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 (10)
| Name (Synonyms) | Correlation | |
|---|---|---|
| drug317 | Convalescent anti-SARS-CoV-2 plasma Wiki | 0.50 |
| drug854 | Placebo Administration Wiki | 0.50 |
| drug375 | Dociparastat sodium Wiki | 0.50 |
| drug1337 | mRNA-1273 Wiki | 0.50 |
| drug799 | Oral placebo Wiki | 0.50 |
| drug584 | Injective placebo Wiki | 0.50 |
| drug659 | Lucinactant Wiki | 0.50 |
| drug1012 | Sarilumab Wiki | 0.20 |
| drug505 | Hydroxychloroquine Wiki | 0.11 |
| drug850 | Placebo Wiki | 0.04 |
Correlated MeSH Terms (8)
| Name (Synonyms) | Correlation | |
|---|---|---|
| D055370 | Lung Injury NIH | 0.25 |
| D055371 | Acute Lung Injury NIH | 0.13 |
| D012128 | Respiratory Distress Syndrome, Adult NIH | 0.11 |
| D011014 | Pneumonia NIH | 0.07 |
| D011024 | Pneumonia, Viral NIH | 0.07 |
| D012127 | Respiratory Distress Syndrome, Newborn NIH | 0.06 |
| D045169 | Severe Acute Respiratory Syndrome NIH | 0.06 |
| D018352 | Coronavirus Infections NIH | 0.05 |
There are 4 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
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
3 A Phase II Randomized Double-Blind Trial of Baricitinib or Placebo Combined With Antiviral Therapy in Patients With Moderate and Severe COVID-19
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 daysThis phase II trial studies the effect of baricitinib in combination with antiviral therapy for the treatment of patients with moderate or severe coronavirus disease-2019 (COVID-19). Treatment with antiviral medications such as hydroxychloroquine, lopinavir/ritonavir, and/or remdesivir may act against infection caused by the virus responsible for COVID-19. Baricitinib may reduce lung inflammation. Giving baricitinib in combination with antiviral therapy may reduce the risk of the disease from getting worse and may help prevent the need for being placed on a ventilator should the disease worsen compared to antiviral therapy alone.
NCT04373044 Symptomatic COVID-19 Infection Laboratory-Confirmed Drug: Baricitinib Drug: Hydroxychloroquine Drug: Placebo Administration MeSH:Laboratory Infection
Primary Outcomes
Description: Descriptive statistics, including means, standard deviations, and ranges for continuous variables, as well as percentages and frequencies for categorical variables, will be provided to describe all the clinical findings in a cohort of symptomatic coronavirus disease 2019 (COVID-19)-infected subjects. The collected data will also be graphically presented in boxplots, histograms, and scatter plots. Investigations for outliers and assumptions for statistical analysis, e.g., normality and homoscedasticity, will be made. Group comparisons will be made using either the parametric tests such as t-test and analysis of variance (ANOVA), or the non-parametric statistical method such as Wilcoxon and Kruskal-Wallis tests for continuous variable and Chi-square test for categorical variables. Point estimates, along with the corresponding p-values and 95% confidence intervals will be reported.
Measure: Proportion of patients requiring invasive mechanical ventilation or dying Time: Up to 14 daysSecondary Outcomes
Description: Body temperature will be measured in degrees Fahrenheit using an automated thermometer.
Measure: Identification of clinical features (vitals signs - body temperature) Time: Up to 28 daysDescription: Respiratory rate in times/minute
Measure: Identification of clinical features (vital signs - respiratory rate) Time: Up to 28 daysDescription: Heart rate in beats/minute
Measure: Identification of clinical features (vital signs - heart rate) Time: Up to 28 daysDescription: Blood pressure in mmHg
Measure: Identification of clinical features (vital signs - blood pressure) Time: Up to 28 daysDescription: Chest X-ray or pulmonary computed tomography (CT) will be performed
Measure: Identification of clinical features (Imaging) Time: Up to 28 daysDescription: Assessment via standard blood chemistry and metabolic panel
Measure: Identification of clinical features (Lab - White Blood Count) Time: Up to 28 daysDescription: Assessment via standard blood chemistry and metabolic panel
Measure: Identification of clinical features (Lab - Absolute Lymphocyte Count) Time: Up to 28 daysDescription: Assessment via standard blood chemistry and metabolic panel
Measure: Identification of clinical features (Lab - Hemoglobin) Time: Up to 28 daysDescription: Assessment via standard blood chemistry and metabolic panel
Measure: Identification of clinical features (Lab - Creatinine) Time: Up to 28 daysDescription: CRP is assessed by routinely used determination of CRP.
Measure: Identification of biomarkers (C-reactive protein) Time: Up to 14 daysDescription: IL-6 levels will be assessed using commercial ELISA method
Measure: Identification of biomarkers (Interleukin-6) Time: Up to 14 daysDescription: Tumor Necrosis Factor-alpha as measured in hospital laboratory
Measure: Identification of biomarkers (Tumor Necrosis Factor-alpha) Time: Up to 14 daysDescription: Descriptive statistics, including means, standard deviations, and ranges for continuous variables, as well as percentages and frequencies for categorical variables, will be provided to describe all the clinical findings in a cohort of symptomatic COVID-19-infected subjects. The collected data will also be graphically presented in boxplots, histograms, and scatter plots. Investigations for outliers and assumptions for statistical analysis, e.g., normality and homoscedasticity, will be made. Group comparisons will be made using either the parametric tests such as t-test and ANOVA, or the non-parametric statistical method such as Wilcoxon and Kruskal-Wallis tests for continuous variable and Chi-square test for categorical variables. Point estimates, along with the corresponding p-values and 95% confidence intervals will be reported.
Measure: Identification of adverse events Time: Up to 14 daysOther Outcomes
Measure: Measurement of COVID19 viral burden Time: Up to 14 days4 A proof-of Concept Study of the Use of Janus Kinase 1 and 2 Inhibitor, Baricitinib, in the Treatment of COVID-19-related Pneumonia
The objective of the study is to assess the efficacy and safety of Baricitinib in the treatment of patients with COVID-19 pneumonia. This will be a proof-of-concept trial with an exploratory single-arm proof of concept Phase IIa study to assess the efficacy and safety profile of Baricitinib in a limited number of patients with severe acute respiratory syndrome (SARS)-CoV-2 pneumonia. If the initial proof of concept phase will lead to favourable results, an open-label, Phase II, randomized controlled trial will be then designed and performed to confirm the results obtained in the proof of concept phase. The proof-of-concept phase guarantees that no safety issues arise on a limited number of patients in the use of a drug new to the current condition being treated.
