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D000208: Acute Disease

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 (10)


Name (Synonyms) Correlation
drug1600 ION-827359 Wiki 0.71
drug32 25-OH cholecalciferol Wiki 0.71
drug2699 Public Health England Gold Standard Wiki 0.71
Name (Synonyms) Correlation
drug3756 Zinc gluconate Wiki 0.71
drug2938 SAMBA II (Diagnostic for the Real World) Wiki 0.71
drug714 Cambridge Validated Viral Detection Method Wiki 0.71
drug2797 Radiological Detection Wiki 0.71
drug38 2D Telemedicine Wiki 0.50
drug46 3D Telemedicine Wiki 0.41
drug2505 Placebo Wiki 0.03

Correlated MeSH Terms (7)


Name (Synonyms) Correlation
D029481 Bronchitis, Chronic NIH 0.71
D001991 Bronchitis NIH 0.71
D029424 Pulmonary Disease, Chronic Obstructive NIH 0.20
Name (Synonyms) Correlation
D008173 Lung Diseases, Obstructive NIH 0.20
D008171 Lung Diseases, NIH 0.15
D014777 Virus Diseases NIH 0.08
D018352 Coronavirus Infections NIH 0.03

Correlated HPO Terms (5)


Name (Synonyms) Correlation
HP:0012387 Bronchitis HPO 0.71
HP:0004469 Chronic bronchitis HPO 0.71
HP:0006510 Chronic pulmonary obstruction HPO 0.24
Name (Synonyms) Correlation
HP:0006536 Pulmonary obstruction HPO 0.22
HP:0002088 Abnormal lung morphology HPO 0.16

Clinical Trials

Navigate: Correlations   HPO

There are 2 clinical trials


1 Evaluation of Novel Diagnostic Tests for 2019-nCOV

COVID-19 (also known as Coronavirus) originated in the Wuhan China and has since spread to at least 159 countries around the world. It was declared a pandemic by the World health organisation on the 11th of March 2020. The cases in the United Kingdom continue to increase exponentially with up to 5 683 people diagnosed as on the 22nd of March 2020. It is estimated that 1 in 5 people diagnosed will require hospital admission and 1 in 20 intensive care treatment. By developing and improving diagnostic testing, we can accurately diagnose infected cases to triage appropriate treatments, identify individuals for quarantine in order to prevent transmission and obtain information regarding patient's immune systems. At present, the diagnostic test is a highly specific method of genetic amplification called 'Reverse Transcription - Polymerase Chain Reaction' or RT-PCR, which allows detection of very small amounts of genetic mutations caused by the COVID-19 virus. However, this method must be completed in highly specialised facilities, which are few and far between, increasing time to diagnosis (currently 48-72 hours), increasing exposure to non-infected individuals, and overburdening the analysing facilities. The ideal solution is a point of care (POC) test that can give results immediately. This study aims to harness the point of care technology of the SAMBA II device (Diagnostics for the Real World Ltd.), which is a CE-marked device that has been used with success in the identification of Human Immunodeficiency Virus (HIV), by amplifying genetic material without the need to increase and decrease temperatures during the amplification process. In the COVIDx study, 200 patients meeting the Public Health England's (PHE) inpatient definition of having suspected COVID-19 will be approached, consented and a sample from throat and nasal swab (combined) or tracheal fluid taken and tested using the SAMBA II method. A combination of the standard PHE RT-PCR and an additional validated laboratory PCR technique will be used as a control in line with standard clinical practice. Patients will undergo an additional serum tests on existing samples as made available after routine clinical assessments to monitor antibody response. Patients will be followed for clinical outcomes at 28 days post-admission.

