is used
Measure: Mean change in the ranking on an ordinal scale from baseline Time: Inclusion to day 29, daily evaluationDescription: the National Early Warning Score includes respiratory rate, oxygen saturation, use of supplemental oxygen, temperature, systolic blood pressure, heart rate and levels of consciousness (AVPU Scale)
Measure: time to discharge or a National Early Warning Score (NEWS) ≤2 (maintained for 24h), whichever occurs first Time: Inclusion to day 29, daily evaluationDescription: The scale described in the primary endpoint is used
Measure: change from baseline in National Early Warning Score (NEWS) Time: Inclusion to day 29, daily evaluationDescription: new oxygen may include insufflation or oxygen mask, high flow oxygen devices, non-invasive ventilation devices or mechanical ventilation
Measure: Incidence of new oxygen use during the trial Time: Inclusion to day 29, daily evaluationDescription: number of days with requirement of mechanical ventilation
Measure: Ventilator free days until day 29 Time: Inclusion to day 29, daily evaluationDescription: obtained by polymerase chain reaction in nasal/oropharyngeal swabs, performed at baseline and then three times a week, if possible
Measure: Viral load/viral clearance Time: Inclusion to day 29, daily evaluationDescription: BMI (kg/m2), within all subjects the impact of obesity on overall mortality will be investigated
Measure: Obesity - mortality Time: BMI at admission, mortality until day 29Description: BMI (kg/m2) , within all subjects the impact of obesity on the duration of hospitalization will be investigated
Measure: Obesity - duration of hospitalization Time: BMI at admission, duration of hospitalization until day 29 or dischargeDescription: BMI (kg/m2) , within all subjects the impact of obesity on ICU admission will be investigated
Measure: Obesity - ICU admission Time: BMI at admission, ICU admission until day 29 or dischargeDescription: BMI (kg/m2) new oxygen may include insufflation or oxygen mask, high flow oxygen devices, non-invasive ventilation devices or mechanical ventilation
Measure: Obesity - new oxygen use Time: BMI at admission, new oxygen use until day 29 or dischargeDescription: lopinavir and ritonavir both interact with numerous other drugs by inhibiting the cytochrome enzymes 3A4. Using commercially available drug-interaction programs, the number and severity grading of drug-drug-interactions will be documented (for instance uptodate interaction tool, medscape). This is an exploratory analysis of drug-drug interactions with the above mentioned substances. severity grading usually encompass "contraindicated", "serious", "monitor closely", "minor" interaction.
Measure: Drug-drug interactions with lopinavir/ritonavir Time: Inclusion to day 29, daily evaluationDescription: for sub-study B only: RAS fingerprint measures metabolites involved in the renin-angiotensin-system. The influence of randomized treatment with candesartan (RAS blockade) will be analyzed
Measure: Renin Angiotensin System (RAS) fingerprint Time: Inclusion to day 29, daily evaluationIn this study Investigators propose to administer clazakizumab to patients with life-threatening COVID-19 infection manifest by pulmonary failure and a clinical picture consistent with a cytokine storm syndrome. This is a single-center randomized, double-blind, placebo-controlled trial in which 30 patients will be enrolled and randomly assigned in a 1:1 ratio to two study arms that will receive clazakizumab at a dose of 25 mg or placebo.
Description: Serum CRP (measured in mg/dl) will be evaluated at baseline and on days 1 and 2 following clazakizumab or placebo administration to assess response
Measure: Change in C-reactive protein (CRP) level Time: Up to 3 daysIn this study, the investigators propose to administer clazakizumab to patients with life-threatening Coronavirus Disease 2019 (COVID-19) infection manifest by pulmonary failure and a clinical picture consistent with a cytokine storm syndrome. This is a single-center randomized, double-blind, placebo-controlled trial in which 30 patients will be enrolled and randomly assigned in a 1:1 ratio to two study arms and receive clazakizumab at a dose of 25 mg or placebo.
Description: Number of participants alive at day 28.
Measure: Patient Survival Time: 28 daysDescription: Number of participants alive at day 60, end of study.
Measure: Patient Survival Time: 60 daysThe purpose of this study is to investigate the effectiveness and safety of treatment with clazakizumab compared to a placebo (inactive substance). We are proposing to try this drug to treat coronavirus disease 2019 (COVID-19) infection. Patients with COVID-19 infection have been shown to have increases in certain inflammatory processes. Clazakizumab is an antibody (immune system protein) that blocks certain inflammatory processes. The treatment plan is to attempt to inhibit or block these inflammatory processes in order to try to limit the damage COVID-19 causes to the lungs.
Description: Proportion of participants who experience treatment-related adverse events (TEAE) ≥ Grade 3 (CTCAE v5.0) during the first 24 hours after infusion of clazakizumab or placebo
Measure: Primary Endpoint Time: 24 hoursDescription: Proportion of participants who need mechanical ventilation and/or extracorporeal membrane oxygenation (ECMO) after the first dose of clazakizumab or placebo
Measure: Requirement for mechanical ventilation and/or extracorporeal membrane oxygenation (ECMO) Time: 14 daysDescription: Proportion of participants who experience infusion-related reactions during the first 24 hours after infusion of clazakizumab or placebo
Measure: Infusion-related reactions during 24 hours from the time of infusion Time: 24 hoursDescription: Proportion of participants alive at day 28 after the first dose of clazakizumab or placebo
Measure: Patient survival at 28 days Time: 28 daysDescription: Proportion of participants alive at day 60 after the first dose of clazakizumab or placebo
Measure: Patient survival at 60 days Time: 60 daysDescription: Proportion of participants who require an open-label dose of clazakizumab
Measure: Requirement for open-label clazakizumab Time: 14 daysDescription: Number of days in the ICU following the first dose of clazakizumab or placebo
Measure: Time in the intensive care unit (ICU) Time: 60 daysDescription: Number of days in the hospital following the first dose of clazakizumab or placebo
Measure: Time in the hospital Time: 60 daysDescription: Number of days from first dose of clazakizumab or placebo to requiring mechanical ventilation
Measure: Time to mechanical ventilation Time: 60 daysDescription: Difference in WHO Clinical Progression Scale between clazakizumab and placebo
Measure: Clinical status improvement assessed by the World Health Organization (WHO) Clinical Progression Scale at day 14 Time: 14 daysDescription: Difference in WHO Clinical Progression Scale between clazakizumab and placebo
Measure: Clinical status improvement assessed by World Health Organization (WHO) Clinical Progression Scale at day 28 Time: 28 daysDescription: Difference in mean or median change in radiologic assessment of lung edema (RALE) score at day 14 from baseline between clazakizumab or placebo
Measure: Change in Radiologic Assessment of Lung Edema (RALE) at day 14 Time: 14 daysDescription: Difference in mean or median change in radiologic assessment of lung edema (RALE) score at day 28 from baseline between clazakizumab or placebo
Measure: Change in Radiologic Assessment of Lung Edema (RALE) at day 28 Time: 28 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