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CM4620-Injectable EmulsionWiki

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


Correlated Drug Terms (0)

Name (Synonyms) Correlation

Correlated MeSH Terms (1)

Name (Synonyms) Correlation
D011014 Pneumonia NIH 0.07

Correlated HPO Terms (1)

Name (Synonyms) Correlation
HP:0002090 Pneumonia HPO 0.07

There is one clinical trial.

Clinical Trials

1 A Randomized Controlled Open-Label Study of CM4620 Injectable Emulsion in Patients With Severe COVID-19 Pneumonia

This open-label randomized controlled study will evaluate safety, efficacy, and the pharmacokinetic profile of CM4620-IE in patients with severe COVID-19 pneumonia. Forty patients on low flow oxygen and forty patients on high flow oxygen will receive 2.0 mg/kg of CM4620-IE by continuous IV infusion on Day 1, followed by 1.6 mg/kg for days 2 and 3. Another 20 patients of each will receive local standard of care only. The infusion of CM4620-IE will start within 8 hours from the time the patient or LAR provides informed consent.

NCT04345614 Pneumonia Drug: CM4620-Injectable Emulsion
MeSH:Pneumonia
HPO:Pneumonia

Primary Outcomes

Description: The ordinal scale is an assessment of the clinical status at a given day. Each day, the worst score from the previous day will be recorded. The scale is as follows: 1. Death 2. Hospitalized, on invasive mechanical ventilation or ECMO 3. Hospitalized, on non-invasive ventilation or high flow oxygen devices 4. Hospitalized, requiring low flow supplemental oxygen 5. Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (coronavirus (COVID-19) related or otherwise) 6. Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care (other than per protocol study drug administration) 7. Not hospitalized

Measure: Improvement on a 7-point Ordinal Scale

Time: Upon enrollment into the study through hospital discharge, up to day 28

Description: Defined as the number of participants who experience TEAEs with investigator-specified relationship to CM4620-IE and assessment of severity.

Measure: Incidence of treatment-emergent adverse events (TEAE) (safety and tolerability)

Time: from enrollment and up to 60 days

Secondary Outcomes

Description: Defined as the change in the ratio of arterial oxygen partial pressure to fractional inspired oxygen

Measure: Change in estimated PaO2/FiO2

Time: from enrollment and up to day 28

Description: Defined as the number of days that a participant is both alive and free of mechanical ventilation

Measure: Number of days alive and free of mechanical ventilation

Time: from enrollment and up to day 60

Description: Defined as the number of days from hospital admission to discharge alive from the hospital

Measure: Time to discharge alive from hospital

Time: From day 1 of hospital admission to hospital discharge, up to day 28

Measure: Number of patients alive on day 30 and day 60

Time: Day 30 and day 60

Description: Measurement of IL-6 levels in patient blood

Measure: Change in interleukin (IL)-6 level

Time: from enrollment until day 10

Description: Measurement of IL-17 levels in patient blood

Measure: Change in IL-17 level

Time: from enrollment until day 10

Description: Measurement of tumor necrosis factor-alpha in patient blood

Measure: Change in tumor necrosis factor-alpha level

Time: from enrollment until day 10

Description: Measurement of cytokines in patient blood

Measure: Change in cytokine levels

Time: from enrollment until day 10

Description: Concentration measured using a validated assay

Measure: CM4620-IE serum concentration

Time: enrollment through 72 hours

Description: Measurement of procalcitonin in patient blood

Measure: Procalcitonin levels

Time: from enrollment through day 28

Description: Defined as the time to peripheral capillary oxygen saturation (SpO2) >94% sustained for at least 24 hours

Measure: Normalization of oxygen saturation

Time: from enrollment until day 28

Description: Defined as the time to peripheral capillary oxygen saturation (SpO2) >94%

Measure: Time to first normalization of oxygen saturation

Time: from enrollment until day 28

Related HPO nodes (Using clinical trials)

HP:0002090: Pneumonia
Genes 211
CCDC103 JAK3 IL2RG CD247 DNAI1 DOCK8 CSPP1 RYR1 IL2RG DNAAF2 JAK3 OFD1 PRKCD RSPH4A IGHM CCNO GAS8 DCLRE1C ZBTB24 NOTCH3 ZAP70 OSTM1 TK2 LRRC56 TGFB1 NKX2-1 DNAH11 CHD7 FOXP3 RANBP2 DNAI2 CR2 RNU4ATAC SETBP1 NADK2 SPAG1 COL11A2 TNFRSF13C SFTPC HYDIN DNAH9 IL2RG SRP54 TNFSF12 ICOS FCGR2A ADA DNAH5 GRHL3 UBB AFF4 KIAA0586 IL7R TERT DNAH1 DNAI1 ORC6 MASP2 DCLRE1C RSPH3 MTHFD1 AFF4 IRF8 ELANE CCDC39 NME8 CASP8 CARD11 DNAAF4 SLC35C1 EPM2A CD81 KMT2D TNFSF12 UNC119 LRBA NCF2 USB1 CCDC114 NBN DCLRE1C RMRP NFKB2 SFTPA2 RSPH1 RAG2 ADA EGFR CCDC114 WAS TNFRSF13C KDM6A IL21R TNFRSF13B TBC1D24 ICOS SLC25A24 NFKB1 PNP NFIX RAG1 ARMC4 ADA STAT3 DNMT3B RAG2 CFAP300 BTK GFI1 TAF1 SPEF2 RNF125 IL2RG NCF1 TNFRSF13C CXCR4 CARD11 CD55 OFD1 CCDC151 FOXJ1 ZMYND10 PEPD GNPTAB RAG1 PIGN ALMS1 MED25 CFAP410 BTK RAC1 ACP5 ACTA1 CD19 GBA TNFRSF11A CD79B DRC1 SMARCD2 NFKB2 STK36 ZAP70 RNU4ATAC DNAAF3 P4HTM RSPH9 SAMD9 IGLL1 RPGR TNFRSF13B LTBP3 DNAL1 CFAP298 CYBA BTK MS4A1 ICOS DNAAF1 LIG4 CR2 ACADVL RAG1 GAS2L2 NSMCE3 CFAP221 SGCG FMO3 DNAAF6 DNAAF5 TTC25 PMM2 COL11A2 TCIRG1 TIMM8A SELENON RAG2 MUC5B SLC35A1 PGM3 EXTL3 KPTN CACNA1C CD3E CD19 CYBB LRRC6 KCNJ6 RNF168 IFNGR1 CD3D GAS8 CFTR PLOD1 POLA1 NBN PANK2 BLNK CFB WDR19 IL7R SP110 MCIDAS PTPRC TBCD CCDC40 NIPBL LEP NHLRC1 DDR2 DNAJB13 CCDC65
Protein Mutations 6
A2063G G551D K55R L460D R287Q S1009A
SNP 0