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CYT107Wiki

Developed by Shray Alag
Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation


Correlated Drug Terms (1)

Name (Synonyms) Correlation
drug1822 Placebo Wiki 0.08

Correlated MeSH Terms (1)

Name (Synonyms) Correlation
D008231 Lymphopenia NIH 0.63

Correlated HPO Terms (1)

Name (Synonyms) Correlation
HP:0001888 Lymphopenia HPO 0.63

There are 2 clinical trials

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. US Oncology Cohort

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

NCT04426201 COVID-19 Lymphocytopenia Drug: CYT107 Drug: Placebo
MeSH:Lymphopenia
HPO:Lymphopenia

Primary Outcomes

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 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: "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 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: 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 days

Description: 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 days

Description: Number of days in ICU during index hospitalization

Measure: length of stay in ICU compared to placebo arm

Time: 45 days

Description: Readmissions to ICU through Day 45

Measure: number of readmissions to ICU compared to placebo arm

Time: 45 days

Description: 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 days

Description: Number of readmissions to the hospital through Day 45

Measure: Frequency of re-hospitalization through day 45 compared to placebo arm

Time: 45 days

Description: All-cause mortality through Day 45

Measure: All-cause mortality through day 45 compared to placebo arm

Time: 45 days

Description: 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 days

Description: 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 days

Description: 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 days

Description: 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 days

Description: 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 days

Other Outcomes

Description: 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 days

2 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. US Infectious Cohort

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

NCT04442178 COVID-19 Lymphocytopenia Drug: CYT107 Drug: Placebo
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), whichever occurs first

Time: one 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: "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 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: 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: frequency of secondary infections through day 45 compared to placebo arm

Time: 45 days

Description: 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 days

Description: Number of days in ICU during index hospitalization

Measure: Length of stay in ICU compared to placebo arm

Time: 45 days

Description: Readmissions to ICU through Day 45

Measure: number of readmissions to ICU compared to placebo arm

Time: 45 days

Description: 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 days

Description: Number of readmissions to the hospital through Day 45

Measure: Frequency of re-hospitalization through day 45 compared to placebo arm

Time: 45 days

Description: All-cause mortality through Day 45

Measure: All-cause mortality through day 45 compared to placebo arm

Time: 45 days

Description: 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 days

Description: 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 days

Description: 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 days

Description: 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 days

Description: 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 days

Other Outcomes

Description: 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 days

Related HPO nodes (Using clinical trials)

HP:0001888: Lymphopenia
Genes 132
DOCK8 SMARCAL1 ICOS NHEJ1 RAG1 PIK3R1 G6PC3 ELANE PSMB9 WIPF1 IL2RG SRP54 SGPL1 NFKB1 TERT CORO1A STAT1 RAG2 WAS EPG5 IKZF1 PTEN CASP10 EXTL3 FOXN1 UNC119 MS4A1 GATA2 FOXN1 RASGRP1 RAG1 STAT4 CD81 SAMD9 ATM WAS TTC37 SKIV2L ATM CDCA7 TRNT1 CHD7 FOXN1 RAG1 TTI2 DNMT3B CD19 LEP ADAMTS3 ZBTB24 JAK3 PGM3 TNFRSF13B RAG1 STK4 CD3E CTLA4 IRAK1 ICOS CD8A TNFRSF13C TCIRG1 IL7R SEMA3E RFXAP XRCC4 SMARCAL1 MSN RMRP LEPR CTPS1 MYSM1 RAG2 HELLS TINF2 FASLG CD3G SP110 PIK3CD RFXANK CXCR4 FAS ACP5 TERC PTPRC ZAP70 CCBE1 NFKB2 DCLRE1C PSMB4 GFI1 CIITA MTHFD1 TNFSF12 AK2 TPP2 MAGT1 RAG2 TCN2 TFR2 CR2 IL2RA MYC LCK DNMT3B BCL11B DOCK2 CD3D EXTL3 TCF3 NBN NFKB2 ADA IL7R TNFSF12 IGHM TNFAIP3 SPP1 FAS WIPF1 PNP PTEN PRKCD RFX5 PRKCD FAT4 STAT1 ADA CD247 PGM3 IL2RG GFI1
Protein Mutations 0
SNP 0