Health TrialsbyHealthPanel

Light-based Immunomodulation for Guarding Against Human Respiratory Tract Infections

ConditionsCOVID-19 Respiratory InfectionInfluenza
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorDavid Moss

About this trial

The purpose of trial is to determine if daily usage of a photobiomodulation device will decrease the incidence of upper respiratory tract infections (URI) due to COVID, influenza or other viruses.The RD-X10 device is handheld, can be self-administered, and has been shown to be safe in invivo studies.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Active Duty and DoD Beneficiaries (i.e. former military, spouse, dependent child) aged 18 years and older who work in the Mike O'Callaghan Military Medical Center at Nellis Air Force Base.

Disqualifiers

Unable to comfortably insert RD-X19 into the mouth and keep in place for 5 minutes

Plans for head, neck or mouth surgery during the study period

Plans for major dental procedures (ie implants, wisdom teeth extraction etc) during the study

Trial design

Design model

Parallel

Treatments tested in this trial

  • RD-X19

    Device

    * Subject will be given the RD-X19 device and shown how to use the device * Subjects will be instructed to use the device for 5 minutes every other day * Subject will be given "Instructions for Treatment" handout

  • RD-X19 Sham

    Device

    * Subject will be given the sham RD-X19 device and shown how to use the device * Subjects will be instructed to use the sham device for 5 minutes every other day * Subject will be given "Instructions for Treatment" handout

Treatment groups

130 Participants
are divided into 2 treatment groups
Group A: Group 1: Active RD-X19 every other day for 3 monthsExperimental treatment 1 intervention
Group B: Group 2: Sham RD-X19 every other day for 3 monthsSham comparator 1 intervention

Trial outcomes

Primary outcomes

1

difference in PCR confirmed URI (any virus)

difference in PCR confirmed URI (any virus) between active and sham groups between treatment period

Time frame
visit 2 (week 2), visit 3 (week 4), visit 4 (week 6), visit 5 (week 8), visit 6 (week 10), visit 7 (week 12)

Secondary outcomes

1

duration of symptoms

Any subjects with confirmed or unconfirmed PCR URI will be contacted daily until symptoms subside to assess duration of symptoms (days)

Time frame
upper respiratory infection duration, an average of 2 weeks
2

missed days of work

Any subjects with confirmed or unconfirmed PCR URI will be contacted daily until symptoms subside to assess missed days of work

Time frame
upper respiratory infection duration, an average of 2 weeks
3

outpatient visits

Any subjects with confirmed or unconfirmed PCR URI will be contacted daily until symptoms subside to assess number of outpatient visits

Time frame
upper respiratory infection duration, an average of 2 weeks
4

emergency department visits

Any subjects with confirmed or unconfirmed PCR URI will be contacted daily until symptoms subside to assess number of emergency department visits

Time frame
upper respiratory infection duration, an average of 2 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

David Moss

Lead sponsor

Mike O'Callaghan Military Hospital

Sponsor institution

Source ClinicalTrials.gov
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