CovidResearchTrials by Shray Alag

CovidResearchTrials Covid 19 Research using Clinical Trials (Home Page)

LenzilumabWiki

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


Correlated Drug Terms (3)

Name (Synonyms) Correlation
drug2880 mRNA-1273 Wiki 0.71
drug2319 Standard of Care Wiki 0.20
drug1822 Placebo Wiki 0.06

Correlated MeSH Terms (2)

Name (Synonyms) Correlation
D011014 Pneumonia NIH 0.06
D018352 Coronavirus Infections NIH 0.04

Correlated HPO Terms (1)

Name (Synonyms) Correlation
HP:0002090 Pneumonia HPO 0.06

There is one clinical trial.

Clinical Trials

1 A Phase 3 Randomized, Placebo-Controlled Study of Lenzilumab in Hospitalized Patients With Severe and Critical COVID-19 Pneumonia

The primary objective of this study is to assess whether the use of lenzilumab in addition to current standard of care can alleviate the immune-mediated cytokine release syndrome (CRS) and reduce the time to recovery in hospitalized subjects with severe or critical COVID-19 pneumonia.

NCT04351152 Coronavirus Disease 2019 (COVID-19) Pneumonia Biological: Lenzilumab Drug: Standard of Care
MeSH:Coronavirus Infections Pneumonia
HPO:Pneumonia

Primary Outcomes

Description: Time to recovery is defined as the first day on which a subject satisfies one of the following 3 categories from the 8-point ordinal scale (Hospitalized, not requiring supplemental oxygen-no longer requires ongoing medical care; Not hospitalized, limitation on activities and/or requiring home oxygen; Not hospitalized, no limitations on activities).

Measure: Time to Recovery

Time: Up to 28 days

Secondary Outcomes

Measure: Incidence of Invasive Mechanical Ventilation and/or Death

Time: Up to 28 days

Measure: Incidence of severe acute respiratory distress syndrome (ARDS)

Time: Up to 28 days

Measure: Duration of Intensive Care Unit (ICU) Stay

Time: Up to 28 days

Measure: Ventilator-free Days

Time: Up to 60 days

Measure: Duration of Hospitalization

Time: Up to 28 days

Measure: Time to Improvement in 1 or 2 Categories using 8-point Ordinal Scale

Time: Up to Day 28

Measure: Time to Death

Time: Up to Day 28

Measure: Number of Subjects Alive and Off Oxygen

Time: Up to 60 days

Description: Using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0

Measure: Percentage of Participants Experiencing Adverse Events

Time: Up to 60 days

Description: Using the NCI CTCAE version 5.0

Measure: Percentage of Participants Experiencing Serious Adverse Events

Time: Up to 60 days

Measure: Proportion of Subjects Discharged from Hospital

Time: Up to Day 60

Measure: All-cause Mortality and Proportion of Subjects Alive

Time: Day 28 and Day 60

Measure: Time to improvement in oxygenation for > 48 hours

Time: Up to Day 28

Measure: Incidence of Non-invasive Ventilation (or Use of High-flow Oxygen Device)

Time: Up to Day 28

Description: NEWS2 consists of: Physiological Parameters: respiration rate (per minute), SpO2 Scale 1 (%), SpO2 Scale 2 (%), use of air or oxygen, systolic blood pressure (mmHg), pulse (per minute), consciousness and temperature (°C)

Measure: Time to Clinical Improvement, Defined as NEWS2 < 2 Maintained for 24 Hours

Time: Up to Day 28

Measure: Change from Baseline to Day 28 in Clinical status Based on the 8-point Ordinal Scale

Time: Up to Day 28

Measure: Duration of Time on Low-flow or High-flow Supplemental Oxygen

Time: Up to Day 28

Related HPO nodes (Using clinical trials)

HP:0002090: Pneumonia
Genes 220
KMT2D OSTM1 GBA RSPH1 DOCK8 NKX2-1 RNU4ATAC SPAG1 RAG1 MCIDAS AFF4 TNFRSF13C DNAH1 NOTCH3 CD19 ALMS1 NADK2 UNC119 SFTPC FOXN1 CD79B CFAP221 CD81 SAMD9 MED25 ZAP70 RAG2 IGLL1 DNAAF1 RPGR STK36 LTBP3 PLOD1 DNAH9 BTK TERT COL11A2 OFD1 TNFRSF11A LRBA RSPH4A CD19 NME8 SMARCD2 GAS8 CFTR TNFRSF13B CCDC65 CFAP298 COL11A2 RAG1 ORC6 P4HTM MAN2B1 CFAP300 JAK3 CACNA1C ICOS SETBP1 TNFRSF13C SPEF2 LIG4 NIPBL STAT3 ZMYND10 IL7R MAN2B1 HLA-DQA1 IL21R SELENON SP110 ACADVL CCDC39 ARMC4 NSMCE3 NFIX DNAI2 ACP5 PTPRC ZAP70 KIAA0586 FCGR2A NFKB2 NEK10 MTHFD1 EGFR RYR1 ADA DNAI1 TGFB1 DNAAF6 IL2RG KCNJ6 DCLRE1C CCDC103 IGHM GNPTAB DNAAF4 PNP CFB DCLRE1C TAF1 CARD11 USB1 ADA ICOS FMO3 IL2RG HLA-DQB1 GFI1 SFTPA2 ICOS CD3D FOXJ1 CRLF1 ELANE IL2RG SRP54 NFKB1 PANK2 GAS2L2 CD247 IRF8 GAS8 RAG2 CCDC151 WAS ZBTB24 CD3E DNAL1 EXTL3 SLC35A1 NCF1 TK2 MS4A1 IFNGR1 RNF168 RMRP RSPH9 NHLRC1 MUC5B TNFRSF13C DNAH5 DNMT3B RNF125 EPM2A TTC12 JAK3 LEP RAC1 CYBA PGM3 NOS1 DDR2 AFF4 TBC1D24 CHD7 TNFRSF13B OFD1 DNAI1 RANBP2 TCIRG1 DNAJB13 CR2 CCDC40 IL2RG NCF2 RAG2 SLC25A24 SGCG WDR19 FOXP3 RNU4ATAC ACTA1 UBB CFAP410 BTK TTC25 CARD11 DNAAF2 CXCR4 MASP2 DRC1 TBCD DCLRE1C CYBB RSPH3 LRRC6 PIGN TNFSF12 DNAAF5 CCNO CSPP1 CR2 SLC35C1 HYDIN TIMM8A NBN NFKB2 CCDC114 CASP8 ADA IL7R CCDC114 TNFSF12 BTK LRRC56 PEPD BLNK CD55 GRHL3 NBN PRKCD KPTN PMM2 DNAAF3 KDM6A POLA1 RAG1 DNAH11
Protein Mutations 6
A2063G G551D K55R L460D R287Q S1009A
SNP 0