Developed by Shray Alag, The Harker School
Sections: Correlations,
Clinical Trials, and HPO
Navigate: Clinical Trials and HPO
| Name (Synonyms) | Correlation | |
|---|---|---|
| drug4796 | use and exposure to disinfectants during the coronavirus pandemic Wiki | 1.00 |
| drug2925 | Placebo (human albumin 1%) Wiki | 1.00 |
| Name (Synonyms) | Correlation |
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Navigate: Correlations HPO
There is one clinical trial.
The objectives of the trial are to evaluate the efficacy and safety of trimodulin as add-on therapy to standard of care (SoC) compared to placebo treatment in adult hospitalized subjects with severe COVID-19. Additionally, pharmacodynamic (PD) and pharmacokinetic (PK) properties of trimodulin will be evaluated in all subjects.
Description: Percentage of subjects with a change of clinical status to score 6 or 7 on the 9-category ordinal scale
Measure: Clinical detoriation rate Time: Between day 6 and day 29Description: Percentage of subjects with a change to score 8 on the 9-category ordinal scale
Measure: 28-day all-cause mortality rate Time: Between day 1 and day 29Description: Percentage of subjects with a change to score 6-7
Measure: Clinical deterioration rate Time: Days 1-29 and days 6-29Description: Percentage of subjects with score=8, assessed at the end-of-trial visit on day 29 [+3].
Measure: 28-days all-cause mortality rate on day 29 Time: Day 29Description: Number of days to first change from score 5 (enrollment) to score 6-7
Measure: Time to clinical deterioration Time: Time Frame: between Days 1-29 and days 6-29Description: Number of days to change to score =8
Measure: Time to Mortality Time: Time Frame: between Day 1 and day 29Description: Number of patients by score on specific study days
Measure: Proportion of subjects in each of the 9-categories of the ordinal scale Time: Days 7, 14, 21, 29Description: Number of days to change to score 4 (mild disease, with supplemental oxygen) or score 3 (mild disease, no supplemental oxygen)
Measure: Time to clinical improvement Time: Day 29Description: Proporation of subjects that improved to score ≤2
Measure: Proportion of subjects with score ≤2 Time: Day 29Description: Number of calendar days on IMV until day 29
Measure: Days on IMV Time: Until day 29Description: Number of calendar days without any form of oxygen support until day 29
Measure: Days without oxygen supply Time: Until day 29Description: Time to definite stop of any form of additional oxygenation, irrespective of short interruptions
Measure: Time to discontinuation from any form of oxygen supply Time: Until day 29Description: Proportion of subjects that improved to not requiring supplemental oxygen.
Measure: Proportion of subjects without any form of oxygen supply Time: Day 29Description: Calendar days between hospital discharge and day 29
Measure: Hospital-free-days Time: Until day 29Description: Time to SARS-CoV-2 negative status
Measure: SARS-CoV-2 status Time: Until day 29Description: Number, severity, causality, outcome, and seriousness of all. AE, TEAEs that led to permanent withdrawal of IMP, and TEAEs that led to discontinuation of the trial.
Measure: Adverse events (AEs), treatment-emergent AEs (TEAEs), AEs of special interest, infusional TEAEs Time: Until day 29Description: Number of all infusion related TEAEs
Measure: TEAEs Time: Until day 29Description: Number, severity, causality, and outcome of all SAEs
Measure: SAEs Time: Until day 29Description: Dose modifications (incl. reductions and changes in infusion rate)
Measure: Dose modifications Time: Day 1-5Description: Number of days to change to score ≤2 (hospital discharged or meets discharge criteria)
Measure: Time to recovery Time: Day 29Description: ECG recordings, (including heart rate, PR interval, RR interval, QRS interval, QT-interval, QTcF) showing abnormal, clinically relevant findings will be reported as adverse event.
Measure: Change over time in ECG parameters Time: Until day 29Description: Changes in recordings of vital sign parameters (including systolic and diastolic blood pressure, Arterial oxygen saturation, heart rate, respiratory rate and body temperature) showing clinically significant measurements outside the normal range will be reported as adverse event.
Measure: Change over time in vital signs Time: Until day 29Description: Assessment of changes in serum concentrations (g/L) of IgM, IgA, and IgG before, during and after treatment.
Measure: Pharmacokinetic assessment of immunoglobulins Time: Day 1(baseline) to day 29Description: Assessment of relative changes in serum concentrations from baseline before, during and after treatment including inflammation markers (e.g. % change in CRP, PCT, Ferritin, TNF-alpha, IL-6, IL-8 and IL-10), biomarkers (e.g. % change in p-selectin) and complement factors (e.g. % change in C3, C4).
Measure: Pharmacodynamic assessment of disease related serum proteins Time: Day 1(baseline) to day 29Alphabetical 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