NCT04399798 Corona Virus Infection Drug: Baricitinib MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome Pneumonia
HPO:Pneumonia
Primary Outcomes
Description: A patient is consider responder in the absence of either moderate to severe oxygenation impairment according to Berlin criteria - measured as Partial pressure of oxygen/fraction inspired oxygen (PaO2/FiO2)
Measure: Response to treatment: absence of moderate to severe oxygenation impairment (Berlin criteria) Time: 8 days
Description: Absence of death within 8 days from enrollment
Measure: Response to treatment: survival Time: 8 days
Secondary Outcomes
Description: Moderate to severe oxygenation impairment according to Berlin criteria (measured as PaO2/FiO2)
Measure: To quantify the rate of each of: moderate or severe oxygenation impairment within 8 days Time: 8 days
Description: Moderate to severe oxygenation impairment according to Berlin criteria (measured as PaO2/FiO2)
Measure: To quantify the rate of each of: moderate or severe oxygenation impairment within 15 days Time: 15 days
Description: To quantify mortality within 8 and 15 days
Measure: Mortality Time: 8 days and 15 days
Description: SpO2 will be assessed with the median and 25th-75th percentiles
Measure: Peripheral capillary oxygen saturation (SpO2) Time: 8 days; 15 days
Description: PaO2/FiO2 will be assessed with the median and 25th-75th percentiles
Measure: Partial pressure of oxygen/fraction inspired oxygen (PaO2/FiO2) Time: 8 days; 15 days
Description: Number of patients over the number of patients enrolled
Measure: To assess the rate of patients admitted to the intensive care unit Time: 8 days; 15 days
Description: Median number of days and 25th-75th percentiles
Measure: To measure the length of hospital stay Time: 8 days; 15 days
Description: To quantify 28-day mortality
Measure: 28-day mortality Time: 28 days
Description: Number of patients readmitted over the number patients enrolled
Measure: To quantify the rate of re-admission within 28 days Time: 28 days
Description: Number, type, and severity of adverse events
Measure: To quantify the cumulative incidence and severity of adverse events Time: 28 days
Description: Serial serum assessments from baseline up to 15 days
Measure: Interleukin (IL)-1; IL-2; IL-10; IL-6; IL-8; IL-17; IL-2 receptor levels; Time: 15 days
Description: Serial serum assessments from baseline up to 15 days
Measure: TNFalpha; vascular endothelial growth factor (VEGF); interferon gamma (IFNgamma) levels Time: 15 days
Description: Serial assessments from baseline up to 15 days for viral load persistence
Measure: Viral load analyses Time: 15 days
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 SNP 0
Primary Outcomes
Description: A patient is consider responder in the absence of either moderate to severe oxygenation impairment according to Berlin criteria - measured as Partial pressure of oxygen/fraction inspired oxygen (PaO2/FiO2)
Measure: Response to treatment: absence of moderate to severe oxygenation impairment (Berlin criteria) Time: 8 daysDescription: Absence of death within 8 days from enrollment
Measure: Response to treatment: survival Time: 8 daysSecondary Outcomes
Description: Moderate to severe oxygenation impairment according to Berlin criteria (measured as PaO2/FiO2)
Measure: To quantify the rate of each of: moderate or severe oxygenation impairment within 8 days Time: 8 daysDescription: Moderate to severe oxygenation impairment according to Berlin criteria (measured as PaO2/FiO2)
Measure: To quantify the rate of each of: moderate or severe oxygenation impairment within 15 days Time: 15 daysDescription: To quantify mortality within 8 and 15 days
Measure: Mortality Time: 8 days and 15 daysDescription: SpO2 will be assessed with the median and 25th-75th percentiles
Measure: Peripheral capillary oxygen saturation (SpO2) Time: 8 days; 15 daysDescription: PaO2/FiO2 will be assessed with the median and 25th-75th percentiles
Measure: Partial pressure of oxygen/fraction inspired oxygen (PaO2/FiO2) Time: 8 days; 15 daysDescription: Number of patients over the number of patients enrolled
Measure: To assess the rate of patients admitted to the intensive care unit Time: 8 days; 15 daysDescription: Median number of days and 25th-75th percentiles
Measure: To measure the length of hospital stay Time: 8 days; 15 daysDescription: To quantify 28-day mortality
Measure: 28-day mortality Time: 28 daysDescription: Number of patients readmitted over the number patients enrolled
Measure: To quantify the rate of re-admission within 28 days Time: 28 daysDescription: Number, type, and severity of adverse events
Measure: To quantify the cumulative incidence and severity of adverse events Time: 28 daysDescription: Serial serum assessments from baseline up to 15 days
Measure: Interleukin (IL)-1; IL-2; IL-10; IL-6; IL-8; IL-17; IL-2 receptor levels; Time: 15 daysDescription: Serial serum assessments from baseline up to 15 days
Measure: TNFalpha; vascular endothelial growth factor (VEGF); interferon gamma (IFNgamma) levels Time: 15 daysDescription: Serial assessments from baseline up to 15 days for viral load persistence
Measure: Viral load analyses Time: 15 days