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Name (Synonyms) | Correlation | |
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drug4127 | unfractionated heparin Wiki | 1.00 |
drug2032 | Methylprednisolone Wiki | 0.26 |
drug1193 | Enoxaparin Wiki | 0.25 |
Navigate: Correlations HPO
There is one clinical trial.
Adult female and male patients, hospitalized with Covid-19 infection (confirmed by reverse transcription polymerase chain reaction [RT-PCR]), will be screened for participation in this prospective, multi-center, double-blind, randomised, placebo-controlled trial. Enrolled patients will be randomized (1:1) into 2 treatment groups: Group 1 will receive the active treatment with Amizon® Max (international nonproprietary name enisamium iodide), one capsule (each containing 500 mg of enisamium iodide) 4 times daily every 6 hours for 7 days; patients in treatment Group 2 will receive a matching placebo capsule, 4 times daily every 6 hours for 7 days. Patient observation and follow-up are planned for 29 days, unless discharged before Day 29. The effect of treatment on Covid-19 will be evaluated by time from day of randomization to an increase of at least two points (from the status at randomization) on the severity rating scale (SR), the Time to Clinical Recovery (TTCR) of main Covid-19 symptoms / complications and the Sum of Severity Rating from Day 2 to Day 15 (SSR-15). Safety and tolerability of the study drug will be evaluated based on the intensity and course of treatment-emergent adverse events (TEAEs). Enisamium iodide is an antiviral small molecule. Enisamium inhibits replication of alpha- and beta- coronaviruses (human coronavirus NL63 and SARS-CoV-2, respectively) and influenza virus A and B. Mechanism of action against SARS-CoV-2 includes the direct inhibition of the viral RNA polymerase.
Description: Time from day of randomization to an increase of at least two points (from the status at randomization) on the following severity rating (SR) scale in days: - Death - Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO) - Hospitalized, on non-invasive ventilation or high flow oxygen devices - Hospitalized, requiring supplemental oxygen - Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (Covid-19 related or otherwise) - Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care - Not hospitalized, limitation on activities and/or requiring home oxygen - Not hospitalized, no limitations on activities
Measure: Efficacy - Time from Day 1 (randomization and treatment start) to clinical change Time: Day 0 to Day 29Description: Time to recovery (TTR) from day of randomisation: Day of recovery is defined as the first day on which the subject satisfies one of the following three categories from the ordinal scale (same scale being used as for the primary endpoint): 6 - Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care 7 - Not hospitalized, limitation on activities and/or requiring home oxygen 8 - Not hospitalized, no limitations on activities
Measure: Efficacy - Time to recovery (TTR) from Day 1 (randomization and treatment start) Time: Day 0 to Day 29Description: Time to Clinical Recovery (TTCR) of main Covid-19 symptoms/complications or discharge, whichever comes first: TTCR is defined as the time (Days) from randomisation (active or placebo) until normalization of fever, respiratory rate, oxygen saturation, and cough, sustained for at least 48 hours. Normalization and alleviation criteria: Fever ≤37.2°C Respiratory rate - ≤24/minute on room air Oxygen saturation - >94% on room air Cough: absent
Measure: Time to Clinical Recovery (TTCR) of main Covid-19 symptoms/complications or discharge Time: Day 0 to Day 29Description: Sum of Severity Rating from Day 2 to Day 15 (SSR-15): Daily reporting of severity rating on an 8-point ordinal scale. The ordinal scale is an assessment of the clinical status starting from initiation of study treatment (active or placebo) from Day 2 to Day 15. The scale from 1 to 8 as defined for the primary endpoint.
Measure: Sum of Severity Rating from Day 2 to Day 15 (SSR-15) Time: Day 2 to Day 15Description: Severity Rating on Day 15 (SR-15): Reporting of severity rating on Day 15 or Day of discharge whichever occurs first on an 8-point ordinal scale. The ordinal scale is an assessment of the clinical status. The scale is defined from 1 (Death) to 8 (Not hospitalized, no limitations on activities) as defined for the primary endpoint.
