Name (Synonyms) | Correlation | |
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drug593 | Interleukin-7 Wiki | 1.00 |
drug872 | Placebos Wiki | 0.25 |
Name (Synonyms) | Correlation |
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There is one clinical trial.
Comparison of the effects of CYT107 vs Placebo administered IM at 10µg/kg twice a week for two 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), whicheve Time: 1 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: To obtain "clinical improvement" as defined by a 2 points improvement in a 7-point ordinal scale for Clinical Assessment, through day 30 or HD. Time: 1 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: determine if CYT107 will lead to 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: To compare the effect of CYT107 versus placebo on the frequency of secondary infections through day 45 Time: 45 daysDescription: Number of days of hospitalization during index hospitalization (defined as time from initial Study drug treatment through HD)
Measure: To compare the effect of CYT107 versus placebo on the length of hospitalization Time: 45 daysDescription: Number of days in ICU during index hospitalization
Measure: To compare the effect of CYT107 versus placebo on the length of stay in ICU Time: 45 daysDescription: Readmissions to ICU through Day 45
Measure: To compare the effect of CYT107 versus placebo on readmissions to ICU Time: 45 daysDescription: Organ support free days (OSFDs) during index hospitalization (This includes ventilator assistance free days.)
Measure: To compare the effect of CYT107 versus placebo on organ support free days Time: 45 daysDescription: Number of readmissions to the hospital through Day 45
Measure: To compare the effect of CYT107 versus placebo on the frequency of re-hospitalization through day 45 Time: 45 daysDescription: All-cause mortality through Day 45
Measure: To assess the impact of CYT107 on all-cause mortality through day 45 Time: 45 daysDescription: Absolute numbers of CD4+ and CD8+ T-cell counts at timepoints indicated on the Schedule of Activities (SoA) through Day 30 or HD
Measure: To determine the effect of CYT107 on CD4+ and CD8+ T cell counts Time: 30 daysDescription: Track and evaluate other known biomarkers of inflammation, Ferritin, from baseline to day 30
Measure: To track and evaluate other known biomarkers of inflammation: Ferritin Time: 30 daysDescription: Track and evaluate other known biomarkers of inflammation, CRP from baseline to day 30
Measure: To track and evaluate other known biomarkers of inflammation: CRP Time: 30 daysDescription: Track and evaluate other known biomarkers of inflammation, D-dimer from baseline to day 30
Measure: To track and evaluate other known biomarkers of inflammation: D-dimer Time: 30 daysDescription: Evaluate improvement of the NEWS2 score value
Measure: Evaluation of physiological status through NEWS2 score Time: 30 daysDescription: Incidence and scoring of all grade 3-4 adverse events through Day 45 (using CTCAE Version 5.0 to assess severity)
Measure: Safety assessment Time: 45 days