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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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04418505
Recruitment Status : Unknown
Verified June 2021 by Vielight Inc..
Recruitment status was:  Active, not recruiting
First Posted : June 5, 2020
Last Update Posted : June 14, 2021
Sponsor:
Information provided by (Responsible Party):
Vielight Inc.

Study Description
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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.

Condition or disease Intervention/treatment Phase
COVID-19 Device: Vielight RX Plus Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 295 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Prospective, randomized trial
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Study Evaluating the Efficacy of the Vielight RX Plus in the Treatment of COVID-19 Respiratory Symptoms
Actual Study Start Date : September 2, 2020
Estimated Primary Completion Date : July 30, 2021
Estimated Study Completion Date : September 30, 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. Time to recovery [ Time Frame: 30 days ]

Secondary Outcome Measures :
  1. Time to elimination of COVID-19 related symptoms [ Time Frame: 30 days ]
  2. Mean number of days with mild COVID-19 related symptoms [ Time Frame: 30 days ]
  3. Mean number of days with mild overall respiratory symptoms [ Time Frame: 30 days ]
  4. Time to symptom reduction [ Time Frame: 30 days ]
  5. Time to elimination of symptoms [ Time Frame: 30 days ]
  6. Average number of days with mild respiratory symptoms [ Time Frame: 30 days ]
  7. Oxygen saturation [ Time Frame: 30 days ]
  8. Hospitalization rate [ Time Frame: 30 days ]
  9. Mortality [ Time Frame: 30 days ]

Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04418505


Locations
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United States, Florida
Progressive Medical Research
Port Orange, Florida, United States, 32127
Canada, Ontario
Dr. Michael Zahavi
Oshawa, Ontario, Canada, L1H1G6
Sponsors and Collaborators
Vielight Inc.
More Information
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Responsible Party: Vielight Inc.
ClinicalTrials.gov Identifier: NCT04418505    
Other Study ID Numbers: VL-2020-02
First Posted: June 5, 2020    Key Record Dates
Last Update Posted: June 14, 2021
Last Verified: June 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Vielight Inc.:
COVID-19
SARS-CoV-2
Photobiomodulation
Low level light therapy
PBM
 Red light
Near-infrared light
At-home treatment
Remote
Additional relevant MeSH terms:
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COVID-19
Signs and Symptoms, Respiratory
Pneumonia, Viral
Pneumonia
Respiratory Tract Infections
Infections
Virus Diseases
 Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases