<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04418505</url>
  </required_header>
  <id_info>
    <org_study_id>VL-2020-02</org_study_id>
    <nct_id>NCT04418505</nct_id>
  </id_info>
  <brief_title>Vielight RX Plus for the Treatment of COVID-19 Respiratory Symptoms</brief_title>
  <acronym>COVIDLight</acronym>
  <official_title>A Randomized Study Evaluating the Efficacy of the Vielight RX Plus in the Treatment of COVID-19 Respiratory Symptoms</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Vielight Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Vielight Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The objective of this study is to obtain data on the efficacy of the Vielight RX Plus in&#xD;
      decreasing time to recovery of symptoms in subjects with COVID-19. The study will be&#xD;
      conducted among COVID-19 positive subjects at home in self-isolation via electronic data&#xD;
      collection (EDC). There will be no physical contact between the subjects and the Qualified&#xD;
      Investigator (QI) or other study staff. This study aims to demonstrate that the Vielight RX&#xD;
      Plus is a useful adjunct to standard of care (SOC). We hypothesize that the Vielight RX Plus&#xD;
      will accelerate recovery and reduce viral infection severity.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study is conducted entirely online. At no point will study staff be in direct contact&#xD;
      with participants. The study will be managed by an independent clinical research organization&#xD;
      (CRO), supporting a Qualified Investigator (QI). Vielight Inc will supply the RX Plus devices&#xD;
      free of charge and will sponsor the study.&#xD;
&#xD;
      Potential participants will be prompted to complete an online screening form if they are&#xD;
      interested in participating. During the screening, the potential participant will be asked to&#xD;
      upload a copy of their positive COVID-19 infection confirmation report and a valid ID. If the&#xD;
      potential subject qualifies for the study, by statisfying all inclusion and exclusion&#xD;
      criteria, the potential participant will then be prompted to complete an electronic informed&#xD;
      consent form (ICF) via the electronic data collection (EDC) platform and will be enrolled&#xD;
      into the study.&#xD;
&#xD;
      This is a 30-day, prospective, randomized study, with no blinding. 280 participants will be&#xD;
      randomized into two groups: Group 1: Standard of Care; Group 2: Standard of Care + Vielight&#xD;
      RX Plus treatment. In Group 2, the Vielight RX Plus will be administered for 20 minutes twice&#xD;
      a day, separated by at least 6 hours for the first 5 days. For the subsequent 25 days,&#xD;
      treatment will be once per day. The Vielight RX Plus will be positioned over the upper most&#xD;
      part of the breastbone to stimulate the thymus gland and within one nostril.&#xD;
&#xD;
      During each of the 30-days, participants will be asked to complete a questionnaire to assess&#xD;
      respiratory symptom severity, and log a daily dairy as well as oxygen saturation level (using&#xD;
      a portable oximeter).&#xD;
&#xD;
      The primary measure is time to overall recovery in days.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">September 2, 2020</start_date>
  <completion_date type="Anticipated">September 30, 2021</completion_date>
  <primary_completion_date type="Anticipated">July 30, 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Prospective, randomized trial</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Time to recovery</measure>
    <time_frame>30 days</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Time to elimination of COVID-19 related symptoms</measure>
    <time_frame>30 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean number of days with mild COVID-19 related symptoms</measure>
    <time_frame>30 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean number of days with mild overall respiratory symptoms</measure>
    <time_frame>30 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to symptom reduction</measure>
    <time_frame>30 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to elimination of symptoms</measure>
    <time_frame>30 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Average number of days with mild respiratory symptoms</measure>
    <time_frame>30 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Oxygen saturation</measure>
    <time_frame>30 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hospitalization rate</measure>
    <time_frame>30 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mortality</measure>
    <time_frame>30 days</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">295</enrollment>
  <condition>COVID-19</condition>
  <arm_group>
