Covid19
Conditions
Brief summary
To determine if a reduction of pneumonic inflammation occurs after treatment with Low-Level Laser Therapy (LLLT) applying red-light technology in the respiratory system of COVID-19 patients suffering from acute viral pneumonia.
Detailed description
This clinical trial is a blinded before and after comparison of the effect on patients treated with a red-light LLLT therapy for acute lung inflammation as a result of COVID-19 infection. Patients are enrolled to undergo LLLT therapy in addition to all standard ongoing therapies for COVID-19. Outcomes for patients receiving LLLT in addition to their standard care (the treatment group) are compared to the group receiving only standard therapy for COVID-19 (control group). Effects of LLLT treatment are measured immediately following treatment, and outcome measurements are compared to the pre-treatment baseline.
Interventions
DEVICENon-invasive red LLLT treatment to chest of patient.
Expose patient to LLLT light while lying on their back, elevated at an angle of approximately 45 degrees from horizontal. Position light over the patient's chest at a 33-degree bias to their right and left sides for 20 minutes each side respectively.
DEVICESham Device Treatment
Expose patient to sham device while lying on their back, elevated at an angle of approximately 45 degrees from horizontal. Position light over the patient's chest at a 33-degree bias to their right and left sides for 20 minutes each side respectively.
Sponsors
Ward Photonics LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
All participants undergo LLLT treatment; however, the active group receives LED light in the red and IR range while the placebo group is told they are receiving IR light not visible to naked eye. All participants continue receiving standard treatments for COVID19 symptoms.
Intervention model description
Blinded before and after comparison of COVID-19 patients treated with a red-light LLLT therapy in addition to standard treatment measures compared to a control group receiving only standard treatment measures.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Participant is diagnosed with COVID-19. * Study participant is 18 years of age or older. * Patient exhibiting moderate-to-acute respiratory distress.
Exclusion criteria
* Photosensitive condition or medication. * Active chemotherapy treatment or other cancer treatment. * Autoimmune Disorder. * Pregnant, possibly pregnant or planning pregnancy prior to the end of study participation. * Developmental disability or cognitive impairment that, in the opinion of the investigator, would preclude adequate comprehension of the informed consent form and/or ability to record the necessary study measurements.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Inflammation of the lungs - O2 | 10 days | Change in inflammation of the lungs as measured by O2 saturation levels |
| Inflammation of the lungs - CRP | 10 days | Change in inflammation of the lungs as measured by C-Reactive Protein (CRP) Test |
| Inflammation of the lungs - IL6 | 10 days | Change in inflammation of the lungs as measured by IL-6 Levels |
Countries
United States
Outcome results
None listed