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D007251: Influenza, Human

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 (50)


Name (Synonyms) Correlation
drug549 Baloxavir Marboxil Wiki 0.27
drug3669 Respiratory infections Wiki 0.19
drug3472 Quadrivalent RIV with 2018-2019 NH H3 strain Wiki 0.19
Name (Synonyms) Correlation
drug4615 VRC-FLUNPF0103-00-VP VRC-FLUNPF0103-00-VP (H10ssF-6473) Wiki 0.19
drug3604 Recombinant influenza vaccines Wiki 0.19
drug3477 Quadrivalent RIV with H3 strain 2 and adjuvant Wiki 0.19
drug1968 Hydroxychloroquine Pre-Exposure Prophylaxis Wiki 0.19
drug2434 Lung CT Wiki 0.19
drug1459 Egg based influenza vaccines Wiki 0.19
drug2109 Indomethacin Wiki 0.19
drug2265 Kagocel Wiki 0.19
drug3473 Quadrivalent RIV with 2018-2019 NH H3 strain and adjuvant Wiki 0.19
drug2867 Norketotifen Wiki 0.19
drug359 Appeals Wiki 0.19
drug1687 FluBlok Wiki 0.19
drug3474 Quadrivalent RIV with H3 strain 1 Wiki 0.19
drug362 Application of tele-rehabilitation Wiki 0.19
drug4833 artus Influenza A/B RT-PCR Test Wiki 0.19
drug4792 Zithromax Oral Product Wiki 0.19
drug4409 Throat swab and/or nasopharyngeal swab Wiki 0.19
drug2591 Message directing subjects to information on COVID-19 vaccine safety and efficacy Wiki 0.19
drug3475 Quadrivalent RIV with H3 strain 1 and adjuvant Wiki 0.19
drug2141 Instramuscular vaccine Wiki 0.19
drug3886 Scanning Chest X-rays and performing AI algorithms on images Wiki 0.19
drug1577 Experimental drug Wiki 0.19
drug934 Cell-culture based influenza vaccines Wiki 0.19
drug2114 Influenza vaccination at different time points Wiki 0.19
drug4076 Standard Dose Quadrivalent Inactivated Influenza Vaccine Wiki 0.19
drug5163 qRT-PCR and serology Wiki 0.19
drug2451 MCC IMS Wiki 0.19
drug4400 Thoraxic computed tomography Wiki 0.19
drug4656 Video about safety and effectiveness of adult seasonal flu vaccination Wiki 0.19
drug1881 High Dose Quadrivalent Inactivated Influenza Vaccine Wiki 0.19
drug3476 Quadrivalent RIV with H3 strain 2 Wiki 0.19
drug3982 Single Dose of Hydroxychloroquine Wiki 0.14
drug128 ARB Wiki 0.14
drug92 ACE inhibitor Wiki 0.11
drug1260 Data collection Wiki 0.10
drug2149 Interferon Beta-1A Wiki 0.10
drug2366 Lopinavir / Ritonavir Wiki 0.09
drug986 Cholecalciferol Wiki 0.09
drug895 Camostat Wiki 0.09
drug1224 DAS181 Wiki 0.08
drug2995 Oseltamivir Wiki 0.07
drug654 Blood sample Wiki 0.06
drug2230 Ivermectin Wiki 0.04
drug3195 Placebo Wiki 0.04
drug3273 Placebo oral tablet Wiki 0.03
drug453 Azithromycin Wiki 0.03
drug1950 Hydroxychloroquine Wiki 0.02

Correlated MeSH Terms (21)


Name (Synonyms) Correlation
D003384 Coxsackievirus Infections NIH 0.19
D012141 Respiratory Tract Infections NIH 0.11
D018184 Paramyxoviridae Infections NIH 0.11
Name (Synonyms) Correlation
D001424 Bacterial Infections NIH 0.11
D000257 Adenoviridae Infections NIH 0.10
D012327 RNA Virus Infections NIH 0.07
D003141 Communicable Diseases NIH 0.07
D053717 Pneumonia, Ventilator-Associated NIH 0.06
D018357 Respiratory Syncytial Virus Infections NIH 0.06
D007239 Infection NIH 0.06
D014777 Virus Diseases NIH 0.06
D017563 Lung Diseases, Interstitial NIH 0.05
D018450 Disease Progression NIH 0.04
D055370 Lung Injury NIH 0.04
D004630 Emergencies NIH 0.03
D011024 Pneumonia, Viral NIH 0.02
D018352 Coronavirus Infections NIH 0.02
D013577 Syndrome NIH 0.02
D045169 Severe Acute Respiratory Syndrome NIH 0.02
D055371 Acute Lung Injury NIH 0.02
D011014 Pneumonia NIH 0.01

Correlated HPO Terms (3)


Name (Synonyms) Correlation
HP:0011947 Respiratory tract infection HPO 0.11
HP:0006515 Interstitial pneumonitis HPO 0.05
HP:0002090 Pneumonia HPO 0.01

Clinical Trials

Navigate: Correlations   HPO

There are 27 clinical trials


1 An International Observational Study to Characterize Adults Who Are Hospitalized With Influenza or Other Targeted Respiratory Viruses

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.

NCT01056185
Conditions
  1. Influenza
  2. Novel Respiratory Virus-1 Middle Eastern Respiratory Syndrome Coronavirus (MERS-CoV)
  3. Novel Respiratory Virus-2 Severe Acute Respiratory Syndrome Coronavirus (SARS-CoV)
MeSH:Virus Diseases Influenza, Human Coronavirus Infections Severe Acute Respiratory Syndrome Syndrome

Primary Outcomes

Measure: Death

Time: 60-day period following enrollment

Secondary Outcomes

Measure: Recovery from influenza illness (including days lost from normal activities) duration of hospitalization, days in intensive care, days of mechanical ventilation, days of dialysis, pregnancy outcome

Time: approximately 60 days
2 An International Observational Study to Characterize Adults With Influenza or Other Targeted Respiratory Viruses

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

NCT01056354
Conditions
  1. Influenza and Other Novel Respiratory Viruses
MeSH:Influenza, Human

Primary Outcomes

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 enrollment

Secondary Outcomes

Measure: Days of work/school lost, duration of symptoms, use of antivirals

Time: 14 days
3 Testing of Respiratory Specimens for the Validation of the QIAGEN ResPlex II Advanced Panel Test and the Artus Influenza A/B RT-PCR Test

The 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.

NCT01302418
Conditions
  1. QIAGEN ResPlex II Advanced Panel
  2. Influenza A
  3. Respiratory Syncytial Virus Infections
  4. Infection Due to Human Parainfluenza Virus 1
  5. Parainfluenza Type 2
  6. Parainfluenza Type 3
  7. Parainfluenza Type 4
  8. Human Metapneumovirus A/B
  9. Rhinovirus
  10. Coxsackie Virus/Echovirus
  11. Adenovirus Types B/C/E
  12. Coronavirus Subtypes 229E
  13. Coronavirus Subtype NL63
  14. Coronavirus Subtype OC43
  15. Coronavirus Subtype HKU1
  16. Human Bocavirus
  17. Artus Influenza A/B RT-PCR Test
  18. Influenza B
Interventions
  1. Device: artus Influenza A/B RT-PCR Test
MeSH:Infection Communicable Diseases Virus Diseases Influenza, Human Coronavirus Infections Adenoviridae Infections Respiratory Syncytial Virus Infections Paramyxoviridae Infections Coxsackievirus Infections

Primary Outcomes

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.
4 SEA022 Oseltamivir Treatment in Children Under One Year of Age With Moderate or Severe Influenza Lower Respiratory Tract Infection - a Clinical and Pharmacokinetic Study.

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.

NCT01546935
Conditions
  1. Influenza
Interventions
  1. Drug: Oseltamivir
MeSH:Infection Respiratory Tract Infections Influenza, Human
HPO:Respiratory tract infection

Primary Outcomes

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 days

Description: • Cmax, Tmax, AUC, apparent volume of distribution, clearance, terminal elimination half-life

Measure: Pharmacokinetics of Oseltamivir

Time: Day 0 and Day 9

Secondary Outcomes

Description: 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 days

Description: 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 days

Description: 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 days
5 Burden of Influenza-related Hospitalizations and Emergency Room Visits in Children in Spain

This 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.

NCT01592799
Conditions
  1. Influenza
Interventions
  1. Procedure: Throat swab and/or nasopharyngeal swab
  2. Other: Data collection
MeSH:Influenza, Human Emergencies

Primary Outcomes

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 28-37

Description: 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 28-37

Secondary Outcomes

Description: 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 28-37

Description: 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 28-37

Description: The outcome assessed the various complications by laboratory-confirmed influenza status.

Measure: Number of Subjects With Secondary Bacterial Infections

Time: Day 0 till Day 28-37

Description: 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 28-37

Description: 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 28-37

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 Prescribed During Hospitalization or ER Visit by Laboratory-confirmed Influenza Status

Time: Day 0 till Day 28-37

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 Prescribed Since Hospitalization or ER Visit by Laboratory-confirmed Influenza Status

Time: Day 0 till Day 28-37

Description: 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 28-37

Description: 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 28-37

Description: 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 28-37

Description: 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 28-37

Description: 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 28-37
6 A Multicenter, Single-Arm, Open-Label Study to Assess the Safety, Pharmacokinetics, and Efficacy of Baloxavir Marboxil in Otherwise Healthy Pediatric Patients From Birth to < 1 Year With Influenza-Like Symptoms

This study will evaluate the safety, pharmacokinetics and efficacy of baloxavir marboxil in healthy pediatric participants from birth to <1 year with influenza like symptoms

NCT03653364
Conditions
  1. Influenza
Interventions
  1. Drug: Baloxavir Marboxil
MeSH:Influenza, Human

Primary Outcomes

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 29

Secondary Outcomes

Measure: Plasma Concentrations of Baloxavir Marboxil and S-033447

Time: Day 2 and Day 4

Measure: Area Under the Concentration to Time Curve from Time 0 to Infinity (AUC0-inf) of baloxavir marboxil and S-033447

Time: Up to Day 10

Measure: Maximum Plasma Concentration (Cmax) of baloxavir marboxil and S-033447

Time: Up to Day 10

Measure: Time to Maximum Plasma Concentration (Tmax) of baloxavir marboxil and S-033447

Time: Up to Day 10

Measure: Apparent Half-Life (T1/2) of baloxavir marboxil and S-033447

Time: Up to Day 10

Description: 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 15

Description: 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 15

Description: 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 15

Measure: Time to Return to Normal Health and Activity

Time: Up to Day 15

Description: 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 29

Measure: Percentage of Participants Requiring Antibiotics

Time: Up to Day 29

Measure: Time to Cessation of Viral Shedding by Virus Titer and by RT-PCR

Time: Day 1 - Day 29

Measure: Change from Baseline in Influenza Virus Titer and in the Amount of Virus RNA (RT-PCR) at Day 2, 4, 6, 10, 15, 29

Time: Baseline, Day 2, 4, 6, 10, 15, 29

Measure: Percentage of Participants with Positive Influenza Virus Titer and Positive by RT-PCR at Day 2, 4, 6, 10, 15, 29

Time: Day 2, 4, 6, 10, 15, 29

Measure: Area Under the Curve in Virus Titer and in the Amount of Virus RNA (RT-PCR)

Time: Day 1 - Day 29
7 A Pragmatic Assessment of Influenza Vaccine Effectiveness in the DoD

A total of 15,000 eligible subjects (or 5,000subject distributed evenly between the 3 study arms) will be enrolled. Eligible subjects will be randomized in 1:1:1 (cell-culture-based vaccine, the recombinant vaccine, or the egg-based vaccine) over two influenza seasons (2018-2019, 2019-2020, 2020-2021).

NCT03734237
Conditions
  1. Influenza
  2. Influenza-like Illness
Interventions
  1. Biological: Egg based influenza vaccines
  2. Biological: Recombinant influenza vaccines
  3. Biological: Cell-culture based influenza vaccines
MeSH:Influenza, Human

Primary Outcomes

Description: Laboratory-confirmed influenza as ascertained by a sensitive and specific assay is needed to assess effectiveness.

Measure: Laboratory confirmed influenza attack rates

Time: Onset > 13 days after vaccination up to 1 year

Secondary Outcomes

Description: A subset of volunteers may participate it in this outcome.

Measure: Hemagglutination Inhibition (HI) titer responses to vaccine and circulating strains of influenza

Time: Baseline to 21-35 days post vaccine

Description: A subset of volunteers may participate it in this outcome.

Measure: Pseudovirion neutralization (PVN) responses to vaccine and circulating strains of influenza

Time: Baseline to 21-35 days post vaccine

Description: A subset of volunteers may participate it in this outcome.

Measure: Anti-Neuraminidase (Anti-NA) titer responses to vaccine and circulating strains of influenza

Time: Baseline to 21-35 days post vaccine

Description: A subset of volunteers may participate it in this outcome.

Measure: Cellular Responses: Frequency of antigen specific CD4 and CD8 cells, B cells

Time: Baseline to 21-35 days post vaccine

Measure: Rate of Influenza-like Illness

Time: Onset > 13 days after vaccination up to 1 year

Measure: Frequency of influenza confirmed hospitalization

Time: Onset > 13 days after vaccination up to 1 year

Measure: Number of duty (work) days lost due to Influenza-like Illness

Time: Onset > 13 days after vaccination up to 1 year

Other Outcomes

Description: Endpoints: incidence of COVID-19 incidence of co-infection with influenza & Severity of COVID-19, symptoms associated with COVID-19 infection (compared with influenza, other respiratory viruses)

Measure: Tertiary Arm- Assess the burden of covid-19 and explore the inter-relationship between influenza and covid-19

Time: onset >13 days after vaccination
8 A Phase IIIB, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Clinical Efficacy Study of Baloxavir Marboxil for the Reduction of Direct Transmission of Influenza From Otherwise Healthy Patients to Household Contacts

Otherwise 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.

NCT03969212
Conditions
  1. Influenza
Interventions
  1. Drug: Baloxavir Marboxil
  2. Drug: Placebo
MeSH:Influenza, Human

Primary Outcomes

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)

Secondary Outcomes

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)

Measure: Percentage of IPs With Adverse Events (AEs)

Time: Baseline to Day 9 (≥12 years old) and Day 21 (<12 years old)

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 9

Description: 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 9
9 Persuasion in Medicine: Experimental Evidence on Sender and Signal Effects

The aim of the study is to identify what sender/signal combinations are most persuasive in encouraging low socioeconomic males living in the U.S. to take-up seasonal flu vaccination. The investigators plan to recruit male subjects and randomly assign them to four persuasion treatments: three of which vary dimensions of the sender of a medical recommendation (racial concordance, gender concordance, and authority treatments) and one which varies the signal (standard vs. empathetic). Specifically, the investigators will show subjects videos of either Black or white actors/actresses providing scripted information on the flu vaccination. The investigators will randomize the race of the sender and if the subject is Black, also randomize the authority of the sender, with the actor portraying either a doctor or a layperson. Conditional on project funding, subjects assigned to a concordant sender will have the gender of the sender randomized. In addition, the investigators will vary the script used in the experiment between one that acknowledges past injustices (indicated as an empathetic script hereafter) and one that does not (indicated as a standard script hereafter). The investigators will provide subjects a free flu shot coupon and elicit the price at which subjects would be willing to give up this coupon for a cash reward. Lastly, in light of the relevance of vaccination take-up in combating COVID-19 pandemic, the investigators will assess demand for information about a COVID-19 vaccine, with subjects invited to receive results of a safety and efficacy review from a trusted or standard source. The design requires collection of baseline and endline surveys combined with administrative data from pharmacies about coupon redemption. The primary outcomes of interest are posterior beliefs about seasonal flu vaccination, demand and willingness-to-pay (WTP) for a free flu shot coupon, redemption of the coupon, and demand for information about a COVID-19 vaccine.

NCT04160975
Conditions
  1. Flu, Human
  2. Influenza, Human
  3. Covid19
Interventions
  1. Behavioral: Video about safety and effectiveness of adult seasonal flu vaccination
  2. Behavioral: Message directing subjects to information on COVID-19 vaccine safety and efficacy
MeSH:Influenza, Human

Primary Outcomes

Description: The investigators will examine whether a subject updated their beliefs about the risk and benefits of the flu shot after watching the infomercial video.

Measure: Posterior beliefs about the risk/benefits of the flu shot

Time: This outcome will be assessed during Baseline survey, which takes approximately 20 minutes.

Description: The investigators will examine whether subjects invited to receive information on COVID-19 vaccine safety and efficacy from a concordant source exhibited higher demand for such information.

Measure: Demand for information about a COVID-19 vaccine

Time: This outcome will be assessed during Baseline survey, which takes approximately 20 minutes.

Description: The investigators will elicit and measure a subject's flu shot coupon valuations.

Measure: Willingness-to-pay (WTP) for a free flu shot coupon

Time: This outcome will be assessed during Baseline survey, which takes approximately 20 minutes.

Description: The investigators will measure a subject's level of attention and recall from the infomercial video, which could potentially affect their belief updating and decisions on coupon redemption.

Measure: Level of attention and recall from the infomercial video during Baseline survey

Time: This outcome will be assessed during Baseline survey, which takes approximately 20 minutes.

Description: The investigators will measure a subject's level of attention and recall from the infomercial video, which could potentially affect their belief updating and decisions on coupon redemption.

Measure: Level of attention and recall from the infomercial video during Endline survey

Time: This outcome will be assessed during Endline survey, which takes approximately 2 weeks to 3 months after the intervention (depending on the characteristics of the flu season).

Description: The investigators will collect information indicating whether a subject redeemed a flu shot coupon after watching the infomercial video.

Measure: Redemption of said coupon

Time: This outcome will be assessed during the time between Baseline and Endline survey (approximately 2 weeks to 3 months time gap, depending on the characteristics of the flu season).
10 Detection of Influenza or SARS-CoV-2 Infection by IMS of Nasal Air Sampling

Multicapillary Ion mobility spectrometry of nasal air aspirates shall be investigated as screening tool for the detection of Influenza and SARS-CoV-2- infection.

NCT04282135
Conditions
  1. Influenza
Interventions
  1. Diagnostic Test: MCC IMS
MeSH:Influenza, Human

Primary Outcomes

Description: Cluster Analysis of MCC IMS spectra will be obtained immediately after sampling

Measure: Cluster Analysis of MCC IMS spectra.

Time: immediatly after sampling
11 A Phase IIb Randomized Placebo-Controlled Study to Examine the Efficacy and Safety of DAS181 for the Treatment of Severe Influenza Infection

This 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.

NCT04298060
Conditions
  1. Influenza Infection
  2. SAD-RV Infection and COVID-19
Interventions
  1. Drug: DAS181
  2. Drug: Placebo
MeSH:Infection Communicable Diseases Influenza, Human

Primary Outcomes

Description: Percent of subjects who have returned to room air

Measure: Percent of subjects who have returned to room air

Time: 7 days

Description: 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 days
12 The Benefits of Artificial Intelligence Algorithms (CNNs) for Discriminating Between COVID-19 and Influenza Pneumonitis in an Emergency Department Using Chest X-Ray Examinations

This 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

NCT04313946
Conditions
  1. COVID-19
  2. Pneumonia, Viral
  3. Influenza With Pneumonia
  4. Flu Symptom
  5. Flu Like Illness
  6. Pneumonia, Interstitial
  7. Pneumonia, Ventilator-Associated
  8. Pneumonia Atypical
Interventions
  1. Diagnostic Test: Scanning Chest X-rays and performing AI algorithms on images
MeSH:Pneumonia, Ventilator-Associated Influenza, Human Pneumonia, Viral Pneumonia Lung Diseases, Interstitial
HPO:Abnormal pulmonary Interstitial morphology Interstitial pneumonitis Pneumonia

Primary Outcomes

Description: Number of participants with pneumonitis on Chest X-Ray and COVID 19 positive

Measure: COVID-19 positive X-Rays

Time: 6 months

Description: Number of participants with pneumonitis on Chest X-Ray and COVID 19 negative

Measure: COVID-19 negative X-Rays

Time: 6 months
13 Evaluation of Influenza Vaccination and Treatment With ACEI and ARB in the Evolution of SARS-Covid19 Infection

Some 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.

NCT04367883
Conditions
  1. COVID19
  2. Influenza Vaccination
  3. ACE Inhibitors
  4. ARB
Interventions
  1. Drug: ACE inhibitor
  2. Drug: ARB
MeSH:Influenza, Human

Primary Outcomes

Description: exitus vs hospital output

Measure: hospital output

Time: from March 1, 2020.

Secondary Outcomes

Description: lenght of the hospital stay

Measure: hospital stay

Time: From March 1, 2020.
14 Safety and Immunogenicity of Quadrivalent Recombinant Influenza Vaccine Formulations Containing Different H3 Hemagglutinin Antigens Without or With Adjuvant in Healthy Adult Subjects

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.

NCT04451954
Conditions
  1. Influenza
Interventions
  1. Biological: Quadrivalent RIV with H3 strain 1
  2. Biological: Quadrivalent RIV with H3 strain 1 and adjuvant
  3. Biological: Quadrivalent RIV with H3 strain 2
  4. Biological: Quadrivalent RIV with H3 strain 2 and adjuvant
  5. Biological: Quadrivalent RIV with 2018-2019 NH H3 strain
  6. Biological: Quadrivalent RIV with 2018-2019 NH H3 strain and adjuvant
MeSH:Influenza, Human

Primary Outcomes

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 vaccination

Description: 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 7

Description: 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 28

Description: Serious adverse events are collected throughout the study

Measure: Number of participants with serious adverse events

Time: From Day 0 to Day 365

Description: 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 365

Description: 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 7

Description: 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 365

Description: 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 90

Description: 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 28

Description: Influenza vaccine antibody titers are measured by HAI assay

Measure: HAI Ab titer ≥ 40 [1/dil]

Time: From Day 0 to Day 365

Description: 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 28

Secondary Outcomes

Description: 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 365

Description: 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 90

Description: 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 28

Description: 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 365
15 Pulmonary Tomographic Findings in COVID-19 and Influenza H1N1 Patients

The 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.

NCT04497311
Conditions
  1. SARS-CoV-2
  2. Covid19
  3. H1N1 Influenza
  4. Computed Tomography
Interventions
  1. Diagnostic Test: Thoraxic computed tomography
MeSH:Influenza, Human

Primary Outcomes

Description: Lung CT radiological patterns associated with COVID-19 or Influenza H1N1

Measure: Radiological findings

Time: 24 hours

Secondary Outcomes

Description: Intrahospital and overall survival at 28 days from hospital admission.

Measure: Survival

Time: 28 days
16 Pulmonary Tomographic Findings in COVID-19 and Influenza H1N1 Patients at IMSS Guanajuato

The 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.

NCT04499378
Conditions
  1. Covid19
  2. Influenza A H1N1
  3. Intubation Complication
  4. Morality
  5. Lung Injury, Acute
Interventions
  1. Diagnostic Test: Lung CT
MeSH:Influenza, Human Lung Injury Acute Lung Injury

Primary Outcomes

Description: Need for oral intubation within the first 10 days.

Measure: Oral intubation

Time: 10 days

Secondary Outcomes

Description: 28-day survival analysis using the Kaplan Meyer and Cox regression models.

Measure: Survival

Time: 28 days
17 Influence of Prior Infection With COVID-19 on Occurrence of Influenza-like Illness or Acute Respiratory Infection (PICOV) A Multicentre Academic Prospective Cohort Study in Nursing Home During the Winter Season 2020-2021

Background: 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.

NCT04527614
Conditions
  1. Influenza, Human
  2. SARS Virus
  3. COVID-19
  4. Espiratory Tract Infections
Interventions
  1. Diagnostic Test: qRT-PCR and serology
MeSH:Infection Communicable Diseases Respiratory Tract Infections Influenza, Human
HPO:Respiratory tract infection

Primary Outcomes

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 months

Secondary Outcomes

Measure: Number of patients with ILI or ARI, diagnosed with COVID-19, influenza, RSV

Time: up to 8 months

Measure: Validation of (SimplySpiro) to replace nasopharyngeal swabs

Time: up to 8 months

Measure: Identify the antibody characteristics in participants with reinfection with SARS-CoV-2

Time: up to 8 months

Description: 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 months

Measure: Correlation of the level of neutralization antibodies against influenza subtypes with protection against influenza reinfection

Time: up to 8 months
18 Influenza 2020/2021. A Survey to Assess How People's Political Attitudes and Messages Influence Their Behavioral Intentions in the United Kingdom.

As 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.

NCT04546854
Conditions
  1. Influenza Vaccine
Interventions
  1. Behavioral: Appeals
MeSH:Influenza, Human

Primary Outcomes

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 day
19 Evaluation of Cell-mediated and Humoral Immunity Following COVID-19 in Pregnancy

The proposed study is designed to investigate if and how pregnant women infected with Coronavirus Disease-19 (COVID-19) infection go on to develop long-term immunity. In December 2019, a group of people in Wuhan, China presented with symptoms of a pneumonia of an unknown cause that led to the discovery of a new coronavirus called COVID-19. COVID-19 has caused a global pandemic with 7,140,000 confirmed cases and 418,000 deaths as of 13th June 2020. In the United Kingdom (UK), there have been 294,000 cases and 41,662 deaths as of 13th June 2020. In humans, this infection primarily involves the upper part of the lungs, but it can also affect other organs. It causes mild symptoms in the majority of people affected but some people can have severe infections, with some even requiring critical care in hospital. During Severe acute respiratory syndrome (SARS), a previous coronavirus epidemic, pregnant women were disproportionately affected with severe illness. Understanding how the immune system responds long-term to this infection may hold the key to developing better vaccines and efficient treatment plans. Specialised immunity develops when individuals are infected by this and other viruses. The investigators of this study propose that, in pregnancy, this specialised immunity may not behave effectively. This may affect their ability to develop long lasting immunity and make them more vulnerable to re-infection. In this study, the investigators aim to recruit patients across 6 groups including COVID-19 newly infected pregnant women, and people with differing illness severity, mild to moderate, severe/critical, no infection (controls), as well as pregnant women with influenza and those receiving influenza vaccine. The study team will compare COVID-19 in pregnancy with non-pregnant infected and with influenza infected and vaccinated pregnant women. The study team will consent patients in all of these groups to provide a series of blood samples at different time points in a 12-month period.

NCT04568044
Conditions
  1. COVID-19
  2. Pregnancy Related
  3. Influenza, Human
Interventions
  1. Procedure: Blood sample
MeSH:Influenza, Human

Primary Outcomes

Description: Devise a flow cytometry panel to phenotype B cells.

Measure: Phenotyping antibody secreting cells (ASCs) and memory B cells during COVID-19 infection, and post recovery.

Time: Groups A, B, D: Between 4 months with a minimum of 2 time points (i.e. 8 and 12 months), and 12 months with a maximum 5 time points (i.e. 7-14 days, then 1, 4, 8, 12 months) post infection. Group C: 1 day. 1 time point.

Description: B cell ELISpot assay and quantify Immunoglobulin A (IgA) and IgG using Enzyme-linked immunosorbent assay (ELISA) from plasma and/or serum from COVID-19 recovered individuals.

Measure: Quantification of SARS-CoV-2 specific IgG production by memory B cells to measure long-lasting immune protection against re-infection.

Time: Groups A, B, D: Between 4 months with a minimum of 2 time points (i.e. 8 and 12 months), and 12 months with a maximum 5 time points (i.e. 7-14 days, then 1, 4, 8, 12 months) post infection. Group C: 1 day. 1 time point.

Secondary Outcomes

Description: Use real-time PCR (RT-PCR) and nested PCR to detect SARS-CoV-2 viral load

Measure: Quantification of SARS-COV-2 viral load using PCR.

Time: Groups A, B, D: at 7-14 days and during recovery phase. Group C: 1 day. 1 time point.

Description: Devise a flow cytometry panel to phenotype cTFH cells.

Measure: Immuno-phenotype circulatory T follicular helper cells (cTFH) cells post SARS-CoV-2 infection.

Time: Groups A, B, D: at 7-14 days post infection or vaccination. Group C: 1 day. 1 time point.

Description: Use a combination of flow cytometry, enzyme-linked immunospot (ELISpot) assays, and DNA/RNA analysis.

Measure: Investigating T cell mediated immune function post COVID-19

Time: Groups A, B, D: Between 4 months with a minimum of 2 time points (i.e. 8 and 12 months), and 12 months with a maximum 5 time points (i.e. 7-14 days, then 1, 4, 8, 12 months) post infection/vaccination. Group C: 1 day. 1 time point.

Description: Parameters including antibody titres, cTFH and memory B cell and ASC proportions, and T cell function will be compared between COVID-19 infected, and influenza infected and vaccinated pregnant women.

Measure: In pregnancy, comparing antibody production, and immune phenotype and function (as outlined above) between COVID-19 infection, and influenza infected or vaccinated.

Time: Groups A, B, D, E and F: Between 4 months with a minimum of 2 time points (i.e. 8 and 12 months), and 12 months with a maximum 5 time points (i.e. 7-14 days, then 1, 4, 8, 12 months) post infection/vaccination. Group C: 1 day. 1 time point.
20 Broadening Our Understanding of Early Versus Late Influenza Vaccine

This study uses a prospective cohort design to investigate if the seasonal influenza vaccine is equally effective when given early and late before the proceeding influenza season. All health care workers will be vaccinated for seasonal influenza either 3 months before or 1 month prior to the start of the influenza season. HCWs that consent to take part in the study will have 4 blood samples taken for an antibody check. The initial antibody checks will be done just prior to vaccination as well as 2 weeks after vaccination. Subsequent samples will be taken at the peak of influenza season and at the end of the influenza season. HCWs that develop ILI during the course of the influenza season will be asked to complete a questionnaire and oropharyngeal self-swab. HCWs will also provide exhaled breath samples and wear a mask in order to evaluate novel non-invasive methods for diagnosis of influenza. Influenza positive and negative inpatients identified through the University of Leicester's laboratory system will also be asked to provide breath samples to evaluate this technique for the diagnosis of influenza.

NCT04570904
Conditions
  1. Influenza
  2. Influenza -Like Illness
Interventions
  1. Biological: Influenza vaccination at different time points
MeSH:Influenza, Human

Primary Outcomes

Description: Difference in antibody titres at set time points during the 2020/21 influenza season in HCWs stratified by those who are vaccinated early and late

Measure: Difference in antibody titre

Time: Antibody titres to be analysed at the end of the study once all samples collected - estimated May 2021

Secondary Outcomes

Description: The number of laboratory-confirmed influenza infections by real time PCR in HCWs vaccinated early and late

Measure: Influenza infections

Time: Influenza positive swabs to be analysed at the end of the study once all samples collected - estimated May 2021

Description: The detection of markers of influenza infection in breath samples using GC-IMS, eNose and GC-MS

Measure: Breath analysis for influenza diagnosis

Time: Results to be analysed post influenza season - estimated May 2021

Description: The detection of influenza by PCR using a novel mask sampling technique

Measure: Mask sampling for influenza diagnosis

Time: Results to be analysed post influenza season - estimated May 2021
21 The Dynamics of the Immune Responses to Repeat Influenza Vaccination Exposures (DRIVE) Study - a Randomized Controlled Trial

The aims of this vaccine trial are: (1) to measure humoral and selected cellular immune responses to repeated influenza vaccination with Flublok, including these responses' associations with age, birth year, and prior vaccination history; (2) to identify the characteristics of study participants who are vaccinated but still become infected with influenza virus ("vaccine failures") and participants who have poor immune responses to vaccination; and (3) to predict how influenza vaccinations and infections shape immunity.

NCT04576377
Conditions
  1. Influenza, Human
Interventions
  1. Biological: FluBlok
  2. Other: Placebo
MeSH:Influenza, Human

Primary Outcomes

Description: The proportion of participants who achieve a target rise in antibody titre against each of the vaccine strains at 30 days (the targeted rise in antibody titre is defined as the proportion of participants with a four-fold or greater rise in titer, i.e. either a pre-vaccination hemagglutination inhibition titer <10 and a post-vaccination hemagglutination inhibition titre ≥20, or a pre- vaccination hemagglutination inhibition titer ≥10 and at least a four-fold rise in post-vaccination hemagglutination inhibition antibody titer)

Measure: Immune response to vaccination (4-fold rise in titer at day 30)

Time: 30 days after vaccination

Description: The geometric mean titer (GMT) ratios between the vaccine group and the comparator group (placebo) against each of the vaccine strains at 30 days and 182 days

Measure: Immune response to vaccination (GMT ratio at day 30 and 182)

Time: 30 days and 182 days after vaccination

Secondary Outcomes

Description: The proportion of participants who achieve an HAI titer ≥40 after each vaccination (or neutralization assay for H3N2 and any other non-hemagglutinating strains).

