Covid 19 Research using Clinical Trials (Home Page)
Report for D008231: Lymphopenia NIH
(Synonyms: Lymphopenia)
Developed by Shray Alag
Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation
Correlated Drug Terms (2)
| Name (Synonyms) | Correlation | |
|---|---|---|
| drug593 | Interleukin-7 Wiki | 1.00 |
| drug872 | Placebos Wiki | 0.25 |
Correlated MeSH Terms (0)
| Name (Synonyms) | Correlation |
|---|
There is one clinical trial.
Clinical Trials
1 A Multicenter, Randomized, Double-blinded Placebo-controlled Study of Recombinant Interleukin-7 (CYT107) for Immune Restoration of Hospitalized Lymphopenic Patients With Coronavirus COVID-19 Infection in UK
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.
NCT04379076 COVID-19 Lymphocytopenia Drug: Interleukin-7 Drug: Placebos MeSH:Lymphopenia
HPO:Lymphopenia
Primary Outcomes
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 month
Secondary Outcomes
Description: 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 month
Description: 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 month
Description: 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 days
Description: 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 days
Description: 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 days
Description: Readmissions to ICU through Day 45
Measure: To compare the effect of CYT107 versus placebo on readmissions to ICU Time: 45 days
Description: 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 days
Description: 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 days
Description: All-cause mortality through Day 45
Measure: To assess the impact of CYT107 on all-cause mortality through day 45 Time: 45 days
Description: 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 days
Description: 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 days
Description: 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 days
Description: 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 days
Description: Evaluate improvement of the NEWS2 score value
Measure: Evaluation of physiological status through NEWS2 score Time: 30 days
Other Outcomes
Description: 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
HPO Nodes
HP:0001888: Lymphopenia
Genes 140
LEPR TNFAIP3 JAK3 IL2RG CD247 SKIV2L DOCK8 CXCR4 EPG5 CTPS1 LEP DNMT3B PRKCD AK2 IGHM FOXN1 HELLS TTC37 TPP2 CD3G CORO1A RAG1 DOCK2 XRCC4 RAG1 TCN2 FASLG IKZF1 ATM RASGRP1 RAG2 CASP10 CD8A ACP5 EXTL3 MYSM1 PNP CR2 STAT4 TRNT1 RMRP IRAK1 STAT1 CD3E CD3D WAS NFKB2 TINF2 ZAP70 IL2RA NHEJ1 IL2RG SRP54 IL7R TNFSF12 ZBTB24 SMARCAL1 SMARCAL1 ICOS TFR2 SAMD9 ADA MAGT1 PSMB4 MS4A1 TCF3 RFX5 LCK CHD7 PRKCD PTEN MTHFD1 G6PC3 CCBE1 TERC MYC PTEN C1QA ELANE PIK3CD RAG2 CD81 TNFSF12 UNC119 RAG1 TCIRG1 RAG2 CDCA7 PSMB9 CTLA4 DCLRE1C RAG1 PGM3 FAS NFKB2 EXTL3 TERT SGPL1 CD3E SPP1 CD19 CD247 PGM3 RAG2 FAT4 PIK3R1 STAT1 WAS RFXANK TNFRSF13C MSN TNFRSF13B ICOS CD3D WIPF1 NFKB1 BCL11B PNP NBN RAG1 STK4 TTI2 CIITA FAS DCLRE1C IL7R SP110 PTPRC RFXAP ADA DNMT3B GFI1 SEMA3E ATM GATA2 C1R GFI1 ADAMTS3 FOXN1 WIPF1 Protein Mutations 0
SNP 0
Primary Outcomes
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 monthSecondary Outcomes
Description: 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 daysOther Outcomes
Description: 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