Covid 19 Research using Clinical Trials (Home Page)
BaricitinibWiki
Developed by Shray Alag
Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation
Correlated Drug Terms (6)
| Name (Synonyms) | Correlation | |
|---|---|---|
| drug693 | Remestemcel-L Wiki | 0.71 |
| drug581 | Oral placebo Wiki | 0.71 |
| drug426 | Injective placebo Wiki | 0.71 |
| drug229 | Convalescent anti-SARS-CoV-2 plasma Wiki | 0.71 |
| drug732 | Sarilumab Wiki | 0.29 |
| drug360 | Hydroxychloroquine Wiki | 0.09 |
Correlated MeSH Terms (9)
| Name (Synonyms) | Correlation | |
|---|---|---|
| D011024 | Pneumonia, Viral NIH | 0.12 |
| D055371 | Acute Lung Injury NIH | 0.11 |
| D013577 | Syndrome NIH | 0.11 |
| D012127 | Respiratory Distress Syndrome, Newborn NIH | 0.11 |
| D012128 | Respiratory Distress Syndrome, Adult NIH | 0.09 |
| D014777 | Virus Diseases NIH | 0.08 |
| D011014 | Pneumonia NIH | 0.06 |
| D045169 | Severe Acute Respiratory Syndrome NIH | 0.05 |
| D018352 | Coronavirus Infections NIH | 0.04 |
Correlated HPO Terms (0)
| Name (Synonyms) | Correlation |
|---|
There are 2 clinical trials
Clinical Trials
1 Safety and Efficacy of Baricitinib for COVID-19
This study plans to learn more about the effects of a medicine called baricitinib on the progression of COVID-19 (coronavirus disease of 2019), the medical condition caused by the Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2). Baricitinib is FDA-approved for the treatment of rheumatoid arthritis, an autoimmune condition. This study intends to define the impact of baricitinib on the severity and progression of COVID-19. This drug might to lower the hyperinflammation caused by the virus, which would prevent damage to the lungs and possibly other organs. The study will recruit patients who have been diagnosed with COVID-19. The goal is to recruit 80 patients.
NCT04340232 COVID-19 Drug: Baricitinib
Primary Outcomes
Description: Description: Grade 3 AEs are defined as events that interrupt usual activities of daily living, or significantly affects clinical status, or may require intensive therapeutic intervention. Severe events are usually incapacitating. Grade 4 AEs are defined as events that are potentially life threatening. AEs will be collected and graded daily and cumulative incidence will be reported.
Measure: Phase 2: Cumulative incidence of Grade 3 and 4 adverse events (AEs) Time: Day 0 (screening) through Day 29Description: Description: An SAE is defined as an AE that is life-threatening or results in death, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, or a congenital anomaly/birth defect. SAEs will be collected and graded daily and cumulative incidence will be reported.
Measure: Phase 2: Cumulative incidence of serious adverse events (SAEs) Time: Day 0 (screening) through Day 29Description: Safety assessment via standard blood chemistry and metabolic panels will be performed daily as recommended by participant's physician as standard of care (SOC). Mean changes from baseline to Day 15 will be reported.
Measure: Phase 2: Changes in white blood cell count (CBC) through Day 15 Time: Day 1 to Day 15Measure: Phase 2: Changes in hemoglobin through Day 15 Time: Day 1 to Day 15
Measure: Phase 2: Changes in platelets through Day 15 Time: Day 1 to Day 15
Measure: Phase 2: Changes in creatinine through Day 15 Time: Day 1 to Day 15
Measure: Phase 2: Changes in glucose through Day 15 Time: Day 1 to Day 15
Measure: Phase 2: Changes in prothrombin time (PT) through Day 15 Time: Day 1 to Day 15
Measure: Phase 2: Changes in total bilirubin through Day 15 Time: Day 1 to Day 15
Measure: Phase 2: Changes in ALT through Day 15 Time: Day 1 to Day 15
Measure: Phase 2: Changes in AST through Day 15 Time: Day 1 to Day 15
Description: Safety assessment via standard blood chemistry and metabolic panels will be performed daily as recommended by participant's physician as SOC. Mean changes from baseline to EOS will be reported.
