NCT04418505

Brief Summary

The objective of this study is to obtain data on the efficacy of the Vielight RX Plus in decreasing time to recovery of symptoms in subjects with COVID-19. The study will be conducted among COVID-19 positive subjects at home in self-isolation via electronic data collection (EDC). There will be no physical contact between the subjects and the Qualified Investigator (QI) or other study staff. This study aims to demonstrate that the Vielight RX Plus is a useful adjunct to standard of care (SOC). We hypothesize that the Vielight RX Plus will accelerate recovery and reduce viral infection severity.

Trial Health

47
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
295

participants targeted

Target at P50-P75 for not_applicable covid19

Timeline
Completed

Started Sep 2020

Typical duration for not_applicable covid19

Geographic Reach
2 countries

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 3, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 5, 2020

Completed
3 months until next milestone

Study Start

First participant enrolled

September 2, 2020

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2021

Completed
Last Updated

June 14, 2021

Status Verified

June 1, 2021

Enrollment Period

11 months

First QC Date

June 3, 2020

Last Update Submit

June 10, 2021

Conditions

COVID-19

Keywords

COVID-19SARS-CoV-2PhotobiomodulationLow level light therapyPBMRed lightNear-infrared lightAt-home treatmentRemote

Outcome Measures

Primary Outcomes (1)

  • Time to recovery

    30 days

Secondary Outcomes (9)

  • Time to elimination of COVID-19 related symptoms

    30 days

  • Mean number of days with mild COVID-19 related symptoms

    30 days

  • Mean number of days with mild overall respiratory symptoms

    30 days

  • Time to symptom reduction

    30 days

  • Time to elimination of symptoms

    30 days

  • +4 more secondary outcomes

Study Arms (2)

Standard of Care

NO INTERVENTION

This group will not receive Vielight RX Plus treatment. Instead, they will follow the COVID-19 standard of treatment recommended by Health Canada.

Standard of Care + Vielight RX Plus Treatment

EXPERIMENTAL

The is group will receive Vielight RX Plus treatment and follow the COVID-19 standard of treatment recommended by Health Canada.

Device: Vielight RX Plus

Interventions

Vielight RX PlusDEVICE

The Vielight RX Plus is designed to deliver near-infrared light and red light via LEDs placed directly on the manubrium of the sternum (which covers the thymus gland) and inside one nostril, respectively.

Standard of Care + Vielight RX Plus Treatment

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Confirmation of COVID-19 infection
  • Experiencing moderate to severe respiratory symptoms
  • Between 18-65 years of age

You may not qualify if:

  • Need for hospitalization at the time of diagnosis
  • Current need for supplemental oxygen or positive pressure support and/or has required supplemental oxygen or positive pressure support for \>or= 24 hours
  • \>10 days since symptom onset
  • Diagnosis of Chronic Obstructive Pulmonary Disease (COPD)
  • Pregnant
  • Positive for Hepatitis C Virus (HCV), Hepatitis B Virus (HBV) or Human Immunodeficiency Virus
  • Inability to electronically complete study questionnaires in English

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Progressive Medical Research

Port Orange, Florida, 32127, United States

Location

Dr. Michael Zahavi

Oshawa, Ontario, L1H1G6, Canada

Location

Related Publications (1)

  • Lim L, Hosseinkhah N, Van Buskirk M, Berk A, Loheswaran G, Abbaspour Z, Karimpoor M, Smith A, Ho KF, Pushparaj A, Zahavi M, White A, Rubine J, Zidel B, Henderson C, Clayton RG, Tingley DR, Miller DJ, Karimpoor M, Hamblin MR. Photobiomodulation Treatment with a Home-Use Device for COVID-19: A Randomized Controlled Trial for Efficacy and Safety. Photobiomodul Photomed Laser Surg. 2024 Jun;42(6):393-403. doi: 10.1089/pho.2023.0179. Epub 2024 Jun 19.

    PMID: 38940733DERIVED

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Prospective, randomized trial
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 3, 2020

First Posted

June 5, 2020

Study Start

September 2, 2020

Primary Completion

July 30, 2021

Study Completion

September 30, 2021

Last Updated

June 14, 2021

Record last verified: 2021-06

Data Sharing

IPD Sharing
Will not share

Locations

US(1)CA(1)