Developed by Shray Alag, The Harker School
Sections: Correlations,
Clinical Trials, and HPO
Navigate: Clinical Trials and HPO
Navigate: Correlations HPO
There are 2 clinical trials
Comparison of the effects of CYT107 vs Placebo administered IM at 10μg/kg twice a week for three weeks on immune reconstitution of lymphopenic COVID-19 patients
Description: A statistically significant increase of the absolute lymphocyte count (ALC) from randomization to day 30 or HospitalDischarge
Measure: Improvement of the absolute lymphocyte count (ALC) of lymphopenic (ALC≤1000/mm3) COVID-19 infected participants out to approximately 30 days following initial Study drug administration or Hospital discharge (HD), whichever occurs first Time: one monthDescription: The time to clinical improvement to determine if CYT107 will improve the clinical status of hospitalized COVID-19 patients as measured by clinical improvement score
Measure: "clinical improvement" as defined by a 2 points improvement in a 7-point ordinal scale for Clinical Assessment, through day 30 or HD. Time: one monthDescription: The decrease of SARS-CoV-2 viral load from measurements at baseline and days of treatment dose 4 and dose 5, Day 21 and Day 30 or HD (whichever occurs first)
Measure: a significant decline of SARS-CoV-2 viral load through day 30 or HD Time: 1 month or HD (whichever occurs first)Description: Incidence of secondary infections based on pre-specified criteria as adjudicated by the Secondary Infections Committee (SIC) through Day 45
Measure: frequency of secondary infections through day 45 compared to placebo arm Time: 45 daysDescription: Number of days of hospitalization during index hospitalization (defined as time from initial Study drug treatment through HD)
Measure: length of hospitalization compared to placebo arm Time: 45 daysDescription: Number of days in ICU during index hospitalization
Measure: length of stay in ICU compared to placebo arm Time: 45 daysDescription: Readmissions to ICU through Day 45
Measure: number of readmissions to ICU compared to placebo arm Time: 45 daysDescription: Organ support free days (OSFDs) during index hospitalization (This includes ventilator assistance free days)
Measure: organ support free days compared to placebo arm Time: 45 daysDescription: Number of readmissions to the hospital through Day 45
Measure: Frequency of re-hospitalization through day 45 compared to placebo arm Time: 45 daysDescription: All-cause mortality through Day 45
Measure: All-cause mortality through day 45 compared to placebo arm Time: 45 daysDescription: Absolute numbers of CD4+ and CD8+ T-cell counts at time points indicated on the Schedule of Activities (SoA) through Day 30 or HD
Measure: CD4+ and CD8+ T cell counts compared to placebo arm Time: 30 daysDescription: Track and evaluate other known biomarkers of inflammation, Ferritin, from baseline to day 30
Measure: level of other known biomarkers of inflammation: Ferritin compared to placebo arm Time: 30 daysDescription: Track and evaluate other known biomarkers of inflammation, CRP from baseline to day 30
Measure: Level of other known biomarkers of inflammation: CRP compared to placebo arm Time: 30 daysDescription: Track and evaluate other known biomarkers of inflammation, D-dimer from baseline to day 30
Measure: Level of other known biomarkers of inflammation: D-dimer compared to placebo arm Time: 30 daysDescription: Evaluate improvement of the NEWS2 score value. Score form 0 to 4: NO Risk Score of 7 or more: High risk
Measure: Physiological status through NEWS2 evaluation compared to Placebo arm Time: 30 daysDescription: Incidence and scoring of all grade 3-4 adverse events through Day 45 (using CTCAE Version 5.0) to assess safety
Measure: Safety assessment through incidence and scoring of grade 3-4 adverse events Time: 45 daysComparison of the effects of CYT107 vs Placebo administered IM at 10μg/kg twice a week for three weeks on immune reconstitution of lymphopenic COVID-19 patients
Description: A statistically significant increase of the absolute lymphocyte count (ALC) from randomization to day 30 or Hospital Discharge
Measure: Improvement of the absolute lymphocyte count (ALC) of lymphopenic (ALC≤1000/mm3) COVID-19 infected participants out to approximately 30 days following initial Study drug administration or Hospital discharge (HD), whichever occurs first Time: one monthDescription: The time to clinical improvement to determine if CYT107 will improve the clinical status of hospitalized COVID-19 patients as measured by clinical improvement score
Measure: "clinical improvement" as defined by a 2 points improvement in a 7-point ordinal scale for Clinical Assessment, through day 30 or HD. Time: one monthDescription: The decrease of SARS-CoV-2 viral load from measurements at baseline and days of treatment dose 4 and dose 5, Day 21 and Day 30 or HD (whichever occurs first)
Measure: a significant decline of SARS-CoV-2 viral load through day 30 or HD Time: one monthDescription: Incidence of secondary infections based on pre-specified criteria as adjudicated by the Secondary Infections Committee (SIC) through Day 45
Measure: frequency of secondary infections through day 45 compared to placebo arm Time: 45 daysDescription: Number of days of hospitalization during index hospitalization (defined as time from initial Study drug treatment through HD)
Measure: length of hospitalization compared to placebo arm Time: 45 daysDescription: Number of days in ICU during index hospitalization
Measure: Length of stay in ICU compared to placebo arm Time: 45 daysDescription: Readmissions to ICU through Day 45
Measure: number of readmissions to ICU compared to placebo arm Time: 45 daysDescription: Organ support free days (OSFDs) during index hospitalization (This includes ventilator assistance free days)
Measure: organ support free days compared to placebo arm Time: 45 daysDescription: Number of readmissions to the hospital through Day 45
Measure: Frequency of re-hospitalization through day 45 compared to placebo arm Time: 45 daysDescription: All-cause mortality through Day 45
Measure: All-cause mortality through day 45 compared to placebo arm Time: 45 daysDescription: Absolute numbers of CD4+ and CD8+ T-cell counts at time points indicated on the Schedule of Activities (SoA)through Day 30 or HD
Measure: CD4+ and CD8+ T cell counts compared to placebo arm Time: 30 daysDescription: Track and evaluate other known biomarkers of inflammation, Ferritin, from baseline to day 30
Measure: level of other known biomarkers of inflammation: Ferritin compared to placebo a Time: 30 daysDescription: Level of other known biomarkers of inflammation: CRP compared to placebo arm
Measure: Level of other known biomarkers of inflammation: CRP compared to placebo arm Time: 30 daysDescription: Track and evaluate other known biomarkers of inflammation, D-dimer from baseline to day 30
Measure: Level of other known biomarkers of inflammation: D-dimer compared to placebo arm Time: 30 daysDescription: Evaluate improvement of the NEWS2 score value. Score form 0 to 4: NO Risk Score of 7 or more: High risk
Measure: Physiological status through NEWS2 evaluation compared to Placebo arm Time: 30 daysDescription: Incidence and scoring of all grade 3-4 adverse events through Day 45 (using CTCAE Version 5.0) to assess safety
Measure: Safety assessment through incidence and scoring of grade 3-4 adverse events Time: 45 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