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

• ClinicalTrials.gov Identifier: NCT04418505
• Recruitment Status: Unknown
• First Posted: June 5, 2020
• Last Update Posted: June 14, 2021
• Sponsor: Vielight Inc.
• Information provided by (Responsible Party): Vielight Inc.

Tracking Information

• First Submitted Date: June 3, 2020
• First Posted Date: June 5, 2020
• Last Update Posted Date: June 14, 2021
• Actual Study Start Date: September 2, 2020
• Estimated Primary Completion Date: July 30, 2021 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: June 5, 2020): Time to recovery [ Time Frame: 30 days ]

Original Primary Outcome Measures (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.

Current Secondary Outcome Measures (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 (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: Vielight RX Plus for the Treatment of COVID-19 Respiratory Symptoms
• Official Title: 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: Interventional
• Study Phase: Not Applicable

Study Design

Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

Prospective, randomized trial

Masking: None (Open Label)
Primary Purpose: Treatment

• Condition: COVID-19

Intervention

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

• 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

Recruitment Information

• Recruitment Status: Unknown status
• Actual Enrollment (submitted: June 10, 2021): 295
• Original Estimated Enrollment (submitted: June 3, 2020): 280
• Estimated Study Completion Date: September 30, 2021
• Estimated Primary Completion Date: July 30, 2021 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

• Sexes Eligible for Study: All

• Ages: 18 Years to 65 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Canada, United States

Administrative Information

• NCT Number: NCT04418505
• Other Study ID Numbers: 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

• Plan to Share IPD: No

• Current Responsible Party: Vielight Inc.
• Original Responsible Party: Same as current
• Current Study Sponsor: Vielight Inc.
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Vielight Inc.
• Verification Date: June 2021