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Navigate: Clinical Trials and HPO
| Name (Synonyms) | Correlation | |
|---|---|---|
| drug438 | Baloxavir Marboxil Wiki | 0.35 |
| drug2725 | Quadrivalent RIV with H3 strain 1 and adjuvant Wiki | 0.25 |
| drug1920 | MCC IMS Wiki | 0.25 |
| Name (Synonyms) | Correlation | |
|---|---|---|
| drug3789 | artus Influenza A/B RT-PCR Test Wiki | 0.25 |
| drug2726 | Quadrivalent RIV with H3 strain 2 Wiki | 0.25 |
| drug4063 | qRT-PCR and serology Wiki | 0.25 |
| drug3054 | Scanning Chest X-rays and performing AI algorithms on images Wiki | 0.25 |
| drug3469 | Throat swab and/or nasopharyngeal swab Wiki | 0.25 |
| drug1963 | Mannitol Wiki | 0.25 |
| drug1625 | Imaging by thoracic scanner Wiki | 0.25 |
| drug1905 | Lung CT Wiki | 0.25 |
| drug2723 | Quadrivalent RIV with 2018-2019 NH H3 strain and adjuvant Wiki | 0.25 |
| drug286 | Appeals Wiki | 0.25 |
| drug2722 | Quadrivalent RIV with 2018-2019 NH H3 strain Wiki | 0.25 |
| drug1403 | Glucose tablets Wiki | 0.25 |
| drug2724 | Quadrivalent RIV with H3 strain 1 Wiki | 0.25 |
| drug3465 | Thoraxic computed tomography Wiki | 0.25 |
| drug2727 | Quadrivalent RIV with H3 strain 2 and adjuvant Wiki | 0.25 |
| drug369 | Azithromycin 500Mg Oral Tablet Wiki | 0.25 |
| drug360 | Ayurveda Wiki | 0.18 |
| drug95 | ARB Wiki | 0.18 |
| drug1532 | Hydroxychloroquine 200 Mg Oral Tablet Wiki | 0.18 |
| drug68 | ACE inhibitor Wiki | 0.14 |
| drug997 | Data collection Wiki | 0.14 |
| drug963 | DAS181 Wiki | 0.10 |
| drug2351 | Oseltamivir Wiki | 0.09 |
| drug1196 | Enoxaparin Wiki | 0.07 |
| drug1520 | Hydroxychloroquine Wiki | 0.03 |
| drug2505 | Placebo Wiki | 0.02 |
| Name (Synonyms) | Correlation | |
|---|---|---|
| D003384 | Coxsackievirus Infections NIH | 0.25 |
| D018184 | Paramyxoviridae Infections NIH | 0.14 |
| D000257 | Adenoviridae Infections NIH | 0.14 |
| Name (Synonyms) | Correlation | |
|---|---|---|
| D012141 | Respiratory Tract Infections NIH | 0.09 |
| D018357 | Respiratory Syncytial Virus Infections NIH | 0.09 |
| D053717 | Pneumonia, Ventilator-Associated NIH | 0.08 |
| D017563 | Lung Diseases, Interstitial NIH | 0.07 |
| D003141 | Communicable Diseases NIH | 0.06 |
| D014777 | Virus Diseases NIH | 0.05 |
| D007239 | Infection NIH | 0.05 |
| D055370 | Lung Injury NIH | 0.05 |
| D004630 | Emergencies NIH | 0.04 |
| D011024 | Pneumonia, Viral NIH | 0.03 |
| D013577 | Syndrome NIH | 0.02 |
| D055371 | Acute Lung Injury NIH | 0.02 |
| D018352 | Coronavirus Infections NIH | 0.02 |
| D011014 | Pneumonia NIH | 0.01 |
| D045169 | Severe Acute Respiratory Syndrome NIH | 0.01 |
| Name (Synonyms) | Correlation | |
|---|---|---|
| HP:0006515 | Interstitial pneumonitis HPO | 0.07 |
| HP:0011947 | Respiratory tract infection HPO | 0.05 |
| HP:0002090 | Pneumonia HPO | 0.01 |
Navigate: Correlations HPO
There are 16 clinical trials
Following the sudden and unexpected emergence of influenza A(H1N1)pdm09 (2009 H1N1) virus, this observational study was initiated to estimate rates of morbidity and mortality and to examine predictors of severity among participants with 2009 H1N1 infection. In 2011, as surveillance indicated that 2009 H1N1 virus was co-circulating with other seasonal influenza A and B viruses worldwide, the protocol was expanded to include other influenza A subtypes and influenza B viruses. The current version of the protocol (released in August 2013) further broadens the scope of this observational study. With the recognition that novel respiratory viruses other than novel influenza A viruses, e.g., Middle East Respiratory Syndrome Coronavirus (MERS-CoV), could become prevalent and of major public health importance, the objectives of this protocol have been expanded.
