Developed by Shray Alag, The Harker School
Sections: Correlations,
Clinical Trials, and HPO
Navigate: Clinical Trials and HPO
| Name (Synonyms) | Correlation | |
|---|---|---|
| drug3255 | Racial/Ethnic Frame Wiki | 1.00 |
| drug2571 | No Messaging Wiki | 1.00 |
| drug1376 | Emphasis of Academic Researchers Involvement Wiki | 1.00 |
| Name (Synonyms) | Correlation | |
|---|---|---|
| D003141 | Communicable Diseases NIH | 0.07 |
| D007239 | Infection NIH | 0.05 |
| Name (Synonyms) | Correlation |
|---|
Navigate: Correlations HPO
There is one clinical trial.
Treatments for COVID-19 are urgently needed. Hydroxychloroquine (HCQ) is an antimalarial and immunomodulatory agent being repurposed for COVID-19 therapy based off in vitro data suggesting a possible antiviral effect. However, HCQ's effect on COVID-19 in human infection remains unknown. To fill this knowledge gap, we will enroll 626 adult patients hospitalized with laboratory-confirmed COVID-19 and randomize them 1:1 to a five-day course of HCQ or placebo. Notable exclusion criteria include ICU admission or ventilation on enrollment, prior therapy with HCQ, and baseline prolonged qTC. Our primary endpoint is a severe disease progression composite outcome (death, ICU admission, mechanical ventilation, ECMO, , and/or vasopressor requirement) at the 14-day post-treatment evaluation. Notable secondary clinical outcomes include 30-day mortality, hospital length of stay, noninvasive ventilator support, and cytokine release syndrome (CRS) grading scale. Secondary exploratory objectives will examine SARS-CoV-2 viral eradication at the EOT, changes in COVID-19 putative prognostic markers and cytokine levels, and titers of anti-SARS-CoV-2 antibodies. This randomized trial will determine if HCQ is effective as treatment in hospitalized non-ICU patients with COVID-19.
Description: Including any of the following: mortality, ICU admission, invasive mechanical ventilation, ECMO, and/or hypotension requiring vasopressor support by the 14-day post-treatment evaluation (PTE)
Measure: Severe disease progression composite outcome Time: 14 daysDescription: Events = mortality, ICU admission, invasive mechanical ventilation, ECMO, and/or hypotension requiring vasopressor support
Measure: Cumulative incidence of events Time: 30 daysDescription: LOS is defined as the interval (in days) that the patient was admitted to a non-rehabilitation floor, categorized as short (<7 days), moderate (7-10 days), or extended (>10 days)
Measure: Hospital length of stay Time: 30 daysDescription: Defined as number of days with temperature >100.4 degrees Fahrenheit.
Measure: Days of fever Time: 14 daysDescription: Defined as days the patient is placed on non-invasive ventilator support (CPAP or BiPAP), excluding routine CPAP use for sleep apnea.
Measure: Days of non-invasive ventilator use Time: 14 daysDescription: Defined as the number of days the subject was on a non-rebreather mask.
Measure: Days of non-rebreather mask oxygen supplementation Time: 14 daysDescription: Grade 1 (mild) = able to be managed with nonparenteral supportive care, Grade 2 (moderate) = at least one of the following present (hospitalization needed for management of CRS-related symptoms, parenteral nutrition or supportive care required, signs of moderate/severe organ dysfunction), Grade 3 (severe) = hospitalization needed for management of at least one of the following (hypotension, hypoxia, organ dysfunction, coagulopathy), Grade 4 (life-threatening) = at least one of the following present (hypotension requiring high-dose vasopressors, hypoxia requiring mechanical ventilation).
Measure: Score on Cytokine Release Syndrome (CRS) Grading Scale Time: Day 1Description: Grade 1 (mild) = able to be managed with nonparenteral supportive care, Grade 2 (moderate) = at least one of the following present (hospitalization needed for management of CRS-related symptoms, parenteral nutrition or supportive care required, signs of moderate/severe organ dysfunction), Grade 3 (severe) = hospitalization needed for management of at least one of the following (hypotension, hypoxia, organ dysfunction, coagulopathy), Grade 4 (life-threatening) = at least one of the following present (hypotension requiring high-dose vasopressors, hypoxia requiring mechanical ventilation).
Measure: Score on Cytokine Release Syndrome (CRS) Grading Scale Time: Day 6Description: The scale is as follows: 1) Death; 2) Hospitalized, on invasive mechanical ventilation or ECMO; 3) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4) Hospitalized, requiring supplemental oxygen; 5) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 6) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 7) Not hospitalized, limitation on activities and/or requiring home oxygen; 8) Not hospitalized, no limitations on activities.
Measure: Percentage of subjects reporting each severity score on 8 point ordinal scale Day 1 and EOT (End of Treatment - Day 6) Time: 6 daysDescription: (≥470 milliseconds in men; ≥480 milliseconds in women) on electrocardiogram at EOT (Day 6)
Measure: Percentage of subjects with qTC prolongation at EOT Time: 6 DaysDescription: Individual component of severe disease progression composite endpoint evaluated
Measure: Cumulative Incidence of mortality Time: 30 daysDescription: Individual component of severe disease progression composite endpoint evaluated
Measure: Cumulative Incidence of ICU admission Time: 30 DaysDescription: Individual component of severe disease progression composite endpoint evaluated
Measure: Cumulative Incidence of Invasive mechanical ventilation Time: 30 DaysDescription: Individual component of severe disease progression composite endpoint evaluated
Measure: Cumulative Incidence of ECMO Time: 30 DaysDescription: Individual component of severe disease progression composite endpoint evaluated
Measure: Cumulative Incidence of hypotension requiring vasopressor support Time: 30 DaysDescription: Laboratory endpoint, measured by RT-PCR
Measure: SARS-CoV-2 viral eradication from nasopharyngeal specimens at EOT Time: 6 daysDescription: Biochemistry lab-work will be completed to obtain ALT levels (if not obtained as part of routine clinical care, the research team will order for clinical lab to add onto remnant specimens, if available).
Measure: Change in Alanine Aminotransferase (ALT) levels Time: Baseline, 6 daysDescription: Biochemistry lab-work will be completed to obtain AST levels (if not obtained as part of routine clinical care, the research team will order for clinical lab to add onto remnant specimens, if available).
Measure: Change in Aspartate Aminotransferase (AST) levels Time: Baseline, 6 daysDescription: Biochemistry lab-work will be completed to obtain Creatinine levels (if not obtained as part of routine clinical care, the research team will order for clinical lab to add onto remnant specimens, if available).
Measure: Change in Creatinine levels Time: Baseline, 6 daysDescription: Biochemistry lab-work will be completed to obtain Glucose levels (if not obtained as part of routine clinical care, the research team will order for clinical lab to add onto remnant specimens, if available).
Measure: Change in Glucose levels Time: Baseline, 6 daysDescription: Hematology lab-work will be completed to obtain WBC count (if not obtained as part of routine clinical care, the research team will order for clinical lab to add onto remnant specimens, if available).
Measure: Change in White Blood Cell (WBC) count Time: Baseline, 6 daysDescription: Hematology lab-work will be completed to obtain hemoglobin levels (if not obtained as part of routine clinical care, the research team will order for clinical lab to add onto remnant specimens, if available).
Measure: Change in Hemoglobin levels Time: Baseline, 6 daysDescription: Hematology lab-work will be completed to obtain platelet count (if not obtained as part of routine clinical care, the research team will order for clinical lab to add onto remnant specimens, if available).
Measure: Change in Platelet count Time: Baseline, 6 daysDescription: Biochemistry lab-work will be completed to obtain bilirubin levels (if not obtained as part of routine clinical care, the research team will order for clinical lab to add onto remnant specimens, if available).
Measure: Change in total bilirubin levels Time: Baseline, 6 daysDescription: Biochemistry lab-work will be completed to obtain LDH levels (if not obtained as part of routine clinical care, the research team will order for clinical lab to add onto remnant specimens, if available).
Measure: Change in Lactate Dehydrogenase (LDH) levels Time: Baseline, 6 daysDescription: Biochemistry lab-work will be completed to obtain CRP levels (if not obtained as part of routine clinical care, the research team will order for clinical lab to add onto remnant specimens, if available).
Measure: Change in C-Reactive Protein (CRP) levels Time: Baseline, 6 daysDescription: Biochemistry lab-work will be completed to obtain IL-6 levels (if not obtained as part of routine clinical care, the research team will order for clinical lab to add onto remnant specimens, if available).
Measure: Change in Interleukin 6 (IL-6) levels Time: Baseline, 6 daysDescription: A titer is the concentration of an antibody. ELISA (enzyme-linked immunosorbent assay) is a plate-based assay technique designed for detecting and quantifying antibodies. Titers will be measured by ELISA.
Measure: Titers of serum anti-SARS-CoV-2 antibodies Time: 8 weeksDescription: Real-time polymerase chain reaction (real-time PCR), also known as quantitative polymerase chain reaction (qPCR) (a laboratory technique of molecular biology) will be used to measure antigen-specific T cell count.
Measure: Antigen-specific T cell count Time: 8 weeksAlphabetical 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