NCT04326387
Conditions
  1. Acute Disease
  2. Coronavirus
  3. Respiratory Viral Infection
Interventions
  1. Diagnostic Test: SAMBA II (Diagnostic for the Real World)
  2. Diagnostic Test: Public Health England Gold Standard
  3. Diagnostic Test: Cambridge Validated Viral Detection Method
  4. Diagnostic Test: Radiological Detection
MeSH:Coronavirus Infections Virus Diseases Acute Disease

Primary Outcomes

Description: Measuring the diagnostic accuracy of the SAMBA II POC-sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV) tested against a dual composite reference standard

Measure: SAMBA COVID-19 POC PCR Test

Time: 28 days

Secondary Outcomes

Description: Evaluating the participant acceptability of the SAMBA swab intervention using a participant reported discomfort scale

Measure: Patient acceptability

Time: 28 days

Description: Time to positive IgM/IgG test positivity

Measure: Immune Response Positivity

Time: 40 days
2 A Double-Blind, Placebo-Controlled, Phase 2a Study to Assess the Safety, Tolerability, and Efficacy of ION-827359 in Patients With Mild to Moderate COPD With Chronic Bronchitis

The purpose of this study is to evaluate the effect of ION-827359 on forced expiratory volume in 1 second (FEV1) in patients with mild to moderate COPD with CB.

NCT04441788
Conditions
  1. Chronic Bronchitis
  2. Chronic Obstructive Pulmonary Disease
Interventions
  1. Drug: ION-827359
  2. Drug: Placebo
MeSH:Lung Diseases Lung Diseases, Obstructive Pulmonary Disease, Chronic Obstructive Bronchitis Bronchitis, Chronic Acute Disease
HPO:Abnormal lung morphology Bronchitis Chronic bronchitis Chronic pulmonary obstruction Pulmonary obstruction

Primary Outcomes

Measure: Change From Baseline to the Primary Time Point in Forced Expiratory Volume in 1 Second (FEV1) Compared to Placebo

Time: From Baseline up to average of Weeks 13 and 14

Secondary Outcomes

Description: The EXACT (E-RS) scale is a participant-reported outcome (PRO) designed to measure the symptoms of participants with COPD. The E-RS utilizes 11 respiratory symptom items from the existing and validated 14-item EXACT, which measures symptoms of exacerbation. The E-RS total score quantifies respiratory symptom severity, and 3 domains assess breathlessness, cough and sputum, and chest symptoms. The E-RS will be collected on the daily e-diary, which will include all 14 items from the EXACT questionnaire.

Measure: Change From Baseline in the EXACT Respiratory Symptoms (E-RS) Daily Symptom Diary to the Primary Time Point

Time: One week prior to first dose through one week after the last dose.

Description: The CAT is an eight-item questionnaire that will be completed by the participant and is designed to quantify the impact of COPD symptoms on the health status of participants. The CAT provides a score of 0-40 to indicate the impact of the disease.

Measure: Change From Baseline in the COPD Assessment Test (CAT) to the Week 14 Time Point

Time: From Baseline up to Week 14

Description: The SGRQ is a participant completed, a disease-specific instrument designed to measure impact on overall health, daily life, and perceived well-being in participants with obstructive airway disease. Scores of the SGRQ-C range from 0 to 100, with higher scores indicating more limitations.

Measure: Change From Baseline in St. George's Respiratory Questionnaire (SGRQ) to the Week 14 Time Point

Time: From Baseline up to Week 14

Measure: Change from Baseline in Post-Bronchodilator FEV1

Time: From Baseline up to average of Weeks 13 and 14

Measure: Cmax: Maximum Observed Plasma Concentration for ION-827359

Time: Up to Week 24

Measure: Tmax: Time to Reach the Maximum Plasma Concentration for ION-827359

Time: Up to Week 24

Measure: AUC[0-t]: Area Under the Plasma Concentration-Time Curve from Time Zero to t for ION-827359

Time: Up to Week 24

Measure: Incidence of Participants With at Least One Treatment-Emergent Adverse Event (TEAE), Graded by Severity

Time: Up to Week 24

Measure: Number of Participants With Abnormal Laboratory Values

Time: Up to Week 24

Measure: Number of Participants With Abnormal Vital Signs Measurements

Time: Up to Week 24

HPO Nodes


HPO

Alphabetical listing of all HPO terms. Navigate: Correlations   Clinical Trials


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.

Drug Reports   MeSH Reports   HPO Reports  

Interventions

4,180 reports on interventions/drugs

MeSH

691 reports on MeSH terms

HPO

263 reports on HPO terms

All Terms

Alphabetical index of all Terms

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Python example via Google Colab Notebook