Following the sudden and unexpected emergence of influenza A(H1N1)pdm09 (2009 H1N1) virus, this observational study was initiated to describe participants seeking medical care in geographically diverse locations with 2009 H1N1 infection and their clinical course over a 14-day period following enrollment. In 2011, as surveillance indicated that 2009 H1N1 virus was co-circulating with other seasonal influenza A and B viruses worldwide, the protocol was expanded to include other influenza A subtypes and influenza B viruses. This version of the protocol further broadens the scope of this observational study. With the recognition that novel respiratory viruses other than novel influenza A viruses, e.g., Middle East Respiratory Syndrome Coronavirus (MERS-CoV), could become prevalent and of major public health importance, the objectives of this protocol have been expanded
Description: Death or hospitalization within 14 days of enrollment or the development of one severe complication.
Measure: Death or Hospitalization Time: 14-day period following enrollmentThe study will be conducted using nasopharyngeal swab specimens collected prospectively from individuals suspected of having the signs and symptoms of an acute respiratory tract infection caused by a respiratory virus. A series of standard viral culture tests validated for routine use in the clinical laboratory, and/or a series of PCR-based Laboratory Developed Tests (PCR-LDT) validated by a central reference laboratory will be used to verify the performance of the investigational artus Influenza A/B RT-PCR test and the QIAGEN ResPlex II Advanced Panel test. From each specimen five (5) aliquots will be prepared: (a) one aliquot will be tested in real-time using the assigned viral culture reference methods; (b) one aliquot will be used to extract nucleic acid in real-time for investigational testing; (c) one aliquot of the specimen will be stored at --70C for subsequent shipment to the reference laboratory for PCR-LDT testing, (d) one aliquot will be archived at -70C for subsequent follow-up by the reference laboratory (e.g., bi-directional sequencing of positive specimens), and (e) any remaining specimen will be stored for the Fresh vs. Frozen Study. The extracted nucleic acid generated from the second aliquot (i.e., "b" above) will be split and subjected to testing by both the artus Influenza A/B RT-PCR test and the ResPlex II Advanced Panel test.
Description: The presence of Influenza A or Influenza B virus.
Measure: Detection of Respiratory Viruses Time: Specimens will be taken within 5 days of the appearance of symptoms.Currently, there is no treatment for children less than one year of age with influenza related lower respiratory tract infection that is either considered standard or registered in any country. This dismal scenario exists even though influenza related LRTI is a significant illness causing morbidity and mortality, especially in children less than 6 months of age. Avian influenza has been reported rarely in children less than one. There are no data in Vietnam and very few data in Thailand on the burden of influenza in children less than one. This young age group suffers high mortality. Oseltamivir may be beneficial in such children. This is basis of this trial.
Description: Viral clearance on Day 5 (human influenza) on a throat swab, assessed by RT PCR. Viral clearance on Day 10 (avian influenza) on a throat swab, assessed by RT PCR.
