Low-Level Laser Therapy Treatment of Lung Inflammation in Post-COVID-19 Recovery

An informational evaluation of COVID-19 patients who receive low-level laser therapy in addition to a normal regimen of treatment for symptoms associate with COVID-19. Results are compared to statistical observations published in literature from patients receiving standard care for COVID-19 symptoms without low-level laser therapy.

Study Overview

• Status: Terminated
• Conditions: COVID-19; Acute Respiratory Distress Syndrome
• Intervention / Treatment: Device: LLLT Photobiomodulation

Detailed Description

Since the emergence of COVID-19, the world has become familiar with the symptoms and acute effects of COVID-19 infection including hospitalization and death. However, we now know that COVID-19 can cause persistent ill-health even after patients recover from active infection. Around a quarter of people who have had the virus experience symptoms that continue for at least a month but one in 10 are still unwell after 12 weeks. This has been described by patient groups as "Long COVID," a colloquial term used to describe signs and symptoms that continue or develop after the acute phase of the coronavirus (COVID-19). This encompasses the terms "ongoing symptomatic COVID-19" (4 to 12 weeks after infection) and "post-COVID-19 syndrome" (more than 12 weeks after infection).

Data from recent studies shows that approximately 9-15% of patients who were hospitalized with COVID-19 are readmitted within two months of discharge, and nearly 30% are readmitted within six months of discharge.

This highlights the fact that sequelae after recovery from acute COVID19 may require ongoing treatment to help return patients to their prior quality of life. Reasons for hospital readmission in these post-covid recovery patients range from respiratory distress, sepsis, pneumonia, heart failure, thrombotic episodes, psychiatric illness, and falls, among other causes. Risk factors for readmission have included older age, certain underlying conditions (e.g., chronic obstructive pulmonary disease, hypertension), shorter initial length of stay, and lower rates of in-hospital treatment-dose anticoagulation

The prevalence of long COVID symptoms and accompanying respiratory inflammation are understood through statistical survey of populations. A study conducted by the MICOVID19 (Michigan) initiative in July 2020 documented post-COVID recovery rates of 1,648 patients. The goals of the Michigan registry are to Identify factors associated with critical illness/severe course and outcomes, Identify patient characteristics, care practices, and treatment regimens associated with improved outcomes, and Understand the long-term complications for hospitalized patients including subsequent rates of readmission, mortality, and return-to-normal activities (among other specific state goals).Post-acute COVID-19 is defined as persistent symptoms and/or delayed or long-term complications after having moved through the acute phase of the illness.

The MICOVID19 study will serve as a standard comparison to the results of this study, and will show whether patients treated with LLLT red light using the UltraSlim device have statistically better outcomes than the patients surveyed in the MICOVID19 study.

• Study Type: Observational
• Enrollment (Actual): 5

Contacts and Locations

Study Locations

• United States
  • California
    • Berkeley, California, United States, 94705
      • MD at Bedside
    • Los Angeles, California, United States, 90066
      • Health Atlast
    • Santa Monica, California, United States, 90025
      • Longevity
  • Delaware
    • Millsboro, Delaware, United States, 19966
      • Wellness Junction
  • Hawaii
    • 'Ewa Beach, Hawaii, United States, 96706
      • Diet MD
    • Honolulu, Hawaii, United States, 96817
      • Diet MD
  • New York
    • Brooklyn, New York, United States, 11238
      • Healing Health Services

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Adults who have been infected with COVID-19, but no longer active virus, and who have lingering acute respiratory effects from infection.

Description

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
• Under 18
• Active cancer
• pre-existing pulmonary disease (asthma chronic bronchitis, emphasema
• 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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Decreased inflammation of the lungs	Inflammation of the lungs is decreased more for patients treated with LLLT in addition to the standard treatments for COVID-19 than patients who do not receive LLLT treatments as compared to literature studies available for comparison. The decrease in inflammation is measured by showing statistical improvements in O2 saturation, D-Dimer levels, C-reactive Protein, and IL-6 levels.	3 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Subjective assessment of overall health	A secondary objective of the trial is to determine whether quality of life/well-being is improved for patients suffering from lingering health effects from COVID-19 by using LLLT treatment post-COVID. Patient quality of life is improved as measured through subjective assessment (survey) of wellbeing.	3 weeks

Collaborators and Investigators

• Sponsor: Ward Photonics LLC

Study record dates

Study Major Dates

• Study Start (Actual): February 24, 2022
• Primary Completion (Actual): November 21, 2022
• Study Completion (Actual): November 21, 2022

Study Registration Dates

• First Submitted: February 24, 2022
• First Submitted That Met QC Criteria: February 24, 2022
• First Posted (Actual): February 28, 2022

Study Record Updates

• Last Update Posted (Actual): November 28, 2022
• Last Update Submitted That Met QC Criteria: November 21, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Respiration Disorders; Pneumonia, Viral; Lung Diseases; Infant, Newborn, Diseases; Lung Injury; Infant, Premature, Diseases; COVID-19; Inflammation; Pneumonia; Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Acute Lung Injury
• Other Study ID Numbers: CP21-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No