COVID-19COVIDLightNCT04418505
Vielight RX Plus for the Treatment of COVID-19 Respiratory Symptoms
A study testing Vielight RX Plus in people with COVID-19, run by Vielight Inc. at 2 sites in 2 countries.
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). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- COVID-19
- What is being tested?
- Vielight RX Plus
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 295 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 2 Sep 2020to 30 Sep 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Confirmation of COVID-19 infection
- Experiencing moderate to severe respiratory symptoms
- Between 18-65 years of age
Who cannot join
- 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
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
United States1 site
Progressive Medical Research
Port Orange, Florida, 32127
About this study
Official title: A Randomized Study Evaluating the Efficacy of the Vielight RX Plus in the Treatment of COVID-19 Respiratory Symptoms
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.
Read the 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.
- Conditions
- COVID-19
- Being tested
- Vielight RX Plus
- Keywords
- COVID-19, SARS-CoV-2, Photobiomodulation, Low level light therapy, PBM, Red light, Near-infrared light, At-home treatment, Remote
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vielight RX PlusDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care | No intervention | This group will not receive Vielight RX Plus treatment. Instead, they will follow the COVID-19 standard of treatment recommended by Health Canada. |
| Standard of Care + Vielight RX Plus Treatment | Experimental | The is group will receive Vielight RX Plus treatment and follow the COVID-19 standard of treatment recommended by Health Canada. Receives: Device: Vielight RX Plus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to recovery
Measured: 30 days
Secondary outcomes (9)
Time to elimination of COVID-19 related symptoms
Measured: 30 days
Mean number of days with mild COVID-19 related symptoms
Measured: 30 days
Mean number of days with mild overall respiratory symptoms
Measured: 30 days
Time to symptom reduction
Measured: 30 days
Time to elimination of symptoms
Measured: 30 days
Average number of days with mild respiratory symptoms
Measured: 30 days
Oxygen saturation
Measured: 30 days
Hospitalization rate
Measured: 30 days
Mortality
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2020
- Study start2 Sep 2020
- Primary completion30 Jul 2021 (estimated)
- Study completion30 Sep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective, randomized trial
- Masking
- None (open label)
- Enrolment
- 295 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vielight Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04418505
- Sponsor's protocol ID
- VL-2020-02
- Acronym
- COVIDLight
- Status last verified
- Jun 2021
- First submitted
- 3 Jun 2020
- Last updated
- 14 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lim L, Hosseinkhah N, Van Buskirk M, Berk A, Loheswaran G, Abbaspour Z, Karimpoor M, Smith A, Ho KF, Pushparaj A, Zahavi M, White A, Rubine J, Zidel B, Henderson C, Clayton RG, Tingley DR, Miller DJ, Karimpoor M, Hamblin MR. Photobiomodulation Treatment with a Home-Use Device for COVID-19: A Randomized Controlled Trial for Efficacy and Safety. Photobiomodul Photomed Laser Surg. 2024 Jun;42(6):393-403. doi: 10.1089/pho.2023.0179. Epub 2024 Jun 19.
PubMed 38940733
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Study Evaluating the Efficacy of the Vielight RX Plus in the Treatment of COVID-19 Respiratory Symptoms
- ClinicalTrials.gov ID
- NCT04418505
- Acronym / sponsor ID
- COVIDLight / VL-2020-02
- Conditions
- COVID-19
- Keywords
- COVID-19, SARS-CoV-2, Photobiomodulation, Low level light therapy, PBM, Red light, Near-infrared light, At-home treatment
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 295 participants (actual)
- Lead sponsor
- Vielight Inc.Industry (pharma, biotech, devices)
- Study start
- 2 Sep 2020 (actual)
- Primary completion
- 30 Jul 2021 (estimated)
- Study completion
- 30 Sep 2021 (estimated)
- First posted
- 5 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Prospective, randomized trial
| Arm | Type | Receives |
|---|---|---|
| Standard of Care | No intervention | –This group will not receive Vielight RX Plus treatment. Instead, they will follow the COVID-19 standard of treatment recommended by Health Canada. |
| Standard of Care + Vielight RX Plus Treatment | Experimental | Device: Vielight RX PlusThe is group will receive Vielight RX Plus treatment and follow the COVID-19 standard of treatment recommended by Health Canada. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Confirmation of COVID-19 infection
- Experiencing moderate to severe respiratory symptoms
- Between 18-65 years of age
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vielight RX PlusThe 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. | Device | Standard of Care + Vielight RX Plus Treatment |
Primary outcome
Time to recovery
Time frame: 30 days
9 secondary outcomes
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2021.
- Derived from this study: PubMed 38940733Lim L, Hosseinkhah N, Van Buskirk M, Berk A, Loheswaran G, Abbaspour Z, Karimpoor M, Smith A, Ho KF, Pushparaj A, Zahavi M, White A, Rubine J, Zidel B, Henderson C, Clayton RG, Tingley DR, Miller DJ, Karimpoor M, Hamblin MR. Photobiomodulation Treatment with a Home-Use Device for COVID-19: A Randomized Controlled Trial for Efficacy and Safety. Photobiomodul Photomed Laser Surg. 2024 Jun;42(6):393-403. doi: 10.1089/pho.2023.0179. Epub 2024 Jun 19.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vielight RX Plus in people with COVID-19, run by Vielight Inc. at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to recovery (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04418505, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jun 2021.