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  • HP:0100827: Lymphocytosis
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    HP:0100827: Lymphocytosis

    Developed by Shray Alag, The Harker School
    Sections: Correlations, Clinical Trials, and HPO

    Correlations computed by analyzing all clinical trials.

    Navigate: Clinical Trials and HPO


    Correlated Drug Terms (4)


    Name (Synonyms) Correlation
    drug496 BRII-196 Wiki 1.00
    drug1876 Ibrutinib Wiki 0.71
    drug545 Best Practice Wiki 0.45
    Name (Synonyms) Correlation
    drug2916 Placebo Wiki 0.04

    Correlated MeSH Terms (6)


    Name (Synonyms) Correlation
    D000741 Anemia, Aplastic NIH 1.00
    D010265 Paraproteinemias NIH 1.00
    D008998 Monoclonal Gammopathy of Undetermined Significance NIH 1.00
    Name (Synonyms) Correlation
    D008218 Lymphocytosis NIH 1.00
    D009190 Myelodysplastic Syndromes NIH 0.71
    D009369 Neoplasms, NIH 0.17

    Correlated HPO Terms (3)


    Name (Synonyms) Correlation
    HP:0012133 Erythroid hypoplasia HPO 1.00
    HP:0002863 Myelodysplasia HPO 0.71
    HP:0002664 Neoplasm HPO 0.17

    Clinical Trials

    Navigate: Correlations   HPO

    There is one clinical trial.


    1 Randomized Double-Blind Phase 2 Trial of Ibrutinib Versus Standard Treatment for COVID-19 Illness Requiring Hospitalization With Safety Lead-In

    This phase Ib/II trial studies the side effects and best dose of ibrutinib and how well it works in treating patients with COVID-19 requiring hospitalization. Ibrutinib may help improve COVID-19 symptoms by lessening the inflammatory response in the lungs, while preserving overall immune function. This may reduce the need to be on a ventilator to help with breathing.

    NCT04439006
    Conditions
    1. Aplastic Anemia
    2. Hematopoietic and Lymphoid Cell Neoplasm
    3. Malignant Solid Neoplasm
    4. Monoclona
    5. Monoclonal B-Cell Lymphocytosis
    6. Monoclonal Gammopathy of Undetermined Significance
    7. Myelodysplastic Syndrome
    8. Symptomatic COVID-19 Infection Laboratory-Confirmed
    Interventions
    1. Other: Best Practice
    2. Drug: Ibrutinib
    MeSH:Laboratory Infection Neoplasms Myelodysplastic Syndromes Anemia, Aplastic Paraproteinemias Monoclonal Gammopathy of Undetermined Significance Lymphocytosis
    HPO:Aplastic anemia Erythroid hypoplasia Hypoplastic anemia Lymphocytosis Myelodysplasia Neoplasm

    Primary Outcomes

    Description: Associations between baseline characteristics and the primary endpoint will be evaluated with logistic regression, adjusting for arm. These analyses will be largely descriptive, as a result of a limited sample size.

    Measure: Proportion of patients with diminished respiratory failure and death

    Time: During hospitalization for COVID-19 infection or within 30 days of registration

    Measure: Death

    Time: During hospitalization for COVID-19 infection or within 30 days of registration

    Secondary Outcomes

    Description: Fever-free will be assessed by a temperature of < 100.5 degrees Fahrenheit orally. Will be estimated for each arm using the method of Kaplan-Meier. Medians estimates and/or estimates at specific time points will be provided with 95% confidence intervals.

    Measure: Time from study initiation to 48 hours fever-free

    Time: Up to 14 days

    Description: Will be estimated for each arm using the method of Kaplan-Meier. Medians estimates and/or estimates at specific time points will be provided with 95% confidence intervals.

    Measure: Duration of hospitalization

    Time: Up to 14 days

    Measure: Time in intensive care unit (ICU)

    Time: Up to 14 days

    Measure: Time to ICU admission

    Time: Up to 14 days

    Measure: Number of days requiring supplemental oxygen

    Time: Up to 14 days

    Measure: Total days of mechanical ventilation

    Time: Up to 14 days

    Measure: Time to mechanical ventilation

    Time: Up to 14 days

    Measure: Shock and need for pressure support

    Time: Up to 14 days

    Measure: Incidence of any infection (viral, fungal, bacterial)

    Time: Up to 14 days

    Measure: Time to clinical resolution

    Time: Up to 14 days

    Description: Adverse events will be summarized by grade, type, and attribution (regardless of attribution and treatment-related) for each arm.

    Measure: Incidence of grade 3 or higher adverse events

    Time: Up to 12 months

    Description: The proportion of patients with viral clearance at the time of hospital discharge will be estimated with 95% confidence intervals for each arm.

    Measure: At the end of therapy (day 14)

    Time: Up to 14 days

    Description: Will be estimated for each arm using the method of Kaplan-Meier. Medians estimates and/or estimates at specific time points will be provided with 95% confidence intervals.

    Measure: Time to viral clearance

    Time: Up to 12 months

    Description: Patients will be followed for up to 12 months or until death or withdrawal of study consent for further follow-up. Following hospitalization, study visits will be telephone or video encounters.

    Measure: Survival

    Time: Up to12 months

    HPO Nodes


    Reports

    Data processed on September 26, 2020.

    An HTML report was created for each of the unique drugs, MeSH, and HPO terms associated with COVID-19 clinical trials. Each report contains a list of either the drug, the MeSH terms, or the HPO terms. All of the terms in a category are displayed on the left-hand side of the report to enable easy navigation, and the reports contain a list of correlated drugs, MeSH, and HPO terms. Further, all reports contain the details of the clinical trials in which the term is referenced. Every clinical trial report shows the mapped HPO and MeSH terms, which are also hyperlinked. Related HPO terms, with their associated genes, protein mutations, and SNPs are also referenced in the report.

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