Trial Outcomes & Findings for Assessment of Wearable Sensors During Experimental Human Influenza Infection (Sigma Plus) (NCT NCT04204993)
NCT ID: NCT04204993
Last Updated: 2023-08-21
Results Overview
Nasal wash viral load by quantitative polymerase chain reaction (qPCR)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
20 participants
Primary outcome timeframe
Baseline to day 28
Results posted on
2023-08-21
Participant Flow
20 healthy volunteers were enrolled in the study and followed up from the period 11th February 2020 to 17th May 2021. The study was suspended from March to August 2020 due to the global SARS-CoV-2 pandemic.
Participant milestones
| Measure |
Experimental: Influenza A
Participants were inoculated with Influenza A/Belgium/4217/2015 at a dose of 5x10\^5 TCID50 in a volume of 0,5mL via intranasal drops. They were monitored as in-patients for 10 days with daily clinical assessment and blood, respiratory tract sampling, and sensor monitoring. Following discharge, they were followed up for 6 months post-inoculation.
Lumee Oxygen Platform: Two sensors were inserted (one in the skin of the upper arm and one on the side of the chest). A wireless patch reader was placed on top of the skin over the area where the sensor was placed to measure local oxygen content.
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|---|---|
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Overall Study
STARTED
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20
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|
Overall Study
Group A
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4
|
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Overall Study
Group B
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6
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Overall Study
Group C
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6
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Overall Study
Group D
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4
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Overall Study
COMPLETED
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20
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Overall Study
NOT COMPLETED
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Assessment of Wearable Sensors During Experimental Human Influenza Infection (Sigma Plus)
Baseline characteristics by cohort
| Measure |
Experimental: Influenza A
n=20 Participants
Participants were inoculated with Influenza A/Belgium/4217/2015 at a dose of 5x10\^5 TCID50 in a volume of 0,5mL via intranasal drops. They were then monitored as in-patients for 10 days with daily clinical assessment and blood, respiratory tract sampling, and sensor monitoring. Following discharge, they were followed up for up to 6 months post-inoculation.
Lumee Oxygen Platform: Two sensors were inserted (one in the skin for the upper arm and one on the side of the chest). A wireless patch reader was placed on top of the skin over the area where the sensor was placed to measure local oxygen content.
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|---|---|
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Age, Categorical
<=18 years
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0 Participants
n=5 Participants
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Age, Categorical
Between 18 and 65 years
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20 Participants
n=5 Participants
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Age, Categorical
>=65 years
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0 Participants
n=5 Participants
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Sex: Female, Male
Female
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10 Participants
n=5 Participants
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Sex: Female, Male
Male
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10 Participants
n=5 Participants
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Race/Ethnicity, Customized
Ethnicity · White British
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7 Participants
n=5 Participants
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Race/Ethnicity, Customized
Ethnicity · White Irish
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2 Participants
n=5 Participants
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Race/Ethnicity, Customized
Ethnicity · White (all other)
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4 Participants
n=5 Participants
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Race/Ethnicity, Customized
Ethnicity · Black or Black British (African)
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1 Participants
n=5 Participants
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Race/Ethnicity, Customized
Ethnicity · Black or Black British (all other)
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1 Participants
n=5 Participants
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Race/Ethnicity, Customized
Ethnicity · Asian or Asian British (Indian)
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2 Participants
n=5 Participants
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Race/Ethnicity, Customized
Ethnicity · Asian or Asian British (Pakistani)
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1 Participants
n=5 Participants
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Race/Ethnicity, Customized
Ethnicity · Chinese
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1 Participants
n=5 Participants
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Race/Ethnicity, Customized
Ethnicity · All other ethnic groups
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1 Participants
n=5 Participants
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PRIMARY outcome
Timeframe: Baseline to day 28Population: One participant who was PCR positive for the challenge agent also tested positive for Rhinovirus on Day 4 post-inoculation therefore this participant was excluded from all further analyses.
Nasal wash viral load by quantitative polymerase chain reaction (qPCR)
Outcome measures
| Measure |
Experimental: Influenza A
n=20 Participants
Participants were inoculated with Influenza A/Belgium/4217/2015 at a dose of 5x10\^5 TCID50 in a volume of 0,5mL via intranasal drops. They were then monitored as in-patients for 10 days with daily clinical assessment and blood, respiratory tract sampling, and sensor monitoring. Following discharge, they were followed up for up to 6 months post-inoculation.
Lumee Oxygen Platform: Two sensors were inserted (one in the skin fo the upper arm and one on the side of the chest). A wireless patch reader was placed on top of the skin over the area where the sensor was placed to measure local oxygen content.
|
Group B
Participants were inoculated with Influenza A/Belgium/4217/2015 at a dose of 5x10\^5 TCID50 in a volume of 0,5mL via intranasal drops. They were then monitored as in-patients for 10 days with daily clinical assessment and blood, respiratory tract sampling, and sensor monitoring. Following discharge, they were followed up for up to 6 months post-inoculation.
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Group D
Participants were inoculated with Influenza A/Belgium/4217/2015 at a dose of 5x10\^5 TCID50 in a volume of 0,5mL via intranasal drops. They were then monitored as in-patients for 10 days with daily clinical assessment and blood, respiratory tract sampling, and sensor monitoring. Following discharge, they were followed up for up to 6 months post-inoculation.
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|---|---|---|---|
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Number of PCR-confirmed Influenza Infections
PCR positive Influenza infection
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17 Participants
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—
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—
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Number of PCR-confirmed Influenza Infections
PCR negative Influenza infection
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3 Participants
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—
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—
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SECONDARY outcome
Timeframe: Baseline to day 10Population: All metrics were expressed as z-scores matched for physical activity level. Multivariate process control techniques were used to quantify the change in the multidimensional HRV parameter space relative to baseline and formulated an algorithm for the detection of the illness. 170 total days monitored. Mean parameter values were computed on 24hr increments.
Sensor data read-outs
Outcome measures
| Measure |
Experimental: Influenza A
n=20 Participants
Participants were inoculated with Influenza A/Belgium/4217/2015 at a dose of 5x10\^5 TCID50 in a volume of 0,5mL via intranasal drops. They were then monitored as in-patients for 10 days with daily clinical assessment and blood, respiratory tract sampling, and sensor monitoring. Following discharge, they were followed up for up to 6 months post-inoculation.
Lumee Oxygen Platform: Two sensors were inserted (one in the skin fo the upper arm and one on the side of the chest). A wireless patch reader was placed on top of the skin over the area where the sensor was placed to measure local oxygen content.
|
Group B
Participants were inoculated with Influenza A/Belgium/4217/2015 at a dose of 5x10\^5 TCID50 in a volume of 0,5mL via intranasal drops. They were then monitored as in-patients for 10 days with daily clinical assessment and blood, respiratory tract sampling, and sensor monitoring. Following discharge, they were followed up for up to 6 months post-inoculation.
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Group D
Participants were inoculated with Influenza A/Belgium/4217/2015 at a dose of 5x10\^5 TCID50 in a volume of 0,5mL via intranasal drops. They were then monitored as in-patients for 10 days with daily clinical assessment and blood, respiratory tract sampling, and sensor monitoring. Following discharge, they were followed up for up to 6 months post-inoculation.
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|---|---|---|---|
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Time to Algorithmic Detection of Heart Rate Abnormalities
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52 hours post-inoculation
Standard Deviation 17
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—
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—
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SECONDARY outcome
Timeframe: Baseline to day 10Population: Data collected with the Lumee devices per group (A, B, and D). Lumee devices were not used in Group C. LOI = Lumee Oxygen Index which is a measure proportional to micro-molar concentration of Oxygen in the interstitial fluid. The normal range for LOI is 10-52. A higher LOI corresponds to higher micro-molar concentration of Oxygen in the interstitial fluid.
Sensor data read-outs
Outcome measures
| Measure |
Experimental: Influenza A
n=4 Participants
Participants were inoculated with Influenza A/Belgium/4217/2015 at a dose of 5x10\^5 TCID50 in a volume of 0,5mL via intranasal drops. They were then monitored as in-patients for 10 days with daily clinical assessment and blood, respiratory tract sampling, and sensor monitoring. Following discharge, they were followed up for up to 6 months post-inoculation.
Lumee Oxygen Platform: Two sensors were inserted (one in the skin fo the upper arm and one on the side of the chest). A wireless patch reader was placed on top of the skin over the area where the sensor was placed to measure local oxygen content.
|
Group B
n=6 Participants
Participants were inoculated with Influenza A/Belgium/4217/2015 at a dose of 5x10\^5 TCID50 in a volume of 0,5mL via intranasal drops. They were then monitored as in-patients for 10 days with daily clinical assessment and blood, respiratory tract sampling, and sensor monitoring. Following discharge, they were followed up for up to 6 months post-inoculation.
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Group D
n=4 Participants
Participants were inoculated with Influenza A/Belgium/4217/2015 at a dose of 5x10\^5 TCID50 in a volume of 0,5mL via intranasal drops. They were then monitored as in-patients for 10 days with daily clinical assessment and blood, respiratory tract sampling, and sensor monitoring. Following discharge, they were followed up for up to 6 months post-inoculation.
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|---|---|---|---|
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Tissue Oxygen Levels
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12.6 LOI
Standard Deviation 8.8
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13.7 LOI
Standard Deviation 8.5
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12.5 LOI
Standard Deviation 6.8
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SECONDARY outcome
Timeframe: Day 1, Day 3 and Day 10Population: 13 of 16 PCR positive participants (1 participant was excluded from the analysis due to co-infection with Rhinovirus) developed influenza-like symptom following inoculation. The 3 remaining participants were asymptomatic with modified Jackson's symptom scoring system.