Measure: Phase 2: Changes in white blood cell count (CBC) through End of Study (EOS) Time: Day through Day 29 or hospital discharge, whichever is firstMeasure: Phase 2: Changes in hemoglobin through End of Study (EOS) Time: Day 1 through Day 29 or hospital discharge, whichever is first
Measure: Phase 2: Changes in platelets through End of Study (EOS) Time: Day 1 through Day 29 or hospital discharge, whichever is first
Measure: Phase 2: Changes in creatinine through End of Study (EOS) Time: Day 1 through Day 29 or hospital discharge, whichever is first
Measure: Phase 2: Changes in glucose through End of Study (EOS) Time: Day 1 through Day 29 or hospital discharge, whichever is first
Measure: Phase 2: Changes in prothrombin time (PT) though End of Study (EOS) Time: Day 1 through Day 29 or hospital discharge, whichever is first
Measure: Phase 2: Changes in total bilirubin through End of Study (EOS) Time: Day 1 through Day 29 or hospital discharge, whichever is first
Measure: Phase 2: Changes in ALT through End of Study (EOS) Time: Day 1 through Day 29 or hospital discharge, whichever is first
Measure: Phase 2: Changes in AST through End of Study (EOS) Time: Day 1 through Day 29 or hospital discharge, whichever is first
Description: The 8-point ordinal scale described below, where a lower score indicates a worse outcome, will be performed daily or as recommended by participant's physician as SOC. The percent of participants scored at each severity will be reported on Day 15. The 8-point ordinal scale is as follows: Death Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO) Hospitalized, on non-invasive ventilation or high flow oxygen devices Hospitalized, requiring supplemental oxygen Hospitalized, not requiring supplemental oxygen, requiring ongoing medical care (COVID-19 related or otherwise) 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: Phase 3: Percentage of patients reporting each severity on an 8-point ordinal scale at Day 15 Time: Day 15Secondary Outcomes
Description: The 8-point ordinal scale described above will be assessed using MR data collected as SOC or follow-up phone call on Day 29, where a lower score indicates a worse outcome. Mean changes from baseline to Day 29 will be reported.
Measure: Phase 2: Change in the 8-point ordinal scale Time: Day 1 to Day 29Description: The NEWS is a cumulative score (range: 0 - 20) based on 7 clinical parameters as depicted below and discriminates patients at risk of poor outcomes. A higher score indicates a higher risk. The assessment will be calculated daily using MR data collected as SOC. Mean changes from baseline to End of Study (Day 29 or discharge) will be reported.
Measure: Phase 2: Change in National Early Warning Score (NEWS) Time: Day 1 through Day 29 or hospital discharge, whichever is firstDescription: The 8-point ordinal scale described above will be assessed daily using MR data collected as SOC or follow-up phone call, where a lower score indicates a worse outcome. Mean changes from baseline to Day 29 will be reported.
Measure: Phase 3: Change in the 8-point ordinal scale Time: Day 1 to Day 29Description: The NEWS is a cumulative score (range: 0 - 20) based on 7 clinical parameters as depicted below and discriminates patients at risk of poor outcomes. A higher score indicates a higher risk. The assessment will be calculated daily using MR data collected as SOC. Mean changes from baseline to End of Study (Day 29 or discharge) will be reported.
Measure: Phase 3: Change in National Early Warning Score (NEWS) Time: Day 1 to Day 29 or hospital discharge, whichever is firstDescription: The 8-point ordinal scale described above will be assessed daily using MR data collected as SOC, where a lower score indicates a worse outcome. Mean time in days to a one-category improvement will be reported.
Measure: Phase 3: Time to an improvement of one category using the 8-point ordinal scale Time: Day 1 to Day 29 or hospital discharge, whichever is firstDescription: The 8-point ordinal scale described above will be assessed daily, where a lower score indicates a worse outcome. Mean time in days to a two-category improvement will be reported.
Measure: Phase 3: Time to an improvement of two categories using the 8-point ordinal scale Time: Day 1 to Day 29 or hospital discharge, whichever is firstDescription: The NEWS will be calculated daily. Mean time in days to achieve a score of ≤2 and maintain this score for at least 24 hours OR to be discharged from the hospital, whichever occurs first, will be reported. A higher score indicates a higher risk. End of study is defined as day 29 or discharge, whichever occurs first.