Measure: Immune response to vaccination (antibody titer >=40 at day 30 and 182)

Time: 30 days and 182 days after vaccination

Description: The vaccine-induced influenza-specific CD4+ and CD8+ T cell responses 7 and 30 days post-vaccination, including cytokine production evaluated by Intracellular Cytokine Staining (ICS) assay. Responses for these and other relevant biomarkers are compared to the corresponding pre-vaccination values for each participant.

Measure: Immune response to vaccination (cell-mediated immunity)

Time: 7 days and 30 days after vaccination

Description: The fine-grained specificity and phenotypes of antibodies and influenza-positive B and T cell populations before and after vaccination and natural infection.

Measure: Immune response to vaccination (antibody specificity)

Time: 30 days and 182 days after vaccination

Description: The rate of adverse events within 30 days after receipt of vaccination or placebo

Measure: Incidence of reactions after vaccination [Safety]

Time: 30 days after vaccination

Description: The rate of polymerase chain reaction (PCR)-confirmed influenza virus infection.

Measure: Incidence of laboratory-confirmed influenza after vaccination (vaccine failure)

Time: One year after vaccination

Description: The occurrence of other respiratory infections, including COVID-19 infections, in participants, determined by PCR or serology

Measure: Incidence of other respiratory infections

Time: One year after vaccination
22 VRC 323: A Phase I Open-Label Clinical Trial to Evaluate the Dose, Safety, Tolerability and Immunogenicity of an Influenza H10 Stabilized Stem Ferritin Vaccine, VRC-FLUNPF0103-00-VP, in Healthy Adults

Background: Influenza (flu) is a contagious respiratory illness. It is caused by influenza viruses that infect the nose, throat, and lungs. Some people, such as older people, young children, and people with certain health conditions, are at high risk of serious flu complications. Researchers want to test a vaccine to prevent flu. Objective: To see if the H10 Ferritin vaccine is safe and how the body responds to it. Eligibility: Healthy adults ages 18-70. Design: Participants will be screened with: Medical history Physical exam Blood tests Pregnancy test (if needed). Participants will get 1-2 injections of the study vaccine in the upper arm. They will stay in the clinic for at least 30 minutes after each vaccination. Participants will keep a diary card for 7 days after each vaccination. They will record their temperature and any symptoms. They will measure any skin changes at the injection site. Participants may have nose and throat secretions, and/or oral mucosal samples, collected with a disposable swab. Participants will have blood drawn. Some participants may have apheresis. A needle is placed into a vein in both arms. Blood is removed through a needle in the vein of one arm. The blood is spun in a machine that separates the white blood cells. The rest of the blood is returned to the participant through a needle in the other arm. Before apheresis, participants weight, pulse, and blood pressure will be checked. Their medical history will be taken. Participants will have 8-10 follow-up visits. Participation will last about 10 months.

NCT04579250
Conditions
  1. Influenza
Interventions
  1. Biological: VRC-FLUNPF0103-00-VP VRC-FLUNPF0103-00-VP (H10ssF-6473)
MeSH:Influenza, Human

Primary Outcomes

Description: Occurrence of local reactogenicity signs and symptoms

Measure: Local Reactogenicity

Time: 7 days after each product administration

Description: Occurrence of systemic reactogenicity signs and symptoms

Measure: Systemic Reactogenicity

Time: 7 days after each product administration

Description: Occurrence of laboratory safety measures

Measure: Laboratory measures

Time: Day O through 28 days post product administration

Description: Occurrence of serious adverse events

Measure: Serious adverse events

Time: Day O through Day 28O

Description: Occurrence of new-onset of chronic medical conditions

Measure: New chronic medical conditions

Time: Day O through Day 28O

Description: Occurrence of unsolicited non-serious adverse events

Measure: Unsolicited adverse events

Time: Day O through 28 days post product administration

Secondary Outcomes

Description: Stem-specific antibody responses to HlOssF-6473

Measure: Group 1: vaccine-induced antibodies

Time: Day O and 28 days post product administration

Description: Stem-specific antibody responses to HlOssF-6473

Measure: Group 2A-2B: vaccine-induced antibodies

Time: Day O and 2 weeks after each product administration
23 A Phase 2b Double-blind, Randomized, Placebo-controlled, Parallel-group Study of the Efficacy and Safety of Norketotifen (NKT) in the Treatment of Acute Uncomplicated Influenza-like Illness (ILI)

This is a Phase 2b, multi-center, double-blind, randomized, placebo-controlled, parallel-group study of NKT versus placebo in otherwise healthy adults presenting with acute uncomplicated ILI due to influenza or other respiratory viruses in a community setting.

NCT04610047
Conditions
  1. Influenza
  2. Influenza -Like Illness
Interventions
  1. Drug: Norketotifen
  2. Drug: Placebo
MeSH:Influenza, Human

Primary Outcomes

Description: Time to alleviation of the symptoms of ILI (headache, feverishness/chills, muscle/joint pain, fatigue, cough, sore throat, nasal congestion)

Measure: Time to alleviation of symptoms

Time: 14 days

Secondary Outcomes

Measure: Time to resolution of fever (body temperature equal to or less than 37ºC)

Time: 14 days

Measure: Proportion of subjects whose symptoms have been alleviated at each time point through Day 14

Time: 14 days

Measure: Change from baseline in composite symptom score at each time point through Day 14

Time: 14 days

Measure: Body temperature at each time point through Day 14

Time: 14 days

Measure: Time to alleviation of individual symptoms (headache, feverishness/chills, muscle/joint pain, fatigue, cough, sore throat, nasal congestion)

Time: 14 days

Measure: Time to resumption of normal activity

Time: 14 days

Measure: Use of rescue medication (acetaminophen)

Time: 14 days

Measure: Time to alleviation of symptoms by confirmed viral pathogen (influenza vs non influenza)

Time: 14 days

Measure: Time to resolution of fever by confirmed viral pathogen (influenza vs non influenza)

Time: 14 days
24 Comparison of High vs. Standard Dose Influenza Vaccines in Adult Solid Organ Transplant Recipients

