Assessment of Wearable Sensors During Experimental Human Influenza Infection (Sigma Plus)

NCT04204993 | Completed Results DMC FDA Device

• 1 other identifier: 19HH5451
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Influenza A H3N2

Keywords

Influenza A H3N2

Outcome Measures

Primary Outcomes (1)

• Number of PCR-confirmed Influenza Infections

  Nasal wash viral load by quantitative polymerase chain reaction (qPCR)

  Baseline to day 28

Secondary Outcomes (3)

• Time to Algorithmic Detection of Heart Rate Abnormalities

  Baseline to day 10

• Tissue Oxygen Levels

  Baseline to day 10

• Participant-reported Total Symptom Score

  Day 1, Day 3 and Day 10

Study Arms (1)

Experimental: Influenza A

EXPERIMENTAL

Participants will be inoculated with Influenza A/Belgium/4217/2015 at a dose of 5x105 TCID50 in a volume of 0,5mL via intranasal drops or spray. They will then be monitored as in-patients for 10 days with daily clinical assessment and blood, respiratory tract sampling, and sensor monitoring. Following discharge, they will be followed up for up to 6 months post-inoculation.

Device: Lumee Oxygen Platform

Interventions

Lumee Oxygen Platform DEVICE

Two sensors will be inserted (one in the skin fo the upper arm and one on the side of the chest). A wireless patch reader is placed on top of the skin over the area where the sensor has been placed to measure local oxygen content.

Experimental: Influenza A

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy persons aged 18 to 55 years, able to give informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Imperial College London: lead
• Duke University: collaborator
• RTI International: collaborator
• Defense Advanced Research Projects Agency: collaborator

Study Sites (1)

Imperial Clinical Research Facility, Imperial College London

London, W2 1PG, United Kingdom

Location

Limitations and Caveats

Lumee oxygen devices failed to charge on the charging stations provided. Advice and support were given by the engineering team but unable to resolve. No Lumee devices were used for participants SPFC011-SPFC016. The devices were shipped to manufacturer for further troubleshooting and investigation. The batteries were repaired, and the devices were returned to ICL for the remaining participants.

Results Point of Contact

• Title: Professor Chris Chiu
• Organization: Imperial College London

c.chiu@imperial.ac.uk

+44 (0)20 8383 2301

Study Officials

• Christopher Chiu

  Imperial College London

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Biological: Influenza A/Belgium/4217/2015 at a dose of 5x105 TCID50 in a volume of 0.5 milliliters via intranasal drops

Study Record Dates

• First Submitted: November 12, 2019
• First Posted: December 19, 2019
• Study Start: February 11, 2020
• Primary Completion: December 31, 2020
• Study Completion: May 17, 2021
• Last Updated: August 21, 2023
• Results First Posted: August 21, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Access Criteria: According to study protocol

Locations

GB (1)