Developed by Shray Alag, The Harker School
Sections: Correlations,
Clinical Trials, and HPO
Navigate: Clinical Trials and HPO
| Name (Synonyms) | Correlation | |
|---|---|---|
| drug501 | BVRS-GamVac-Combi Wiki | 0.50 |
| drug500 | BVRS-GamVac Wiki | 0.50 |
| drug4650 | placebo Wiki | 0.26 |
| Name (Synonyms) | Correlation | |
|---|---|---|
| D013577 | Syndrome NIH | 0.09 |
| D018352 | Coronavirus Infections NIH | 0.04 |
| Name (Synonyms) | Correlation |
|---|
Navigate: Correlations HPO
There are 4 clinical trials
This study is designed to assess pharmacokinetics and pharmacodynamics of interferon beta-1a and peginterferon beta-1a across an appropriate dose range to inform clinical trial operating characteristics for future clinical pharmacology pharmacodynamics similarity studies. This is a randomized, placebo-controlled, single-dose, parallel arm study in 84 healthy subjects assigned to one of three dose groups (low, intermediate, and high) of each drug (interferon beta-1a and peginterferon beta-1a) or placebo.
Description: The values and variability of standard pharmacodynamic (PD) metrics (AUEC and maximal difference at a single time-point) for neopterin at low, intermediate, and high doses of interferon beta-1a and peginterferon beta-1a
Measure: Area under effect curve (AUEC) and maximum change from baseline for neopterin for interferon beta-1a and peginterferon beta-1a Time: 7 or 14 days, depending on treatment armDescription: 2. The values and variability of pharmacokinetic characteristics (Cmax and AUC of free drug concentration) at low, intermediate, and high doses of interferon beta-1a and peginterferon beta-1a
Measure: Maximum concentration (Cmax) and area under the curve (AUC) for interferon beta-1a and peginterferon beta-1a Time: 7 or 14 days, depending on treatment armDescription: 1. The values and variability of standard PD metrics (AUEC and maximal difference at a single time-point) for MxA at low, intermediate, and high doses of interferon beta-1a and peginterferon beta-1a
Measure: Area under effect curve and maximum change from baseline for Myxovirus-resistance protein A (MxA) for interferon beta-1a and peginterferon beta-1a Time: 7 or 14 days, depending on treatment armDescription: 3. Parameters (Emax [maximum effect], and EC50 [half maximal effect concentration]) calculated by the model after combining data from low, intermediate, and high doses of interferon beta-1a and peginterferon beta-1a with placebo data
Measure: Pharmacodynamic model parameters for interferon beta-1a and peginterferon beta-1a Time: 7 or 14 days, depending on treatment armThis study is designed to assess pharmacokinetics and pharmacodynamics of interferon beta-1a and peginterferon beta-1a across an appropriate dose range to inform clinical trial operating characteristics for future clinical pharmacology pharmacodynamics similarity studies. This is a randomized, placebo-controlled, single-dose, parallel arm study in 84 healthy subjects assigned to one of three dose groups (low, intermediate, and high) of each drug (interferon beta-1a and peginterferon beta-1a) or placebo.
