Name (Synonyms) | Correlation | |
---|---|---|
drug1552 | NHANES smell and taste tests Wiki | 0.71 |
drug1979 | Questionnaire Administration Wiki | 0.50 |
drug1368 | Lopinavir/Ritonavir Wiki | 0.41 |
drug315 | Baricitinib Wiki | 0.27 |
drug1086 | Hydroxychloroquine Wiki | 0.07 |
Name (Synonyms) | Correlation | |
---|---|---|
D000370 | Ageusia NIH | 0.71 |
D000857 | Olfaction Disorders NIH | 0.20 |
D009369 | Neoplasms, NIH | 0.16 |
D014777 | Virus Diseases NIH | 0.09 |
D045169 | Severe Acute Respiratory Syndrome NIH | 0.04 |
D018352 | Coronavirus Infections NIH | 0.03 |
Name (Synonyms) | Correlation | |
---|---|---|
HP:0000224 | Hypogeusia HPO | 0.71 |
HP:0000458 | Anosmia HPO | 0.20 |
HP:0002664 | Neoplasm HPO | 0.16 |
There are 2 clinical trials
This 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.
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 daysDescription: 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 daysThis phase II trial studies how well lopinavir/ritonavir works in treating COVID-19 positive patients with cancer and a weakened immune system (immune-suppression) in the last year and have mild or moderate symptoms caused by COVID-19. Lopinavir/ritonavir may help to lessen or prevent COVID-19 symptoms from getting worse in cancer patients.
Description: The severity of symptoms will be categorized as mild, moderate, severe, or critical according to the grading of symptoms. The proportion of participants with progression to more severe symptoms between treatments groups will be compared using a Fisher's Exact test at a 0.05 significance level.
Measure: Severity of symptoms Time: 3 monthsDescription: Will be defined as improvement on symptoms: yes or no. Will be compared between treatment groups using log-rank test. A 95% confidence interval of treatment rate difference in symptom progression will be calculated by the Wald method.
Measure: Clinical benefit rate of lopinavir/ritonavir Time: 3 monthsDescription: Will be compared between treatment groups using log-rank test.
Measure: Time to symptom progression Time: From randomization to the first documented symptoms progression, assessed up to 3 monthsDescription: Will be compared between treatment groups using log-rank test.
Measure: Time to improvement of participants Time: From randomization to first documented complete resolution of symptoms, assessed up to 3 monthsDescription: Will be compared between treatment groups using log-rank test.
Measure: Time to hospital admission for those who develop severe of critical symptoms Time: From time of randomization to the time of hospital admission, assessed up to 3 monthsDescription: Will be compared using Fisher's exact test, and point and interval estimates will be provided.
Measure: Intensive care unit (ICU) admission: yes or no Time: 3 monthsDescription: Will be compared using Fisher's exact test, and point and interval estimates will be provided.
Measure: Receiving ventilator support: yes or no Time: 3 monthsDescription: Will be compared using Fisher's exact test, and point and interval estimates will be provided.
Measure: Overall survival Time: From randomization to death due to any cause, assessed up to 3 monthsDescription: Will be compared between treatments group using t-test or non-parametric comparison if the distribution of lab values are deviated from normal distribution. The proportion of participants of whom lab values are obtained will be tabulated and compared using the chi-square test.
Measure: Potassium level Time: 3 monthsDescription: Will be compared between treatments group using t-test or non-parametric comparison if the distribution of lab values are deviated from normal distribution. The proportion of participants of whom lab values are obtained will be tabulated and compared using the chi-square test.
Measure: Blood oxygen level Time: 3 monthsDescription: Will be compared between treatments group using t-test or non-parametric comparison if the distribution of lab values are deviated from normal distribution. The proportion of participants of whom lab values are obtained will be tabulated and compared using the chi-square test.
Measure: Creatinine level Time: 3 monthsDescription: Will be compared between treatments group using t-test or non-parametric comparison if the distribution of lab values are deviated from normal distribution. The proportion of participants of whom lab values are obtained will be tabulated and compared using the chi-square test.
Measure: Blood pressure Time: 3 monthsDescription: Will evaluate on a subjective basis the ability to remotely consent, monitor and treat patients in the context of a pandemic of a contagious disease. The proportion of participants able to be remotely consented, monitored, and treated in the context of a pandemic of a contagious disease will be tabulated and compared using the chi-square test.
Measure: Ability to remotely consent, monitor, and treat patients in the context of a pandemic of a contagious disease Time: 3 months