CovidResearchTrials by Shray Alag

CovidResearchTrials Covid 19 Research using Clinical Trials (Home Page)

M5049Wiki

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


Correlated Drug Terms (2)

Name (Synonyms) Correlation
drug2897 molecular testing for virus RNA using RT-PCR Wiki 0.71
drug1822 Placebo Wiki 0.04

Correlated MeSH Terms (2)

Name (Synonyms) Correlation
D011014 Pneumonia NIH 0.04
D018352 Coronavirus Infections NIH 0.03

Correlated HPO Terms (1)

Name (Synonyms) Correlation
HP:0002090 Pneumonia HPO 0.04

There are 2 clinical trials

Clinical Trials

1 A Phase II, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of M5049 in Hospitalized Participants With COVID-19 Pneumonia

The study will evaluate the safety and efficacy of orally-administered M5049 in COVID-19 pneumonia participants who are hospitalized but not on mechanical ventilation.

NCT04448756 Coronavirus Disease 2019 Drug: M5049 Drug: M5049 Drug: Placebo
MeSH:Coronavirus Infections Pneumonia
HPO:Pneumonia

Primary Outcomes

Measure: Percentage of Participants Alive and not Requiring Supplemental Oxygenation

Time: Day 14

Measure: Occurrence of Treatment-Emergent Adverse Events (TEAEs), Adverse Events of Special Interests (AESIs), TEAEs Leading to Treatment Discontinuation and Serious AEs (SAEs)

Time: Day 1 through Day 60

Measure: Number of Participants With Clinically Significant Changes in Laboratory Parameters and Electrocardiogram Findings

Time: Day 1 through Day 28

Secondary Outcomes

Description: A nine point ordinal scale - 0: Uninfected No limitation of activities Limitation of activities Hospitalized, mild disease on, no oxygen therapy Hospitalized, with oxygen by mask or nasal prongs Hospitalized, severe disease: noninvasive ventilation or high flow oxygen Hospitalized, severe disease: intubation and mechanical ventilation Hospitalized, severe disease: ventilation plus additional organ support - example, vasopressors, Extracorporeal membrane oxygenation (ECMO) Death.

Measure: Clinical Status of Participants on a 9-Point Ordinal Scale

Time: Day 1 through Day 60

Description: Normal oxygen exchange in room air.

Measure: Time to Reach Peripheral Capillary Oxygen Saturation (SpO2) Greater Than or Equal to 94 Percent for at Least 24 Hours on Room Air

Time: Day 1 through Day 28

Description: Percentage of Participants who die for any reason.

Measure: Percentage of Participants With All-Cause Mortality

Time: Day 1 through Day 28

Description: Clinical Deterioration

Measure: Clinical Deterioration: Time to Intensive Care Unit (ICU) Admission

Time: Day 1 through Day 28

Description: Clinical Deterioration

Measure: Clinical Deterioration: Time to Invasive Mechanical Ventilation

Time: Day 1 through Day 28

Description: Clinical Deterioration

Measure: Clinical Deterioration: Time to Non-Invasive Mechanical Ventilation

Time: Day 1 through Day 28

Measure: Total Length of Stay in Intensive Care Unit (ICU)

Time: Day 1 through Day 60

Measure: Total Length of Hospitalization Stay

Time: Day 1 through Day 60

Measure: Percentage of Participants Alive and not Requiring Supplemental Oxygenation

Time: Day 1 through Day 28

Measure: Percentage Change From Baseline in Inflammatory Biomarkers

Time: Day 1 through Day 28

Description: Relapse refers to rehospitalization due to worsening oxygenation, with either a positive result of any respiratory pathogenic nucleic acid test, or worsening lesions on chest imaging.

Measure: Percentage of Participants With Relapse

Time: Day 5 through Day 60

Description: Percentage or participants who are re-hospitalized for any reason.

Measure: Percentage of Participants who are Re-Hospitalized

Time: Day 5 through Day 60

Description: Only the first 15 participants will be evaluated for Pharmacokinetic parameters.

Measure: Maximum Observed Concentration (Cmax) of M5049

Time: Day 1 and Day 7

Measure: Time to Reach the Maximum Observed Concentration (tmax) of M5049

Time: Day 1 and Day 7

Measure: Terminal Rate Constant (Lambda z) of M5049

Time: Day 1 and Day 7

Measure: Apparent Elimination Half-Life (t1/2) of M5049

Time: Day 1 and Day 7

Measure: Area Under the Plasma Concentration-Time Curve From Time of Dosing to the Time of the Last Observation (AUC0-t) of M5049

Time: Day 1 and Day 7

Measure: Area Under Plasma Concentration-Time Curve From Time of Dosing to 12 Hours Post-Dose (AUC0-12h) of M5049

Time: Day 1 and Day 7

Measure: Area Under the Plasma Concentration-Time Curve From Time of Dosing to Infinity (AUC0-Infinity) of M5049

Time: Day 1 and Day 7

Measure: Apparent Total Body Clearance (CL/F) of M5049

Time: Day 1 and Day 7

Measure: Apparent Volume of Distribution During the Terminal Phase Following Extravascular Administration (Vz/F) of M5049

Time: Day 1 and Day 7

Measure: Dose-Normalized Maximum Observed Concentration (Cmax/Dose) of M5049

Time: Day 1 and Day 7

Measure: Dose-Normalized Area Under the Plasma Concentration-Time Curve From Time of Dosing to the Time of the Last Observation (AUC0-t/Dose) of M5049

Time: Day 1 and Day 7

Measure: Dose-Normalized Area Under Plasma Concentration-Time Curve From Time of Dosing to 12 Hours Post-Dose (AUC0-12h/Dose) of M5049

Time: Day 1 and Day 7

Measure: Dose-Normalized Area Under the Plasma Concentration-Time Curve From Time of Dosing to Infinity (AUC0-Infinity/Dose) of M5049

Time: Day 1 and Day 7

2 A Phase II, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of M5049 in Hospitalized Participants With COVID-19 Pneumonia

The study will evaluate the safety and efficacy of orally-administered M5049 in COVID-19 pneumonia participants who are hospitalized but not on mechanical ventilation.

