Light-based Immunomodulation for Guarding Against Human Respiratory Tract Infections

NCT07610967 | Not Yet Recruiting

• 1 other identifier: MOFMC.2026.0032
• Study Type: interventional
• Target: 130
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

COVID-19 Respiratory Infection; Influenza

Outcome Measures

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

  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 (11)

• duration of symptoms

  upper respiratory infection duration, an average of 2 weeks

• missed days of work

  upper respiratory infection duration, an average of 2 weeks

• outpatient visits

  upper respiratory infection duration, an average of 2 weeks

• emergency department visits

  upper respiratory infection duration, an average of 2 weeks

• hospitalizations

  upper respiratory infection duration, an average of 2 weeks

Study Arms (2)

Group 1: Active RD-X19 every other day for 3 months

EXPERIMENTAL

Device: RD-X19

Group 2: Sham RD-X19 every other day for 3 months

SHAM COMPARATOR

Device: RD-X19 Sham

Interventions

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

Group 1: Active RD-X19 every other day for 3 months

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

Group 2: Sham RD-X19 every other day for 3 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• David Moss: lead

Related Publications (8)

• Stasko N, Arwood L, Jandick N, Spragion D, Roberts RC, Setien M, Henson I, Annas A, Fulcher ML, Brotton M, Kummer L, Szaba F, Reagan M, Lanzer K, Cookenham T, Casey S, Kothapalli N, Hart T, Bradrick SS, Emerson D, Cockrell AS, Randell SH, Kocher JF. The pan-variant potential of light: 425 nm light inactivates SARS-CoV-2 variants of concern and non-cytotoxic doses reduce viral titers in human airway epithelial cells. mSphere. 2025 Jun 25;10(6):e0023025. doi: 10.1128/msphere.00230-25. Epub 2025 May 28.

  PMID: 40434113 BACKGROUND

• Gibson S, Saunders R, Stasko N, Bickerstaff CB, Oakley J, Osterman M, Torres RT, Kish JK, Feinberg BA, Emerson D. Economic and clinical impact of a novel, light-based, at-home antiviral treatment on mild-to-moderate COVID-19. J Med Econ. 2022 Jan-Dec;25(1):503-514. doi: 10.1080/13696998.2022.2055370.

  PMID: 35387539 BACKGROUND

• Stasko N, Cockrell AS, Kocher JF, Henson I, Emerson D, Wang Y, Smith JR, Henderson NH, Wood H, Bradrick SS, Jones T, Santander J, McNeil JG. A randomized, controlled, feasibility study of RD-X19 in subjects with mild-to-moderate COVID-19 in the outpatient setting. Clin Transl Sci. 2022 May;15(5):1291-1303. doi: 10.1111/cts.13249. Epub 2022 Feb 27.

  PMID: 35137532 BACKGROUND

• Zupin L, Gratton R, Fontana F, Clemente L, Pascolo L, Ruscio M, Crovella S. Blue photobiomodulation LED therapy impacts SARS-CoV-2 by limiting its replication in Vero cells. J Biophotonics. 2021 Apr;14(4):e202000496. doi: 10.1002/jbio.202000496. Epub 2021 Mar 1.

  PMID: 33619888 BACKGROUND

• Stasko N, Kocher JF, Annas A, Henson I, Seitz TS, Miller JM, Arwood L, Roberts RC, Womble TM, Keller EG, Emerson S, Bergmann M, Sheesley ANY, Strong RJ, Hurst BL, Emerson D, Tarbet EB, Bradrick SS, Cockrell AS. Visible blue light inhibits infection and replication of SARS-CoV-2 at doses that are well-tolerated by human respiratory tissue. Sci Rep. 2021 Oct 18;11(1):20595. doi: 10.1038/s41598-021-99917-2.

  PMID: 34663881 BACKGROUND

• Stockslager MA, Kocher JF, Arwood L, Stasko N, McDonald RA, Tapsak MA, Emerson D. Efficacy and hazards of 425 nm oral cavity light dosing to inactivate SARS-CoV-2. J Dent. 2022 Aug;123:104203. doi: 10.1016/j.jdent.2022.104203. Epub 2022 Jun 17.

  PMID: 35724941 BACKGROUND

• Kuster SP, Shah PS, Coleman BL, Lam PP, Tong A, Wormsbecker A, McGeer A. Incidence of influenza in healthy adults and healthcare workers: a systematic review and meta-analysis. PLoS One. 2011;6(10):e26239. doi: 10.1371/journal.pone.0026239. Epub 2011 Oct 18.

  PMID: 22028840 BACKGROUND

• Demmler-Harrison GJ. Healthcare-Associated Viral Infections: Considerations for Nosocomial Transmission and Infection Control. Healthcare-Associated Infections in Children. 2018;229-257. Published 2018 Jul 16. doi:10.1007/978-3-319-98122-2_14

  BACKGROUND

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Central Study Contacts

Sandra Huffman

CONTACT

7026533583; Sandra.g.huffman.ctr@health.mil

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: double blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator/ Doctor

Model Details: Group 1: Active RD-X19 every other day for 3 months Group 2: Sham RD-X19 every other day for 3 months

Study Record Dates

• First Submitted: May 14, 2026
• First Posted: May 28, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): June 1, 2028
• Last Updated: May 28, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: All data will be deposited to clinicaltrials following the usual NDA data submission dates.
• Access Criteria: Data will be findable for the research community through the NDA Collection that will be established when this application is funded. For all publications, an NDA study will be created. Each of those studies is assigned a digital object identifier (DOI). This data DOI will be referenced in the publication to allow the research community easy access to the exact data used in the publication. The research community will have access to data when the study ends. As required by NDA, studies will also be created that contain the data used for every publication. Those studies will be shared when the pre-print is available. NDA studies have digital object identifiers (DOI) to aid in findability. We will include that DOI in relevant publications. NDA will make decisions about how long to preserve the data, but that data archive has not deleted any deposited data up to now.