Covid 19 Research using Clinical Trials (Home Page)
HP:0012393: AllergyHPO
Developed by Shray Alag
Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation
Correlated Drug Terms (7)
| Name (Synonyms) | Correlation | |
|---|---|---|
| drug2481 | Tezepelumab Wiki | 0.58 |
| drug2945 | performance evaluation study of RealDetect RT-PCR Kit for COVID-19 detection Wiki | 0.58 |
| drug1347 | Liquid Peanut Extract Wiki | 0.58 |
| drug1832 | Placebo Glycerin SLIT Wiki | 0.58 |
| drug520 | Capillary and salivary sampling Wiki | 0.58 |
| drug2441 | Taking blood samples (capillary and venous), saliva sampling and nasopharyngeal sampling. Wiki | 0.41 |
| drug1822 | Placebo Wiki | 0.03 |
Correlated MeSH Terms (12)
| Name (Synonyms) | Correlation | |
|---|---|---|
| D006967 | Hypersensitivity, NIH | 1.00 |
| D001982 | Bronchial Diseases NIH | 0.58 |
| D005512 | Food Hypersensitivity NIH | 0.58 |
| D006969 | Hypersensitivity, Immediate NIH | 0.58 |
| D012130 | Respiratory Hypersensitivity NIH | 0.58 |
| D021183 | Peanut Hypersensitivity NIH | 0.41 |
| D001249 | Asthma NIH | 0.29 |
| D007154 | Immune System Diseases NIH | 0.24 |
| D008173 | Lung Diseases, Obstructive NIH | 0.19 |
| D008171 | Lung Diseases, NIH | 0.15 |
| D012140 | Respiratory Tract Diseases NIH | 0.14 |
| D007249 | Inflammation NIH | 0.12 |
Correlated HPO Terms (3)
| Name (Synonyms) | Correlation | |
|---|---|---|
| HP:0002099 | Asthma HPO | 0.29 |
| HP:0006536 | Pulmonary obstruction HPO | 0.19 |
| HP:0002088 | Abnormal lung morphology HPO | 0.15 |
There are 3 clinical trials
Clinical Trials
1 Peanut Sublingual Immunotherapy Induction of Clinical Tolerance of Newly Diagnosed Peanut Allergic 12 to 48 Month Old Children
Primary Objective: To determine if 36 months of peanut SLIT as an early intervention in subjects ages 1 to 4 years induces clinical desensitization. The primary outcome of this objective will be a statistically significant difference in challenge scores between the treatment group versus the placebo group during DBPCFC (Double blind placebo controlled food challenge) performed after 36 months of peanut SLIT (desensitization). Challenge scores are measured by the amount of peanut protein participants are able to ingest successfully without symptoms of an allergic reaction. [Time Frame: Baseline, 36 months] Secondary Objectives: A secondary outcome of this objective will be a statistically significant difference in the challenge score of the treatment group versus the placebo group during the DBPCFC performed 3 months after discontinuing therapy (tolerance). To examine the change in immune parameters associated with peanut SLIT and the development of clinical tolerance. Through this objective, the investigators will seek to understand the molecular processes by which SLIT affects the immune system through evaluation of immune mechanisms in relationship to clinical findings of desensitization and tolerance. The investigators will delineate the impact of peanut SLIT on the subsequent cellular and humoral responses to peanut protein: 1) peanut specific IgE, IgG, and IgG4 response, 2) peanut specific basophil activation, 3) mast cell responses through skin prick testing, and 4) specific T-cell cytokine responses and T regulatory cell (TReg) activation. The investigators anticipate that the effect of peanut SLIT will occur by induction of TRegs, conversion of T cells from an allergic (TH2) to a non-allergic (TH1) lymphocyte response (measured by cytokines, antibody levels, and skin prick test size), a change in peanut-specific basophil activation, or through a combination of the above. [Time Frame: Baseline, 39 months]
NCT02304991 Peanut Hypersensitivity Food Allergy Food Hypersensitivity Peanut Allergy Drug: Liquid Peanut Extract Drug: Placebo Glycerin SLIT MeSH:Hypersensitivity Food Hypersensitivity Peanut Hypersensitivity
HPO:Allergy
Primary Outcomes
Description: The primary outcome is to detect a statistically significant difference in reaction thresholds to peanut between the treatment group versus the placebo group during DBPCFC (Double blind placebo controlled food challenge) performed after 36 months of peanut SLIT (desensitization). Challenge scores are measured by the amount of peanut protein participants are able to ingest successfully without symptoms of an allergic reaction. The difference is measured through utilization of an extreme value hazard function.
Measure: Percentage of participants desensitized to peanut using peanut SLIT as an early intervention in subjects ages 1 to 4 years Time: From baseline to 36 months
Secondary Outcomes
Description: Detect a statistically significant difference between reaction thresholds to peanut of the treatment group versus the placebo group during the DBPCFC performed 3 months after discontinuing therapy (tolerance).
Measure: Statistically significant difference in the challenge scores of the treatment group versus the placebo group during the DBPCFC performed 3 months after discontinuing therapy (tolerance) Time: From baseline to 39 months
Description: To examine the change in immune parameters associated with peanut SLIT and the development of clinical tolerance. Through this objective, the investigators will seek to understand the molecular processes by which SLIT affects the immune system through evaluation of immune mechanisms in relationship to clinical findings of desensitization and tolerance. The investigators will delineate the impact of peanut SLIT on the subsequent cellular and humoral responses to peanut protein. Detection of statistically significant differences will be measured through a two-sample t-test.
Measure: The change in peanut specific IgE levels Time: From baseline to 39 months
Description: To examine the change in immune parameters associated with peanut SLIT and the development of clinical tolerance. Through this objective, the investigators will seek to understand the molecular processes by which SLIT affects the immune system through evaluation of immune mechanisms in relationship to clinical findings of desensitization and tolerance. The investigators will delineate the impact of peanut SLIT on the subsequent cellular and humoral responses to peanut protein. Detection of statistically significant differences will be measured through a two-sample t-test.
Measure: The change in peanut specific IgG levels Time: From baseline to 39 months
Description: To examine the change in immune parameters associated with peanut SLIT and the development of clinical tolerance. Through this objective, the investigators will seek to understand the molecular processes by which SLIT affects the immune system through evaluation of immune mechanisms in relationship to clinical findings of desensitization and tolerance. The investigators will delineate the impact of peanut SLIT on the subsequent cellular and humoral responses to peanut protein. Detection of statistically significant differences will be measured through a two-sample t-test.
Measure: The change in peanut specific IgG4 levels Time: From baseline to 39 months
Description: To examine the change in immune parameters associated with peanut SLIT and the development of clinical tolerance. Through this objective, the investigators will seek to understand the molecular processes by which SLIT affects the immune system through evaluation of immune mechanisms in relationship to clinical findings of desensitization and tolerance. The investigators will delineate the impact of peanut SLIT on the subsequent cellular and humoral responses to peanut protein. Detection of statistically significant differences will be measured through a two-sample t-test.
Measure: The change in peanut specific basophil activation Time: From baseline to 39 months
Description: To examine the change in immune parameters associated with peanut SLIT and the development of clinical tolerance. Through this objective, the investigators will seek to understand the molecular processes by which SLIT affects the immune system through evaluation of immune mechanisms in relationship to clinical findings of desensitization and tolerance. The investigators will delineate the impact of peanut SLIT on the subsequent cellular and humoral responses to peanut protein. Detection of statistically significant differences will be measured through a two-sample t-test.
Measure: The change in responses of mast cell as measured by prick skin testing to peanut Time: From baseline to 39 months
Description: To examine the change in immune parameters associated with peanut SLIT and the development of clinical tolerance. Through this objective, the investigators will seek to understand the molecular processes by which SLIT affects the immune system through evaluation of immune mechanisms in relationship to clinical findings of desensitization and tolerance. The investigators will delineate the impact of peanut SLIT on the subsequent cellular and humoral responses to peanut protein. Detection of statistically significant differences will be measured through a two-sample t-test.
