Covid 19 Research using Clinical Trials (Home Page)
Report for D000208: Acute Disease NIH
(Synonyms: Acute Disease)
Developed by Shray Alag
Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation
Correlated Drug Terms (8)
| Name (Synonyms) | Correlation | |
|---|---|---|
| drug35 | 2D Telemedicine Wiki | 1.00 |
| drug44 | 3D Telemedicine Wiki | 0.82 |
| drug2478 | SAMBA II (Diagnostic for the Real World) Wiki | 0.71 |
| drug600 | Cambridge Validated Viral Detection Method Wiki | 0.71 |
| drug2361 | Radiological Detection Wiki | 0.71 |
| drug1362 | ION-827359 Wiki | 0.71 |
| drug2274 | Public Health England Gold Standard Wiki | 0.71 |
| drug2122 | Placebo Wiki | 0.04 |
Correlated MeSH Terms (7)
| Name (Synonyms) | Correlation | |
|---|---|---|
| D029481 | Bronchitis, Chronic NIH | 0.71 |
| D001991 | Bronchitis NIH | 0.71 |
| D029424 | Pulmonary Disease, Chronic Obstructive NIH | 0.25 |
| D008173 | Lung Diseases, Obstructive NIH | 0.24 |
| D008171 | Lung Diseases, NIH | 0.17 |
| 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 | 0.25 |
| HP:0006536 | Pulmonary obstruction HPO | 0.24 |
| HP:0002088 | Abnormal lung morphology HPO | 0.17 |
There are 2 clinical trials
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 Acute Disease Coronavirus Respiratory Viral Infection Diagnostic Test: SAMBA II (Diagnostic for the Real World) Diagnostic Test: Public Health England Gold Standard Diagnostic Test: Cambridge Validated Viral Detection Method Diagnostic Test: Radiological Detection MeSH:Coronavirus Infections Acute Disease Virus Diseases
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 daysSecondary Outcomes
Description: Evaluating the participant acceptability of the SAMBA swab intervention using a participant reported discomfort scale
Measure: Patient acceptability Time: 28 daysDescription: Time to positive IgM/IgG test positivity
Measure: Immune Response Positivity Time: 40 days2 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 Chronic Bronchitis Chronic Obstructive Pulmonary Disease Drug: ION-827359 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
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 14Secondary 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 14Description: 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 14Measure: 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