Measure: Viral clearance Time: 5-10 daysDescription: • Cmax, Tmax, AUC, apparent volume of distribution, clearance, terminal elimination half-life
Measure: Pharmacokinetics of Oseltamivir Time: Day 0 and Day 9Description: Time to viral clearance on a throat swab, assessed by RT PCR. The time to no detectable influenza virus by culture for the throat swab. Change in viral load (log10 copies/mL) over time for all virological samples (lower limit of detection: 1000 copies/mL) Viral susceptibility of cultured influenza virus to antiviral drugs at baseline and post treatment, assessed by genotypical and phenotypical analyses
Measure: Viral end points Time: 5-10 daysDescription: Time to fever clearance In hospital mortality and mortality by follow up Time to death Time to trans cutaneous O2 saturation of ≥ 95% on room air Clinical course: pneumothorax, encephalitis/encephalopathy Number of days in hospital Number of days ventilated
Measure: Clinical Efficacy Endpoints Time: 5-10 daysDescription: Documented serious adverse events (SAEs) and relationships to oseltamivir AEs leading to drug withdrawal Grade 3 & 4 clinical and laboratory AEs that are probably or definitely related to oseltamivir Skin rashes of any grade Changes in haematological and biochemical parameters over time
Measure: Safety Endpoints Time: 5-10 daysThis study aims to quantify the inpatient and ER visits burden of laboratory-confirmed influenza, and compare the clinical features, severity, complications, risk factors and socioeconomic impact of influenza in children presenting with acute respiratory illness (ARI) and/or isolated fever, with or without laboratory-confirmed influenza.
Description: ARI was defined as one or more of the following symptoms: sore throat (in children greater than or equal to (≥) 3 years old), coryza (runny nose), cough, breathing difficulties. Isolated fever was defined as: oral temperature ≥37.5°C / axillary temperature ≥37.5°C / Rectal temperature ≥38°C / tympanic temperature on oral setting ≥37.5°C / tympanic temperature on rectal setting ≥38°C without an obvious cause.
Measure: Number of Subjects With Laboratory-confirmed Influenza Presenting With an Acute Respiratory Illness (ARI) and/or Isolated Fever Time: Day 0 till Day 28-37Description: Ward specific room charge and Intensive Care Unit (ICU) were computed as daily charge multiplied by the number of days.
Measure: Direct Medical Cost Per Hospitalization or ER Visit With Laboratory-confirmed Influenza Time: Day 0 till Day 28-37Description: Among the other laboratory-confirmed respiratory viruses there were:adenovirus, respiratory syncytial virus, parainfluenza virus 1, 2 and 3, metapneumovirus, bocavirus, rhinovirus or coronavirus. The outcome was assessed in subjects with an acute respiratory illness (ARI) and/or isolated fever episode.
Measure: Number of Subjects With Other Laboratory-confirmed Respiratory Viruses Time: Day 0 till Day 28-37Description: Deaths from ARI and/or fever episodes by laboratory-confirmed influenza status were assessed.
Measure: Number of Subjects With Fatal Outcomes Time: Day 0 till Day 28-37Description: The outcome assessed the various complications by laboratory-confirmed influenza status.
Measure: Number of Subjects With Secondary Bacterial Infections Time: Day 0 till Day 28-37Description: Risk factors were classified as pre-existing conditions, breast-feeding status and day-care status.
Measure: Number of Subjects With Potential Risk Factors at Study Start by Laboratory-confirmed Influenza Status Time: Day 0 till Day 28-37Description: The outcomes was assessed in subjects with laboratory-confirmed influenza status
Measure: Number of Days of Hospitalization Time: Day 0 till Day 28-37 (between October 2010 until May 2011)Description: ARI and/or fever related medication included: antivirals, antibiotics, cough suppressants, pain medication, antipyretics and mucolytics.
Measure: Number of Subjects Using Any ARI and/or Fever Related Medication Taken Prior to Hospitalization or ER Visit by Laboratory-confirmed Influenza Status Time: Day 0 till Day 28-37Description: ARI and/or fever related medication included: antivirals, antibiotics, cough suppressants, pain medication, antipyretics and mucolytics.
Measure: Number of Subjects Using Any ARI and/or Fever Related Medication Prescribed During Hospitalization or ER Visit by Laboratory-confirmed Influenza Status Time: Day 0 till Day 28-37Description: ARI and/or fever related medication included: antivirals, antibiotics, cough suppressants, pain medication, antipyretics and mucolytics.
Measure: Number of Subjects Using Any ARI and/or Fever Related Medication Prescribed Since Hospitalization or ER Visit by Laboratory-confirmed Influenza Status Time: Day 0 till Day 28-37Description: ARI and/or fever related medication included: antivirals, antibiotics, cough suppressants, pain medication, antipyretics and mucolytics.
Measure: Number of Subjects Using Any Non-prescribed ARI and/or Fever Related Medication Taken Since Hospitalization or ER Visit Time: Day 0 till Day 28-37Description: School absenteeism was assessed among patients during the follow-up period by laboratory-confirmed influenza status.
Measure: Number of Days of School Absenteeism Time: Day 0 till Day 28-37Description: This outcome assessed absenteeism among caregivers to provide patient care during the follow-up period by laboratory-confirmed influenza status.
Measure: Number of Days of Parent or Caregiver Time Off Work Time: Day 0 till Day 28-37Description: This outcome assessed the number of cases with household contacts presenting influenza like illness symptoms during the follow-up period by laboratory-confirmed influenza status.
Measure: Number of Subjects With Household Members With Influenza-like Illness Time: Day 0 till Day 28-37Description: This outcome assessed the proportion of influenza like illness (ILI) among household members of children < 15 years with and without laboratory-confirmed influenza.
Measure: Proportion of Household Members Presenting Influenza Like Illness Symptoms (ARI and/or Isolated Fever) Time: Day 0 till Day 28-37This study will evaluate the safety, pharmacokinetics and efficacy of baloxavir marboxil in healthy pediatric participants from birth to <1 year with influenza like symptoms
Description: An adverse event (AE) is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not considered related to the medicinal (investigational) product. A serious adverse event (SAE) is any significant hazard, contraindication, side effect that is fatal or life-threatening, requires hospitalization or prolongation of an existing hospitalization, results in persistent or significant disability/ incapacity, is a congenital anomaly/ birth defect, is medically significant or requires intervention to prevent one or other of the outcomes listed above.
Measure: Percentage of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) Time: Up to Day 29Description: Time to alleviation of influenza signs and symptoms is defined as the length of time taken from the start of treatment to the point at which all of the following criteria are met and remain so for at least 21.5 hours: A score of 0 (no problem) or 1 (minor problem) for cough and nasal symptoms (items 14 and 15 of the Canadian Acute Respiratory Illness and Flu Scale [CARIFS]) A "yes" response to the following question on the CARIFS: "Since the last assessment has the subject been able to return to day care/school, or resume his or her normal daily activity in the same way as performed prior to developing the flu?" First return to afebrile state (tympanic temperature ≤37.2 degree Celsius [°C])
Measure: Time to Alleviation of Influenza Signs and Symptoms Time: Up to Day 15Description: Length of time taken by participants to return to afebrile state [tympanic temperature ≤ 37.2°C] and remaining so for at least 21.5 hours.
Measure: Duration of Fever Time: Up to Day 15Description: The efficacy of baloxavir marboxil is evaluated by duration of symptoms i.e., alleviation of all symptoms as defined by a score of 0 [no problem] or 1 [minor problem] and remaining so for at least 21.5 hours, for all 18 symptoms specified in the CARIFS questionnaire).
Measure: Duration of Symptoms Time: Up to Day 15Description: The influenza related complications include death, hospitalization, radiologically confirmed pneumonia, bronchitis, sinusitis, otitis media, encephalitis/encephalopathy, febrile seizures, myositis.
Measure: Frequency of Influenza-Related Complications Time: Up to Day 29Otherwise healthy index patients (IP) are randomized to either baloxavir marboxil or placebo if their influenza symptoms onset was within 48 hours of screening. Their households are enrolled within 24 hours of randomization if at least 2 household contacts (HHC) have not received influenza vaccine within 6 months of screening and if all HHC screen negative for influenza infection. The main endpoints are assessed based on multiple respiratory swabs, obtained from both IP and HHC up to 9 (+/-1) days post IP randomization, and through the assessment of symptoms.
Description: Defined as the percentage of Household Contacts (HHCs) who become Polymerase Chain Reaction Positive (PCR+) for Influenza by Day 5 post IP randomization. HHCs may be symptomatic or asymptomatic and their virus subtype must match that of the index patient (IP) in their household. The primary efficacy analysis population will consist of all enrolled unvaccinated HHCs of the randomized IPs.
Measure: Virological Transmission by Day 5 Time: Baseline to Day 5 (5 days)Description: Defined as the percentage of HHCs who become PCR+ for Influenza by Day 5 post IP randomization and develop Influenza symptoms at any time during the study. HHCs ≥12 years old were defined symptomatic if (1) Presence of temperature ≥38.0 Celsius and one respiratory symptom (cough, sore throat, nasal congestion) or (2) Presence of one respiratory symptom and one general systemic symptom (headache, feverishness or chills, muscle or joint pain, fatigue), with or without fever. HHCs ≥2 and <12 years old were defined symptomatic if presence of temperature ≥38.0 Celsius and cough, nasal congestion, or rhinorrhea. Note: For HHCs of any age, respiratory or general systemic symptoms had to be either (1) new, or (2) worsened versus baseline with baseline symptoms due to a pre-existing comorbidity. HHCs must have their virus subtype match that of the IP.
Measure: Symptomatic Transmission by Day 5 Time: Baseline to Day 5 (5 days)Description: Defined as the percentage of households with at least one HHC who meets the primary endpoint.
Measure: Virological Transmission at the Household Level by Day 5 Time: Baseline to Day 5 (5 days)Description: Defined as the percentage of households with at least one HHC who meets the "Symptomatic transmission by Day 5 endpoint.
Measure: Symptomatic Transmission at the Household Level by Day 5 Time: Baseline to Day 5 (5 days)Description: Defined as the percentage of HHCs who become PCR+ for Influenza by Day 9 post IP randomization. HHCs must have their virus subtype match that of the IP, and include: (1) all HHC meeting primary endpoint, AND (2) all HHC cases detected after Day 5 Visit meeting the following criteria: (2a) included HHC case is in a household where another HHC has already met the primary endpoint, OR (2b) included HHC case is PCR (+) for influenza bearing treatment-emergent amino acid substitutions in the PA protein that have been associated with reduced susceptibility to baloxavir marboxil.
Measure: Virological Transmission by Day 9 Time: Baseline to Day 9 (9 days)Description: Defined as the percentage of HHCs who meet the "Virological transmission by Day 9" endpoint AND are symptomatic per the definition for symptoms in the "Symptomatic transmission by Day 5" endpoint.
Measure: Symptomatic Transmission by Day 9 Time: Baseline to Day 9 (9 Days)Description: Defined as the percentage of HHCs who become PCR (+) for influenza (confirmed at central laboratory) by Day 9.
Measure: Any Virological Infection by Day 9 Time: Baseline to Day 9 (9 Days)Description: Defined as the percentage of households with at least one HHC who meets the "Any virological infection by Day 9" endpoint.
Measure: Any Virological Infection at the Household Level by Day 9 Time: Baseline to Day 9 (9 Days)Description: Defined as the percentage of HHCs who meet the "Any virological infection by Day 9" endpoint AND are symptomatic per the definition for symptoms in the "Symptomatic transmission by Day 5" endpoint.
Measure: Any Symptomatic Infection by Day 9 Time: Baseline to Day 9 (9 Days)Description: Defined as the percentage of households with at least one HHC who meets the "Any symptomatic infection by Day 9" endpoint.
Measure: Any Symptomatic Infection at the Household Level by Day 9 Time: Baseline to Day 9 (9 Days)Description: The EQ-5D-5L is a self-reported health status questionnaire that consists of six questions used to calculate a health utility score for use in health economic analysis. There are two components to the EQ-5D-5L: a five-item health state profile that assesses mobility, self-care, usual activities, pain/discomfort, and anxiety/depression used to obtain an Index Utility Score, as well as a visual analogue scale (VAS) that measures health state. The VAS is designed to rate the participant's current health state on a scale from 0 to 100, where 0 represents the worst imaginable health state and 100 represents the best imaginable health state. An increase in the VAS score of 7 points or greater was defined as the threshold for a meaningful improvement.
Measure: Change from baseline in health-related quality of life according to EuroQol 5 dimensions 5 (EQ-5D-5L; Appendix 3) questionnaire at Day 3 and Day 9 Visits (IPs only) Time: Baseline, Day 3 and Day 9Description: The WPAI is a patient-reported measure which assesses the effect of general health and symptom severity on work productivity and regular activities. The General Health questionnaire asks participants to estimate the number of hours missed from work due to reasons related and unrelated to their health problems, as well as the total number of hours actually worked in the preceding 7-day period. The percentage of participants reporting that they were employed (working for pay) was assessed at baseline was assessed along with Absenteeism (work time missed), Presenteeism (impairment at work / reduced on-the-job effectiveness), Work productivity loss (overall work impairment / absenteeism plus presenteeism), and Activity Impairment.
Measure: Change From Baseline in Work Productivity and Activity Impairment According to Work Productivity and Activity Impairment (WPAI) plus Classroom Impairement Questions Score (IPs only) Time: Baseline and Day 9Multicapillary Ion mobility spectrometry of nasal air aspirates shall be investigated as screening tool for the detection of Influenza and SARS-CoV-2- infection.
Description: Cluster Analysis of MCC IMS spectra will be obtained immediately after sampling
Measure: Cluster Analysis of MCC IMS spectra. Time: immediatly after samplingThis is a Phase IIb study consisting of two cohorts to evaluate efficacy, safety and pharmacokinetics of DAS181 in IFV infection. An approximate total of 280 subjects will be enrolled into this study.
Description: Percent of subjects who have returned to room air
Measure: Percent of subjects who have returned to room air Time: 7 daysDescription: Percent change of subjects return to baseline oxygen requirement by Day 7 compared to Day 1
Measure: Percent change of subjects return to baseline oxygen requirement Time: 7 daysThis project aims to use artificial intelligence (image discrimination) algorithms, specifically convolutional neural networks (CNNs) for scanning chest radiographs in the emergency department (triage) in patients with suspected respiratory symptoms (fever, cough, myalgia) of coronavirus infection COVID 19. The objective is to create and validate a software solution that discriminates on the basis of the chest x-ray between Covid-19 pneumonitis and influenza
Description: Number of participants with pneumonitis on Chest X-Ray and COVID 19 positive
Measure: COVID-19 positive X-Rays Time: 6 monthsDescription: Number of participants with pneumonitis on Chest X-Ray and COVID 19 negative
Measure: COVID-19 negative X-Rays Time: 6 monthsSome authors have proposed the use of the flu vaccine to reduce the severity of COVID-19 cases, while some have proposed the use of ACE Inhibitors (ACEI) or Angiotensin Receptor blockers (ARB), since this virus shares hemagglutinin as a transmission mechanism and acts on the ACE2 enzyme during infection. The aim is to evaluate whether the admitted patients who are previously vaccinated or those who were already receiving treatment show a better evolution.
Description: exitus vs hospital output
Measure: hospital output Time: from March 1, 2020.Description: lenght of the hospital stay
Measure: hospital stay Time: From March 1, 2020.The primary objectives of the study are: - To describe the safety profile of the different formulations in all participants - To describe the hemagglutinin inhibition (HAI) and seroneutralization (SN) antibody responses against hemagglutinin (H1, H3, B/Victoria, and B/Yamagata) antigens present in the control vaccine in all groups at all timepoints. The secondary objectives are: - To describe antigenic coverage in each group by assessing the HAI and SN antibody responses against a panel of H3 antigens (not present in any of the vaccine formulations). - To describe SN antibody responses in each group against each of the H3 antigens. - To compare H3 HAI and SN antibody responses for the groups with quadrivalent recombinant influenza vaccine (RIV) formulations with H3 antigens to those of the quadrivalent RIV control group. - To compare the HAI and SN antibody responses for the groups with quadrivalent RIV formulation with adjuvant to the group without adjuvant.
