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Sections: Correlations,
Clinical Trials, and HPO
Navigate: Clinical Trials and HPO
| Name (Synonyms) | Correlation | |
|---|---|---|
| drug496 | BRII-196 Wiki | 0.71 |
| drug2751 | PARTNER-MH Wiki | 0.71 |
| drug545 | Best Practice Wiki | 0.32 |
| Name (Synonyms) | Correlation | |
|---|---|---|
| D000741 | Anemia, Aplastic NIH | 0.71 |
| D010265 | Paraproteinemias NIH | 0.71 |
| D008998 | Monoclonal Gammopathy of Undetermined Significance NIH | 0.71 |
| Name (Synonyms) | Correlation | |
|---|---|---|
| HP:0100827 | Lymphocytosis HPO | 0.71 |
| HP:0012133 | Erythroid hypoplasia HPO | 0.71 |
| HP:0002863 | Myelodysplasia HPO | 0.50 |
| Name (Synonyms) | Correlation | |
|---|---|---|
| HP:0002664 | Neoplasm HPO | 0.12 |
Navigate: Correlations HPO
There are 2 clinical trials
Coronavirus disease 2019 (COVID-19) is an infectious disease caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Lung failure is the main cause of death related to COVID-19 infection. The main objective of this study is to evaluate if Ibrutinib is safe and can reduce respiratory failure in participants with COVID-19 infection. Ibrutinib is an investigational drug being developed for the treatment of COVID-19. Participants are assigned 1 of 2 groups, called treatment arms. Each group receives a different treatment. There is a 1 in 2 chance that participants will be assigned to placebo. Around 46 adult participants with a diagnosis of COVID-19 will be enrolled at multiple sites in Unites States. Participants will receive oral doses of Ibrutinib or placebo capsules once daily for 4 weeks along with standard care. There may be higher treatment burden for participants in this trial compared to their standard of care. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects.
Description: Respiratory failure is defined by clinical diagnosis of respiratory failure and initiation of 1 of the following therapies: Endotracheal intubation and mechanical ventilation OR Extracorporeal membrane oxygenation OR high-flow nasal cannula oxygen delivery OR non-invasive positive pressure ventilation OR clinical diagnosis of respiratory failure with initiation of none of these measures only when clinical decision-making driven is driven solely by resource limitation.
Measure: Percentage of Participants Alive and Without Respiratory Failure Time: Day 28Description: WHO-8 is an 8 point ordinal scale for clinical improvement with scores ranging from 0 (uninfected) through 8 (Death).
Measure: Change in the World Health Organization (WHO)-8 Point Ordinal Scale From Baseline Time: Day 14Description: Time on supplemental oxygen imputed to the maximum number of days on study drug (28) for all points following the death of a participant.
Measure: Median Reduction in Days Spent on Supplemental Oxygen Time: Up to Day 28Description: Percentage of participants with mortality from any cause.
Measure: All-Cause Mortality Time: Up to Day 28Description: Respiratory failure is defined by clinical diagnosis of respiratory failure and initiation of 1 of the following therapies: Endotracheal intubation and mechanical ventilation OR Extracorporeal membrane oxygenation OR high-flow nasal cannula oxygen delivery OR non-invasive positive pressure ventilation OR clinical diagnosis of respiratory failure with initiation of none of these measures only when clinical decision-making driven is driven solely by resource limitation.
Measure: Percentage of Participants Experiencing Respiratory Failure or Death Time: Up to Day 28Description: Percentage of participants alive and not requiring mechanical ventilation.
Measure: Mechanical Ventilation-Free Survival Time: Up to Day 56Description: Defined as number of days from the first day of using mechanical ventilation to the last day of using mechanical ventilation.
Measure: Days on Mechanical Ventilation Time: Up to Day 56Description: The duration of hospitalization is defined as the time in days from the first day of hospitalized to the date of discharge or death.
Measure: Duration of hospitalization Time: Up to Day 56Description: Time to discharge is defined as the time in days from the first day of hospitalized to the date of discharge.
Measure: Time to Discharge Time: Up to Day 56Description: PaO2:FiO2 ratio is an index of respiratory distress.
Measure: Partial Pressure of Oxygen in Arterial Blood (PaO2) to Fraction of Inspired Oxygen (FiO2) Ratio Time: Up to Day 56Description: Oxygenation Index is a parameter of pulmonary function of participants.
Measure: Oxygenation Index Time: Up to Day 56Description: An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent adverse events (TEAEs) are defined as any event that began or worsened in severity on or after the first dose of study drug.
Measure: Number of Participants With Adverse Events Time: Up to Day 56Description: Laboratory abnormalities will be analyzed according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
Measure: Number of Participants With Abnormal Laboratory Findings Time: Up to Day 56This 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.
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 registrationDescription: 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 daysDescription: 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 daysDescription: 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 monthsDescription: 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 daysDescription: 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 monthsDescription: 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 monthsAlphabetical listing of all HPO terms. Navigate: Correlations Clinical Trials
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.
Drug Reports MeSH Reports HPO Reports