The influenza virus is a significant cause of morbidity in adult solid organ transplant (SOT) recipients. However, these individuals show a suboptimal response to vaccines including the standard-dose (SD) inactivated influenza vaccine (IIV). Recent studies have investigated two strategies to overcome poor immune responses in SOT recipients: (1) administration of high-dose (HD)-IIV compared to SD-IIV and (2) two doses of SD-IIV compared to one dose of SD-IIV in the same influenza season. The first study compared HD-IIV vs. SD-IIV in adult SOT and noted HD-IIV was safe and reported higher immunogenicity; however, the median post-transplant period was 38 months. In another phase II trial of adult SOT recipients, two doses of SD-IIV a month apart compared to one-dose SD-IIV revealed increased immunogenicity, with a median post-transplantation period of 18 months. Therefore, these studies lack evaluation in the early post-transplantation period in this vulnerable population when influenza disease is most severe. The administration of two-doses of HD-IIV in the same influenza season has also not been studied in SOT recipients. Moreover, the vast majority of SOT influenza vaccinations studies have not substantively evaluated prolonged immunogenicity. Thus, the optimal immunization strategy for SOT recipients less than 12 months post-transplant is poorly-defined. In addition, the immunologic predictors and correlates of influenza vaccine immunogenicity in SOT recipients have not been defined. The investigators hypothesize that adult solid organ transplant recipients that are 1-11 months out from transplant and are receiving high-dose inactivated influenza vaccine will have higher hemagglutination inhibition (HAI) geometric mean titers to influenza A antigens compared to adult SOT recipients receiving standard-dose inactivated influenza vaccine. To test this hypothesis and address the above critical knowledge gaps, The investigators propose to conduct a phase II multicenter randomized controlled trial comparing either two doses HD-IIV, two doses of SD-IIV, or one-dose of HD-IIV in adult kidney, heart, and liver SOT recipients 1-11 months post-transplantation. The results of this study will address significant gaps in knowledge regarding influenza vaccine strategies and immune responses in adult SOT recipients and will guide vaccine recommendations in this vulnerable population.

NCT04613206
Conditions
  1. Immunization; Infection
  2. Transplantation Infection
  3. Influenza
  4. Solid Organ Transplant
Interventions
  1. Biological: High Dose Quadrivalent Inactivated Influenza Vaccine
  2. Biological: Standard Dose Quadrivalent Inactivated Influenza Vaccine
MeSH:Infection Communicable Diseases Influenza, Human

Primary Outcomes

Description: Antibody titers will be measured by hemagglutination inhibition assay.

Measure: Geometric Mean Titers of influenza vaccine antibodies.

Time: Day 56 (post-vaccination)

Description: Post-vaccination local adverse events (pain, tenderness, swelling/induration, erythema/redness, swelling/induration size, and erythema/redness size) and systemic adverse events (Fatigue/malaise, headache, nausea, body ache/myalgia (not at the injection site), general activity level, vomiting, and fever).

Measure: The number of participants reporting solicited injection site reactions and systemic reactions.

Time: Within 7 days post-vaccination

Secondary Outcomes

Description: Antibody titers will be measured by hemagglutination inhibition assay.

Measure: Geometric Mean Titers Ratio of influenza vaccine antibodies (post-/pre-vaccination).

Time: Day 56 (post-vaccination)

Description: Antibody titers will be measured by hemagglutination inhibition assay. Seroconversion is defined as ≥ 4-fold rise in hemagglutination inhibition assay titers. Seroprotection is defined as ≥1:40 hemagglutination inhibition assay titer.

Measure: The number of participants achieving seroprotection and seroconversion for influenza virus.

Time: Day 56 (post-vaccination)
25 Randomized, Partially-Blinded, Active Comparator-Controlled, Dose-Ranging, Safety, Tolerability, and Immunogenicity Phase 1/2 Study of an Adjuvanted Seasonal Recombinant QVLP Influenza Vaccine in Adults 65 Years of Age and Older

This randomized, partially-blinded, active comparator-controlled will be conducted at multiple sites. The composition of QVLP to be used in this study includes a mix of recombinant H1, H3, and two B hemagglutinin proteins expressed as VLPs and will be based on the 2020-2021 influenza virus strains. Approximately 400 healthy male and female subjects 65 years of age and older will be enrolled evenly into one of eight parallel treatment groups and subjects will be stratified by age into two groups (65 to 74 years of age and 75 years of age and older) in a 2:1 ratio. Three dose levels of QVLP (15 µg/strain, 30 µg/strain, and 45 µg/strain) will be tested with the adjuvant AS03. The 30 µg/strain is the full dose of QVLP and the 15 µg/strain dose has been included to assess a possible dose-sparing effect in combination with the adjuvant AS03. Subjects will participate in this study approximatly 12 months, during which a first visit will be scheduled on Day 0 for screening and vaccine administration.

NCT04622592
Conditions
  1. Influenza
Interventions
  1. Biological: Instramuscular vaccine
MeSH:Influenza, Human

Primary Outcomes

Description: Percentage, intensity and relationship to vaccination of immediate adverse events (AEs)

Measure: Immediate adverse event (AEs)

Time: 30 minutes

Description: Percentage, intensity, and relationship to vaccination of solicited local and systemic adverse events (AEs) following vaccination

Measure: Solicited local and systemic adverse events (AEs)

Time: Day 7

Description: Percentage, intensity and relationship of unsolicited adverse events (AEs) following vaccination

Measure: Unsolicited adverse events (AEs)

Time: Day 28

Description: Number and percentage of subjects with normal and abnormal, clinically significant urine, haematological and blood biochemistry values, and urinalysis

Measure: Safety labs

Time: Day 28

Description: Occurrences of serious adverse events (SAEs), adverse events (AEs) leading to withdrawal, adverse events of special interest (AESIs), medically attended adverse event (MAAEs), new onset of chronic disease (NOCDs) and deaths from day 183 up to the end of the study (day 365)

Measure: Serious adverse events (SAEs), adverse events (AEs) leading to withdrawal, adverse events of special interest (AESIs), medically attended adverse event (MAAEs), new onset of chronic disease (NOCDs) and deaths

Time: Day 0 to 365

Description: HI antibody response induced by adjuvanted and unadjuvanted QVLP and Fluzone HD Quad against the homologous influenza strains on Day 28, compared to Day 0 values. HI antibody titers will be analyzed using the following parameters: geometric mean titers (GMT), seroconversion (SC) rate, seroprotection (SP) rate, and geometric mean fold rise (GMFR).

