Covid 19 Clinical Trials

This study evaluates TL-895, a tyrosine kinase inhibitor (TKI). This is a 2-part study comprising a Phase 1 safety lead-in (Part 1) that will determine the recommended TL-895 dose for Phase 2 (Part 2). In Part 1, TL-895 open-label will be administered orally at an assigned dose continuously in 7-day cycles for 2 cycles. Up to 3 dose levels will be evaluated. In Part 2, eligible subjects will be randomized in a 1:1 ratio to TL-895 with standard available treatment (SAT), or placebo with SAT. Investigators and Sponsor will be blinded to each subject's assigned study intervention throughout the course of the study.

NCT04419623 COVID-19 Sars-CoV2 Cancer Solid Tumor Carcinoma Blood Cancer Drug: Part 1 - TL-895 Drug: Part 2 - TL-895 Drug: Part 2 - Placebo

MeSH:Hematolog Hematologic Neoplasms

HPO:Hematological neoplasm Leukemia

Primary Outcomes

Description: To determine the recommended dose of TL-895 to be used in Part 2 based on the observed dose limiting toxicity per dose level

Measure: Part 1 - Recommended dose of TL-895

Time: After the day 14 of the 6th subject per dose level

Description: The proportion of subjects in Arm 1 vs Arm 2 requiring artificial ventilation (intubation and mechanical ventilation [MV], extracorporeal membrane oxygenation [ECMO], heated, humidified high-flow nasal cannula oxygen [HFNC], noninvasive positive pressure ventilation [NiPPV]) or death

Measure: Part 2 - Change in the need for artificial ventilation or death

Time: Day 29

Secondary Outcomes

Measure: Part 2 - Change in respiratory failure events that require invasive ventilation or death

Time: 4 months

Related HPO nodes (Using clinical trials)

HP:0004377: Hematological neoplasm

Genes 351

CHEK2 FANCE CBL TERT ATRX TERT RPS24 BIRC3 GATA1 STS JAK2 FANCL POT1 NOP10 TERT GATA2 RFWD3 MLH1 TCF4 LIG4 NPM1 RARA CD19 SH3GL1 CASP10 PDGFRA RPL5 BRIP1 ERBB3 RUNX1 KRAS PIGL CD81 SAMD9 THPO DYNC2LI1 RPS26 RAG2 WRAP53 CBL GFI1B STAT3 ABL1 LPP ATM TP53 IGH NRAS RPL26 RPS29 CALR ASXL1 CEBPA MALT1 ELANE CD19 TET2 NUP214 MSH2 CCND1 HAX1 SMARCD2 MYD88 EVC RAD54B RUNX1 FANCF SAMHD1 TRIP13 TNFRSF13B RUNX1 TP53 RPS10 CALR FLT3 BCL10 NRAS SETBP1 MSH2 TNFRSF13C SH2B3 FANCC BCL6 BLM CD28 LIG4 MCM4 FANCG GATA2 MYD88 GBA BCL2 GINS1 TET2 IL7R MYSM1 SLX4 KIT NBN RASGRP1 RB1 TINF2 RECQL4 FASLG PRF1 BRD4 TREX1 THPO SMPD1 FANCI NBEAL2 BUB3 ATM PDGFRB FAS FANCD2 RPS28 ZAP70 FANCA BAX LIG4 RPL11 LYST ADA CHIC2 POLE XIAP KRAS RTEL1 EVC2 XRCC2 SCN10A MPL CTLA4 ASXL1 MDM2 SAMD9L GATA2 RNASEH2B CBL JAK2 PNP UBE2T CBFB ARHGAP26 SCN11A MPL TINF2 F13A1 DCLRE1C SRP72 BCR SBDS ADA ICOS NAGS FANCB GNB1 TAL1 PIGA NUP214 TYROBP GFI1 RAD51 BCL10 TREM2 ICOS CEP57 MLH1 IGH PICALM FANCM ERCC4 FANCD2 RPS15A FANCE PIK3R1 ELANE WIPF1 IL2RG GATA1 SRP54 RAF1 LIG4 NFKB1 PTPN11 XRCC4 SRP54 TET2 TET2 PTEN EP300 CASP10 DNASE1L3 PTPN11 MS4A1 GATA2 RASGRP1 NUTM1 NTHL1 ETV6 TET2 NPM1 PIGL GFI1 RPS14 BCL10 WAS RPL18 SH2B3 RMRP SRSF2 DNMT3A DNAJC21 RPS27 RPS7 MPL FOXP1 DNMT3A CALR ASXL1 MPL TNFRSF13C TSR2 RUNX1 DKC1 APC ADAR RAD51C BRCA2 GLI1 IFIH1 SCN9A CDKN2A SH2D1A KLHDC8B NSUN2 CREBBP PGM3 SRP54 SBDS SH2B3 DNAJC21 CHD7 MPL BCR GATA2 BRCA1 BUB1B TERC CALR TNFRSF13B CD28 SAMD9L AAGAB BCR TP53 TCIRG1 ADA2 HSPA9 PIK3CA SRSF2 RNF43 TERT CR2 COL14A1 IGH RMRP FANCG IL2RG JAK2 KIF11 FLT3 JAK2 MAD2L2 FANCC RPS17 PARN NUMA1 RAD54L MSH6 RPL35 BRAF RNASEH2C CD70 SF3B1 MSH6 DDX41 TERC RECQL4 PMS2 RPL35A CCND1 BUB1 SF3B1 TERC TET2 RFWD3 CTLA4 MYC DNAJC21 TNFSF12 MAGT1 BLM FANCA KIT ITK RPL31 MLLT10 RPL15 RNASEH2A CR2 NHP2 TAL2 RPS14 NBN CD27 TCF4 NFKB2 RPS19 TNFSF12 HLA-DRB1 FAS RHOH NF1 ABL1 USB1 BUB1B NBN TET2 LIG4 PRKCD CTC1 JAK2 RPL27 PRKCD RPS19 TNFRSF1B BRCA2 DKC1 PALB2 F13B ATRX RAG1 TP63 EFL1 TNFRSF1B TET2 TET2 JAK2 KRAS

Protein Mutations 0

SNP 0

HP:0001909: Leukemia

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Part 1 - TL-895Wiki

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Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation

Correlated Drug Terms (2)

Correlated MeSH Terms (2)

Correlated HPO Terms (1)

Clinical Trials

1 A Phase 1/2, Double-Blind, Randomized, Placebo-Controlled Study of TL-895 With Standard Available Treatment Versus Standard Available Treatment for the Treatment of COVID-19 in Patients With Cancer