Measure: The change in specific T-cell cytokine responses Time: From baseline to 39 months
Description: To examine the change in immune parameters associated with peanut SLIT and the development of clinical tolerance. Through this objective, the investigators will seek to understand the molecular processes by which SLIT affects the immune system through evaluation of immune mechanisms in relationship to clinical findings of desensitization and tolerance. The investigators will delineate the impact of peanut SLIT on the subsequent cellular and humoral responses to peanut protein. Detection of statistically significant differences will be measured through a two-sample t-test.
Measure: The change in T regulatory cell activation Time: From baseline to 39 months
Description: Incidence of all serious adverse events during the study
Measure: Incidence of all serious adverse events during the study Time: From baseline to 39 months
2 A Phase 2, Randomized, Double-blind, Parallel Group, Placebo Controlled Study to Evaluate the Effect of Tezepelumab on Airway Inflammation in Adults With Inadequately Controlled Asthma on Inhaled Corticosteroids and at Least One Additional Asthma Controller (CASCADE)
Primary Outcomes
Description: The primary outcome is to detect a statistically significant difference in reaction thresholds to peanut between the treatment group versus the placebo group during DBPCFC (Double blind placebo controlled food challenge) performed after 36 months of peanut SLIT (desensitization). Challenge scores are measured by the amount of peanut protein participants are able to ingest successfully without symptoms of an allergic reaction. The difference is measured through utilization of an extreme value hazard function.
Measure: Percentage of participants desensitized to peanut using peanut SLIT as an early intervention in subjects ages 1 to 4 years Time: From baseline to 36 monthsSecondary Outcomes
Description: Detect a statistically significant difference between reaction thresholds to peanut of the treatment group versus the placebo group during the DBPCFC performed 3 months after discontinuing therapy (tolerance).
Measure: Statistically significant difference in the challenge scores of the treatment group versus the placebo group during the DBPCFC performed 3 months after discontinuing therapy (tolerance) Time: From baseline to 39 monthsDescription: To examine the change in immune parameters associated with peanut SLIT and the development of clinical tolerance. Through this objective, the investigators will seek to understand the molecular processes by which SLIT affects the immune system through evaluation of immune mechanisms in relationship to clinical findings of desensitization and tolerance. The investigators will delineate the impact of peanut SLIT on the subsequent cellular and humoral responses to peanut protein. Detection of statistically significant differences will be measured through a two-sample t-test.
Measure: The change in peanut specific IgE levels Time: From baseline to 39 monthsDescription: To examine the change in immune parameters associated with peanut SLIT and the development of clinical tolerance. Through this objective, the investigators will seek to understand the molecular processes by which SLIT affects the immune system through evaluation of immune mechanisms in relationship to clinical findings of desensitization and tolerance. The investigators will delineate the impact of peanut SLIT on the subsequent cellular and humoral responses to peanut protein. Detection of statistically significant differences will be measured through a two-sample t-test.
Measure: The change in peanut specific IgG levels Time: From baseline to 39 monthsDescription: To examine the change in immune parameters associated with peanut SLIT and the development of clinical tolerance. Through this objective, the investigators will seek to understand the molecular processes by which SLIT affects the immune system through evaluation of immune mechanisms in relationship to clinical findings of desensitization and tolerance. The investigators will delineate the impact of peanut SLIT on the subsequent cellular and humoral responses to peanut protein. Detection of statistically significant differences will be measured through a two-sample t-test.
Measure: The change in peanut specific IgG4 levels Time: From baseline to 39 monthsDescription: To examine the change in immune parameters associated with peanut SLIT and the development of clinical tolerance. Through this objective, the investigators will seek to understand the molecular processes by which SLIT affects the immune system through evaluation of immune mechanisms in relationship to clinical findings of desensitization and tolerance. The investigators will delineate the impact of peanut SLIT on the subsequent cellular and humoral responses to peanut protein. Detection of statistically significant differences will be measured through a two-sample t-test.
Measure: The change in peanut specific basophil activation Time: From baseline to 39 monthsDescription: To examine the change in immune parameters associated with peanut SLIT and the development of clinical tolerance. Through this objective, the investigators will seek to understand the molecular processes by which SLIT affects the immune system through evaluation of immune mechanisms in relationship to clinical findings of desensitization and tolerance. The investigators will delineate the impact of peanut SLIT on the subsequent cellular and humoral responses to peanut protein. Detection of statistically significant differences will be measured through a two-sample t-test.
Measure: The change in responses of mast cell as measured by prick skin testing to peanut Time: From baseline to 39 monthsDescription: To examine the change in immune parameters associated with peanut SLIT and the development of clinical tolerance. Through this objective, the investigators will seek to understand the molecular processes by which SLIT affects the immune system through evaluation of immune mechanisms in relationship to clinical findings of desensitization and tolerance. The investigators will delineate the impact of peanut SLIT on the subsequent cellular and humoral responses to peanut protein. Detection of statistically significant differences will be measured through a two-sample t-test.
Measure: The change in specific T-cell cytokine responses Time: From baseline to 39 monthsDescription: To examine the change in immune parameters associated with peanut SLIT and the development of clinical tolerance. Through this objective, the investigators will seek to understand the molecular processes by which SLIT affects the immune system through evaluation of immune mechanisms in relationship to clinical findings of desensitization and tolerance. The investigators will delineate the impact of peanut SLIT on the subsequent cellular and humoral responses to peanut protein. Detection of statistically significant differences will be measured through a two-sample t-test.
Measure: The change in T regulatory cell activation Time: From baseline to 39 monthsDescription: Incidence of all serious adverse events during the study
Measure: Incidence of all serious adverse events during the study Time: From baseline to 39 monthsA phase 2, multicentre, randomized, double-blind, placebo-controlled, parallel group study to evaluate the effect of tezepelumab on airway inflammation in adults with inadequately controlled asthma.
NCT03688074 Asthma Bronchial Diseases Respiratory Tract Diseases Lung Diseases, Obstructive Lung Diseases Respiratory Hypersensitivity Hypersensitivity, Immediate Hypersensitivity Immune System Diseases Biological: Tezepelumab Other: Placebo MeSH:Asthma Lung Diseases Lung Diseases, Obstructive Bronchial Diseases Respiratory Hypersensitivity Hypersensitivity Hypersensitivity, Immediate Inflammation Respiratory Tract Diseases Immune System Diseases
HPO:Abnormal lung morphology Allergy Asthma Pulmonary obstruction
Primary Outcomes
Description: The change from baseline in number of airway submucosal inflammatory cells/mm2 of bronchoscopic biopsies.
Measure: The change from baseline in number of airway submucosal inflammatory cells/mm2 of bronchoscopic biopsies. Time: Baseline, End of Treatment (EoT). The EoT will be performed at Week 28 for the majority of subjects but may be performed at later timepoints for some subjects (Week 32, etc.) due to up to 6 additional doses added during the Covid-19 pandemic.
Secondary Outcomes
Description: The change in reticular basement membrane (RBM) thickness from baseline, determined by microscopic evaluation of bronchoscopic biopsies
Measure: The change in reticular basement membrane (RBM) thickness from baseline, determined by microscopic evaluation of bronchoscopic biopsies Time: Baseline, End of Treatment (EoT). The EoT will be performed at Week 28 for the majority of subjects but may be performed at later timepoints for some subjects (Week 32, etc.) due to up to 6 additional doses added during the Covid-19 pandemic.
Description: The change in % airway epithelial integrity from baseline determined by microscopic evaluation of bronchoscopic biopsies
Measure: The change in % airway epithelial integrity from baseline determined by microscopic evaluation of bronchoscopic biopsies Time: Baseline, End of Treatment (EoT). The EoT will be performed at Week 28 for the majority of subjects but may be performed at later timepoints for some subjects (Week 32, etc.) due to up to 6 additional doses added during the Covid-19 pandemic.
Description: The change in number of airway submucosal inflammatory cells per mm2 from baseline, across the spectrum of T2 status, determined by microscopic evaluation of bronchoscopic biopsies
Measure: The change in number of airway submucosal inflammatory cells per mm2 from baseline, across the spectrum of T2 status, determined by microscopic evaluation of bronchoscopic biopsies Time: Baseline, End of Treatment (EoT). The EoT will be performed at Week 28 for the majority of subjects but may be performed at later timepoints for some subjects (Week 32, etc.) due to up to 6 additional doses added during the Covid-19 pandemic.
3 Performance Evaluation of RealDetect™ COVID-19 RT-PCR Kit for the Detection of SARS-CoV-2 Virus
Primary Outcomes
Description: The change from baseline in number of airway submucosal inflammatory cells/mm2 of bronchoscopic biopsies.
Measure: The change from baseline in number of airway submucosal inflammatory cells/mm2 of bronchoscopic biopsies. Time: Baseline, End of Treatment (EoT). The EoT will be performed at Week 28 for the majority of subjects but may be performed at later timepoints for some subjects (Week 32, etc.) due to up to 6 additional doses added during the Covid-19 pandemic.Secondary Outcomes
Description: The change in reticular basement membrane (RBM) thickness from baseline, determined by microscopic evaluation of bronchoscopic biopsies
Measure: The change in reticular basement membrane (RBM) thickness from baseline, determined by microscopic evaluation of bronchoscopic biopsies Time: Baseline, End of Treatment (EoT). The EoT will be performed at Week 28 for the majority of subjects but may be performed at later timepoints for some subjects (Week 32, etc.) due to up to 6 additional doses added during the Covid-19 pandemic.Description: The change in % airway epithelial integrity from baseline determined by microscopic evaluation of bronchoscopic biopsies
Measure: The change in % airway epithelial integrity from baseline determined by microscopic evaluation of bronchoscopic biopsies Time: Baseline, End of Treatment (EoT). The EoT will be performed at Week 28 for the majority of subjects but may be performed at later timepoints for some subjects (Week 32, etc.) due to up to 6 additional doses added during the Covid-19 pandemic.Description: The change in number of airway submucosal inflammatory cells per mm2 from baseline, across the spectrum of T2 status, determined by microscopic evaluation of bronchoscopic biopsies
Measure: The change in number of airway submucosal inflammatory cells per mm2 from baseline, across the spectrum of T2 status, determined by microscopic evaluation of bronchoscopic biopsies Time: Baseline, End of Treatment (EoT). The EoT will be performed at Week 28 for the majority of subjects but may be performed at later timepoints for some subjects (Week 32, etc.) due to up to 6 additional doses added during the Covid-19 pandemic.The novel Severe acute respiratory syndrome coronavirus 2 (SARS-C0V 2) originated in Wuhan, China in December 2019. As of April 15 2020, the virus has spread across 213 countries/territories with 1,914,916 cases and 123,010 deaths and a crude case fatality ratio (CFR) of 6.4%. In Bangladesh, the situation is also grave. As of May 14, 2020, there were 18,863 cases and 283 deaths. In order to suppress COVID-19 transmission, it is important to diagnose COVID-19 patients, which would help in the process of quarantine and isolation of the patients and also in contact tracing. COVID-19 testing can identify the SARS-CoV-2 virus and includes methods that detect the presence of virus itself such as real time reverse-transcription-polymerase chain reaction (RT-PCR), isothermal nucleic acid amplification, antigen) and those that detect antibodies produced in response to infection. Until now, RT-PCR has been known as the best approach for - detection. It would be very useful if Bangladesh had its own locally produced RT-PCR kits, provided that the kits are no less in quality than imported kits in terms of sensitivity, specificity, price etc. The present study aims to carry out the performance evaluation of RealDetect RT-PCR Kit for COVID-19 detection. The RealDetect™ COVID-19 RT-PCR diagnostic panel is a locally produced real-time RT-PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal swab specimens collected from individuals who meet SARS-CoV-2 clinical criteria. The approach is based on the RT-PCR method which uses two (Nucleocapsid 1, Nucleocapsid 2) sets of gene-specific primers and corresponding fluorescent probes to detect two specific regions within the novel coronavirus (SARS-CoV-2) nucleocapsid protein Nucleocapsid gene. This RT-PCR panel detects SARS-CoV-2 Ribonucleic acid (RNA) specifically. The approach does not generate any false positives to other coronaviruses or human microflora. The kit also contains a primer-probe set which detects human housekeeping gene, ribonuclease Protein (RNase P). That is, the Ribonuclease Protein (RNase P) serves as an internal reference control to monitor sample collection, ribonucleic acid (RNA) extraction, and amplification. This is a case control study. The study will analyze 120 samples (60 COVID-19 positive and 60 COVID-19 negative both fresh and frozen) from Institute of Epidemiology, Disease Control and Research (IEDCR). These specimens will be blinded before handing over to Institute for Developing Science & Health Initiatives (ideSHi) for RealDetect Kit. All samples will be analyzed by Real Time PCR System. Necessary validation will also be carried out at the COVID-19 laboratory of the Dhaka Medical College Hospital and an external validation expert will be involved. The Principal Investigator (PI) will also receive the sample information regarding positive/negative status from Institute for Epidemiology, Disease Control and Research (IEDCR) and compare ideSHi and IEDCR data. Unpaired t-test, Wilcox's test, Rank test, Compare test, Mean test, Sensitivity/Specificity test, Regression analysis and Geometric mean with 95% Confidence Interval (CI) will be used to analyze the data. It needs to conduct a univariate analysis.
NCT04403672 High Sensitivity and Specificity (With 95% Confidence Interval) of RealDetect™ COVID-19 RT-PCR Kit Device: performance evaluation study of RealDetect RT-PCR Kit for COVID-19 detection MeSH:Hypersensitivity
HPO:Allergy
Primary Outcomes
Description: Determine Performance evaluation of RealDetect™ COVID-19 RT-PCR kit for the detection of SARS-CoV-2 virus using nasopharyngeal swab specimens collected in the nationwide COVID-19 screening program.
RNA extraction from fresh Nasopharyngeal Swab sample in Viral Transport Medium(VTM) of COVID-19 patients from IEDCR (30 positive & 30 negative)
Analysis of COVID-19 RNA samples using RT-PCR
Measure: Performance evaluation of RealDetect™ COVID-19 RT-PCR kit Time: 2 months
Secondary Outcomes
Description: Supply locally manufacturer COVID-19 Reverse transcription polymerase chain reaction (RT-PCR) kit to govt. & private hospitals for diagnosis of COVID-19 patients.
RNA extraction from frozen Nasopharyngeal Swab sample in Viral Transport Medium(VTM) of COVID-19 patients from IEDCR (30 positive & 30 negative)
Analysis of COVID-19 RNA samples using Reverse transcription polymerase chain reaction (RT-PCR)
Measure: Reduce the price of RT-PCR based COVID-19 diagnostic test kits. Time: 1 month
HPO Nodes
Primary Outcomes
Description: Determine Performance evaluation of RealDetect™ COVID-19 RT-PCR kit for the detection of SARS-CoV-2 virus using nasopharyngeal swab specimens collected in the nationwide COVID-19 screening program. RNA extraction from fresh Nasopharyngeal Swab sample in Viral Transport Medium(VTM) of COVID-19 patients from IEDCR (30 positive & 30 negative) Analysis of COVID-19 RNA samples using RT-PCR
Measure: Performance evaluation of RealDetect™ COVID-19 RT-PCR kit Time: 2 monthsSecondary Outcomes
Description: Supply locally manufacturer COVID-19 Reverse transcription polymerase chain reaction (RT-PCR) kit to govt. & private hospitals for diagnosis of COVID-19 patients. RNA extraction from frozen Nasopharyngeal Swab sample in Viral Transport Medium(VTM) of COVID-19 patients from IEDCR (30 positive & 30 negative) Analysis of COVID-19 RNA samples using Reverse transcription polymerase chain reaction (RT-PCR)
Measure: Reduce the price of RT-PCR based COVID-19 diagnostic test kits. Time: 1 month