    <arm_group_label>Standard of Care</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>This group will not receive Vielight RX Plus treatment. Instead, they will follow the COVID-19 standard of treatment recommended by Health Canada.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard of Care + Vielight RX Plus Treatment</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The is group will receive Vielight RX Plus treatment and follow the COVID-19 standard of treatment recommended by Health Canada.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Vielight RX Plus</intervention_name>
    <description>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.</description>
    <arm_group_label>Standard of Care + Vielight RX Plus Treatment</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Confirmation of COVID-19 infection&#xD;
&#xD;
          -  Experiencing moderate to severe respiratory symptoms&#xD;
&#xD;
          -  Between 18-65 years of age&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Need for hospitalization at the time of diagnosis&#xD;
&#xD;
          -  Current need for supplemental oxygen or positive pressure support and/or has required&#xD;
             supplemental oxygen or positive pressure support for &gt;or= 24 hours&#xD;
&#xD;
          -  &gt;10 days since symptom onset&#xD;
&#xD;
          -  Diagnosis of Chronic Obstructive Pulmonary Disease (COPD)&#xD;
&#xD;
          -  Pregnant&#xD;
&#xD;
          -  Positive for Hepatitis C Virus (HCV), Hepatitis B Virus (HBV) or Human&#xD;
             Immunodeficiency Virus&#xD;
&#xD;
          -  Inability to electronically complete study questionnaires in English&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Progressive Medical Research</name>
      <address>
        <city>Port Orange</city>
        <state>Florida</state>
        <zip>32127</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dr. Michael Zahavi</name>
      <address>
        <city>Oshawa</city>
        <state>Ontario</state>
        <zip>L1H1G6</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2021</verification_date>
  <study_first_submitted>June 3, 2020</study_first_submitted>
  <study_first_submitted_qc>June 3, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 5, 2020</study_first_posted>
  <last_update_submitted>June 10, 2021</last_update_submitted>
  <last_update_submitted_qc>June 10, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">June 14, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>COVID-19</keyword>
  <keyword>SARS-CoV-2</keyword>
  <keyword>Photobiomodulation</keyword>
  <keyword>Low level light therapy</keyword>
  <keyword>PBM</keyword>
  <keyword>Red light</keyword>
  <keyword>Near-infrared light</keyword>
  <keyword>At-home treatment</keyword>
  <keyword>Remote</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>COVID-19</mesh_term>
    <mesh_term>Signs and Symptoms, Respiratory</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04418505
org study id: VL-2020-02
nct id: NCT04418505
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
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.
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.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Prospective, randomized trial
primary purpose: Treatment
masking: None (Open Label)
measure: Time to recovery
time frame: 30 days
measure: Time to elimination of COVID-19 related symptoms
time frame: 30 days
measure: Mean number of days with mild COVID-19 related symptoms
time frame: 30 days
measure: Mean number of days with mild overall respiratory symptoms
time frame: 30 days
measure: Time to symptom reduction
time frame: 30 days
measure: Time to elimination of symptoms
time frame: 30 days
measure: Average number of days with mild respiratory symptoms
time frame: 30 days
measure: Oxygen saturation
time frame: 30 days
measure: Hospitalization rate
time frame: 30 days
measure: Mortality
time frame: 30 days
arm group label: Standard of Care
arm group type: No Intervention
description: This group will not receive Vielight RX Plus treatment. Instead, they will follow the COVID-19 standard of treatment recommended by Health Canada.
arm group label: Standard of Care + Vielight RX Plus Treatment
arm group type: Experimental
description: The is group will receive Vielight RX Plus treatment and follow the COVID-19 standard of treatment recommended by Health Canada.
intervention type: Device
intervention name: Vielight RX Plus
description: 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.
arm group label: Standard of Care + Vielight RX Plus Treatment
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
facility: 
facility: 
country: Canada
country: United States
responsible party type: Sponsor
mesh term: COVID-19
mesh term: Signs and Symptoms, Respiratory
sharing ipd: No