N/A
N=20
Assessment of Wearable Sensors During Experimental Human Influenza Infection (Sigma Plus)
Influenza A H3N2
Bottom Line
View on ClinicalTrials.gov: NCT04204993 ↗Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Aug 2023
Primary outcome: Primary: Number of PCR-confirmed Influenza Infections — 17; 3 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Lumee Oxygen Platform (Device)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Imperial College London
- Primary completion
- Dec 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of PCR-confirmed Influenza Infections |
17; 3 | — |
| SECONDARY Time to Algorithmic Detection of Heart Rate Abnormalities |
52 | — |
| SECONDARY Tissue Oxygen Levels |
12.6; 13.7; 12.5 | — |
| SECONDARY Participant-reported Total Symptom Score |
2.44; 11.50; 1.19 | — |
Summary
The aim of the study is to investigate disease in volunteers deliberately infected with influenza A(H3N2), including biological markers of inflammation and immune response, and changes in physiological parameters including heart rate, respiratory rate, physical activity, oxygen saturation and electrocardiographic data during the onset of influenza infection. Ultimately, this may lead to prediction of symptomatic disease at an earlier stage to allow more effective interventions. The experimental medicine study design will involve human influenza infection challenge, whereby volunteers will be inoculated with influenza virus and monitored in hospital for 10 days as they develop and get better from flu. Continuously-monitoring wearable physiological sensors will be given to the participants 7 days before this and worn continuously until the end of the flu infection.
Eligibility Criteria
Inclusion Criteria
- Healthy persons aged 18 to 55 years, able to give informed consent
Exclusion Criteria
- Chronic respiratory disease (asthma, chronic obstructive pulmonary disease, rhinitis, sinusitis) in adulthood
- Inhaled bronchodilator or steroid use within the last 12 months
- Use of any medication or other product (prescription or over-the-counter) for symptoms of rhinitis or nasal congestion within the last 3 months
- Acute upper respiratory infection (URI or sinusitis) in the past 6 weeks
- Smoking in the past 6 months OR >5 pack-year lifetime history
- Subjects with allergic symptoms present at baseline
- Clinically relevant abnormality on chest X-ray
- Any ECG abnormality deemed clinically significant.
- Those in close domestic contact (i.e. sharing a household with, caring for, or daily face to face contact) with children under 3 years, the elderly (>65 years), immunosuppressed persons, or those with chronic respiratory disease
- Subjects with known or suspected immune deficiency
- Receipt of systemic glucocorticoids (in a dose ≥ 5 mg prednisone daily or equivalent) within one month, or any other cytotoxic or immunosuppressive drug within 6 months prior to challenge
- Known immunoglobulin A deficiency, immotile cilia syndrome, or Kartagener's syndrome
- History of frequent nose bleeds
- Any significant medical condition or prescribed drug deemed by the study doctor to make the participant unsuitable for the study
- Pregnant or breastfeeding women
- Positive urine drug screen
- Detectable baseline antibody titres against influenza challenge strains
- History of hypersensitivity to eggs, egg proteins, gentamicin, gelatin or arginine, or with life-threatening reactions to previous influenza vaccinations.
- Participants may only recruited if they have previously been involved in research if they have completed the earlier study and are beyond the washout period of any administered drugs or period of effect of any intervention that would cause interference for either study.
Data sourced from ClinicalTrials.gov (NCT04204993). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.