Description: The values and variability of standard pharmacodynamic (PD) metrics (AUEC and maximal difference at a single time-point) for neopterin at low, intermediate, and high doses of interferon beta-1a and peginterferon beta-1a
Measure: Area under effect curve (AUEC) and maximum change from baseline for neopterin for interferon beta-1a and peginterferon beta-1a Time: 7 or 14 days, depending on treatment armDescription: 2. The values and variability of pharmacokinetic characteristics (Cmax and AUC of free drug concentration) at low, intermediate, and high doses of interferon beta-1a and peginterferon beta-1a
Measure: Maximum concentration (Cmax) and area under the curve (AUC) for interferon beta-1a and peginterferon beta-1a Time: 7 or 14 days, depending on treatment armDescription: 1. The values and variability of standard PD metrics (AUEC and maximal difference at a single time-point) for MxA at low, intermediate, and high doses of interferon beta-1a and peginterferon beta-1a
Measure: Area under effect curve and maximum change from baseline for Myxovirus-resistance protein A (MxA) for interferon beta-1a and peginterferon beta-1a Time: 7 or 14 days, depending on treatment armDescription: 3. Parameters (Emax [maximum effect], and EC50 [half maximal effect concentration]) calculated by the model after combining data from low, intermediate, and high doses of interferon beta-1a and peginterferon beta-1a with placebo data
Measure: Pharmacodynamic model parameters for interferon beta-1a and peginterferon beta-1a Time: 7 or 14 days, depending on treatment armThis study is designed to assess pharmacokinetics and pharmacodynamics of interferon beta-1a and peginterferon beta-1a across an appropriate dose range to inform clinical trial operating characteristics for future clinical pharmacology pharmacodynamics similarity studies. This is a randomized, placebo-controlled, single-dose, parallel arm study in 84 healthy subjects assigned to one of three dose groups (low, intermediate, and high) of each drug (interferon beta-1a and peginterferon beta-1a) or placebo.
Description: The values and variability of standard pharmacodynamic (PD) metrics (AUEC and maximal difference at a single time-point) for neopterin at low, intermediate, and high doses of interferon beta-1a and peginterferon beta-1a
Measure: Area under effect curve (AUEC) and maximum change from baseline for neopterin for interferon beta-1a and peginterferon beta-1a Time: 7 or 14 days, depending on treatment armDescription: 2. The values and variability of pharmacokinetic characteristics (Cmax and AUC of free drug concentration) at low, intermediate, and high doses of interferon beta-1a and peginterferon beta-1a
Measure: Maximum concentration (Cmax) and area under the curve (AUC) for interferon beta-1a and peginterferon beta-1a Time: 7 or 14 days, depending on treatment armDescription: 1. The values and variability of standard PD metrics (AUEC and maximal difference at a single time-point) for MxA at low, intermediate, and high doses of interferon beta-1a and peginterferon beta-1a
Measure: Area under effect curve and maximum change from baseline for Myxovirus-resistance protein A (MxA) for interferon beta-1a and peginterferon beta-1a Time: 7 or 14 days, depending on treatment armDescription: 3. Parameters (Emax [maximum effect], and EC50 [half maximal effect concentration]) calculated by the model after combining data from low, intermediate, and high doses of interferon beta-1a and peginterferon beta-1a with placebo data
Measure: Pharmacodynamic model parameters for interferon beta-1a and peginterferon beta-1a Time: 7 or 14 days, depending on treatment armACTT-3 will evaluate the combination of interferon beta-1a and remdesivir compared to remdesivir alone. Subjects will be assessed daily while hospitalized. If the subjects are discharged from the hospital, they will have a study visit at Days 15, 22, and 29. For discharged subjects, it is preferred that the Day 15 and 29 visits are in person to obtain safety laboratory tests and oropharyngeal (OP) swab and blood (serum only) samples for secondary research as well as clinical outcome data. However, infection control or other restrictions may limit the ability of the subject to return to the clinic. In this case, these visits may be conducted by phone, and only clinical data will be obtained. The Day 22 visit does not have laboratory tests or collection of samples and is conducted by phone. The primary outcome is time to recovery by Day 29.
Description: Day of recovery is defined as the first day on which the subject satisfies one of the following three categories from the ordinal scale: 1) Hospitalized, not requiring supplemental oxygen and no longer requires ongoing medical care; 2) Not hospitalized, limitation on activities and/or requiring home oxygen; 3) Not hospitalized, no limitations on activities.
