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Name (Synonyms) | Correlation | |
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drug3255 | Racial/Ethnic Frame Wiki | 0.45 |
drug2571 | No Messaging Wiki | 0.45 |
drug422 | Azithromycin (Azithro) Wiki | 0.45 |
Name (Synonyms) | Correlation | |
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drug1376 | Emphasis of Academic Researchers Involvement Wiki | 0.45 |
drug77 | A $10 Survey Incentive Wiki | 0.45 |
drug1087 | Cost-Benefit Frame Wiki | 0.45 |
drug78 | A $20 Survey Incentive Wiki | 0.45 |
drug3517 | Saliva sample Wiki | 0.45 |
drug2961 | Placebo for Hydroxychloroquine Wiki | 0.45 |
drug2802 | Pacebo: Calcium citrate Wiki | 0.45 |
drug1377 | Emphasis of Government Involvement Wiki | 0.45 |
drug2960 | Placebo for Azithromycin Wiki | 0.45 |
drug1289 | Duty Frame Wiki | 0.45 |
drug1168 | Data record Wiki | 0.32 |
drug1160 | Data collection Wiki | 0.22 |
drug2512 | Nasopharyngeal swab Wiki | 0.16 |
drug2981 | Placebo oral tablet Wiki | 0.08 |
Name (Synonyms) | Correlation | |
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D000230 | Adenocarcinoma NIH | 0.45 |
D003141 | Communicable Diseases NIH | 0.13 |
D007239 | Infection NIH | 0.08 |
Name (Synonyms) | Correlation |
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Navigate: Correlations HPO
There are 5 clinical trials
Assessment of the Efficacy and Safety of Hydroxychloroquine (HCQ) Administered as a Prophylaxis for Health Professionals Exposed to COVID19 and Working in Medical Intensive Care Units, in Tunisia. Multicentric, Randomized Comparative Study
Description: Clinical Examination: Symptomatic COVID(+) infection rate (from randomization to the onset of signs suggestive of Covid19 infection or to the end of the study at 60 days) The rate of COVID19 infections is defined by the occurrence of the clinical signs below: Cough Dyspnea Fever Myalgia Arthralgia Rhinorrhea Anosmia Asthenia, fatigability Confirmation of the above symptoms and COVID(+) PCR infection during the 60days treatment period. Biological Examination : Measurement of viral load Ion, liver, kidney, haematological assessment Electrical Examination: ECG
Measure: Symptomatic COVID(+) infection rate Time: 60 daysOff label study to evaluate the efficacy of HCQ for pre-exposure prophylaxis (PrEP) to prevent severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection. 350 participants will be assigned to the group that takes HCQ or the group that opts to not take the study medication. Participants will be NYULH HCW at high risk for occupational exposure to SARS-CoV-2. Study timepoints will include screening/enrollment, 30 day, 60 day, and 90 day visits. Questionnaires, and DBS will be collected in all timepoints.
Description: Antibody titers will be measured to determine seroconversion, a binomial endpoint defined by a four-fold increase in antibody titers compared to baseline.
Measure: Frequency of seroconversion to SARS-CoV-2 Time: baseline, 30 days, 60 days, 90 daysDescription: To characterize whether high-risk HCW who seroconvert to SARS-CoV-2 have asymptomatic infection or report symptoms of COVID-19 in the 4 weeks preceding seroconversion (assessed by symptom questionnaire)
Measure: Incidence of COVID-19 symptoms in the 4 weeks preceding seroconversion Time: baseline, 30 days, 60 days, 90 daysDescription: Data collection from medical chart review
Measure: Hospital admission rate Time: baseline, 30 days, 60 days, 90 daysDescription: Data collection from medical chart review
Measure: ICU admission rate Time: baseline, 30 days, 60 days, 90 daysDescription: Data collection from medical chart review
Measure: Mortality rate Time: baseline, 30 days, 60 days, 90 daysDescription: To assess the tolerability of hydroxychloroquine SARS-CoV-2 PrEP in this population
Measure: Incidents of AEs or SAEs related to HCQ upon study termination time Time: 30 days, 60 days, 90 daysDescription: Measured by Serology test, to characterize whether pre-existing of non-SARS-CoV-2 coronavirus antibodies are capable of causing antibody dependent enhancement of a pseudotyped SARS-CoV-2
Measure: Percentage of cells infected in the laboratory using a standardized dose of pseudotyped SARS-CoV-2 in the presence or absence of blood containing non-SARS-CoV-2 coronaviruses antibodies Time: baseline, 30 days, 60 days, 90 daysDescription: To determine whether hydroxychloroquine reduces time lost from work
Measure: Days away from work Time: baseline, 30 days, 60 days, 90 daysDescription: To assess the compliance of hydroxychloroquine PrEP
Measure: Frequency of missing HCQ dose Time: baseline, 30 days, 60 days, 90 daysThe purpose of this study is to evaluate the efficacy of hydroxychloroquine (HCQ) and azithromycin (Azithro) to prevent hospitalization or death in symptomatic adult outpatients with COVID-19 caused by SARS-CoV-2 infection.