NCT04448756 Coronavirus Disease 2019 Drug: M5049 Drug: M5049 Drug: Placebo
MeSH:Coronavirus Infections Pneumonia
HPO:Pneumonia

Primary Outcomes

Measure: Percentage of Participants Alive and not Requiring Supplemental Oxygenation

Time: Day 14

Measure: Occurrence of Treatment-Emergent Adverse Events (TEAEs), Adverse Events of Special Interests (AESIs), TEAEs Leading to Treatment Discontinuation and Serious AEs (SAEs)

Time: Day 1 through Day 60

Measure: Number of Participants With Clinically Significant Changes in Laboratory Parameters and Electrocardiogram Findings

Time: Day 1 through Day 28

Secondary Outcomes

Description: A nine point ordinal scale - 0: Uninfected No limitation of activities Limitation of activities Hospitalized, mild disease on, no oxygen therapy Hospitalized, with oxygen by mask or nasal prongs Hospitalized, severe disease: noninvasive ventilation or high flow oxygen Hospitalized, severe disease: intubation and mechanical ventilation Hospitalized, severe disease: ventilation plus additional organ support - example, vasopressors, Extracorporeal membrane oxygenation (ECMO) Death.

Measure: Clinical Status of Participants on a 9-Point Ordinal Scale

Time: Day 1 through Day 60

Description: Normal oxygen exchange in room air.

Measure: Time to Reach Peripheral Capillary Oxygen Saturation (SpO2) Greater Than or Equal to 94 Percent for at Least 24 Hours on Room Air

Time: Day 1 through Day 28

Description: Percentage of Participants who die for any reason.

Measure: Percentage of Participants With All-Cause Mortality

Time: Day 1 through Day 28

Description: Clinical Deterioration

Measure: Clinical Deterioration: Time to Intensive Care Unit (ICU) Admission

Time: Day 1 through Day 28

Description: Clinical Deterioration

Measure: Clinical Deterioration: Time to Invasive Mechanical Ventilation

Time: Day 1 through Day 28

Description: Clinical Deterioration

Measure: Clinical Deterioration: Time to Non-Invasive Mechanical Ventilation

Time: Day 1 through Day 28

Measure: Total Length of Stay in Intensive Care Unit (ICU)

Time: Day 1 through Day 60

Measure: Total Length of Hospitalization Stay

Time: Day 1 through Day 60

Measure: Percentage of Participants Alive and not Requiring Supplemental Oxygenation

Time: Day 1 through Day 28

Measure: Percentage Change From Baseline in Inflammatory Biomarkers

Time: Day 1 through Day 28

Description: Relapse refers to rehospitalization due to worsening oxygenation, with either a positive result of any respiratory pathogenic nucleic acid test, or worsening lesions on chest imaging.

Measure: Percentage of Participants With Relapse

Time: Day 5 through Day 60

Description: Percentage or participants who are re-hospitalized for any reason.

Measure: Percentage of Participants who are Re-Hospitalized

Time: Day 5 through Day 60

Description: Only the first 15 participants will be evaluated for Pharmacokinetic parameters.

Measure: Maximum Observed Concentration (Cmax) of M5049

Time: Day 1 and Day 7

Measure: Time to Reach the Maximum Observed Concentration (tmax) of M5049

Time: Day 1 and Day 7

Measure: Terminal Rate Constant (Lambda z) of M5049

Time: Day 1 and Day 7

Measure: Apparent Elimination Half-Life (t1/2) of M5049

Time: Day 1 and Day 7

Measure: Area Under the Plasma Concentration-Time Curve From Time of Dosing to the Time of the Last Observation (AUC0-t) of M5049

Time: Day 1 and Day 7

Measure: Area Under Plasma Concentration-Time Curve From Time of Dosing to 12 Hours Post-Dose (AUC0-12h) of M5049

Time: Day 1 and Day 7

Measure: Area Under the Plasma Concentration-Time Curve From Time of Dosing to Infinity (AUC0-Infinity) of M5049

Time: Day 1 and Day 7

Measure: Apparent Total Body Clearance (CL/F) of M5049

Time: Day 1 and Day 7

Measure: Apparent Volume of Distribution During the Terminal Phase Following Extravascular Administration (Vz/F) of M5049

Time: Day 1 and Day 7

Measure: Dose-Normalized Maximum Observed Concentration (Cmax/Dose) of M5049

Time: Day 1 and Day 7

Measure: Dose-Normalized Area Under the Plasma Concentration-Time Curve From Time of Dosing to the Time of the Last Observation (AUC0-t/Dose) of M5049

Time: Day 1 and Day 7

Measure: Dose-Normalized Area Under Plasma Concentration-Time Curve From Time of Dosing to 12 Hours Post-Dose (AUC0-12h/Dose) of M5049

Time: Day 1 and Day 7

Measure: Dose-Normalized Area Under the Plasma Concentration-Time Curve From Time of Dosing to Infinity (AUC0-Infinity/Dose) of M5049

Time: Day 1 and Day 7

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