Description: Immediate adverse events are unsolicited systemic adverse events reported in the 30 minutes after vaccination
Measure: Number of participants with immediate adverse events Time: Within 30 minutes after vaccinationDescription: Solicited injection site reactions: injection site pain, erythema, swelling, induration and bruising; solicited systemic reactions: fever, headache, malaise, and myalgia
Measure: Number of participants with solicited injection site or systemic reactions Time: From Day 0 to Day 7Description: Unsolicited (spontaneously reported) adverse events not not fulfilling criteria for solicited reactions
Measure: Number of participants with unsolicited adverse events Time: From Day 0 to Day 28Description: Serious adverse events are collected throughout the study
Measure: Number of participants with serious adverse events Time: From Day 0 to Day 365Description: Adverse events of special interest are collected throughout the study
Measure: Number of participants with adverse events of special interest Time: From Day 0 to Day 365Description: Laboratory tests include complete blood count (CBC), platelet count, alanine aminotransferase (ALT), aspartate aminotransferase (AST), total bilirubin, serum creatinine, serum lipase, and serum amylase)
Measure: Clinical safety laboratory test results Time: From Day 0 to Day 7Description: Influenza antibody titers are measured by HAI and SN assays
Measure: HAI and SN antibody titers against influenza antigens in the quadrivalent RIV control vaccine Time: From Day 0 to Day 365Description: Titers ratio is calculated for the following time points: Day 7/Day 0, Day 28/Day 0, and Day 90/Day 0
Measure: Individual HAI and SN titers ratio against influenza antigens in the quadrivalent RIV control vaccine Time: From Day 0 to Day 90Description: Seroconversion is defined as HAI antibody titer < 10 [1/dil] at Day 0 and post-injection titer ≥ 40 [1/dil] at Day 28, or titer ≥ 10 [1/dil] at Day 0 and a ≥ 4-fold increase in titer [1/dil] at Day 28)
Measure: Number of participants with seroconversion to influenza antigens in the quadrivalent RIV control vaccine Time: From Day 0 to Day 28Description: Influenza vaccine antibody titers are measured by HAI assay
Measure: HAI Ab titer ≥ 40 [1/dil] Time: From Day 0 to Day 365Description: Influenza vaccine antibody titers are measured by SN assay
Measure: 2-fold and 4-fold increase in SN titers Time: From Day 0 to Day 28Description: Influenza vaccine antibody titers are measured by HAI and SN assays
Measure: HAI antibody titers against influenza H3 antigens not present in the vaccine formulations and the SN antibody titers against each of the H3 antigens Time: Day 0, Day 7, Day 28, Day 90, Day 180, and Day 365Description: Titer ratio is calculated for the following time points: Day 7/Day 0, Day 28/Day 0, Day 90/Day 0
Measure: Individual HAI titer ratios against influenza H3 antigens not present in the vaccine formulations and individual SN titer ratio against each of the H3 antigens Time: From Day 0 to Day 90Description: Seroconversion is defined as HAI antibody titer < 10 [1/dil] at Day 0 and post-injection titer ≥ 40 [1/dil] at Day 28, or titer ≥ 10 [1/dil] at Day 0 and a ≥ 4-fold increase in titer [1/dil] at Day 28)
Measure: Number of participants with seroconversion to influenza H3 antigens not present in the vaccine formulations Time: Day 0 and Day 28Description: Influenza vaccine antibody titers a are measured by SN assay
Measure: 2-fold and 4-fold rise in SN antibody titers against each of the H3 antigens Time: Day 0, Day 7, Day 28, Day 90, Day 180, and Day 365The investigators decided to conduct a longitudinal study that compares the pulmonary tomographic patterns found in patients with viral pneumonia (i.e. influenza H1N1 and SARS-CoV-2) at a regional hospital. The primary aim of this study is to compare the radiological patterns found in patients with COVID-19 and influenza H1N1. The secondary aims of this study will assess the association between the radiological CT pattern and the need for invasive mechanical ventilation and mortality within the first 28 days of intensive care unit admission.
Description: Lung CT radiological patterns associated with COVID-19 or Influenza H1N1
Measure: Radiological findings Time: 24 hoursDescription: Intrahospital and overall survival at 28 days from hospital admission.
Measure: Survival Time: 28 daysThe investigators decided to conduct a longitudinal study that compares the pulmonary tomographic patterns found in patients with viral pneumonia (i.e. influenza H1N1 and SARS-CoV-2) at a regional hospital. The primary aim of this study is to evaluate the association between the radiological CT pattern and the need for invasive mechanical ventilation. A secondary aim is to assess the mortality within the first 28 days of intensive care unit admission.
Description: Need for oral intubation within the first 10 days.
Measure: Oral intubation Time: 10 daysDescription: 28-day survival analysis using the Kaplan Meyer and Cox regression models.
Measure: Survival Time: 28 daysBackground: Each Belgian winter season is characterized by a wave of influenza like and respiratory symptoms. Especially, the elderly people are more vulnerable to be infected by influenza, but also RSV. The recent COVID-19 pandemic and eventually a next wave, will increase the prevalence of influenza like and respiratory symptoms. Method: A multicentre non-commercial cohort study will be conducted in nursing home staff and residents during the Winter season 2020-2021. Objectives: Primary objective is the difference in incidence of influenza like and respiratory symptoms between cases (cases have evidence of past infection with SARS-CoV-2, referred to as Covid +) and controls (controls have no evidence of previous infection and are referred to as Covid -). The primary outcome analysis as well as the secondary outcome analyses will use two strata: nursing home staff and nursing home residents. The secondary objectives are the difference in incidence of COVID-19, influenza, RSV infections confirmed by PCR between cases and controls, to define a correlate of protection in the covid + group against re-infection with SARS-CoV-2 based on the study of the pre-existing antibody profile (antigen specificity, antibody type and antibody level) at the time of re-exposure. A multiplex assay will be used to assess the antibody profile. Finally, to study the COVID-19 disease severity (7 point WHO ordinal scale, this includes a.o. hospitalisation, mechanical ventilation need and ICU admission, mortality) based on the presence/absence of pre-existing antibodies and the pre-existing antibody profile. For other respiratory infections we will study the need for hospitalization and mortality.
Description: This study will assess the time to the occurrence of influenza-like illness (ILI) or acute respiratory infection (ARI) in subjects previously COVID+ compared to subjects known as COVID- (controls), more specifically subjects will belong to two subgroups: nursing home residents (65+) and nursing home staff (18-65y). COVID+ is defined as a past SARS-CoV-2 infection.
Measure: Time to occurrence of ILI and ARI both in participants previously exposed to SARS-COV-2 and controls Time: up to 8 monthsDescription: Disease severity will be measured by hospitalization and mortality
Measure: Correlation of the pre-existing antibody characteristics for COVID-19 with disease severity. Time: up to 8 monthsAs part of the fight against COVID-19, the UK government has announced its most comprehensive flu campaign to date (https://www.gov.uk/government/news/most-comprehensive-flu-programme-in-uk-history-will-be-ro lled-out-this-winter). This should not be surpising: every year NHS hospitals experience an overwhelming number of influenza cases, and COVID-19 increases this concern. As in previous years, the flu vaccine is free at the point of care for people 65 and over. New this year is that later in the season the vaccine will be made available free at the point of care for people 50 and over. However, if people refuse to take the vaccine this comprehensive program cannot benefit public health. The degree to which vaccine hesitancy is expressed varies across characteristics of the vaccine considered and the time and place it is offered, and across characteristics of the person's perceptions of complacency, convenience, confidence, calculations, and communal responsibility, i.e. the "5Cs". Information campaigns can be used to influence all 5Cs, and public facing information is often a necessary component of public health campaigns that may also include structural components. Largely, information campaigns can be viewed as a type of educational intervention. Educational interventions may fall short of what is needed to alter people's intentions to vaccinate where they focus on system 1 rational thinking processes and neglect system 2 automatic thinking processes. To be more effective, public health messages must be tailored to align with the "beliefs, attitudes, and motivations" of the very people they intend to influence. Fact-led educational interventions to increase parents' intentions to vaccinate their children are particularly ineffective where more subtle content opposes the recipient's deep-seated values. In a different context, recycling behaviour, previous research demonstrated that messages aligned with people's deep-seated values (i.e. the moral foundations that underlie political ideologies) are more likely to promote desired behavioural intentions than unaligned messages. The present research expands the scope of previous research in two ways. First, rather than investigating parental attitudes towards vaccination, the investigators will look at people's intentions to self-vaccinate. Second, the investigators will explore the effectiveness of messages aligned with the moral foundations that underlie individual's political ideologies on their intentions to be vaccinated.
Description: Participants rate their intentions to take up the seasonal influenza vaccination on a 7-point likert scale, from strongly disagree (=1) to strongly agree (=7).
Measure: Intentions to take up the seasonal influenza vaccination Time: 1 dayAlphabetical 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