Description: Hospitalization is defined as requiring at least 24 hours of acute care in a hospital or similar acute care facility, including Emergency Rooms or temporary facilities instituted to address needs during the COVID-19 pandemic. Evaluation at a hospital or similar facility with less than 24 hours of acute care is not considered a hospitalization.
Measure: Proportion of participants who died from any cause or were hospitalized Time: Measured during the 20-day period from and including the day of the first (confirmed) dose of study treatmentDescription: Hospitalization is defined as requiring at least 24 hours of acute care in a hospital or similar acute care facility, including Emergency Rooms or temporary facilities instituted to address needs during the COVID-19 pandemic. Evaluation at a hospital or similar facility with less than 24 hours of acute care is not considered a hospitalization.
Measure: Proportion of participants who died from any cause or were hospitalized through the end of follow-up Time: Measured during the 20-day period from and including the day of the first (confirmed) dose of study treatmentDescription: Defined as the last day in the participant's daily diary card on which a temperature greater than 100.4°F was recorded or a potentially antipyretic drug, such as acetaminophen or ibuprofen, was taken.
Measure: Duration of fever Time: Measured through Day 20Description: Defined as the last day in the participant's daily diary card on which a moderate or worse symptom was recorded
Measure: Duration of symptoms associated with COVID-19 disease Time: Measured through Day 20Description: Defined as the sum of scores for the targeted symptoms (defined in the protocol) in the participant's daily diary record (each individual symptom is scored from 0 to 3).
Measure: Participant-specific area under the curve (AUC) of the symptom score associated with COVID-19 disease over time Time: Measured through Day 20Treatments 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 weeksTo date, no treatment has demonstrated clinical efficacy on COVID 19. However, several therapeutic strategies are being considered and are being evaluated in numerous clinical trials. Among these strategies, the use of hydroxychloroquine (HCQ) seems promising. There is very little information on how to precisely administer hydroxychloroquine to patients infected with SARS-CoV-2 in intensive care, which may be responsible for side effects, some of which are potentially serious. In addition, this treatment has a long half-life which increases the risk of accumulation and therefore toxicity. In view of the lack of knowledge on the pharmacokinetic / pharmacodynamic properties of hydroxychloroquine in intensive care patients infected with SARS-CoV-2, we propose to perform a prospective multicenter cohort study in order to collect the biological data necessary for this evaluation.
Description: measured blood concentration by blood sample results.
Measure: Pharmacokinetics of hydroxychloroquine (HCQ) Time: Up to day 21Description: measured by blood sample and electrocardiogram results.
Measure: Correlation between hydroxychloroquine (HCQ) concentration and cardiac toxicity (QT interval) Time: Up to day 21Description: measured by blood sample
Measure: Correlation between Pharmacokinetic (concentration) and pharmacodynamic (viral load) of hydroxychloroquine (HCQ) Time: Day 1, Day 3, Day 5, Day 7, Day 14, Day 21Description: Pharmacokinetic (area under the curve) analysis will be performed using a population approach with a non-linear mixed effects model.
Measure: Pharmacokinetic model Time: Up to day 21Alphabetical 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