Clinical trial NCT05258617: Low-Level Laser Therapy Treatment of Lung Inflammation in Post-COVID-19 Recovery
Official title: Low-Level Laser Therapy Treatment of Lung Inflammation in Post-COVID-19 Recovery
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: COVID-19
Acute Respiratory Distress Syndrome
Lead sponsor: Ward Photonics LLC
Sponsor class: INDUSTRY
First posted: 2022-02-28
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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Study population: Adults who have been infected with COVID-19, but no longer active virus, and who have lingering acute respiratory effects from infection.

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Decreased inflammation of the lungs
timeFrame: 3 weeks
Secondary outcomes:
measure: Subjective assessment of overall health
timeFrame: 3 weeks
Other outcomes:
Locations:
city: Berkeley
country: United States
facility: MD at Bedside
state: California
city: Los Angeles
country: United States
facility: Health Atlast
state: California
city: Santa Monica
country: United States
facility: Longevity
state: California
city: Millsboro
country: United States
facility: Wellness Junction
state: Delaware
city: 'Ewa Beach
country: United States
facility: Diet MD
state: Hawaii
city: Honolulu
country: United States
facility: Diet MD
state: Hawaii
city: Brooklyn
country: United States
facility: Healing Health Services
state: New York
Study officials:
References: