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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04418505
Recruitment Status : Not yet recruiting
First Posted : June 5, 2020
Last Update Posted : June 9, 2020
Sponsor:
Information provided by (Responsible Party):
Vielight Inc.

Tracking Information
First Submitted Date  ICMJE June 3, 2020
First Posted Date  ICMJE June 5, 2020
Last Update Posted Date June 9, 2020
Estimated Study Start Date  ICMJE July 1, 2020
Estimated Primary Completion Date January 1, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 5, 2020)
Time to recovery [ Time Frame: 30 days ]
Original Primary Outcome Measures  ICMJE
 (submitted: June 3, 2020)
Time to recovery [ Time Frame: 30 days ]
Time to overall recovery in days as measured by item 1 of the WURSS-44 "How sick do you feel today". Recovery is defined as a rating of 0 (not sick) that is confirmed over 3 consecutive days.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 5, 2020)
  • Time to elimination of COVID-19 related symptoms [ Time Frame: 30 days ]
  • Mean number of days with mild COVID-19 related symptoms [ Time Frame: 30 days ]
  • Mean number of days with mild overall respiratory symptoms [ Time Frame: 30 days ]
  • Time to symptom reduction [ Time Frame: 30 days ]
  • Time to elimination of symptoms [ Time Frame: 30 days ]
  • Average number of days with mild respiratory symptoms [ Time Frame: 30 days ]
  • Oxygen saturation [ Time Frame: 30 days ]
  • Hospitalization rate [ Time Frame: 30 days ]
  • Mortality [ Time Frame: 30 days ]
Original Secondary Outcome Measures  ICMJE
 (submitted: June 3, 2020)
  • Time to elimination of symptoms [ Time Frame: 30 days ]
    Time to elimination of symptoms in days on the following items in the WURSS-44, where elimination of symptoms is defined as a rating of 0 (do not have this symptom or not at all) that is confirmed over 3 consecutive days:
    • Item 2 "Cough"
    • Item 12 "Body aches"
    • Item 18 "Feeling tired"
    • Item 37 "Breathe easily"
    • Item 16 "Feeling feverish"
  • Rating between 0-3 [ Time Frame: 30 days ]
    Mean number of days with a rating of 0, 1, 2 or 3 for the following items:
    • Item 1 "How sick do you feel today"
    • Item 2 "Cough"
    • Item 12 "Body aches"
    • Item 18 "Feeling tired"
    • Item 37 "Breathe easily"
    • Item 16 "Feeling feverish"
  • Total WURSS Score [ Time Frame: 30 days ]
    Mean number of days with mild overall respiratory symptoms as measured by a total WURSS-44 score of <=129
  • Time to symptom reduction [ Time Frame: 30 days ]
    Time to reduction in symptoms in days as measured by item 1 of the WURSS-44 "How sick do you feel today". Reduction in symptoms is defined as a rating of 3 or less that is confirmed over X days.
  • Time to elimination of symptoms [ Time Frame: 30 days ]
    Time to elimination of symptoms in days on the following items in the WURSS-44, where elimination of symptoms is defined as a rating of 0 (do not have this symptom or not at all) that is confirmed over 3 consecutive days:
    • Item 16 "Feeling feverish"
    • Item 37 "Breathe easily"
  • Number of days with mild respiratory symptoms [ Time Frame: 30 days ]
    Average number of days spent with mild respiratory symptoms for the 7 questions relating to respiratory symptoms defined below (WURSS-44 respiratory score < or = 21) in treatment group compared to SOC. WURSS-44 rating on past 24hrs for
    • 'cough',
    • 'coughing stuff up',
    • 'cough interfering with sleep',
    • 'chest congestion',
    • 'chest tightness',
    • 'heaviness in chest'
    • 'breathe easily'
  • Oxygen saturation [ Time Frame: 30 days ]
    Oxygen Saturation by Pulse Oximetry
  • Hospitalization rate [ Time Frame: 30 days ]
    Percentage of subjects reporting 'yes' for each disposition category at day 30: 1) Death; 2) Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4) Hospitalized, requiring supplemental oxygen; 5) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 6) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 7) Not hospitalized, limitation on activities and/or requiring home oxygen; 8) Not hospitalized, no limitations on activities.
  • Mortality [ Time Frame: 30 days ]
    A report of the number of deaths during the study.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Vielight RX Plus for the Treatment of COVID-19 Respiratory Symptoms
Official Title  ICMJE A Randomized Study Evaluating the Efficacy of the Vielight RX Plus in the Treatment of COVID-19 Respiratory Symptoms
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.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Prospective, randomized trial
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE COVID-19
Intervention  ICMJE 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.
Study Arms  ICMJE
  • 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.
    Intervention: Device: Vielight RX Plus
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: June 3, 2020)
280
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 1, 2021
Estimated Primary Completion Date January 1, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Andrea Berk 1-800-517-8010 info@covidlight.ca
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04418505
Other Study ID Numbers  ICMJE VL-2020-02
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Vielight Inc.
Study Sponsor  ICMJE Vielight Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Vielight Inc.
Verification Date May 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP