COVID-19
Conditions
Keywords
COVID, Laser, Pulmonary
Brief summary
The aim of this study is to evaluate the effectiveness of MLS laser therapy as a treatment for pulmonary complications due to COVID-19 infection.
Detailed description
Participants will be randomized into treatment vs. control group. Both groups will receive regular inpatient medical treatment. Participants in the experimental arm will receive laser treatments once daily for 4 days. Treatments will be delivered to the patients in a prone position using a 10 by 25 cm laser field across each lung with 7j/cm2 at 1500 Hz. Standard nursing protocols would be used to identify participant's pulmonary status throughout treatment.
Interventions
DEVICEMLS Laser
Treatments will be delivered to the participants days 1-4, in a prone position using a 10 by 25 cm laser field across each lung with 7j/cm2 at 1500 Hz.
OTHERRegular Inpatient Medical Care
Regular inpatient medical care
Sponsors
Lowell General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
This study will utilize a randomized parallel assignment
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* COVID-19 positive * Pulmonary compromise requiring oxygen support of approximately 2-6 liters * Able to self prone, or support in self-sitting position
Exclusion criteria
* Ventilator management * Patients with autoimmune disorders or inflammatory conditions not related to COVID-19 * Pregnant women
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient Disposition Post treatment | 7 days | ICU on vent, ICU not requiring ventilation, Discharge to Rehab requiring assistance, Discharge to Home unable to perform ADL's, Discharge to Home able to perform ADL's |
| oxygenation | Daily for 4 days | Patients oxygen requirements pulse oximetry will be evaluated for change from pre and post individual treatment as well as end of protocol |
| IL-6 levels | First four days of trial | The change in pre treatment levels and 24 hours post final treatment |
| Chest Xray radiographic results | 7 Days | Pre treatment CXR will be compared to post treatment CXR using the RALE CXR evaluation scale |
| Brescia-COVID Respiratory Severity Scale | 7 days | The change in pretreatment and post treatment BCRSS will be evaluated |
| SMART-COP Score | 7 days | The change in pretreatment and post treatment scores will be evaluated |
| PSI Score | 7 days | The change in pretreatment and post treatment scores will be evaluated |
| CRP levels | 7 days | The change in pretreatment and post treatment levels will be evaluated The change in pretreatment and post treatment levels will be evalutated |
Countries
United States
Outcome results
None listed