Measure: Severity Rating on Day 15 (SR-15): Time: Day 15 or Day of discharge (whichever occurs first)Description: The number of days alive and discharged from hospital until day 15 will be calculated for each group and the treatment differences displayed.
Measure: Days Alive and Out of Hospital until Day 15 (DAOH-14) Time: Day 2 to Day 15Description: The proportion of subjects discharged by Day 8, 15, 22 and 29 will be displayed for the two treatment groups.
Measure: Proportion of Subjects Discharged by Day 8, 15, 22, 29 Time: Day 0 to Day 29Description: The analysis of the incidences of non-invasive ventilation will be performed by logistic regression model with the binary outcome as dependent variable, age as covariate, baseline severity rating, centre, treatment and centre x treatment as factors.
Measure: Incidence of non-invasive ventilation Time: Day 0 to Day 29Description: The days until non-invasive ventilation will be calculated and the treatment differences displayed using the stratified log-rank test.
Measure: Days until non-invasive ventilation Time: Day 0 to Day 29Description: The total days of non-invasive ventilation will be evaluated by the generalized linear model based on the Poisson distribution and including age as covariate, baseline severity rating, centre, treatment and centre x treatment as factors into the model.
Measure: Total days of non-invasive ventilation Time: Day 0 to Day 29Description: The analysis of the incidence rate of invasive mechanical ventilation will be performed by logistic regression model with the binary outcome as dependent variable, age as covariate, baseline severity rating, centre, treatment and centre x treatment as factors.
Measure: Incidence of invasive mechanical ventilation or ECMO Time: Day 0 to Day 29Description: The days until invasive mechanical ventilation or ECMO will be calculated and the treatment differences displayed using the stratified log-rank test.
Measure: Days until invasive mechanical ventilation or ECMO Time: Day 0 to Day 29Description: The course of qualitative RT-PCR virus test results will be evaluated by logistic regression with virus test as dependent variable, age as covariate, baseline severity rating, day, centre, treatment as fixed factors. In addition the interaction terms treatment x day and treatment x centre will be included as interaction term as fixed effect into the model. The treatment x day interaction term should detect any differences between treatments in the time until virus deletion.
Measure: Course of qualitative RT-PCR viral test results Time: Day 0 to Day 29Description: Proportion of subjects SARS-CoV-2 free pharyngeal swabs / sputum samples (virus-free) on Days 8, 15, 22, 29
Measure: Viral test evaluation - Proportion of subjects free of SARS-CoV-2 Time: Days 0, 8, 15, 22, 29Description: The investigator and the subject (each separately) will assess the overall (global) efficacy of the IMP, based on the change in symptoms using a Four-point verbal rating scale (VRS-4) (0=no symptoms / cured, 1=symptoms improved compared to Visit 1, 2=symptoms unchanged compared to Visit 1, 3=symptoms deteriorated compared to Visit 1).
Measure: Overall assessment of efficacy (patient and investigator) Time: Day 29 or Day of discharge (whichever occurs first)Description: Evaluate TEAEs by time of onset, actions taken, pattern of occurrence, and outcome
Measure: Treatment emergent adverse events (TEAE) Time: Day 0 to Day 29Description: Difference in the global tolerability judgement scores on Day of Discharge from hospital (or Day 29, end of trial, if not discharged earlier). The investigator and the subject (each separately) will assess the overall (global) tolerability of the IMP using a five-point rating scale (0=very good, 1=good, 2=moderate, 3=poor, 4=very poor).
Measure: Overall assessment of tolerability of treatment (patient and investigator) Time: Day 29 or Day of discharge (whichever occurs first)Alphabetical listing of all HPO terms. Navigate: Correlations Clinical Trials
Data processed on January 01, 2021.
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