Measure: Phase 3: Time to discharge or to a NEWS ≤2 and maintained for 24 hours, whichever occurs first Time: Day 1 through Day 29 or hospital discharge, whichever is firstDescription: Grade 3 AEs are defined as events that interrupt usual activities of daily living, or significantly affects clinical status, or may require intensive therapeutic intervention. Severe events are usually incapacitating. Grade 4 AEs are defined as events that are potentially life threatening. AEs will be collected and graded daily and cumulative incidence will be reported.
Measure: Phase 3: Cumulative incidence of Grade 3 and 4 adverse events (AEs) Time: Day 0 (screening) through Day 29Description: An SAE is defined as an AE that is life-threatening or results in death, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, or a congenital anomaly/birth defect. SAEs will be collected and graded daily and cumulative incidence will be reported.
Measure: Phase 3: Cumulative incidence of serious adverse events (SAEs) Time: Day 0 (screening) through Day 29Description: The mean duration of hospitalization will be reported, measured in days.
Measure: Phase 3: Duration of hospitalization Time: Day 1 through Day 29 or hospital discharge, whichever is firstDescription: The mean duration of new oxygen use will be reported, measured in days.
Measure: Phase 3: Duration of new oxygen use Time: Day 1 through Day 29 or hospital discharge, whichever is firstDescription: The mean duration of new ventilator or ECMO use will be reported, measured in days.
Measure: Phase 3: Duration of new ventilator or ECMO use Time: Day 1 to Day 29 or hospital discharge, whichever is firstDescription: The incidence of interruption of baricitinib treatment, along with mean duration and reasons for the interruptions, will be reported.
Measure: Phase 3: Incidence of discontinuation or temporary suspension of drug for any reason Time: Day 1 through Day 29 or hospital discharge, whichever is firstDescription: The incidence of new oxygen use will be reported.
Measure: Phase 3: Incidence of new oxygen use Time: Day 1 to Day 29 or hospital discharge, whichever is firstDescription: The incidence of new ventilator or ECMO use will be reported.
Measure: Phase 3: Incidence of new ventilator use Time: Day 1 to Day 29 or hospital discharge, whichever is firstDescription: The mean number of days patients are free from use of oxygen will be reported.
Measure: Phase 3: Number of oxygen free days Time: Day 1 through Day 29 or hospital discharge, whichever is firstDescription: The mean number of days patients are free from use of a ventilator or ECMO will be reported.
Measure: Phase 3: Number of ventilator or ECMO free days Time: Day 1 through Day 29 or hospital discharge, whichever is firstDescription: The rate of participant death from Day 1 through Day 15 will be reported.
Measure: Phase 3: 14 day mortality rate Time: Day 1 through Day 15Description: The rate of participant death from Day 1 through Day 29 will be reported.
Measure: Phase 3: 28 day mortality rate Time: Day 1 through Day 29Measure: Phase 3: Changes in white blood cell count (CBC) through Day 15 Time: Day 1 to Day 15
Measure: Phase 3: Changes in hemoglobin through Day 15 Time: Day 1 to Day 15
Measure: Phase 3: Changes in platelets through Day 15 Time: Day 1 to Day 15
Measure: Phase 3: Changes in creatinine through Day 15 Time: Day 1 to Day 15
Measure: Phase 3: Changes in glucose through Day 15 Time: Day 1 to Day 15
Measure: Phase 3: Changes in prothrombin time (PT) through Day 15 Time: Day 1 to Day 15
Measure: Phase 3: Changes in total bilirubin through Day 15 Time: Day 1 to Day 15
Measure: Phase 3: Changes in ALT through Day 15 Time: Day 1 to Day 15
Measure: Phase 3: Changes in AST through Day 15 Time: Day 1 to Day 15
Description: Safety assessment via standard blood chemistry and metabolic panels will be performed daily as recommended by participant's physician as SOC. Mean changes from baseline to EOS will be reported.