Measure: Time to recovery Time: Day 1 through Day 29Description: The NEW score has demonstrated an ability to discriminate patients at risk of poor outcomes. This score is based on 7 clinical parameters (respiration rate, oxygen saturation, any supplemental oxygen, temperature, systolic blood pressure, heart rate, level of consciousness). The NEW Score is being used as an efficacy measure.
Measure: Change in National Early Warning Score (NEWS) from baseline Time: Day 1 through Day 29Description: Grade 3 AEs are defined as events that interrupt usual activities of daily living, or significantly affects clinical status, or may require intensive therapeutic intervention. Severe events are usually incapacitating. Grade 4 AEs are defined as events that are potentially life threatening.
Measure: Cumulative incidence of Grade 3 and 4 clinical and/or laboratory adverse events (AEs) Time: Day 1 through Day 29Description: An SAE is defined as an AE or suspected adverse reaction is considered serious if, in the view of either the investigator or the sponsor, it results in death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, or a congenital anomaly/birth defect.
Measure: Cumulative incidence of serious adverse events (SAEs) Time: Day 1 through Day 29Description: Measured in days.
Measure: Duration of hospitalization Time: Day 1 through Day 29Description: Measured in days.
Measure: Duration of invasive mechanical ventilation Time: Day 1 through Day 29Description: Measured in days.
Measure: Duration of new non-invasive ventilation or high flow oxygen use Time: Day 1 through Day 29Description: Measured in days.
Measure: Duration of new oxygen use Time: Day 1 through Day 29Description: Measured in days.
Measure: Duration of new ventilator or extracorporeal membrane oxygenation (ECMO) use Time: Day 1 through Day 29Description: Measured in days.
Measure: Duration of non invasive ventilation/high flow oxygen use Time: Day 1 through Day 29Description: Measured in days
Measure: Duration of oxygen use Time: Day 1 through Day 29Description: For any reason.
Measure: Incidence of discontinuation or temporary suspension of investigational therapeutics Time: Day 1 through Day 10Description: The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 1) Death; 2) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4) Hospitalized, requiring supplemental oxygen; 5) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 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: Mean change in the ordinal scale Time: Day 1 through Day 29Description: The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 1) Death; 2) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4) Hospitalized, requiring supplemental oxygen; 5) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 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: Participant's clinical status at Day 15 by ordinal scale Time: Day 15Description: The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 1) Death; 2) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4) Hospitalized, requiring supplemental oxygen; 5) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 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: Percentage of subjects reporting each severity rating on an 8 point ordinal scale Time: Days 3, 5, 8, 11, 22, and 29Description: Date and cause of death (if applicable).
Measure: Subject 14-day mortality Time: Day 1 through Day 15Description: Date and cause of death (if applicable).
Measure: Subject 28-day mortality Time: Day 1 through Day 29Description: The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 1) Death; 2) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4) Hospitalized, requiring supplemental oxygen; 5) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 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: Time to an improvement of one category using an ordinal scale Time: Day 1 through Day 29Description: The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 1) Death; 2) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4) Hospitalized, requiring supplemental oxygen; 5) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 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: Time to an improvement of two categories using an ordinal scale Time: Day 1 through Day 29Description: The NEW score has demonstrated an ability to discriminate patients at risk of poor outcomes. This score is based on 7 clinical parameters (respiration rate, oxygen saturation, any supplemental oxygen, temperature, systolic blood pressure, heart rate, level of consciousness). The NEW Score is being used as an efficacy measure.
Measure: Time to discharge or to a National Early Warning Score (NEWS) of Time: Day 1 through Day 29Description: Day of recovery is defined as the first day on which the subject satisfies one of the following three categories from the ordinal scale: 1) Hospitalized, not requiring supplemental oxygen and no longer requires ongoing medical care; 2) Not hospitalized, limitation on activities and/or requiring home oxygen; 3) Not hospitalized, no limitations on activities.
Measure: Time to recovery for participants not on mechanical ventilation (baseline ordinal score of 4, 5, or 6) Time: Day 1 through 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