LLLT Treatment of Lung Inflammation in COVID-19

Not Applicable

Withdrawn

• Conditions: Covid19
• Interventions: Device: Non-invasive red LLLT treatment to chest of patient.; Device: Sham Device Treatment

• Registration Number: NCT04524715
• Lead Sponsor: Ward Photonics LLC

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.

Study Timeline

• Study First Submitted: 2020-08-19
• Study First Submitted QC: 2020-08-20
• Study First Posted: 2020-08-24
• Study Start: 2021-07-31
• Primary Completion: 2022-03-31
• Study Completion: 2022-03-31
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-13
• Last Update Posted: 2022-07-18

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Active Treatment Group	Non-invasive red LLLT treatment to chest of patient.	LLLT Treatment using an UltraSlim red/IR LED device along with all standard treatment measures for COVID19.
Control Group	Sham Device Treatment	Treatment using a Sham comparator along with all standard treatment measures for COVID19.

Primary Outcome Measures

Name	Time	Method
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
Inflammation of the lungs - O2	10 days	Change in inflammation of the lungs as measured by O2 saturation levels

Trial Locations

Locations (1)

Wellness Junction; 🇺🇸 Millsboro, Delaware, United States