Cumulative daily symptom score derived from self-reported upper and lower respiratory and systemic symptoms by diary card using the modified Jackson's symptom scoring system. Eight symptoms were scored: nasal obstruction, nasal discharge, sore throat, sneezing, cough, malaise, headache, and chills. Each symptom was scored 0-3, where 0=absent, 1=mild, 2=moderate and 3=severe. The maximum daily score is 24 and minimum daily score is 0.
Outcome measures
| Measure |
Experimental: Influenza A
n=19 Participants
Participants were inoculated with Influenza A/Belgium/4217/2015 at a dose of 5x10\^5 TCID50 in a volume of 0,5mL via intranasal drops. They were then monitored as in-patients for 10 days with daily clinical assessment and blood, respiratory tract sampling, and sensor monitoring. Following discharge, they were followed up for up to 6 months post-inoculation.
Lumee Oxygen Platform: Two sensors were inserted (one in the skin fo the upper arm and one on the side of the chest). A wireless patch reader was placed on top of the skin over the area where the sensor was placed to measure local oxygen content.
|
Group B
Participants were inoculated with Influenza A/Belgium/4217/2015 at a dose of 5x10\^5 TCID50 in a volume of 0,5mL via intranasal drops. They were then monitored as in-patients for 10 days with daily clinical assessment and blood, respiratory tract sampling, and sensor monitoring. Following discharge, they were followed up for up to 6 months post-inoculation.
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Group D
Participants were inoculated with Influenza A/Belgium/4217/2015 at a dose of 5x10\^5 TCID50 in a volume of 0,5mL via intranasal drops. They were then monitored as in-patients for 10 days with daily clinical assessment and blood, respiratory tract sampling, and sensor monitoring. Following discharge, they were followed up for up to 6 months post-inoculation.
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Participant-reported Total Symptom Score
Day 1
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2.44 scores on a scale
Standard Deviation 2.76
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—
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—
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Participant-reported Total Symptom Score
Day 3 (peak)
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11.50 scores on a scale
Standard Deviation 13.67
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—
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—
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Participant-reported Total Symptom Score
Day 10
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1.19 scores on a scale
Standard Deviation 2.69
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—
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—
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Adverse Events
Experimental: Influenza A
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Experimental: Influenza A
n=20 participants at risk
Participants were inoculated with Influenza A/Belgium/4217/2015 at a dose of 5x10\^5 TCID50 in a volume of 0,5mL via intranasal drops. They were then monitored as in-patients for 10 days with daily clinical assessment and blood, respiratory tract sampling, and sensor monitoring. Following discharge, they were followed up for up to 6 months post-inoculation.
Lumee Oxygen Platform: Two sensors were inserted (one in the skin of the upper arm and one on the side of the chest). A wireless patch reader was placed on top of the skin over the area where the sensor was placed to measure local oxygen content.
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|---|---|
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Skin and subcutaneous tissue disorders
Erythema
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5.0%
1/20 • Number of events 1 • Adverse event data was collected throughout the study period, until the 6 month follow-up visit.
Adverse event data was collected by observations and reports from study participants.
|
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General disorders
Dental issue
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5.0%
1/20 • Number of events 1 • Adverse event data was collected throughout the study period, until the 6 month follow-up visit.
Adverse event data was collected by observations and reports from study participants.
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Skin and subcutaneous tissue disorders
Foot injury
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5.0%
1/20 • Number of events 1 • Adverse event data was collected throughout the study period, until the 6 month follow-up visit.
Adverse event data was collected by observations and reports from study participants.
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Respiratory, thoracic and mediastinal disorders
COVID symptoms
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5.0%
1/20 • Number of events 1 • Adverse event data was collected throughout the study period, until the 6 month follow-up visit.
Adverse event data was collected by observations and reports from study participants.
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Renal and urinary disorders
Cystoscopy
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5.0%
1/20 • Number of events 1 • Adverse event data was collected throughout the study period, until the 6 month follow-up visit.
Adverse event data was collected by observations and reports from study participants.
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Infections and infestations
Rhinovirus positive
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5.0%
1/20 • Number of events 1 • Adverse event data was collected throughout the study period, until the 6 month follow-up visit.
Adverse event data was collected by observations and reports from study participants.
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Infections and infestations
COVID-19 infection
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10.0%
2/20 • Number of events 2 • Adverse event data was collected throughout the study period, until the 6 month follow-up visit.
Adverse event data was collected by observations and reports from study participants.
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Infections and infestations
Ear infection
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5.0%
1/20 • Number of events 1 • Adverse event data was collected throughout the study period, until the 6 month follow-up visit.
Adverse event data was collected by observations and reports from study participants.
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place