Clinical Trial Details
— Status: Terminated
Administrative data
| NCT number |
NCT05258617 |
| Other study ID # |
CP21-01 |
| Secondary ID |
|
| Status |
Terminated |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
February 24, 2022 |
| Est. completion date |
November 21, 2022 |
Study information
| Verified date |
February 2022 |
| Source |
Ward Photonics LLC |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial 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.
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.
