CovidResearchTrials by Shray Alag

CovidResearchTrials Covid 19 Research using Clinical Trials (Home Page)

Placebo AdministrationWiki

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Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation


Correlated Drug Terms (4)

Name (Synonyms) Correlation
drug375 Dociparastat sodium Wiki 1.00
drug140 Baricitinib Wiki 0.50
drug505 Hydroxychloroquine Wiki 0.11
drug850 Placebo Wiki 0.09

Correlated MeSH Terms (3)

Name (Synonyms) Correlation
D055370 Lung Injury NIH 0.25
D055371 Acute Lung Injury NIH 0.13
D012128 Respiratory Distress Syndrome, Adult NIH 0.11

Correlated HPO Terms (0)

Name (Synonyms) Correlation

There is one clinical trial.

Clinical Trials

1 A Phase II Randomized Double-Blind Trial of Baricitinib or Placebo Combined With Antiviral Therapy in Patients With Moderate and Severe COVID-19

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.

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 days

Secondary 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 days

Description: Respiratory rate in times/minute

Measure: Identification of clinical features (vital signs - respiratory rate)

Time: Up to 28 days

Description: Heart rate in beats/minute

Measure: Identification of clinical features (vital signs - heart rate)

Time: Up to 28 days

Description: Blood pressure in mmHg

Measure: Identification of clinical features (vital signs - blood pressure)

Time: Up to 28 days

Description: Chest X-ray or pulmonary computed tomography (CT) will be performed

Measure: Identification of clinical features (Imaging)

Time: Up to 28 days

Description: Assessment via standard blood chemistry and metabolic panel

Measure: Identification of clinical features (Lab - White Blood Count)

Time: Up to 28 days

Description: Assessment via standard blood chemistry and metabolic panel

Measure: Identification of clinical features (Lab - Absolute Lymphocyte Count)

Time: Up to 28 days

Description: Assessment via standard blood chemistry and metabolic panel

Measure: Identification of clinical features (Lab - Hemoglobin)

Time: Up to 28 days

Description: Assessment via standard blood chemistry and metabolic panel

Measure: Identification of clinical features (Lab - Creatinine)

Time: Up to 28 days

Description: CRP is assessed by routinely used determination of CRP.

Measure: Identification of biomarkers (C-reactive protein)

Time: Up to 14 days

Description: IL-6 levels will be assessed using commercial ELISA method

Measure: Identification of biomarkers (Interleukin-6)

Time: Up to 14 days

Description: Tumor Necrosis Factor-alpha as measured in hospital laboratory

Measure: Identification of biomarkers (Tumor Necrosis Factor-alpha)

Time: Up to 14 days

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 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 days

Other Outcomes

Measure: Measurement of COVID19 viral burden

Time: Up to 14 days

No related HPO nodes (Using clinical trials)