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

COVID-19 Clinical Trial

— COVIDLight  

Official title:

A Randomized Study Evaluating the Efficacy of the Vielight RX Plus in the Treatment of COVID-19 Respiratory Symptoms

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04418505
• Other study ID #: VL-2020-02
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 2, 2020
• Est. completion date: September 30, 2021

Study information

• Verified date: June 2021
• Source: Vielight Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 295
• Est. completion date: September 30, 2021
• Est. primary completion date: July 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• Signs and Symptoms, Respiratory

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.

Locations

Country	Name	City	State
Canada	Dr. Michael Zahavi	Oshawa	Ontario
United States	Progressive Medical Research	Port Orange	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Vielight Inc.

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to recovery		30 days
Secondary	Time to elimination of COVID-19 related symptoms		30 days
Secondary	Mean number of days with mild COVID-19 related symptoms		30 days
Secondary	Mean number of days with mild overall respiratory symptoms		30 days
Secondary	Time to symptom reduction		30 days
Secondary	Time to elimination of symptoms		30 days
Secondary	Average number of days with mild respiratory symptoms		30 days
Secondary	Oxygen saturation		30 days
Secondary	Hospitalization rate		30 days
Secondary	Mortality		30 days

External Links

•   Study website