Measure: Phase 3: Changes in white blood cell count (CBC) through End of Study (EOS) Time: Day 1 through Day 29 or hospital discharge, whichever is firstMeasure: Phase 3: Changes in hemoglobin through End of Study (EOS) Time: Day 1 through Day 29 or hospital discharge, whichever is first
Measure: Phase 3: Changes in platelets through End of Study (EOS) Time: Day 1 through Day 29 or hospital discharge, whichever is first
Measure: Phase 3: Changes in creatinine through End of Study (EOS) Time: Day 1 through Day 29 or hospital discharge, whichever is first
Measure: Phase 3: Changes in glucose through End of Study (EOS) Time: Day 1 through Day 29 or hospital discharge, whichever is first
Measure: Phase 3: Changes in prothrombin time (PT) though End of Study (EOS) Time: Day 1 through Day 29 or hospital discharge, whichever is first
Measure: Phase 3: Changes in total bilirubin through End of Study (EOS) Time: Day 1 through Day 29 or hospital discharge, whichever is first
Measure: Phase 3: Changes in ALT through End of Study (EOS) Time: Day 1 through Day 29 or hospital discharge, whichever is first
Measure: Phase 3: Changes in AST through End of Study (EOS) Time: Day 1 through Day 29 or hospital discharge, whichever is first
2 Efficacy and Safety of Novel Treatment Options for Adults With COVID-19 Pneumonia. A Double-blinded, Randomized, Multi-stage, 6-armed Placebo-controlled Trial in the Framework of an Adaptive Trial Platform
CCAP is an investigator-initiated multicentre, randomized, double blinded, placebo-controlled, multi-stage trial, which aims to assess the safety and efficacy of novel treatment option of moderate-severe COVID-19. Participants will be randomized 1:1:1:1:1:1 to parallel treatment arms: Convalescent plasma, sarilumab, hydroxychloroquine, baricitinib, intravenous and subcutaneous placebo, or oral placebo. Primary outcome is a composite endpoint of all-cause mortality or need of invasive mechanical ventilation up to 28 days.
NCT04345289 COVID Corona Virus Infection Viral Pneumonia Biological: Convalescent anti-SARS-CoV-2 plasma Drug: Sarilumab Drug: Baricitinib Drug: Hydroxychloroquine Other: Injective placebo Other: Oral placebo MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome Pneumonia, Viral Pneumonia Virus Diseases
HPO:Pneumonia
Primary Outcomes
Description: Composite outcome
Measure: All-cause mortality or need of invasive mechanical ventilation Time: 28 days
Secondary Outcomes
Description: Number of participants with adverse events with possible relation to study drug
Measure: Frequency of adverse events Time: 90 days
Description: Number of participants with serious adverse events according to International Council of Harmonisation-Good Clinical Practice (ICH-GCP) guidelines
Measure: Frequency of severe adverse events Time: 90 days
Description: Number of days to improvement of at least 2 categories relative to baseline on the ordinal scale. Categories are as follows: Death; Hospitalized, in intensive care requiring Extracorporeal Membrane Oxygenation (ECMO) or mechanical ventilation; Hospitalized, on non-invasive ventilation or high-flow oxygen device; Hospitalized, requiring supplemental oxygen; Hospitalized, not requiring supplemental oxygen; Not hospitalized, limitation on activities and/or requiring home oxygen; Not hospitalized, no limitations on activities
Measure: Time to improvement of at least 2 categories relative to baseline on a 7-category ordinal scale of clinical status Time: 90 days
Description: Number of days without mechanical ventilation
Measure: Ventilator-free days Time: 28 days
Description: Number of days without organ-failure
Measure: Organ failure-free days Time: 28 days
Description: Number of days in ICU
Measure: Duration of ICU stay Time: 90 days
Description: Number of deaths by any cause
Measure: Mortality rate Time: 7, 14, 21, 28 and 90 days
Description: Days from the date of hospital admission for COVID-19 to the date of discharge
Measure: Length of hospital stay Time: 90 days
Description: Days requiring supplement oxygen
Measure: Duration of supplemental oxygen Time: 90 days
Related HPO nodes (Using clinical trials)
HP:0002090: Pneumonia
Genes 208
TIMM8A DNAH9 GAS8 DNAH11 TNFRSF11A TBC1D24 SPAG1 MS4A1 GAS2L2 CCDC151 NIPBL BTK LIG4 NFKB2 TCIRG1 IGLL1 RNF168 STAT3 TAF1 RSPH4A CFTR NME8 DNAAF4 LEP CCDC65 NADK2 CD55 COL11A2 NHLRC1 PEPD CFAP300 LTBP3 WAS DNAI1 TBCD IL2RG GFI1 NBN RSPH1 CCDC39 PMM2 ICOS TNFSF12 IFNGR1 CARD11 SFTPC DNAL1 OFD1 ZMYND10 IL21R FMO3 SLC35A1 PLOD1 ORC6 RAG2 CACNA1C GAS8 RYR1 CFAP298 GNPTAB TNFRSF13B KDM6A PANK2 RANBP2 CYBA USB1 UBB DOCK8 ADA DNAAF2 KMT2D SAMD9 MUC5B IL7R DNAAF1 ICOS RAG2 CARD11 PTPRC ALMS1 NOTCH3 NSMCE3 DNAI1 TNFRSF13C GRHL3 EGFR IL2RG DNAAF6 PNP DNAH5 SETBP1 CR2 CD3E ADA MASP2 SFTPA2 ACTA1 RAC1 TTC25 FCGR2A ZAP70 SPEF2 IGHM DNAAF5 NBN CD247 DDR2 CD19 ACADVL KIAA0586 TK2 BLNK ARMC4 SGCG RAG1 CXCR4 NCF1 SRP54 FOXP3 IRF8 CFAP221 RNU4ATAC KCNJ6 LRBA CD3D P4HTM SELENON CCDC114 TNFRSF13B PLG DCLRE1C SLC25A24 DCLRE1C ICOS IL7R FOXJ1 JAK3 IL2RG CASP8 RAG1 OSTM1 CFAP410 CCNO NCF2 UNC119 TNFRSF13C JAK3 RNF125 STK36 POLA1 CD19 CR2 DNAH1 RSPH3 RSPH9 CYBB DRC1 DCLRE1C CCDC103 DNAAF3 LRRC56 PIGN LRRC6 SP110 PRKCD ACP5 CCDC40 SLC35C1 BTK MTHFD1 PGM3 RAG1 TERT CHD7 CFB TGFB1 RNU4ATAC SMARCD2 NKX2-1 OFD1 ZBTB24 BTK DNAI2 WDR19 ZAP70 CD79B CD81 COL11A2 NFIX RAG2 ELANE AFF4 NFKB1 IL2RG TNFRSF13C TNFSF12 CCDC114 ADA GBA DNAJB13 RPGR CSPP1 RMRP EPM2A DNMT3B NFKB2 MCIDAS HYDIN SNP 0
Primary Outcomes
Description: Composite outcome
Measure: All-cause mortality or need of invasive mechanical ventilation Time: 28 daysSecondary Outcomes
Description: Number of participants with adverse events with possible relation to study drug
Measure: Frequency of adverse events Time: 90 daysDescription: Number of participants with serious adverse events according to International Council of Harmonisation-Good Clinical Practice (ICH-GCP) guidelines
Measure: Frequency of severe adverse events Time: 90 daysDescription: Number of days to improvement of at least 2 categories relative to baseline on the ordinal scale. Categories are as follows: Death; Hospitalized, in intensive care requiring Extracorporeal Membrane Oxygenation (ECMO) or mechanical ventilation; Hospitalized, on non-invasive ventilation or high-flow oxygen device; Hospitalized, requiring supplemental oxygen; Hospitalized, not requiring supplemental oxygen; Not hospitalized, limitation on activities and/or requiring home oxygen; Not hospitalized, no limitations on activities
Measure: Time to improvement of at least 2 categories relative to baseline on a 7-category ordinal scale of clinical status Time: 90 daysDescription: Number of days without mechanical ventilation
Measure: Ventilator-free days Time: 28 daysDescription: Number of days without organ-failure
Measure: Organ failure-free days Time: 28 daysDescription: Number of days in ICU
Measure: Duration of ICU stay Time: 90 daysDescription: Number of deaths by any cause
Measure: Mortality rate Time: 7, 14, 21, 28 and 90 daysDescription: Days from the date of hospital admission for COVID-19 to the date of discharge
Measure: Length of hospital stay Time: 90 daysDescription: Days requiring supplement oxygen
Measure: Duration of supplemental oxygen Time: 90 days