Vielight RX Plus for the Treatment of COVID-19 Respiratory Symptoms (COVIDLight)

A Randomized Study Evaluating the Efficacy of the Vielight RX Plus in the Treatment of COVID-19 Respiratory Symptoms

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.

Study Overview

• Status: Active, not recruiting
• Conditions: COVID-19
• Intervention / Treatment: Device: Vielight RX Plus

Detailed Description

This study is conducted entirely online. At no point will study staff be in direct contact with participants. The study will be managed by an independent clinical research organization (CRO), supporting a Qualified Investigator (QI). Vielight Inc will supply the RX Plus devices free of charge and will sponsor the study.

Potential participants will be prompted to complete an online screening form if they are interested in participating. During the screening, the potential participant will be asked to upload a copy of their positive COVID-19 infection confirmation report and a valid ID. If the potential subject qualifies for the study, by statisfying all inclusion and exclusion criteria, the potential participant will then be prompted to complete an electronic informed consent form (ICF) via the electronic data collection (EDC) platform and will be enrolled into the study.

This is a 30-day, prospective, randomized study, with no blinding. 280 participants will be randomized into two groups: Group 1: Standard of Care; Group 2: Standard of Care + Vielight RX Plus treatment. In Group 2, the Vielight RX Plus will be administered for 20 minutes twice a day, separated by at least 6 hours for the first 5 days. For the subsequent 25 days, treatment will be once per day. The Vielight RX Plus will be positioned over the upper most part of the breastbone to stimulate the thymus gland and within one nostril.

During each of the 30-days, participants will be asked to complete a questionnaire to assess respiratory symptom severity, and log a daily dairy as well as oxygen saturation level (using a portable oximeter).

The primary measure is time to overall recovery in days.

• Study Type: Interventional
• Enrollment (Actual): 295
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Oshawa, Ontario, Canada, L1H1G6
      • Dr. Michael Zahavi
• United States
  • Florida
    • Port Orange, Florida, United States, 32127
      • Progressive Medical Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Standard of Care; This group will not receive Vielight RX Plus treatment. Instead, they will follow the COVID-19 standard of treatment recommended by Health Canada.
Experimental: Standard of Care + Vielight RX Plus Treatment; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Time to recovery	30 days

Secondary Outcome Measures

Outcome Measure	Time Frame
Mortality	30 days
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
Average number of days with mild respiratory symptoms	30 days
Oxygen saturation	30 days
Hospitalization rate	30 days

Collaborators and Investigators

• Sponsor: Vielight Inc.

Study record dates

Study Major Dates

• Study Start (Actual): September 2, 2020
• Primary Completion (Anticipated): July 30, 2021
• Study Completion (Anticipated): September 30, 2021

Study Registration Dates

• First Submitted: June 3, 2020
• First Submitted That Met QC Criteria: June 3, 2020
• First Posted (Actual): June 5, 2020

Study Record Updates

• Last Update Posted (Actual): June 14, 2021
• Last Update Submitted That Met QC Criteria: June 10, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Keywords: SARS-CoV-2; COVID-19; Photobiomodulation; Low level light therapy; Near-infrared light; Red light; PBM; At-home treatment; Remote
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19; Signs and Symptoms, Respiratory
• Other Study ID Numbers: VL-2020-02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No