Vielight RX Plus for the Treatment of COVID-19 Respiratory Symptoms (COVIDLight)
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|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
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|Condition or disease||Intervention/treatment||Phase|
|COVID-19||Device: Vielight RX Plus||Not Applicable|
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 (Clinical Trial)|
|Actual Enrollment :||295 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Prospective, randomized trial|
|Masking:||None (Open Label)|
|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|
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.
- Time to recovery [ Time Frame: 30 days ]
- 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 ]
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.
|Ages Eligible for Study:||18 Years to 65 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- Confirmation of COVID-19 infection
- Experiencing moderate to severe respiratory symptoms
- Between 18-65 years of age
- 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)
- Positive for Hepatitis C Virus (HCV), Hepatitis B Virus (HBV) or Human Immunodeficiency Virus
- Inability to electronically complete study questionnaires in English
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
|United States, Florida|
|Progressive Medical Research|
|Port Orange, Florida, United States, 32127|
|Dr. Michael Zahavi|
|Oshawa, Ontario, Canada, L1H1G6|
|Responsible Party:||Vielight Inc.|
|Other Study ID Numbers:||
|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|
|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|
Low level light therapy
Signs and Symptoms, Respiratory
Respiratory Tract Infections
RNA Virus Infections
Respiratory Tract Diseases