Clinical trial NCT04418505: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: COVID-19
Keywords: COVID-19
SARS-CoV-2
Photobiomodulation
Low level light therapy
PBM
Red light
Near-infrared light
At-home treatment
Remote
Lead sponsor: Vielight Inc.
Sponsor class: INDUSTRY
First posted: 2020-06-05
Enrollment: 295
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective, randomized trial
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Time to recovery
timeFrame: 30 days
Secondary outcomes:
measure: Time to elimination of COVID-19 related symptoms
timeFrame: 30 days
measure: Mean number of days with mild COVID-19 related symptoms
timeFrame: 30 days
measure: Mean number of days with mild overall respiratory symptoms
timeFrame: 30 days
measure: Time to symptom reduction
timeFrame: 30 days
measure: Time to elimination of symptoms
timeFrame: 30 days
measure: Average number of days with mild respiratory symptoms
timeFrame: 30 days
measure: Oxygen saturation
timeFrame: 30 days
measure: Hospitalization rate
timeFrame: 30 days
measure: Mortality
timeFrame: 30 days
Other outcomes:
Locations:
city: Port Orange
country: United States
facility: Progressive Medical Research
state: Florida
city: Oshawa
country: Canada
facility: Dr. Michael Zahavi
state: Ontario
Study officials:
References: