COVID-19NCT05258617
Low-Level Laser Therapy Treatment of Lung Inflammation in Post-COVID-19 Recovery
An observational study of COVID-19 and Acute Respiratory Distress Syndrome, run by Ward Photonics LLC at 7 sites in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19, Acute Respiratory Distress Syndrome
- What is being tested?
- LLLT Photobiomodulation
- Type of treatment
- Medical device
- How many people
- 5 participants
- Where
- 7 sitesUnited States
- Study dates
- 24 Feb 2022to 21 Nov 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults who have been infected with COVID-19, but no longer active virus, and who have lingering acute respiratory effects from infection.
Who may be able to join
- Participant is diagnosed with COVID-19
- Study participant is 18 years of age or older
- Patient exhibiting moderate-to-acute respiratory distress
Who cannot join
- 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
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Diet MD
‘Ewa Beach, Hawaii, 96706
MD at Bedside
Berkeley, California, 94705
Healing Health Services
Brooklyn, New York, 11238
Diet MD
Honolulu, Hawaii, 96817
Health Atlast
Los Angeles, California, 90066
Wellness Junction
Millsboro, Delaware, 19966
Longevity
Santa Monica, California, 90025
About this study
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.
Read the 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.
- Conditions
- COVID-19, Acute Respiratory Distress Syndrome
- Being tested
- LLLT Photobiomodulation
- Medical subject headings
- COVID-19, Respiratory Distress Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LLLT PhotobiomodulationDevice
Treatment with red LED light using UltraSlim device.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 weeks
Secondary outcomes (1)
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.
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2022
- Study start24 Feb 2022
- Primary completion21 Nov 2022
- Study completion21 Nov 2022
Why it stopped: Study was associated with a declining population - COVID 19. Difficulty recruiting participants.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ward Photonics LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05258617
- Sponsor's protocol ID
- CP21-01
- Status last verified
- Feb 2022
- First submitted
- 24 Feb 2022
- Last updated
- 28 Nov 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Low-Level Laser Therapy Treatment of Lung Inflammation in Post-COVID-19 Recovery
- ClinicalTrials.gov ID
- NCT05258617
- Acronym / sponsor ID
- CP21-01
- Conditions
- COVID-19, Acute Respiratory Distress Syndrome
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Study was associated with a declining population - COVID 19. Difficulty recruiting participants.
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Ward Photonics LLCIndustry (pharma, biotech, devices)
- Study start
- 24 Feb 2022 (actual)
- Primary completion
- 21 Nov 2022 (actual)
- Study completion
- 21 Nov 2022 (actual)
- First posted
- 28 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults who have been infected with COVID-19, but no longer active virus, and who have lingering acute respiratory effects from infection.
Key inclusion criteria (3 listed)
- Participant is diagnosed with COVID-19
- Study participant is 18 years of age or older
- Patient exhibiting moderate-to-acute respiratory distress
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LLLT PhotobiomodulationTreatment with red LED light using UltraSlim device. | Device | – |
Primary outcome
Decreased inflammation of the lungs
Time frame: 3 weeks
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.
1 secondary outcome
Subjective assessment of overall health
Time frame: 3 weeks
Results and safety
The study was stopped early (reason given: Study was associated with a declining population - COVID 19. Difficulty recruiting participants.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19 and Acute Respiratory Distress Syndrome, run by Ward Photonics LLC at 7 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 28 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Study was associated with a declining population - COVID 19. Difficulty recruiting participants.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Decreased inflammation of the lungs (time frame: 3 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Nov 2022; AzTrials last refreshed its copy on 7 Nov 2026.