Measure: HI antibody response induced by adjuvanted and unadjuvanted QVLP and Fluzone HD Quad against the homologous influenza strain

Time: Day 28

Secondary Outcomes

Description: MN antibody response induced by adjuvanted and unadjuvanted QVLP and Fluzone HD Quad against the homologous influenza strains on Day 28, compared to Day 0 values. MN antibody titers will be analyzed using the following parameters: GMT, SC rate, and GMFR

Measure: MN antibody response induced by adjuvanted and unadjuvanted QVLP and Fluzone HD Quad against the homologous influenza strains

Time: Day 28

Description: HI antibody response induced by adjuvanted and unadjuvanted QVLP and Fluzone HD Quad against the heterologous influenza strains on Day 28, compared to Day 0 values. HI antibody titers will be analyzed using the following parameters: GMT, SC rate, SP rate, and GMFR

Measure: HI antibody response induced by adjuvanted and unadjuvanted QVLP and Fluzone HD Quad against the heterologous influenza strains

Time: Day 28

Description: Durability of antibody responses, as determined by HI and MN titers against homologous influenza strains (6 and 12 months post-vaccination)

Measure: Durability of antibody responses

Time: 12 months
26 Study of Antiviral Therapy of Influenza and ARVI With Kagocel ® in Children

This study examined the etiology of acute respiratory viral infections (ARVI) during the 2015-2016 season, evaluated the statistics of the incidence of influenza and ARVI in this period (epidemiology: severity of the disease and bacterial exacerbations; demographics of patients; duration and timing of treatment; safety; quality of treatment), and evaluated the effectiveness of complex therapy with an emphasis on the using of interferon inducers in hospitalized children aged 3 to 11 years.

NCT04651491
Conditions
  1. Influenza
  2. Acute Upper Respiratory Infection
Interventions
  1. Drug: Kagocel
MeSH:Infection Respiratory Tract Infections Influenza, Human
HPO:Respiratory tract infection

Primary Outcomes

Description: Identification of respiratory viruses such as influenza a and b, human respiratory syncytial virus, parainfluenza viruses of types 1-4, coronaviruses, metapneumoviruses, rhinoviruses, adenoviruses of groups B, C, E, and bokaviruses, and assessment of the duration of their isolation

Measure: Changes in the number of respiratory viruses in nasopharyngeal smears by multiplex PCR

Time: 2 points: day of hospitalization and 5-6 day of treatment

Measure: Duration and severity of fever in patients with influenza and in patients with ARVI

Time: up to 7 days (at least)

Description: Intoxication syndrome: drowsiness, muscle pain, weakness, sweating, chills, eye pain, headache. Catarrhal syndromes: pharyngeal hyperemia, cough, rhinorrhea, nasal congestion, sore throa. Qualitative signs were evaluated in points-absence of a sign-0 points, weakly expressed sign - 1 point, medium (moderate) expressed-2 points, bright (strongly) expressed-3 points

Measure: The dynamics and the severity of intoxication and catarrhal syndromes in patients with influenza and in patients with ARVI

Time: up to 7 days (at least)

Description: Number of patients with intoxication syndrome (drowsiness, muscle pain, weakness, sweating, chills, eye pain, headache), catarrhal syndromes (pharyngeal hyperemia, cough, rhinorrhea, nasal congestion, sore throa) and fever

Measure: Number of participants with symptoms of ARVI or influenza

Time: up to 7 days (at least)

Measure: Number of participants who required antibiotic therapy

Time: up to 7 days (at least)

Measure: Number of participants with ARVI and influenza complications

Time: up to 7 days (at least)

Secondary Outcomes

Measure: Number of participants with treatment-related adverse events (AE) with regards to type and severity of AE (mild, moderate, severe; according to physician's opinion)

Time: up to 7 days (at least)
27 Predicting Severity and Disease Progression in Influenza-like Illness

Respiratory infections such as colds, flu and pneumonia affect millions of people around the world every year. Most cases are mild, but some people become very unwell. Influenza ('flu') is one of the most common causes of lung infection. Seasonal flu affects between 10% and 46% of the population each year and causes around 12 deaths in every 100,000 people infected. In addition, both influenza and coronaviruses have caused pandemics in recent years, leading to severe disease in many people. Although flu vaccines are available, these need to change every year to overcome rapid changes in the virus and are not completely protective. This study aims to find and develop predictive tests to better understand how and when flu-like illness progresses to more severe disease. This may help to decide which people need to be admitted to hospital, and how their treatment needs to be increased or decreased during infection. The aim is to recruit 100 patients admitted to hospital due to a respiratory infection. It is voluntary to take part and participants can choose to withdraw at any time. The study will involve some blood and nose samples. This will be done on Day 0, Day 2 and Discharge from hospital, and an out-patient follow-up visit on Day 28. The data will be used to develop novel diagnostic tools to assist in rational treatment decisions that will benefit both individual patients and resource allocation. It will also establish research preparedness for upcoming pandemics.

NCT04664075
Conditions
  1. Influenza
  2. SARS (Severe Acute Respiratory Syndrome)
  3. Respiratory Viral Infection
  4. Respiratory Tract Infections
  5. Infection, Bacterial
  6. Infection Viral
  7. Covid19
  8. RNA Virus Infections
Interventions
  1. Biological: Respiratory infections
MeSH:Infection Communicable Diseases Respiratory Tract Infections Bacterial Infections Influenza, Human Virus Diseases Severe Acute Respiratory Syndrome Coronavirus Infec Coronavirus Infections RNA Virus Infections Disease Progression
HPO:Respiratory tract infection

Primary Outcomes

Description: The identity of pathological organisms associated with influenza-like illness (including respiratory viruses and bacteria) will be obtained from the patient's medical record

Measure: Describe the aetiology of influenza-like illness in hospitalised adults

Time: Day 0 to Day 28

Description: The following data will be collected from the patient's medical record. At enrolment, data will consist of: past medical history, clinical signs and symptoms relating to this admission, vital signs (pulse rate, blood pressure, temperature, oxygen saturation), demographics, drug history, laboratory results including diagnostic microbiological tests and interventions. Data collection on Day 28 will consist of clinical diagnosis at discharge, any febrile illness in the 7 days preceding the visit, mortality and complications between Day 0 and 28.

Measure: Describe the clinical outcomes of influenza-like illness in hospitalised adults

Time: Day 0 to Day 28

Secondary Outcomes

Description: Cytokine levels will be measured in plasma and nasal lining fluid samples by MesoScale Discovery

Measure: Identify changes in cytokine levels during influenza-like illness in hospitalised adults

Time: Day 0 to Day 28

HPO Nodes


HPO

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


HPO Nodes


Reports

Data processed on December 13, 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.

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Interventions

4,818 reports on interventions/drugs

MeSH

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HPO

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