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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental | Experimental | Participants will receive MLS laser treatment along with regular inpatient medical care. |
|
| Control Group | Active Comparator | Participants will receive regular inpatient medical care. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MLS Laser | Device | 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Patient Disposition Post treatment | 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 | 7 days |
| oxygenation | Patients oxygen requirements pulse oximetry will be evaluated for change from pre and post individual treatment as well as end of protocol | Daily for 4 days |
| IL-6 levels | The change in pre treatment levels and 24 hours post final treatment | First four days of trial |
| Chest Xray radiographic results | Pre treatment CXR will be compared to post treatment CXR using the RALE CXR evaluation scale | 7 Days |
| Brescia-COVID Respiratory Severity Scale | The change in pretreatment and post treatment BCRSS will be evaluated | 7 days |
| SMART-COP Score | The change in pretreatment and post treatment scores will be evaluated | 7 days |
| PSI Score | The change in pretreatment and post treatment scores will be evaluated | 7 days |
| CRP levels |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Scott Sigman, MD | Lowell General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lowell General Hospital | Lowell | Massachusetts | 01854 | United States |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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This study will utilize a randomized parallel assignment
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| Regular Inpatient Medical Care | Other | Regular inpatient medical care |
|
The change in pretreatment and post treatment levels will be evaluated The change in pretreatment and post treatment levels will be evalutated
| 7 days |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |