PART I: Information Sheet
Responsible Party: Ward Photonics LLC
ClinicalTrials.gov Identifier: NCT05258617
Other Study ID Numbers: CP21-01
Study Description
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
Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
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.
Inclusion Criteria:
1. Participant is diagnosed with COVID-19
2. Study participant is 18 years of age or older
3. Patient exhibiting moderate-to-acute respiratory distress
Exclusion Criteria:
1. Photosensitive condition or medication
2. Active chemotherapy treatment or other cancer treatment
3. Autoimmune Disorder
3. Pregnant, possibly pregnant or planning pregnancy prior to the end of study participation
4. Under 18
5. Active cancer
6. Pre-existing pulmonary disease (asthma chronic bronchitis, emphasema)
7. 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
Outcome Measures
Primary Outcome Measures :
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.
Secondary Outcome Measures :
Subjective assessment of overall health [Time Frame: 3 weeks]
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.
Groups and Cohorts
Intervention Details:
Device: LLLT Photobiomodulation
Treatment with red LED light using UltraSlim device.
Locations:
United States, California
1. MD at Bedside Recruiting
Berkeley, California, United States, 94705
Contact: Annemarie Sheets, MD 510-935-2555 doctor@mdatbedside.com
2. Health Atlast Recruiting
Los Angeles, California, United States, 90066
Contact: Kamau Kokayi, MD 310-966-9194 drkokayi@gmail.com
3. Longevity Recruiting
Santa Monica, California, United States, 90025
Contact: Kamau Kokayi, MD 917-751-6498 drkokayi@gmail.com
United States, Delaware
1. Wellness Junction Recruiting
Millsboro, Delaware, United States, 19966
Contact: Randal Horsley, DC 302-934-7350 DrRLHorsley@gmail.com
Principal Investigator: Randal Horsley, DC
United States, Hawaii
1. Diet MD Recruiting
‘Ewa Beach, Hawaii, United States, 96706
Contact: Bruce Katsura, MD 808-358-1374 bruce@dietmdhawaii.com
Contact: Nam Collins (808) 728-1141
2. Diet MD Recruiting
Honolulu, Hawaii, United States, 96817
Contact: Bruce Katsura, MD 808-551-4348 bruce@dietmdhawaii.com
Contact: Nam Collins (808) 728-1141
United States, New York
1. Healing Health Services Recruiting
Brooklyn, New York, United States, 11238
Contact: Kamau Kokayi, MD 718-622-2042 drkokayi@healinghealthservices.com
Sponsors and Collaborators
Ward Photonics LLC
PART II: Certificate of Consent
I have read the foregoing information, or it has been read to me. I have had the opportunity to ask questions about it and any questions that I have asked have been answered to my satisfaction. I consent voluntarily to participate as a participant in this research.
I have accurately read out the information sheet above, and I understand that the following will be done:
1. My data will be shared with Ward Photonics LLC and its suppliers and partners working on organizing this Clinical Trial.
2. Staff of Ward Photonics LLC and/or its suppliers and partners may contact me to onboard me on to the Clinical Trial.
3. I will have to download a Mobile App.
4. I will be given a medical device to use regularly and the readings from these devices will be captured via the Mobile and shared with Medical staff of Ward Photonics LLC and/or its suppliers and partners.
I confirm that I was given an opportunity to ask questions about the study, and all the questions asked by me have been answered correctly. I confirm that I have not been coerced into giving consent, and the consent has been given freely and voluntarily.